MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068505000

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Abdominal Pain (1685); Abscess (1690); Fatigue (1849); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Chills (2191); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Depression (2361); Numbness (2415); Obstruction/Occlusion (2422); Prolapse (2475); Cognitive Changes (2551); Hematuria (2558); Weight Changes (2607); Dysuria (2684); Constipation (3274); Movement Disorder (4412); Paresthesia (4421); Urethral Stenosis/Stricture (4501); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Muscle Hypotonia (4531); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/29/2010

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an obtryx halo single system was implanted during a procedure performed on (b)(6) 2010.As reported by the patient's attorney, the patient has experienced an unspecified injury.

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2010, as no event date was reported.Initial reporter name and address: this event was reported by the patient's legal representative.The implant surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to november 29, 2010, as no event date was reported.Block e1: this event was reported by the patient's legal representative.(b)(6).Block h6: patient codes e2330, e1002, e0123, e0126, e1310, e1906, e0402, e2326, e1309, e2328, e172001 and e1307, capture the reportable events of pain (severe lower extremity pain, back pain, pelvic and perineal pain, pain in left shoulder, bladder pain, pelvic pain, incisional pain, joint pain), abdominal pain, nerve damage (pudendal and obturator neuralgia, pain radiating down both of her legs), neuropathy (neuropathic pain), urinary tract infection, infection (worsening pyelonephritis), allergic reaction (multiple drug allergies), inflammation (mild chronic inflammation, chronic cystitis), urinary retention (incomplete emptying of bladder), obstruction (bladder outlet obstruction), abscess and urethral stenosis/stricture (strictures from prior radiation), respectively.Impact codes f1905, f1202, f2303 and f23, capture the reportable events of device revision or replacement (transvaginal mesh excision), disability (permanently disabled), medication required (self-start antibiotic therapy, antibiotic management, topical estrogen replacement, cranberry supplementation) and unexpected medical intervention (pain control), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an obtryx halo single system was implanted during a cystocele repair, major urethral transobturator sling and cystoscopy procedure performed on (b)(6) 2010, for the treatment of urethral hypermobility, stress urinary incontinence, and cystocele.The patient had a history of advanced colorectal cancer, had two pelvic and abdominal surgeries after chemotherapy and radiation, and had developed stress urinary incontinence in recent years.She was originally seen in the early stages of incontinence over the last few years.She was originally seen in the early part of 2010 with the recommendations for urodynamics and to consider vaginal surgery for her incontinence.She finally followed up in early november, wishing to pursue her surgery now that she has been in a state of remission for her colorectal malignancy.Urodynamics were performed, demonstrating stress urinary incontinence with a low valsalva leak point pressure, and her physical exam confirmed the presence of hypermobility and a central cystocele.There was some descent of her uterus, but not enough to call it a uterine prolapse.Moreover, the options for the patient were reviewed by the physician, which included observation, kegel exercises, collagen injection, and a sling procedure with cystocele repair.The physician explained to the patient that he would keep her procedure very basic and not pursue anything with extensive surgical intervention due to her previous pelvic radiation, chemotherapy, and previous abdominal pelvic surgery.The physician recommended a simple cystocele repair and the insertion of a mid-urethral sling either by a pubovaginal approach or a transobturator approach.The physician explained the side effects of doing this surgery, such as infection, bleeding, erosion, retention, pain, and failure to resolve her incontinence.The physician also told the patient that he would make his decision on the type of sling once he performed the operation and looked inside of her bladder.In the past, her bladder was consistent with radiation changes.He also gave the patient the option of a second opinion as well.After reviewing and hearing the physician's recommendation, the patient wishes to pursue the surgery on (b)(6) 2010.On (b)(6), 2017, the patient was presented to the emergency department (ed) from uro-gyn for admission for iv antibiotics due to worsening pyelonephritis after receiving a cystoscopy.The patient was admitted with urinary tract infection (uti), voiding difficulties, and multiple drug allergies.She began experiencing recurrent utis earlier this year.She had a proteus uti earlier this year and had an escherichia coli uti in (b)(6).Because of her repeated utis, she was referred to a physician form urogynecology where she underwent cystoscopy last week.Thereafter, she had ongoing dysuria and a reaction to ciprofloxacin with severe lower extremity pain which she described as ripping in her muscles in her lower legs.The patient was in for antibiotic management and pain control.She has some ongoing mild suprapubic discomfort, but dysuria has resolved and there was no incontinence.Moreover, she had urethral sling procedure about 5 years ago.She stated that her sling may be a little bit overcorrected, and she typically had a residual of approximately 40cc.The patient had an element of bladder outlet obstruction which could lead to residuals though her reported residuals was only 40cc which was acceptable.If she did have an element of bladder outlet obstruction from an overcorrected urethra from a prior sling procedure, she may have high pressure voiding which could place her at risk for repeated utis.This could be evaluated with multichannel urodynamics.Furthermore, the patient is on prophylactic therapy for utis which included cranberry supplementation and estrogen replacement.She should be considered for self-start antibiotic therapy typically consisting of one pill twice daily for 3 days as soon as patient begins experiencing symptoms but due to her multiple drug allergies, her best drug of choice in this instance would be nitrofurantoin.She did have underlying dyspareunia since the surgery and there was no known history of a urethral diverticulum.Additionally, the patient felt improved, no fevers or chills, continues to have dysuria, and left calf pain resolved.The patient was also checked for generalized abdominal pain related to pyelonephritis and abscess status post procedure cystoscopy.On (b)(6), 2017, the patient returned to the company office of her husband for follow-up of urinary tract infection (uti) and dysuria.She was discharged on macrobid which she completed last friday.She continues to have symptoms of burning, lower abdominal pain and low back pain.She stated that she had not felt right since the cystoscopic examination performed by a physician.She underwent multichannel urodynamics.There was no evidence of bladder outlet obstruction.Pressure flow nomogram was consistent with absence of the obstruction.She had high flow low pressure voiding.All her urinary symptoms, lower back pain and lower abdominal pain have resolved.At the present time, she is asymptomatic.After her urodynamics, she was recommended to try estring but she developed significant reaction and she subsequently discontinued the medication with resolution of her symptoms.During assessment, the patient did not have any voiding difficulties.It took about 6 weeks for her to recover from her cystoscopy which raised the question as to whether she had an allergic reaction of some type to the prep solution or the cystoscopic sterilization process that was performed at her uro-gynecologist's office.She does not have evidence of bladder outlet obstruction from her prior sling procedure.Discussion was held as to how to manage her repeated utis.Reportedly, she remained on theragran hp, and discussed with her physician other estrogen replacements including estrace or oral tablets.In addition, they also discussed self-start therapy with antibiotics such as nitrofurantoin.She also indicated that she developed some type of facial skin reaction after being on a suppressive antibiotic which she does not recall the name.Moreover, the physician advised the patient not to be given with any additional antibiotic until they know what medication that was.She has a multitude of drug allergies making antibiotic options for treatment difficult.On (b)(6), 2020, the patient with a past medical history of stage 4 colon cancer with hemicolectomy and colostomy bag as well as hypothyroidism who presented to ed with a month history of pelvic pain with radiation to lower back constantly for a week.Also, she presented with abdominal pain and dyspareunia.She stated that she has history of bladder prolapse in 2010 where she had mesh sling placed and was evaluated by her urologist a week ago who noted that the patient had prolapse at that time and was advised to have a follow-up with a specialist.Furthermore, the patient's appointment was not until next week but due to continued pain, she came to ed for evaluation.It was also noted that the patient had occasional nausea and left shoulder pain, that was not worse with movement.The patient had taken ibuprofen.On (b)(6), 2020, the patient presented with symptoms of pudendal neuralgia following history of colon cancer/treatment, bladder suspension and frequent falls.She had high tone pelvic floor musculature r>l and reported significant pain with sitting.She will benefit from physical therapy to reduce pain symptoms and educate patient in self-care management.The patient arrived and stated that she started to have pain this winter in her vulva, lower abdomen and lower back.Her symptoms were reported as pins and needles/ burnings/coldness.She stated that she felt like there was a ball in her vagina and had been diagnosed with slight uterine prolapse.Her chief complaint was pain with sitting and had inability to have penetrative intercourse with her husband.She was then referred to physical therapy.Previously, the patient was not working due to being permanently disabled.She stopped working and was not able to walk 10 years ago.She was unable to walk currently and has boot on right foot secondary to possible metatarsal fracture.Her physical therapy (pt) evaluation revealed abnormal muscle tone, decreased strength, pain, decreased flexibility, impaired sensation resulting in self-care, home management, community/leisure limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab, patient goals and maximize prior level of function (plof) of chosen activities of daily living (adl).On (b)(6), 2020, the patient was admitted to emergency department (ed) for evaluation of urinary urgency, frequency, dysuria and hematuria since friday.The patient was seen on friday for evaluation of ongoing lower abdominal pain that the patient suspected may be due to implanted mesh used for repair of prolapse.The patient has had prior outpatient imaging.The patient had a straight catheterization, which she stated was traumatic and painful due to known strictures from prior radiation.The patient noted that she was especially susceptible to uti, after instrumentation and has had many previously.Additionally, she had episode of gross hematuria last night with continued urethral discomfort.On (b)(6), 2020, she had returned to physical therapy with pelvic pain.She felt her pain was associated to her cystocele repair with mesh insertion 10 years ago.She had a follow-up with a physician, had bladder installations and injections into pfm of trameel.She stated nothing was working and she continued to have pain constantly in low back, across lower abdomen and numbness in perineum.The patient reported that her interstitial cystitis was treated, and she felt that it was not the issue.She was then referred to pt.On (b)(6) 2020, the patient had a telehealth visit regarding pelvic pain and possible pudendal and obturator neuralgia.The patient has a history of colon cancer status post low anterior resection in 2008.The patient had a recurrence and underwent a left hemicolectomy with proctectomy and total mesenteric excision in 2009.The patient also had an obtryx tvt-o sling placed in 2010 for relatively mild stress urinary incontinence.The patient did well for several years.The patient was very active with exercise, including biking.She noted the onset of symptoms approximately 5 years ago, but over the last year the patient has noted increasing pain complaints.She notes pain radiating down both of her legs.She also notes a foreign object sensation in the vagina that feels like a billiard ball.She has pain with adduction of her legs.She had burning pain where her rectum was.Her pain was increased with sitting.She did have some symptoms going back 5 years, but much worse since (b)(6) of this year.She can no longer have sex due to pain.She notes bladder pain with urinary urgency.She also has slow voiding with mixed incontinence.Moreover, potential diagnoses were reviewed such as obturator neuralgia and pudendal neuralgia.The mesh itself can also be a pain trigger, especially for vaginal and bladder pain.She was also at increased risk for a pudendal nerve problem given that she has had a proctectomy.On (b)(6) 2021, she was for in-person consultation after a phone consult in december.The patient had a complicated surgical history including left hemicolectomy with proctectomy and permanent colostomy.The patient also had a mid-urethral trans obturator sling placed in 2010.Patient initially did relatively well but over the last 1-2 years was noted with progressive pain which is now quite distressing.The patient's pain complaints were consistent with both obturator and pudendal neuralgia.On (b)(6), 2021, the patient underwent transvaginal mesh excision with cystocele repair and bilateral groin exploration for the treatment of her bladder pain, pelvic pain, postoperative obturator neuralgia, and pudendal neuralgia.The patient noted that she was doing well having bowel movements and tolerating p.O.Until 2 nights ago feeling sort chills and weakness.She noted today at 1pm that she had increased abdominal pain, and positive distention.The patient also noted that her stool is like hard balls since yesterday, which was not like her usual formed stool.Patient denied dysuria, fevers, and shortness of breath or chest pain.The patient developed a spinal headache from the spinal anesthesia administered to augment her postoperative pain control.She underwent a blood patch on postoperative day 1.On postoperative day 2, the patient voided with a low postvoid residual.Pain control was adequate with oral oxycodone.She was considered stable for discharge.She was discharged to stay in a local hotel for follow-up with her physician next week.She was given routine instructions.It was found that there was a large amount of mesh excised from the vagina all the way up under the pubic bone to the level of the obturator membrane, cystocele repaired, no mesh could be obtained from either groin exploration.On (b)(6), 2021, according to the pathology report, the vaginal mesh excision consisted with fibrous and skeletal muscle tissue with mild chronic inflammation, rare multinucleated giant cells, and foreign body consistent with mesh.On (b)(6), 2021, the patient was in for her routine post operation check-up.She was doing relatively well.Her vaginal pain was minimal and her incisional pain from groin exploration was also tolerable.She continued to have obturator nerve pain which was more difficult for her.Furthermore, she was voiding normally with no stress incontinence, and she was moving her bowels normally.Her biggest concern was pain control.The physician and the patient discussed their alternatives, and they will try switching her to hydromorphone from the oxycodone.The patient will continue with very light activity over the next few weeks.She will follow-up with her local gynecologist in 4-5 weeks for a postop check, and a new prescription for dilaudid was given by her physician.The patient will have a follow-up via telehealth visit with the physician in approximately 3 months to monitor her progress regarding her neuropathic pain.On (b)(6), 2021, she was admitted for pelvic prolapse, cystocele, and urinary tract infections.Approximately 2 weeks ago, the patient developed symptoms of urinary tract infection with bladder pain and irritation.She described it as a sensation of suprapubic imitation.She also had some mild dysuria.A urinalysis was performed by her gynecologist which apparently revealed an e.Coli urinary tract infection.She was then placed on macrobid for 5 days.She presented with some persistent symptoms of bladder irritation and inflammation.Her symptoms have partially improved but she was completing the 5-day course of nitrofurantoin.Today, her urinalysis was normal with negative leukocytes and negative nitrites.On (b)(6), 2021, the patient was in for patient evaluation for outpatient therapy for her pelvic pain, hip pain, limited hip abduction, and other symptoms and signs involving the musculoskeletal system.Physical therapy evaluation reveals abnormal muscle tone, decreased flexibility, impaired coordination, decreased rom, decreased endurance, impaired balance, and pain (bladder function) resulting in limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab and patient goals and maximize plof of chosen adls.

Event Description

It was reported to boston scientific corporation that an obtryx halo single system was implanted during a cystocele repair, major urethral transobturator sling and cystoscopy procedure performed on (b)(6) 2010, for the treatment of urethral hypermobility, stress urinary incontinence, and cystocele.The patient had a history of advanced colorectal cancer, had two pelvic and abdominal surgeries after chemotherapy and radiation, and had developed stress urinary incontinence in recent years.She was originally seen in the early stages of incontinence over the last few years.She was originally seen in the early part of 2010 with the recommendations for urodynamics and to consider vaginal surgery for her incontinence.She finally followed up in early november, wishing to pursue her surgery now that she has been in a state of remission for her colorectal malignancy.Urodynamics were performed, demonstrating stress urinary incontinence with a low valsalva leak point pressure, and her physical exam confirmed the presence of hypermobility and a central cystocele.There was some descent of her uterus, but not enough to call it a uterine prolapse.Moreover, the options for the patient were reviewed by the physician, which included observation, kegel exercises, collagen injection, and a sling procedure with cystocele repair.The physician explained to the patient that he would keep her procedure very basic and not pursue anything with extensive surgical intervention due to her previous pelvic radiation, chemotherapy, and previous abdominal pelvic surgery.The physician recommended a simple cystocele repair and the insertion of a mid-urethral sling either by a pubovaginal approach or a transobturator approach.The physician explained the side effects of doing this surgery, such as infection, bleeding, erosion, retention, pain, and failure to resolve her incontinence.The physician also told the patient that he would make his decision on the type of sling once he performed the operation and looked inside of her bladder.In the past, her bladder was consistent with radiation changes.He also gave the patient the option of a second opinion as well.After reviewing and hearing the physician's recommendation, the patient wishes to pursue the surgery on (b)(6) 2010.On (b)(6) 2017, the patient was presented to the emergency department (ed) from uro-gyn for admission for iv antibiotics due to worsening pyelonephritis after receiving a cystoscopy.The patient was admitted with urinary tract infection (uti), voiding difficulties, and multiple drug allergies.She began experiencing recurrent utis earlier this year.She had a proteus uti earlier this year and had an escherichia coli uti in july.Because of her repeated utis, she was referred to a physician from urogynecology where she underwent cystoscopy last week.Thereafter, she had ongoing dysuria and a reaction to ciprofloxacin with severe lower extremity pain which she described as ripping in her muscles in her lower legs.The patient was in for antibiotic management and pain control.She has some ongoing mild suprapubic discomfort, but dysuria has resolved and there was no incontinence.Moreover, she had urethral sling procedure about 5 years ago.She stated that her sling may be a little bit overcorrected, and she typically had a residual of approximately 40cc.The patient had an element of bladder outlet obstruction which could lead to residuals though her reported residuals was only 40cc which was acceptable.If she did have an element of bladder outlet obstruction from an overcorrected urethra from a prior sling procedure, she may have high pressure voiding which could place her at risk for repeated utis.This could be evaluated with multichannel urodynamics.Furthermore, the patient is on prophylactic therapy for utis which included cranberry supplementation and estrogen replacement.She should be considered for self-start antibiotic therapy typically consisting of one pill twice daily for 3 days as soon as patient begins experiencing symptoms but due to her multiple drug allergies, her best drug of choice in this instance would be nitrofurantoin.She did have underlying dyspareunia since the surgery and there was no known history of a urethral diverticulum.Abdominal ct was performed for generalized abdominal pain to rule out pyelonephritis and abscess status post procedure cystoscopy.No acute abnormality was noted.The assessment was complicated uti.The plan was to treat with rocephin, iv fluids, enoxaparin, and hydromorphone.On (b)(6) 2017, the patient returned to the office with her husband for follow-up of urinary tract infection (uti) and dysuria.She was discharged on macrobid which she completed last friday.She continues to have symptoms of burning, lower abdominal pain, low back pain and fatigue.She stated that she had not felt right since the cystoscopic examination.She underwent multichannel urodynamics.There was no evidence of bladder outlet obstruction.Pressure flow nomogram was consistent with absence of the obstruction.She had high flow low pressure voiding.All her urinary symptoms, lower back pain and lower abdominal pain have resolved.At the present time, she is asymptomatic.After her urodynamics, she was recommended to try estring but she developed significant reaction and she subsequently discontinued the medication with resolution of her symptoms.During assessment, the patient did not have any voiding difficulties.It took about 6 weeks for her to recover from her cystoscopy which raised the question as to whether she had an allergic reaction of some type to the prep solution or the cystoscopic sterilization process that was performed at her uro-gynecologist's office.She does not have evidence of bladder outlet obstruction from her prior sling procedure.Discussion was held as to how to manage her repeated utis.Reportedly, she remained on theragran hp, and discussed with her physician other estrogen replacements including estrace or oral tablets.In addition, they also discussed self-start therapy with antibiotics such as nitrofurantoin.She also indicated that she developed some type of facial skin reaction after being on a suppressive antibiotic which she does not recall the name.Moreover, the physician advised the patient not to be given with any additional antibiotic until they know what medication that was.She has a multitude of drug allergies making antibiotic options for treatment difficult.On (b)(6) 2020, the patient with a past medical history of stage 4 colon cancer with hemicolectomy and colostomy bag as well as hypothyroidism who presented to ed with a month history of pelvic pain with radiation to lower back constantly for a week.Also, she presented with abdominal pain and dyspareunia.She stated that she has history of bladder prolapse in 2010 where she had mesh sling placed and was evaluated by her urologist a week ago who noted that the patient had prolapse at that time and was advised to have a follow-up with a specialist.Furthermore, the patient's appointment was not until next week but due to continued pain, she came to ed for evaluation.It was also noted that the patient had occasional nausea and left shoulder pain, that was not worse with movement.The patient had taken ibuprofen.Physical exam revealed suprapubic tenderness, mildly erythematous vaginal vault, uterine prolapse, and mild tenderness to bilateral paravertebral lumbar spine.Ct was consistent with uterine prolapse.The patient was to follow up with urogyn.On (b)(6) 2020, the patient presented for physical therapy (pt) evaluation with symptoms of pudendal neuralgia following history of colon cancer/treatment, bladder suspension and frequent falls.She had high tone pelvic floor musculature r>l and reported significant pain with sitting.She will benefit from physical therapy to reduce pain symptoms and educate patient in self-care management.The patient arrived and stated that she started to have pain this winter in her vulva, lower abdomen and lower back.Her symptoms were reported as pins and needles/ burnings/coldness.She stated that she felt like there was a ball in her vagina and had been diagnosed with slight uterine prolapse.Her chief complaint was pain with sitting and had inability to have penetrative intercourse with her husband.She was then referred to physical therapy.Previously, the patient was not working due to being permanently disabled.She stopped working and was not able to walk 10 years ago.She was unable to walk currently and has boot on right foot secondary to possible metatarsal fracture.Her physical therapy (pt) evaluation revealed abnormal muscle tone, decreased strength, pain, decreased flexibility, impaired sensation resulting in self-care, home management, community/leisure limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab, patient goals and maximize prior level of function (plof) of chosen activities of daily living (adl).On (b)(6) 2020, the patient presented to emergency department (ed) for evaluation of urinary urgency, frequency, dysuria and hematuria since friday.The patient was seen on friday for evaluation of ongoing lower abdominal pain that the patient suspected may be due to implanted mesh used for repair of prolapse.The patient has had prior outpatient imaging.The patient had a straight catheterization, which she stated was traumatic and painful due to known strictures from prior radiation.The patient noted that she was especially susceptible to uti, after instrumentation and has had many previously.Additionally, she had episode of gross hematuria last night with continued urethral discomfort.Urinalysis was abnormal with moderate bacteria, blood, and leukocytes.A urine culture was submitted.The patient was diagnosed with acute cystitis with hematuria and prescribed macrobid pending culture results.On (b)(6) 2020, she had returned to physical therapy with pelvic pain.She felt her pain was associated to her cystocele repair with mesh insertion 10 years ago.She had a follow-up with a physician, had bladder installations and injections into pfm of trameel.She stated nothing was working and she continued to have pain constantly in low back, across lower abdomen and numbness in perineum.The patient reported that her interstitial cystitis was treated, and she felt that it was not the issue.Atrophic changes were noted in the vulva vestibule as was tenderness to adductors and piriformis.She had abnormal muscle tone and decreased strength.The plan was for weekly pt and therapeutic activities at home.On (b)(6) 2020, the patient had a telehealth visit regarding pelvic pain and possible pudendal and obturator neuralgia.The patient has a history of colon cancer status post low anterior resection in 2008.The patient had a recurrence and underwent a left hemicolectomy with proctectomy and total mesenteric excision in 2009.The patient also had an obtryx tvt-o sling placed in 2010 for relatively mild stress urinary incontinence.The patient did well for several years.The patient was very active with exercise, including biking.She noted the onset of symptoms approximately 5 years ago, but over the last year the patient has noted increasing pain complaints.She notes pain radiating down both of her legs.She also notes a foreign object sensation in the vagina that feels like a billiard ball.She has pain with adduction of her legs.She had burning pain where her rectum was.Her pain was increased with sitting.She did have some symptoms going back 5 years, but much worse since january of this year.She can no longer have sex due to pain.She notes bladder pain with urinary urgency.She also has slow voiding with mixed incontinence.Moreover, potential diagnoses were reviewed such as obturator neuralgia and pudendal neuralgia.The mesh itself can also be a pain trigger, especially for vaginal and bladder pain.She was also at increased risk for a pudendal nerve problem given that she has had a proctectomy.On (b)(6) 2021, she was for in-person consultation after a phone consult in december.The patient had a complicated surgical history including left hemicolectomy with proctectomy and permanent colostomy.The patient also had a mid-urethral trans obturator sling placed in 2010.Patient initially did relatively well but over the last 1-2 years was noted with progressive pain which is now quite distressing.The patient's pain complaints were consistent with both obturator and pudendal neuralgia.Physical exam revealed cystocele, mesh was tender to palpation, and levator plate tender to palpation especially over sacrospinous areas.The impression was that the patient had multiple potential reasons to have pain.The sling itself appeared to be a pain generator as well as the possibility of obturator neuralgia.The patient could have pudendal neuralgia both from the proctectomy and from the sling placement.The plan was for complete removal of the tvt-o sling including both groin components.On (b)(6) 2021, the patient underwent transvaginal mesh excision with cystocele repair and bilateral groin exploration for the treatment of her bladder pain, pelvic pain, postoperative obturator neuralgia, and pudendal neuralgia.The mesh was identified and divided in the midline.A large portion of mesh was dissected and removed from both sides up to the groin.On the left side, it was noted that the mesh must have retracted into the groin and was not in a space that could be accessed.It was felt that any further dissection would lead to further muscle loss to the adductor muscle group.A tiny bit of mesh was still palpable in the obturator muscle that could not be retrieved.On the right side, an identical groin dissection was performed and once again was unable to identify any mesh in this compartment.No mesh could be recovered from the groin, so once again, as much of the mesh from the vaginal aspect was removed as possible leaving only a tiny bit of mesh adherent to the underside of the bone and in the obturator internus muscle and membrane.The patient developed a spinal headache from the spinal anesthesia administered to augment her postoperative pain control.She underwent a blood patch on postoperative day 1.On postoperative day 2, the patient voided with a low postvoid residual.Pain control was adequate with oral oxycodone.She was considered stable for discharge.She was discharged to stay in a local hotel for follow-up with her physician next week.She was given routine instructions.On (b)(6) 2021, according to the pathology report, the vaginal mesh excision consisted with fibrous and skeletal muscle tissue with mild chronic inflammation, rare multinucleated giant cells, and foreign body consistent with mesh.On (b)(6) 2021, the patient was in for her routine post operation check-up.She was doing relatively well.Her vaginal pain was minimal and her incisional pain from groin exploration was also tolerable.She continued to have obturator nerve pain which was more difficult for her.Furthermore, she was voiding normally with no stress incontinence, and she was moving her bowels normally.Her biggest concern was pain control.The physician and the patient discussed their alternatives, and they will try switching her to hydromorphone from the oxycodone.The patient will continue with very light activity over the next few weeks.She will follow-up with her local gynecologist in 4-5 weeks for a postop check, and a new prescription for dilaudid was given by her physician.The patient will have a follow-up via telehealth visit with the physician in approximately 3 months to monitor her progress regarding her neuropathic pain.On february 20, 2021, the patient presented to the er with chills, nausea and weakness that started 2 days prior, increased abdominal pain that radiated to her back, distention, and hard stool.She had not been ambulatory since her surgery on february 4th which normally helps her bowel regimen.Imaging showed constipation, and the patient was going to add miralax and senna in addition to colace.On (b)(6) 2021, the patient was seen by a urologist for pelvic prolapse, cystocele, and urinary tract infections.Approximately 2 weeks ago, the patient developed symptoms of urinary tract infection with bladder pain and irritation.She described it as a sensation of suprapubic irritation.She also had some mild dysuria.A urinalysis was performed by her gynecologist which apparently revealed an e.Coli urinary tract infection.She was then placed on macrobid for 5 days.She presented with some persistent symptoms of bladder irritation and inflammation.Her symptoms have partially improved but she was completing the 5-day course of nitrofurantoin.Today, her urinalysis was normal with negative leukocytes and negative nitrites.Her antibiotics were extended for an additional 7 days, and she was given samples of uribel to be used as needed for irritation/inflammation.On (b)(6) 2021, the patient was seen by her obgyn for a follow-up on pelvic pain.Despite extensive groin dissections during mesh removal in february, no additional mesh could be retrieved from these areas.The patient continued to have symptoms of both pudendal and obturator neuralgia.Repeating her groin dissection was not recommended due to the risks and likelihood of being unsuccessful.Transgluteal pudendal nerve decompression was discussed with a potential for unilateral procedure on the left side where the patient's symptoms were worse.The patient was also advised of the protracted nature of nerve healing taking up to 2 years to see maximal improvement along with the clinical failure rate of at least 20%.The possibility of pudendal nerve cryoablation or drg stimulator which has the advantage of potentially treating more than 1 pain generator were also discussed as options.The assessment was continued obturator and pudendal neuralgia.The patient planned to consider her options.On (b)(6) 2021, the patient was in for patient evaluation for outpatient therapy for her pelvic pain, hip pain, limited hip abduction, and other symptoms and signs involving the musculoskeletal system.She had pelvic pain secondary to pelvic floor dysfunction as well as mesh removal in february.She was also deconditioned due to bed rest after surgery as she had been told to rest up due to hemorrhaging after surgery.She reported urinary frequency, incontinence with a full bladder and bending over, difficulty feeling if she has emptied her bladder, pain with initial bladder emptying, and pain with intercourse.Physical therapy evaluation reveals abnormal muscle tone, decreased flexibility, impaired coordination, decreased rom, decreased endurance, impaired balance, and pain (bladder function) resulting in limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab and patient goals and maximize plof of chosen adls.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to november 29, 2010, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6), (b)(6) hospital united states.Dr.(b)(6), phone number: (b)(6).Wyrnewood pa 19096 phone no.(b)(6), fax.No.(b)(6).(b)(6) hospital.St (b)(6) , phone number: (b)(6), dr.(b)(6).Block h6: patient codes e2330, e1002, e0123, e0126, e1310, e1906, e2326, e1309, and e2328, capture the reportable events of pain (severe lower extremity pain, back pain, pelvic and perineal pain, pain in left shoulder, bladder pain, pelvic pain, incisional pain, joint pain), abdominal pain, nerve damage (pudendal and obturator neuralgia, pain radiating down both of her legs), neuropathy (neuropathic pain), urinary tract infection, infection (worsening pyelonephritis), inflammation (mild chronic inflammation, chronic cystitis), urinary retention (incomplete emptying of bladder), and obstruction (bladder outlet obstruction), respectively.Impact codes f1905, f1202, f08, f2303 and f23, capture the reportable events of device revision or replacement (transvaginal mesh excision), disability (permanently disabled), hospitalization or prolonged hospitalization, medication required (self-start antibiotic therapy, antibiotic management, topical estrogen replacement, cranberry supplementation) and unexpected medical intervention (pain control), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.The complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to november 29, 2010, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).Block h6: patient codes e2330, e1002, e0123, e0126, e1310, e1906, e2326, e1309, and e2328, capture the reportable events of pain (severe lower extremity pain, back pain, pelvic and perineal pain, pain in left shoulder, bladder pain, pelvic pain, incisional pain, joint pain), abdominal pain, nerve damage (pudendal and obturator neuralgia, pain radiating down both of her legs), neuropathy (neuropathic pain), urinary tract infection, infection (worsening pyelonephritis), inflammation (mild chronic inflammation, chronic cystitis), urinary retention (incomplete emptying of bladder), and obstruction (bladder outlet obstruction), respectively.Impact codes f1905, f1202, f08, f2303 and f23, capture the reportable events of device revision or replacement (transvaginal mesh excision), disability (permanently disabled), hospitalization or prolonged hospitalization, medication required (self-start antibiotic therapy, antibiotic management, topical estrogen replacement, cranberry supplementation) and unexpected medical intervention (pain control), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks b5, b7, h6, and h10 have been updated based on the additional information on october 18, 2022.Block h6: patient code e0122 was utilized to capture the reportable event of walking difficulty.Block h11: block a1 has been corrected.Blocks a4, b5, h6 and h10 have been updated based on the additional information received on november 11, 2022.Block h6: patient code e020201 captures the reportable event of anxiety.Patient code e020202 captures the reportable event of depression.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: block h6 has been updated based on medical review received on december 12, 2022.

Event Description

It was reported to boston scientific corporation that an obtryx halo single system was implanted during a cystocele repair, major urethral transobturator sling and cystoscopy procedure performed on (b)(6) 2010, for the treatment of urethral hypermobility, stress urinary incontinence, and cystocele.The patient had a history of advanced colorectal cancer, had two pelvic and abdominal surgeries after chemotherapy and radiation, and had developed stress urinary incontinence in recent years.She was originally seen in the early stages of incontinence over the last few years.She was originally seen in the early part of 2010 with the recommendations for urodynamics and to consider vaginal surgery for her incontinence.She finally followed up in early november, wishing to pursue her surgery now that she has been in a state of remission for her colorectal malignancy.Urodynamics were performed, demonstrating stress urinary incontinence with a low valsalva leak point pressure, and her physical exam confirmed the presence of hypermobility and a central cystocele.There was some descent of her uterus, but not enough to call it a uterine prolapse.Moreover, the options for the patient were reviewed by the physician, which included observation, kegel exercises, collagen injection, and a sling procedure with cystocele repair.The physician explained to the patient that he would keep her procedure very basic and not pursue anything with extensive surgical intervention due to her previous pelvic radiation, chemotherapy, and previous abdominal pelvic surgery.The physician recommended a simple cystocele repair and the insertion of a mid-urethral sling either by a pubovaginal approach or a transobturator approach.The physician explained the side effects of doing this surgery, such as infection, bleeding, erosion, retention, pain, and failure to resolve her incontinence.The physician also told the patient that he would make his decision on the type of sling once he performed the operation and looked inside of her bladder.In the past, her bladder was consistent with radiation changes.He also gave the patient the option of a second opinion as well.After reviewing and hearing the physician's recommendation, the patient wishes to pursue the surgery on (b)(6) 2010.On (b)(6)2017, the patient was presented to the emergency department (ed) from uro-gyn for admission for iv antibiotics due to worsening pyelonephritis after receiving a cystoscopy.The patient was admitted with urinary tract infection (uti), voiding difficulties, and multiple drug allergies.She began experiencing recurrent utis earlier this year.She had a proteus uti earlier this year and had an escherichia coli uti in july.Because of her repeated utis, she was referred to a physician from urogynecology where she underwent cystoscopy last week.Thereafter, she had ongoing dysuria and a reaction to ciprofloxacin with severe lower extremity pain which she described as ripping in her muscles in her lower legs.The patient was in for antibiotic management and pain control.She has some ongoing mild suprapubic discomfort, but dysuria has resolved and there was no incontinence.Moreover, she had urethral sling procedure about 5 years ago.She stated that her sling may be a little bit overcorrected, and she typically had a residual of approximately 40cc.The patient had an element of bladder outlet obstruction which could lead to residuals though her reported residuals was only 40cc which was acceptable.If she did have an element of bladder outlet obstruction from an overcorrected urethra from a prior sling procedure, she may have high pressure voiding which could place her at risk for repeated utis.This could be evaluated with multichannel urodynamics.Furthermore, the patient is on prophylactic therapy for utis which included cranberry supplementation and estrogen replacement.She should be considered for self-start antibiotic therapy typically consisting of one pill twice daily for 3 days as soon as patient begins experiencing symptoms but due to her multiple drug allergies, her best drug of choice in this instance would be nitrofurantoin.She did have underlying dyspareunia since the surgery and there was no known history of a urethral diverticulum.Abdominal ct was performed for generalized abdominal pain to rule out pyelonephritis and abscess status post procedure cystoscopy.No acute abnormality was noted.The assessment was complicated uti.The plan was to treat with rocephin, iv fluids, enoxaparin, and hydromorphone.On (b)(6) 2017, the patient returned to the office with her husband for follow-up of urinary tract infection (uti) and dysuria.She was discharged on macrobid which she completed last friday.She continues to have symptoms of burning, lower abdominal pain, low back pain and fatigue.She stated that she had not felt right since the cystoscopic examination.She underwent multichannel urodynamics.There was no evidence of bladder outlet obstruction.Pressure flow nomogram was consistent with absence of the obstruction.She had high flow low pressure voiding.All her urinary symptoms, lower back pain and lower abdominal pain have resolved.At the present time, she is asymptomatic.After her urodynamics, she was recommended to try estring but she developed significant reaction and she subsequently discontinued the medication with resolution of her symptoms.During assessment, the patient did not have any voiding difficulties.It took about 6 weeks for her to recover from her cystoscopy which raised the question as to whether she had an allergic reaction of some type to the prep solution or the cystoscopic sterilization process that was performed at her uro-gynecologist's office.She does not have evidence of bladder outlet obstruction from her prior sling procedure.Discussion was held as to how to manage her repeated utis.Reportedly, she remained on theragran hp, and discussed with her physician other estrogen replacements including estrace or oral tablets.In addition, they also discussed self-start therapy with antibiotics such as nitrofurantoin.She also indicated that she developed some type of facial skin reaction after being on a suppressive antibiotic which she does not recall the name.Moreover, the physician advised the patient not to be given with any additional antibiotic until they know what medication that was.She has a multitude of drug allergies making antibiotic options for treatment difficult.On (b)(6) 2020, the patient with a past medical history of stage 4 colon cancer with hemicolectomy and colostomy bag as well as hypothyroidism who presented to ed with a month history of pelvic pain with radiation to lower back constantly for a week.Also, she presented with abdominal pain and dyspareunia.She stated that she has history of bladder prolapse in 2010 where she had mesh sling placed and was evaluated by her urologist a week ago who noted that the patient had prolapse at that time and was advised to have a follow-up with a specialist.Furthermore, the patient's appointment was not until next week but due to continued pain, she came to ed for evaluation.It was also noted that the patient had occasional nausea and left shoulder pain, that was not worse with movement.The patient had taken ibuprofen.Physical exam revealed suprapubic tenderness, mildly erythematous vaginal vault, uterine prolapse, and mild tenderness to bilateral paravertebral lumbar spine.Ct was consistent with uterine prolapse.The patient was to follow up with urogyn.On (b)(6) 2020, the patient presented for physical therapy (pt) evaluation with symptoms of pudendal neuralgia following history of colon cancer/treatment, bladder suspension and frequent falls.She had high tone pelvic floor musculature r>l and reported significant pain with sitting.She will benefit from physical therapy to reduce pain symptoms and educate patient in self-care management.The patient arrived and stated that she started to have pain this winter in her vulva, lower abdomen and lower back.Her symptoms were reported as pins and needles/ burnings/coldness.She stated that she felt like there was a ball in her vagina and had been diagnosed with slight uterine prolapse.Her chief complaint was pain with sitting and had inability to have penetrative intercourse with her husband.She was then referred to physical therapy.Previously, the patient was not working due to being permanently disabled.She stopped working and was not able to walk 10 years ago.She was unable to walk currently and has boot on right foot secondary to possible metatarsal fracture.Her physical therapy (pt) evaluation revealed abnormal muscle tone, decreased strength, pain, decreased flexibility, impaired sensation resulting in self-care, home management, community/leisure limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab, patient goals and maximize prior level of function (plof) of chosen activities of daily living (adl).On (b)(6) 2020, the patient presented to emergency department (ed) for evaluation of urinary urgency, frequency, dysuria and hematuria since friday.The patient was seen on friday for evaluation of ongoing lower abdominal pain that the patient suspected may be due to implanted mesh used for repair of prolapse.The patient has had prior outpatient imaging.The patient had a straight catheterization, which she stated was traumatic and painful due to known strictures from prior radiation.The patient noted that she was especially susceptible to uti, after instrumentation and has had many previously.Additionally, she had episode of gross hematuria last night with continued urethral discomfort.Urinalysis was abnormal with moderate bacteria, blood, and leukocytes.A urine culture was submitted.The patient was diagnosed with acute cystitis with hematuria and prescribed macrobid pending culture results.On (b)(6)2020, she had returned to physical therapy with pelvic pain.She felt her pain was associated to her cystocele repair with mesh insertion 10 years ago.She had a follow-up with a physician, had bladder installations and injections into pfm of trameel.She stated nothing was working and she continued to have pain constantly in low back, across lower abdomen and numbness in perineum.The patient reported that her interstitial cystitis was treated, and she felt that it was not the issue.Atrophic changes were noted in the vulva vestibule as was tenderness to adductors and piriformis.She had abnormal muscle tone and decreased strength.The plan was for weekly pt and therapeutic activities at home.On (b)(6) 2020, the patient had a telehealth visit regarding pelvic pain and possible pudendal and obturator neuralgia.The patient has a history of colon cancer status post low anterior resection in 2008.The patient had a recurrence and underwent a left hemicolectomy with proctectomy and total mesenteric excision in 2009.The patient also had an obtryx tvt-o sling placed in 2010 for relatively mild stress urinary incontinence.The patient did well for several years.The patient was very active with exercise, including biking.She noted the onset of symptoms approximately 5 years ago, but over the last year the patient has noted increasing pain complaints.She notes pain radiating down both of her legs.She also notes a foreign object sensation in the vagina that feels like a billiard ball.She has pain with adduction of her legs.She had burning pain where her rectum was.Her pain was increased with sitting.She did have some symptoms going back 5 years, but much worse since january of this year.She can no longer have sex due to pain.She notes bladder pain with urinary urgency.She also has slow voiding with mixed incontinence.Moreover, potential diagnoses were reviewed such as obturator neuralgia and pudendal neuralgia.The mesh itself can also be a pain trigger, especially for vaginal and bladder pain.She was also at increased risk for a pudendal nerve problem given that she has had a proctectomy.On (b)(6) 2021, she was for in-person consultation after a phone consult in december.The patient had a complicated surgical history including left hemicolectomy with proctectomy and permanent colostomy.The patient also had a mid-urethral trans obturator sling placed in 2010.Patient initially did relatively well but over the last 1-2 years was noted with progressive pain which is now quite distressing.The patient's pain complaints were consistent with both obturator and pudendal neuralgia.Physical exam revealed cystocele, mesh was tender to palpation, and levator plate tender to palpation especially over sacrospinous areas.The impression was that the patient had multiple potential reasons to have pain.The sling itself appeared to be a pain generator as well as the possibility of obturator neuralgia.The patient could have pudendal neuralgia both from the proctectomy and from the sling placement.The plan was for complete removal of the tvt-o sling including both groin components.On (b)(6) 2021, the patient underwent transvaginal mesh excision with cystocele repair and bilateral groin exploration for the treatment of her bladder pain, pelvic pain, postoperative obturator neuralgia, and pudendal neuralgia.The mesh was identified and divided in the midline.A large portion of mesh was dissected and removed from both sides up to the groin.On the left side, it was noted that the mesh must have retracted into the groin and was not in a space that could be accessed.It was felt that any further dissection would lead to further muscle loss to the adductor muscle group.A tiny bit of mesh was still palpable in the obturator muscle that could not be retrieved.On the right side, an identical groin dissection was performed and once again was unable to identify any mesh in this compartment.No mesh could be recovered from the groin, so once again, as much of the mesh from the vaginal aspect was removed as possible leaving only a tiny bit of mesh adherent to the underside of the bone and in the obturator internus muscle and membrane.The patient developed a spinal headache from the spinal anesthesia administered to augment her postoperative pain control.She underwent a blood patch on postoperative day 1.On postoperative day 2, the patient voided with a low postvoid residual.Pain control was adequate with oral oxycodone.She was considered stable for discharge.She was discharged to stay in a local hotel for follow-up with her physician next week.She was given routine instructions.On (b)(6) 2021, according to the pathology report, the vaginal mesh excision consisted with fibrous and skeletal muscle tissue with mild chronic inflammation, rare multinucleated giant cells, and foreign body consistent with mesh.On (b)(6) 2021, the patient was in for her routine post operation check-up.She was doing relatively well.Her vaginal pain was minimal and her incisional pain from groin exploration was also tolerable.She continued to have obturator nerve pain which was more difficult for her.Furthermore, she was voiding normally with no stress incontinence, and she was moving her bowels normally.Her biggest concern was pain control.The physician and the patient discussed their alternatives, and they will try switching her to hydromorphone from the oxycodone.The patient will continue with very light activity over the next few weeks.She will follow-up with her local gynecologist in 4-5 weeks for a postop check, and a new prescription for dilaudid was given by her physician.The patient will have a follow-up via telehealth visit with the physician in approximately 3 months to monitor her progress regarding her neuropathic pain.On (b)(6) 2021, the patient presented to the er with chills, nausea and weakness that started 2 days prior, increased abdominal pain that radiated to her back, distention, and hard stool.She had not been ambulatory since her surgery on (b)(6) which normally helps her bowel regimen.Imaging showed constipation, and the patient was going to add miralax and senna in addition to colace.On (b)(6) 2021, the patient was seen by a urologist for pelvic prolapse, cystocele, and urinary tract infections.Approximately 2 weeks ago, the patient developed symptoms of urinary tract infection with bladder pain and irritation.She described it as a sensation of suprapubic irritation.She also had some mild dysuria.A urinalysis was performed by her gynecologist which apparently revealed an e.Coli urinary tract infection.She was then placed on macrobid for 5 days.She presented with some persistent symptoms of bladder irritation and inflammation.Her symptoms have partially improved but she was completing the 5-day course of nitrofurantoin.Today, her urinalysis was normal with negative leukocytes and negative nitrites.Her antibiotics were extended for an additional 7 days, and she was given samples of uribel to be used as needed for irritation/inflammation.On (b)(6)2021, the patient was seen by her obgyn for a follow-up on pelvic pain.Despite extensive groin dissections during mesh removal in february, no additional mesh could be retrieved from these areas.The patient continued to have symptoms of both pudendal and obturator neuralgia.Repeating her groin dissection was not recommended due to the risks and likelihood of being unsuccessful.Transgluteal pudendal nerve decompression was discussed with a potential for unilateral procedure on the left side where the patient's symptoms were worse.The patient was also advised of the protracted nature of nerve healing taking up to 2 years to see maximal improvement along with the clinical failure rate of at least 20%.The possibility of pudendal nerve cryoablation or drg stimulator which has the advantage of potentially treating more than 1 pain generator were also discussed as options.The assessment was continued obturator and pudendal neuralgia.The patient planned to consider her options.On (b)(6)2021, the patient was in for patient evaluation for outpatient therapy for her pelvic pain, hip pain, limited hip abduction, and other symptoms and signs involving the musculoskeletal system.She had pelvic pain secondary to pelvic floor dysfunction as well as mesh removal in february.She was also deconditioned due to bed rest after surgery as she had been told to rest up due to hemorrhaging after surgery.She reported urinary frequency, incontinence with a full bladder and bending over, difficulty feeling if she has emptied her bladder, pain with initial bladder emptying, and pain with intercourse.Physical therapy evaluation reveals abnormal muscle tone, decreased flexibility, impaired coordination, decreased rom, decreased endurance, impaired balance, and pain (bladder function) resulting in limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab and patient goals and maximize plof of chosen adls.***additional information october 18, 2022*** on (b)(6) 2022, the patient was seen and examined for impaired glucose tolerance, hypothyroidism/hashimoto's, and hyperlipidemia, colon cancer status post total colectomy, chemo and radiation in 2009.The patient has had problems with a mesh placed for bladder prolapse which had nerve impingement and pain down her leg.She has been unable to exercise this year.She walks 30 min to an hour per day.She was previously very athletic.The patient has difficulty losing weight since she had bilateral oopherectomy in 2009 when she had colectomy for colon cancer.The patient has also seen several nutritionists.Upon examination the patient reported hearing loss.The patient also reported problems with urination.The patient reported alternately too hot and too cold.The patient reported easy bleeding and a tendency for easy bruising.The patient reported back pain, muscle aches, pain localized to one or more joints, and joint stiffness localized to one or more joints.The patient reported difficulty walking.The patient reported glaucoma or cataracts.The patient reported thyroid disorder.The patient reported currently wearing eyeglasses or contact lenses.A follow up was scheduled for january.Current medication: - advil 200 mg oral capsule 0 days, 0 refills - synthroid 88 mcg oral tablet once a day 0 days, 0 refills past medical/surgical history: retinal or dilated eye exam within 1 year.Pregnancy: previously pregnant 2 time(s).Social history: tobacco use: smoking status: never smoker.Alcohol: alcohol use.Habits: exercising regularly.Marital: currently married.***additional information received on november 11, 2022*** on (b)(6) 2022, the patient was seen and examined for her yearly follow up status post lower anterior resection (lar) last january 16, 2008, and a recent reconstructive surgery because of problems with bladder mesh in (b)(6) 2021.The patient was reported to be getting physical therapy (pt) for both shoulder and pelvic pain.The patient was doing generally well, however, she still needed a colonoscopy.The patient's urinary tract infections were less common - none this past year.She continued with the same peripheral neuropathy in hands and feet.Fine motor worse.She had a reaction to eye drops with some hearing loss in the interim.Cognitively, she feels about the same, and her family agreed.She is not rowing.She walks about 1.5 miles in 30 min.She has trouble with stairs.She reports significant worsening of bilateral hip and left shoulder pain.Mri of the left shoulder showed significant soft tissue injury - there has been modest improvement with pt.Her last bowel obstruction reported was on (b)(6)2015 and she was hospitalized at virtua hospital.Obstruction was resolved with bowel rest.The patient was trying to lose weight but was not succeeding due to limited by inability to exercise.Pain at worst 6/10 in the lower back associated with sciatica, sacrum and hips which was not constant.The patient did not require pain medication.Upon examination the patient was positive for cognitive defects.The patient's pain score was 8 out of 10 at worst and currently at 0 out of 10 which was mainly in felt in the hip and bladder.The patient was also depressed.The physician's impression includes: 1.Rectal cancer, well-differentiated adenocarcinoma, stage i resected 1/16/08.For genetic counseling and germline testing was done which did not identify any pathogenic or clinically significant mutations.Tumor marker remains normal.2.Recurrent rectal cancer,(b)(6)2009, treated with pre-operative chemo rads, and followed by apr on 5/16109.Had post-op folfox 8 cycles till (b)(6)09.3.Utis, pyelonephritis 4.Hypothyroidism, medically managed 5.Anxiety, depression: currently not being followed 6.Oxaliplatin neuropathy, persistent, with occasional falls 7.Cognitive sequelae of - chemotherapy - stably disabled with this 8.Knee arthritis 9.Intermittent bowel obstruction - last in 2025 10.She has had side-effects of unusual severity from chemo rads - likely dna repair defect, and they need to check germ line.As part of the patient's plan, she needed to continue with pt for ongoing neurological problems, and new pelvic floor problems.Clinically and radiographically without evidence of disease, now with an mri and ct showing no new abnormalities.Colonoscopy due - her gastroenterologist has retired, and they will ask another physician to see her.The patient needed to continue ongoing follow up and see in 1 year for clinical evaluation.

Event Description

It was reported to boston scientific corporation that an obtryx halo single system was implanted during a cystocele repair, major urethral transobturator sling and cystoscopy procedure performed on november 29, 2010, for the treatment of urethral hypermobility, stress urinary incontinence, and cystocele.The patient had a history of advanced colorectal cancer, had two pelvic and abdominal surgeries after chemotherapy and radiation, and had developed stress urinary incontinence in recent years.She was originally seen in the early stages of incontinence over the last few years.She was originally seen in the early part of 2010 with the recommendations for urodynamics and to consider vaginal surgery for her incontinence.She finally followed up in early november, wishing to pursue her surgery now that she has been in a state of remission for her colorectal malignancy.Urodynamics were performed, demonstrating stress urinary incontinence with a low valsalva leak point pressure, and her physical exam confirmed the presence of hypermobility and a central cystocele.There was some descent of her uterus, but not enough to call it a uterine prolapse.Moreover, the options for the patient were reviewed by the physician, which included observation, kegel exercises, collagen injection, and a sling procedure with cystocele repair.The physician explained to the patient that he would keep her procedure very basic and not pursue anything with extensive surgical intervention due to her previous pelvic radiation, chemotherapy, and previous abdominal pelvic surgery.The physician recommended a simple cystocele repair and the insertion of a mid-urethral sling either by a pubovaginal approach or a transobturator approach.The physician explained the side effects of doing this surgery, such as infection, bleeding, erosion, retention, pain, and failure to resolve her incontinence.The physician also told the patient that he would make his decision on the type of sling once he performed the operation and looked inside of her bladder.In the past, her bladder was consistent with radiation changes.He also gave the patient the option of a second opinion as well.After reviewing and hearing the physician's recommendation, the patient wishes to pursue the surgery on november 29, 2010.On (b)(6) 2017, the patient was presented to the emergency department (ed) from uro-gyn for admission for iv antibiotics due to worsening pyelonephritis after receiving a cystoscopy.The patient was admitted with urinary tract infection (uti), voiding difficulties, and multiple drug allergies.She began experiencing recurrent utis earlier this year.She had a proteus uti earlier this year and had an escherichia coli uti in july.Because of her repeated utis, she was referred to a physician from urogynecology where she underwent cystoscopy last week.Thereafter, she had ongoing dysuria and a reaction to ciprofloxacin with severe lower extremity pain which she described as ripping in her muscles in her lower legs.The patient was in for antibiotic management and pain control.She has some ongoing mild suprapubic discomfort, but dysuria has resolved and there was no incontinence.Moreover, she had urethral sling procedure about 5 years ago.She stated that her sling may be a little bit overcorrected, and she typically had a residual of approximately 40cc.The patient had an element of bladder outlet obstruction which could lead to residuals though her reported residuals was only 40cc which was acceptable.If she did have an element of bladder outlet obstruction from an overcorrected urethra from a prior sling procedure, she may have high pressure voiding which could place her at risk for repeated utis.This could be evaluated with multichannel urodynamics.Furthermore, the patient is on prophylactic therapy for utis which included cranberry supplementation and estrogen replacement.She should be considered for self-start antibiotic therapy typically consisting of one pill twice daily for 3 days as soon as patient begins experiencing symptoms but due to her multiple drug allergies, her best drug of choice in this instance would be nitrofurantoin.She did have underlying dyspareunia since the surgery and there was no known history of a urethral diverticulum.Abdominal ct was performed for generalized abdominal pain to rule out pyelonephritis and abscess status post procedure cystoscopy.No acute abnormality was noted.The assessment was complicated uti.The plan was to treat with rocephin, iv fluids, enoxaparin, and hydromorphone.On (b)(6) 2017, the patient returned to the office with her husband for follow-up of urinary tract infection (uti) and dysuria.She was discharged on macrobid which she completed last friday.She continues to have symptoms of burning, lower abdominal pain, low back pain and fatigue.She stated that she had not felt right since the cystoscopic examination.She underwent multichannel urodynamics.There was no evidence of bladder outlet obstruction.Pressure flow nomogram was consistent with absence of the obstruction.She had high flow low pressure voiding.All her urinary symptoms, lower back pain and lower abdominal pain have resolved.At the present time, she is asymptomatic.After her urodynamics, she was recommended to try estring but she developed significant reaction and she subsequently discontinued the medication with resolution of her symptoms.During assessment, the patient did not have any voiding difficulties.It took about 6 weeks for her to recover from her cystoscopy which raised the question as to whether she had an allergic reaction of some type to the prep solution or the cystoscopic sterilization process that was performed at her uro-gynecologist's office.She does not have evidence of bladder outlet obstruction from her prior sling procedure.Discussion was held as to how to manage her repeated utis.Reportedly, she remained on theragran hp, and discussed with her physician other estrogen replacements including estrace or oral tablets.In addition, they also discussed self-start therapy with antibiotics such as nitrofurantoin.She also indicated that she developed some type of facial skin reaction after being on a suppressive antibiotic which she does not recall the name.Moreover, the physician advised the patient not to be given with any additional antibiotic until they know what medication that was.She has a multitude of drug allergies making antibiotic options for treatment difficult.On (b)(6) 2020, the patient with a past medical history of stage 4 colon cancer with hemicolectomy and colostomy bag as well as hypothyroidism who presented to ed with a month history of pelvic pain with radiation to lower back constantly for a week.Also, she presented with abdominal pain and dyspareunia.She stated that she has history of bladder prolapse in 2010 where she had mesh sling placed and was evaluated by her urologist a week ago who noted that the patient had prolapse at that time and was advised to have a follow-up with a specialist.Furthermore, the patient's appointment was not until next week but due to continued pain, she came to ed for evaluation.It was also noted that the patient had occasional nausea and left shoulder pain, that was not worse with movement.The patient had taken ibuprofen.Physical exam revealed suprapubic tenderness, mildly erythematous vaginal vault, uterine prolapse, and mild tenderness to bilateral paravertebral lumbar spine.Ct was consistent with uterine prolapse.The patient was to follow up with urogyn.On (b)(6) 2020, the patient presented for physical therapy (pt) evaluation with symptoms of pudendal neuralgia following history of colon cancer/treatment, bladder suspension and frequent falls.She had high tone pelvic floor musculature r>l and reported significant pain with sitting.She will benefit from physical therapy to reduce pain symptoms and educate patient in self-care management.The patient arrived and stated that she started to have pain this winter in her vulva, lower abdomen and lower back.Her symptoms were reported as pins and needles/ burnings/coldness.She stated that she felt like there was a ball in her vagina and had been diagnosed with slight uterine prolapse.Her chief complaint was pain with sitting and had inability to have penetrative intercourse with her husband.She was then referred to physical therapy.Previously, the patient was not working due to being permanently disabled.She stopped working and was not able to walk 10 years ago.She was unable to walk currently and has boot on right foot secondary to possible metatarsal fracture.Her physical therapy (pt) evaluation revealed abnormal muscle tone, decreased strength, pain, decreased flexibility, impaired sensation resulting in self-care, home management, community/leisure limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab, patient goals and maximize prior level of function (plof) of chosen activities of daily living (adl).On (b)(6) 2020, the patient presented to emergency department (ed) for evaluation of urinary urgency, frequency, dysuria and hematuria since friday.The patient was seen on friday for evaluation of ongoing lower abdominal pain that the patient suspected may be due to implanted mesh used for repair of prolapse.The patient has had prior outpatient imaging.The patient had a straight catheterization, which she stated was traumatic and painful due to known strictures from prior radiation.The patient noted that she was especially susceptible to uti, after instrumentation and has had many previously.Additionally, she had episode of gross hematuria last night with continued urethral discomfort.Urinalysis was abnormal with moderate bacteria, blood, and leukocytes.A urine culture was submitted.The patient was diagnosed with acute cystitis with hematuria and prescribed macrobid pending culture results.On (b)(6) 2020, she had returned to physical therapy with pelvic pain.She felt her pain was associated to her cystocele repair with mesh insertion 10 years ago.She had a follow-up with a physician, had bladder installations and injections into pfm of trameel.She stated nothing was working and she continued to have pain constantly in low back, across lower abdomen and numbness in perineum.The patient reported that her interstitial cystitis was treated, and she felt that it was not the issue.Atrophic changes were noted in the vulva vestibule as was tenderness to adductors and piriformis.She had abnormal muscle tone and decreased strength.The plan was for weekly pt and therapeutic activities at home.On (b)(6) 2020, the patient had a telehealth visit regarding pelvic pain and possible pudendal and obturator neuralgia.The patient has a history of colon cancer status post low anterior resection in 2008.The patient had a recurrence and underwent a left hemicolectomy with proctectomy and total mesenteric excision in 2009.The patient also had an obtryx tvt-o sling placed in 2010 for relatively mild stress urinary incontinence.The patient did well for several years.The patient was very active with exercise, including biking.She noted the onset of symptoms approximately 5 years ago, but over the last year the patient has noted increasing pain complaints.She notes pain radiating down both of her legs.She also notes a foreign object sensation in the vagina that feels like a billiard ball.She has pain with adduction of her legs.She had burning pain where her rectum was.Her pain was increased with sitting.She did have some symptoms going back 5 years, but much worse since january of this year.She can no longer have sex due to pain.She notes bladder pain with urinary urgency.She also has slow voiding with mixed incontinence.Moreover, potential diagnoses were reviewed such as obturator neuralgia and pudendal neuralgia.The mesh itself can also be a pain trigger, especially for vaginal and bladder pain.She was also at increased risk for a pudendal nerve problem given that she has had a proctectomy.On (b)(6) 2021, she was for in-person consultation after a phone consult in december.The patient had a complicated surgical history including left hemicolectomy with proctectomy and permanent colostomy.The patient also had a mid-urethral trans obturator sling placed in 2010.Patient initially did relatively well but over the last 1-2 years was noted with progressive pain which is now quite distressing.The patient's pain complaints were consistent with both obturator and pudendal neuralgia.Physical exam revealed cystocele, mesh was tender to palpation, and levator plate tender to palpation especially over sacrospinous areas.The impression was that the patient had multiple potential reasons to have pain.The sling itself appeared to be a pain generator as well as the possibility of obturator neuralgia.The patient could have pudendal neuralgia both from the proctectomy and from the sling placement.The plan was for complete removal of the tvt-o sling including both groin components.On (b)(6) 2021, the patient underwent transvaginal mesh excision with cystocele repair and bilateral groin exploration for the treatment of her bladder pain, pelvic pain, postoperative obturator neuralgia, and pudendal neuralgia.The mesh was identified and divided in the midline.A large portion of mesh was dissected and removed from both sides up to the groin.On the left side, it was noted that the mesh must have retracted into the groin and was not in a space that could be accessed.It was felt that any further dissection would lead to further muscle loss to the adductor muscle group.A tiny bit of mesh was still palpable in the obturator muscle that could not be retrieved.On the right side, an identical groin dissection was performed and once again was unable to identify any mesh in this compartment.No mesh could be recovered from the groin, so once again, as much of the mesh from the vaginal aspect was removed as possible leaving only a tiny bit of mesh adherent to the underside of the bone and in the obturator internus muscle and membrane.The patient developed a spinal headache from the spinal anesthesia administered to augment her postoperative pain control.She underwent a blood patch on postoperative day 1.On postoperative day 2, the patient voided with a low postvoid residual.Pain control was adequate with oral oxycodone.She was considered stable for discharge.She was discharged to stay in a local hotel for follow-up with her physician next week.She was given routine instructions.On (b)(6) 2021, according to the pathology report, the vaginal mesh excision consisted with fibrous and skeletal muscle tissue with mild chronic inflammation, rare multinucleated giant cells, and foreign body consistent with mesh.On (b)(6) 2021, the patient was in for her routine post operation check-up.She was doing relatively well.Her vaginal pain was minimal and her incisional pain from groin exploration was also tolerable.She continued to have obturator nerve pain which was more difficult for her.Furthermore, she was voiding normally with no stress incontinence, and she was moving her bowels normally.Her biggest concern was pain control.The physician and the patient discussed their alternatives, and they will try switching her to hydromorphone from the oxycodone.The patient will continue with very light activity over the next few weeks.She will follow-up with her local gynecologist in 4-5 weeks for a postop check, and a new prescription for dilaudid was given by her physician.The patient will have a follow-up via telehealth visit with the physician in approximately 3 months to monitor her progress regarding her neuropathic pain.On (b)(6) 2021, the patient presented to the er with chills, nausea and weakness that started 2 days prior, increased abdominal pain that radiated to her back, distention, and hard stool.She had not been ambulatory since her surgery on february 4th which normally helps her bowel regimen.Imaging showed constipation, and the patient was going to add miralax and senna in addition to colace.On (b)(6) 2021, the patient was seen by a urologist for pelvic prolapse, cystocele, and urinary tract infections.Approximately 2 weeks ago, the patient developed symptoms of urinary tract infection with bladder pain and irritation.She described it as a sensation of suprapubic irritation.She also had some mild dysuria.A urinalysis was performed by her gynecologist which apparently revealed an e.Coli urinary tract infection.She was then placed on macrobid for 5 days.She presented with some persistent symptoms of bladder irritation and inflammation.Her symptoms have partially improved but she was completing the 5-day course of nitrofurantoin.Today, her urinalysis was normal with negative leukocytes and negative nitrites.Her antibiotics were extended for an additional 7 days, and she was given samples of uribel to be used as needed for irritation/inflammation.On (b)(6) 2021, the patient was seen by her obgyn for a follow-up on pelvic pain.Despite extensive groin dissections during mesh removal in february, no additional mesh could be retrieved from these areas.The patient continued to have symptoms of both pudendal and obturator neuralgia.Repeating her groin dissection was not recommended due to the risks and likelihood of being unsuccessful.Transgluteal pudendal nerve decompression was discussed with a potential for unilateral procedure on the left side where the patient's symptoms were worse.The patient was also advised of the protracted nature of nerve healing taking up to 2 years to see maximal improvement along with the clinical failure rate of at least (b)(4).The possibility of pudendal nerve cryoablation or drg stimulator which has the advantage of potentially treating more than 1 pain generator were also discussed as options.The assessment was continued obturator and pudendal neuralgia.The patient planned to consider her options.On (b)(6) 2021, the patient was in for patient evaluation for outpatient therapy for her pelvic pain, hip pain, limited hip abduction, and other symptoms and signs involving the musculoskeletal system.She had pelvic pain secondary to pelvic floor dysfunction as well as mesh removal in february.She was also deconditioned due to bed rest after surgery as she had been told to rest up due to hemorrhaging after surgery.She reported urinary frequency, incontinence with a full bladder and bending over, difficulty feeling if she has emptied her bladder, pain with initial bladder emptying, and pain with intercourse.Physical therapy evaluation reveals abnormal muscle tone, decreased flexibility, impaired coordination, decreased rom, decreased endurance, impaired balance, and pain (bladder function) resulting in limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab and patient goals and maximize plof of chosen adls.Additional information october 18, 2022: on (b)(6) 2022, the patient was seen and examined for impaired glucose tolerance, hypothyroidism/hashimoto's, and hyperlipidemia, colon cancer status post total colectomy, chemo and radiation in 2009.The patient has had problems with a mesh placed for bladder prolapse which had nerve impingement and pain down her leg.She has been unable to exercise this year.She walks 30 min to an hour per day.She was previously very athletic.The patient has difficulty losing weight since she had bilateral oopherectomy in 2009 when she had colectomy for colon cancer.The patient has also seen several nutritionists.Upon examination the patient reported hearing loss.The patient also reported problems with urination.The patient reported alternately too hot and too cold.The patient reported easy bleeding and a tendency for easy bruising.The patient reported back pain, muscle aches, pain localized to one or more joints, and joint stiffness localized to one or more joints.The patient reported difficulty walking.The patient reported glaucoma or cataracts.The patient reported thyroid disorder.The patient reported currently wearing eyeglasses or contact lenses.A follow up was scheduled for (b)(6).

Manufacturer Narrative

Block b3 date of event: date of event was approximated to november 29, 2010, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6); (b)(6) hospital.(b)(6) hospital health information management (b)(6).Dr.(b)(6); phone number: (b)(6).(b)(6) physical therapy; (b)(6); phone no.(b)(6); fax.No.(b)(6).(b)(6).(b)(6).Dr.(b)(6); phone number: (b)(6).Dr.(b)(6); (b)(6) physical therapy.(b)(6).Block h6: patient codes e2330, e1002, e0123, e0126, e1310, e1906, e2326, e1309, and e2328, capture the reportable events of pain (severe lower extremity pain, back pain, pelvic and perineal pain, pain in left shoulder, bladder pain, pelvic pain, incisional pain, joint pain), abdominal pain, nerve damage (pudendal and obturator neuralgia, pain radiating down both of her legs), neuropathy (neuropathic pain), urinary tract infection, infection (worsening pyelonephritis), inflammation (mild chronic inflammation, chronic cystitis), urinary retention (incomplete emptying of bladder), and obstruction (bladder outlet obstruction), respectively.Impact codes f1905, f1202, f08, f2303 and f23, capture the reportable events of device revision or replacement (transvaginal mesh excision), disability (permanently disabled), hospitalization or prolonged hospitalization, medication required (self-start antibiotic therapy, antibiotic management, topical estrogen replacement, cranberry supplementation) and unexpected medical intervention (pain control), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks b5, b7, h6, and h10 have been updated based on the additional information on october 18, 2022.Block h6: patient code e0122 was utilized to capture the reportable event of walking difficulty.

Event Description

It was reported to boston scientific corporation that an obtryx halo single system was implanted during a cystocele repair, major urethral transobturator sling and cystoscopy procedure performed on (b)(6) 2010, for the treatment of urethral hypermobility, stress urinary incontinence, and cystocele.The patient had a history of advanced colorectal cancer, had two pelvic and abdominal surgeries after chemotherapy and radiation, and had developed stress urinary incontinence in recent years.She was originally seen in the early stages of incontinence over the last few years.She was originally seen in the early part of 2010 with the recommendations for urodynamics and to consider vaginal surgery for her incontinence.She finally followed up in early november, wishing to pursue her surgery now that she has been in a state of remission for her colorectal malignancy.Urodynamics were performed, demonstrating stress urinary incontinence with a low valsalva leak point pressure, and her physical exam confirmed the presence of hypermobility and a central cystocele.There was some descent of her uterus, but not enough to call it a uterine prolapse.Moreover, the options for the patient were reviewed by the physician, which included observation, kegel exercises, collagen injection, and a sling procedure with cystocele repair.The physician explained to the patient that he would keep her procedure very basic and not pursue anything with extensive surgical intervention due to her previous pelvic radiation, chemotherapy, and previous abdominal pelvic surgery.The physician recommended a simple cystocele repair and the insertion of a mid-urethral sling either by a pubovaginal approach or a transobturator approach.The physician explained the side effects of doing this surgery, such as infection, bleeding, erosion, retention, pain, and failure to resolve her incontinence.The physician also told the patient that he would make his decision on the type of sling once he performed the operation and looked inside of her bladder.In the past, her bladder was consistent with radiation changes.He also gave the patient the option of a second opinion as well.After reviewing and hearing the physician's recommendation, the patient wishes to pursue the surgery on (b)(6) 2010.On (b)(6) 2017, the patient was presented to the emergency department (ed) from uro-gyn for admission for iv antibiotics due to worsening pyelonephritis after receiving a cystoscopy.The patient was admitted with urinary tract infection (uti), voiding difficulties, and multiple drug allergies.She began experiencing recurrent utis earlier this year.She had a proteus uti earlier this year and had an escherichia coli uti in july.Because of her repeated utis, she was referred to a physician from urogynecology where she underwent cystoscopy last week.Thereafter, she had ongoing dysuria and a reaction to ciprofloxacin with severe lower extremity pain which she described as ripping in her muscles in her lower legs.The patient was in for antibiotic management and pain control.She has some ongoing mild suprapubic discomfort, but dysuria has resolved and there was no incontinence.Moreover, she had urethral sling procedure about 5 years ago.She stated that her sling may be a little bit overcorrected, and she typically had a residual of approximately 40cc.The patient had an element of bladder outlet obstruction which could lead to residuals though her reported residuals was only 40cc which was acceptable.If she did have an element of bladder outlet obstruction from an overcorrected urethra from a prior sling procedure, she may have high pressure voiding which could place her at risk for repeated utis.This could be evaluated with multichannel urodynamics.Furthermore, the patient is on prophylactic therapy for utis which included cranberry supplementation and estrogen replacement.She should be considered for self-start antibiotic therapy typically consisting of one pill twice daily for 3 days as soon as patient begins experiencing symptoms but due to her multiple drug allergies, her best drug of choice in this instance would be nitrofurantoin.She did have underlying dyspareunia since the surgery and there was no known history of a urethral diverticulum.Abdominal ct was performed for generalized abdominal pain to rule out pyelonephritis and abscess status post procedure cystoscopy.No acute abnormality was noted.The assessment was complicated uti.The plan was to treat with rocephin, iv fluids, enoxaparin, and hydromorphone.On (b)(6) 2017, the patient returned to the office with her husband for follow-up of urinary tract infection (uti) and dysuria.She was discharged on macrobid which she completed last friday.She continues to have symptoms of burning, lower abdominal pain, low back pain and fatigue.She stated that she had not felt right since the cystoscopic examination.She underwent multichannel urodynamics.There was no evidence of bladder outlet obstruction.Pressure flow nomogram was consistent with absence of the obstruction.She had high flow low pressure voiding.All her urinary symptoms, lower back pain and lower abdominal pain have resolved.At the present time, she is asymptomatic.After her urodynamics, she was recommended to try estring but she developed significant reaction and she subsequently discontinued the medication with resolution of her symptoms.During assessment, the patient did not have any voiding difficulties.It took about 6 weeks for her to recover from her cystoscopy which raised the question as to whether she had an allergic reaction of some type to the prep solution or the cystoscopic sterilization process that was performed at her uro-gynecologist's office.She does not have evidence of bladder outlet obstruction from her prior sling procedure.Discussion was held as to how to manage her repeated utis.Reportedly, she remained on theragran hp, and discussed with her physician other estrogen replacements including estrace or oral tablets.In addition, they also discussed self-start therapy with antibiotics such as nitrofurantoin.She also indicated that she developed some type of facial skin reaction after being on a suppressive antibiotic which she does not recall the name.Moreover, the physician advised the patient not to be given with any additional antibiotic until they know what medication that was.She has a multitude of drug allergies making antibiotic options for treatment difficult.On (b)(6) 2020, the patient with a past medical history of stage 4 colon cancer with hemicolectomy and colostomy bag as well as hypothyroidism who presented to ed with a month history of pelvic pain with radiation to lower back constantly for a week.Also, she presented with abdominal pain and dyspareunia.She stated that she has history of bladder prolapse in 2010 where she had mesh sling placed and was evaluated by her urologist a week ago who noted that the patient had prolapse at that time and was advised to have a follow-up with a specialist.Furthermore, the patient's appointment was not until next week but due to continued pain, she came to ed for evaluation.It was also noted that the patient had occasional nausea and left shoulder pain, that was not worse with movement.The patient had taken ibuprofen.Physical exam revealed suprapubic tenderness, mildly erythematous vaginal vault, uterine prolapse, and mild tenderness to bilateral paravertebral lumbar spine.Ct was consistent with uterine prolapse.The patient was to follow up with urogyn.On (b)(6) 2020, the patient presented for physical therapy (pt) evaluation with symptoms of pudendal neuralgia following history of colon cancer/treatment, bladder suspension and frequent falls.She had high tone pelvic floor musculature r>l and reported significant pain with sitting.She will benefit from physical therapy to reduce pain symptoms and educate patient in self-care management.The patient arrived and stated that she started to have pain this winter in her vulva, lower abdomen and lower back.Her symptoms were reported as pins and needles/ burnings/coldness.She stated that she felt like there was a ball in her vagina and had been diagnosed with slight uterine prolapse.Her chief complaint was pain with sitting and had inability to have penetrative intercourse with her husband.She was then referred to physical therapy.Previously, the patient was not working due to being permanently disabled.She stopped working and was not able to walk 10 years ago.She was unable to walk currently and has boot on right foot secondary to possible metatarsal fracture.Her physical therapy (pt) evaluation revealed abnormal muscle tone, decreased strength, pain, decreased flexibility, impaired sensation resulting in self-care, home management, community/leisure limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab, patient goals and maximize prior level of function (plof) of chosen activities of daily living (adl).On (b)(6) 2020, the patient presented to emergency department (ed) for evaluation of urinary urgency, frequency, dysuria and hematuria since friday.The patient was seen on friday for evaluation of ongoing lower abdominal pain that the patient suspected may be due to implanted mesh used for repair of prolapse.The patient has had prior outpatient imaging.The patient had a straight catheterization, which she stated was traumatic and painful due to known strictures from prior radiation.The patient noted that she was especially susceptible to uti, after instrumentation and has had many previously.Additionally, she had episode of gross hematuria last night with continued urethral discomfort.Urinalysis was abnormal with moderate bacteria, blood, and leukocytes.A urine culture was submitted.The patient was diagnosed with acute cystitis with hematuria and prescribed macrobid pending culture results.On (b)(6) 2020, she had returned to physical therapy with pelvic pain.She felt her pain was associated to her cystocele repair with mesh insertion 10 years ago.She had a follow-up with a physician, had bladder installations and injections into pfm of trameel.She stated nothing was working and she continued to have pain constantly in low back, across lower abdomen and numbness in perineum.The patient reported that her interstitial cystitis was treated, and she felt that it was not the issue.Atrophic changes were noted in the vulva vestibule as was tenderness to adductors and piriformis.She had abnormal muscle tone and decreased strength.The plan was for weekly pt and therapeutic activities at home.On (b)(6) 2020, the patient had a telehealth visit regarding pelvic pain and possible pudendal and obturator neuralgia.The patient has a history of colon cancer status post low anterior resection in 2008.The patient had a recurrence and underwent a left hemicolectomy with proctectomy and total mesenteric excision in 2009.The patient also had an obtryx tvt-o sling placed in 2010 for relatively mild stress urinary incontinence.The patient did well for several years.The patient was very active with exercise, including biking.She noted the onset of symptoms approximately 5 years ago, but over the last year the patient has noted increasing pain complaints.She notes pain radiating down both of her legs.She also notes a foreign object sensation in the vagina that feels like a billiard ball.She has pain with adduction of her legs.She had burning pain where her rectum was.Her pain was increased with sitting.She did have some symptoms going back 5 years, but much worse since january of this year.She can no longer have sex due to pain.She notes bladder pain with urinary urgency.She also has slow voiding with mixed incontinence.Moreover, potential diagnoses were reviewed such as obturator neuralgia and pudendal neuralgia.The mesh itself can also be a pain trigger, especially for vaginal and bladder pain.She was also at increased risk for a pudendal nerve problem given that she has had a proctectomy.On (b)(6) 2021, she was for in-person consultation after a phone consult in december.The patient had a complicated surgical history including left hemicolectomy with proctectomy and permanent colostomy.The patient also had a mid-urethral trans obturator sling placed in 2010.Patient initially did relatively well but over the last 1-2 years was noted with progressive pain which is now quite distressing.The patient's pain complaints were consistent with both obturator and pudendal neuralgia.Physical exam revealed cystocele, mesh was tender to palpation, and levator plate tender to palpation especially over sacrospinous areas.The impression was that the patient had multiple potential reasons to have pain.The sling itself appeared to be a pain generator as well as the possibility of obturator neuralgia.The patient could have pudendal neuralgia both from the proctectomy and from the sling placement.The plan was for complete removal of the tvt-o sling including both groin components.On (b)(6) 2021, the patient underwent transvaginal mesh excision with cystocele repair and bilateral groin exploration for the treatment of her bladder pain, pelvic pain, postoperative obturator neuralgia, and pudendal neuralgia.The mesh was identified and divided in the midline.A large portion of mesh was dissected and removed from both sides up to the groin.On the left side, it was noted that the mesh must have retracted into the groin and was not in a space that could be accessed.It was felt that any further dissection would lead to further muscle loss to the adductor muscle group.A tiny bit of mesh was still palpable in the obturator muscle that could not be retrieved.On the right side, an identical groin dissection was performed and once again was unable to identify any mesh in this compartment.No mesh could be recovered from the groin, so once again, as much of the mesh from the vaginal aspect was removed as possible leaving only a tiny bit of mesh adherent to the underside of the bone and in the obturator internus muscle and membrane.The patient developed a spinal headache from the spinal anesthesia administered to augment her postoperative pain control.She underwent a blood patch on postoperative day 1.On postoperative day 2, the patient voided with a low postvoid residual.Pain control was adequate with oral oxycodone.She was considered stable for discharge.She was discharged to stay in a local hotel for follow-up with her physician next week.She was given routine instructions.On (b)(6) 2021, according to the pathology report, the vaginal mesh excision consisted with fibrous and skeletal muscle tissue with mild chronic inflammation, rare multinucleated giant cells, and foreign body consistent with mesh.On (b)(6) 2021, the patient was in for her routine post operation check-up.She was doing relatively well.Her vaginal pain was minimal and her incisional pain from groin exploration was also tolerable.She continued to have obturator nerve pain which was more difficult for her.Furthermore, she was voiding normally with no stress incontinence, and she was moving her bowels normally.Her biggest concern was pain control.The physician and the patient discussed their alternatives, and they will try switching her to hydromorphone from the oxycodone.The patient will continue with very light activity over the next few weeks.She will follow-up with her local gynecologist in 4-5 weeks for a postop check, and a new prescription for dilaudid was given by her physician.The patient will have a follow-up via telehealth visit with the physician in approximately 3 months to monitor her progress regarding her neuropathic pain.On (b)(6) 2021, the patient presented to the er with chills, nausea and weakness that started 2 days prior, increased abdominal pain that radiated to her back, distention, and hard stool.She had not been ambulatory since her surgery on february 4th which normally helps her bowel regimen.Imaging showed constipation, and the patient was going to add miralax and senna in addition to colace.On (b)(6) 2021, the patient was seen by a urologist for pelvic prolapse, cystocele, and urinary tract infections.Approximately 2 weeks ago, the patient developed symptoms of urinary tract infection with bladder pain and irritation.She described it as a sensation of suprapubic irritation.She also had some mild dysuria.A urinalysis was performed by her gynecologist which apparently revealed an e.Coli urinary tract infection.She was then placed on macrobid for 5 days.She presented with some persistent symptoms of bladder irritation and inflammation.Her symptoms have partially improved but she was completing the 5-day course of nitrofurantoin.Today, her urinalysis was normal with negative leukocytes and negative nitrites.Her antibiotics were extended for an additional 7 days, and she was given samples of uribel to be used as needed for irritation/inflammation.On (b)(6) 2021, the patient was seen by her obgyn for a follow-up on pelvic pain.Despite extensive groin dissections during mesh removal in february, no additional mesh could be retrieved from these areas.The patient continued to have symptoms of both pudendal and obturator neuralgia.Repeating her groin dissection was not recommended due to the risks and likelihood of being unsuccessful.Transgluteal pudendal nerve decompression was discussed with a potential for unilateral procedure on the left side where the patient's symptoms were worse.The patient was also advised of the protracted nature of nerve healing taking up to 2 years to see maximal improvement along with the clinical failure rate of at least 20%.The possibility of pudendal nerve cryoablation or drg stimulator which has the advantage of potentially treating more than 1 pain generator were also discussed as options.The assessment was continued obturator and pudendal neuralgia.The patient planned to consider her options.On (b)(6) 2021, the patient was in for patient evaluation for outpatient therapy for her pelvic pain, hip pain, limited hip abduction, and other symptoms and signs involving the musculoskeletal system.She had pelvic pain secondary to pelvic floor dysfunction as well as mesh removal in february.She was also deconditioned due to bed rest after surgery as she had been told to rest up due to hemorrhaging after surgery.She reported urinary frequency, incontinence with a full bladder and bending over, difficulty feeling if she has emptied her bladder, pain with initial bladder emptying, and pain with intercourse.Physical therapy evaluation reveals abnormal muscle tone, decreased flexibility, impaired coordination, decreased rom, decreased endurance, impaired balance, and pain (bladder function) resulting in limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab and patient goals and maximize plof of chosen adls.On (b)(6) 2022, the patient was seen and examined for impaired glucose tolerance, hypothyroidism/hashimoto's, and hyperlipidemia, colon cancer status post total colectomy, chemo and radiation in 2009.The patient has had problems with a mesh placed for bladder prolapse which had nerve impingement and pain down her leg.She has been unable to exercise this year.She walks 30 min to an hour per day.She was previously very athletic.The patient has difficulty losing weight since she had bilateral oophorectomy in 2009 when she had colectomy for colon cancer.The patient has also seen several nutritionists.Upon examination the patient reported hearing loss.The patient also reported problems with urination.The patient reported alternately too hot and too cold.The patient reported easy bleeding and a tendency for easy bruising.The patient reported back pain, muscle aches, pain localized to one or more joints, and joint stiffness localized to one or more joints.The patient reported difficulty walking.The patient reported glaucoma or cataracts.The patient reported thyroid disorder.The patient reported currently wearing eyeglasses or contact lenses.A follow up was scheduled for january.Current medication: advil 200 mg oral capsule 0 days, 0 refills.Synthroid 88 mcg oral tablet once a day 0 days, 0 refills.Past medical/surgical history: retinal or dilated eye exam within 1 year.Pregnancy: previously pregnant 2 time(s).Social history: tobacco use: smoking status: never smoker.Alcohol: alcohol use.Habits: exercising regularly.Marital: currently married.On (b)(6) 2022, the patient was seen and examined for her yearly follow up status post lower anterior resection (lar) last (b)(6) 2008, and a recent reconstructive surgery because of problems with bladder mesh in (b)(6) 2021.The patient was reported to be getting physical therapy (pt) for both shoulder and pelvic pain.The patient was doing generally well, however, she still needed a colonoscopy.The patient's urinary tract infections were less common - none this past year.She continued with the same peripheral neuropathy in hands and feet.Fine motor worse.She had a reaction to eye drops with some hearing loss in the interim.Cognitively, she feels about the same, and her family agreed.She is not rowing.She walks about 1.5 miles in 30 min.She has trouble with stairs.She reports significant worsening of bilateral hip and left shoulder pain.Mri of the left shoulder showed significant soft tissue injury - there has been modest improvement with pt.Her last bowel obstruction reported was on (b)(6) 2015 and she was hospitalized at (b)(6) hospital.Obstruction was resolved with bowel rest.The patient was trying to lose weight but was not succeeding due to limited by inability to exercise.Pain at worst 6/10 in the lower back associated with sciatica, sacrum and hips which was not constant.The patient did not require pain medication.Upon examination the patient was positive for cognitive defects.The patient's pain score was 8 out of 10 at worst and currently at 0 out of 10 which was mainly in felt in the hip and bladder.The patient was also depressed.The physician's impression includes: 1.Rectal cancer, well-differentiated adenocarcinoma, stage i resected (b)(6) 2008.For genetic counseling and germline testing was done which did not identify any pathogenic or clinically significant mutations.Tumor marker remains normal.2.Recurrent rectal cancer, (b)(6) 2009, treated with pre-operative chemo rads, and followed by (b)(6).Had post-op folfox 8 cycles till (b)(6) 2009.3.Utis, pyelonephritis.4.Hypothyroidism, medically managed.5.Anxiety, depression: currently not being followed.6.Oxaliplatin neuropathy, persistent, with occasional falls.7.Cognitive sequelae of - chemotherapy - stably disabled with this.8.Knee arthritis.9.Intermittent bowel obstruction - last in 2025.10.She has had side-effects of unusual severity from chemo rads - likely dna repair defect, and they need to check germ line.As part of the patient's plan, she needed to continue with pt for ongoing neurological problems, and new pelvic floor problems.Clinically and radiographically without evidence of disease, now with an mri and ct showing no new abnormalities.Colonoscopy due - her gastroenterologist has retired, and they will ask another physician to see her.The patient needed to continue ongoing follow up and see in 1 year for clinical evaluation.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2010, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: (b)(6).Block h6: patient codes e2330, e1002, e0123, e0126, e1310, e1906, e2326, e1309, and e2328, capture the reportable events of pain (severe lower extremity pain, back pain, pelvic and perineal pain, pain in left shoulder, bladder pain, pelvic pain, incisional pain, joint pain), abdominal pain, nerve damage (pudendal and obturator neuralgia, pain radiating down both of her legs), neuropathy (neuropathic pain), urinary tract infection, infection (worsening pyelonephritis), inflammation (mild chronic inflammation, chronic cystitis), urinary retention (incomplete emptying of bladder), and obstruction (bladder outlet obstruction), respectively.Impact codes f1905, f1202, f08, f2303 and f23, capture the reportable events of device revision or replacement (transvaginal mesh excision), disability (permanently disabled), hospitalization or prolonged hospitalization, medication required (self-start antibiotic therapy, antibiotic management, topical estrogen replacement, cranberry supplementation) and unexpected medical intervention (pain control), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks b5, b7, h6, and h10 have been updated based on the additional information on october 18, 2022.Block h6: patient code e0122 was utilized to capture the reportable event of walking difficulty.Block h11: block a1 has been corrected.Blocks a4, b5, h6 and h10 have been updated based on the additional information received on november 11, 2022.Block h6: patient code e0107 captures the reportable event of cognitive changes.Patient code e020201 captures the reportable event of anxiety.Patient code e020202 captures the reportable event of depression.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to november 29, 2010, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6) (b)(6) hospital (b)(6) (b)(6) hospital (b)(6) dr.(b)(6) (b)(6) (b)(6) hospital (b)(6) (b)(6) hospital (b)(6) (b)(6) hospital (b)(6) dr.(b)(6) (b)(6) dr.(b)(6) (b)(6) block h6: patient codes e2330, e1002, e0123, e0126, e1310, e1906, e2326, e1309, and e2328, capture the reportable events of pain (severe lower extremity pain, back pain, pelvic and perineal pain, pain in left shoulder, bladder pain, pelvic pain, incisional pain, joint pain), abdominal pain, nerve damage (pudendal and obturator neuralgia, pain radiating down both of her legs), neuropathy (neuropathic pain), urinary tract infection, infection (worsening pyelonephritis), inflammation (mild chronic inflammation, chronic cystitis), urinary retention (incomplete emptying of bladder), and obstruction (bladder outlet obstruction), respectively.Impact codes f1905, f1202, f08, f2303 and f23, capture the reportable events of device revision or replacement (transvaginal mesh excision), disability (permanently disabled), hospitalization or prolonged hospitalization, medication required (self-start antibiotic therapy, antibiotic management, topical estrogen replacement, cranberry supplementation) and unexpected medical intervention (pain control), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks b5, b7, h6, and h10 have been updated based on the additional information on october 18, 2022.Block h6: patient code e0122 was utilized to capture the reportable event of walking difficulty.Block h11: block a1 has been corrected.Blocks a4, b5, h6 and h10 have been updated based on the additional information received on november 11, 2022.Block h6: patient code e020201 captures the reportable event of anxiety.Patient code e020202 captures the reportable event of depression.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: block h6 has been updated based on medical review received on december 12, 2022.Block h11: block b5 has been updated based on additional information received on january 4, 2023.

Event Description

It was reported to boston scientific corporation that an obtryx halo single system was implanted during a cystocele repair, major urethral transobturator sling and cystoscopy procedure performed on (b)(6) 2010, for the treatment of urethral hypermobility, stress urinary incontinence, and cystocele.The patient had a history of advanced colorectal cancer, had two pelvic and abdominal surgeries after chemotherapy and radiation, and had developed stress urinary incontinence in recent years.She was originally seen in the early stages of incontinence over the last few years.She was originally seen in the early part of 2010 with the recommendations for urodynamics and to consider vaginal surgery for her incontinence.She finally followed up in early november, wishing to pursue her surgery now that she has been in a state of remission for her colorectal malignancy.Urodynamics were performed, demonstrating stress urinary incontinence with a low valsalva leak point pressure, and her physical exam confirmed the presence of hypermobility and a central cystocele.There was some descent of her uterus, but not enough to call it a uterine prolapse.Moreover, the options for the patient were reviewed by the physician, which included observation, kegel exercises, collagen injection, and a sling procedure with cystocele repair.The physician explained to the patient that he would keep her procedure very basic and not pursue anything with extensive surgical intervention due to her previous pelvic radiation, chemotherapy, and previous abdominal pelvic surgery.The physician recommended a simple cystocele repair and the insertion of a mid-urethral sling either by a pubovaginal approach or a transobturator approach.The physician explained the side effects of doing this surgery, such as infection, bleeding, erosion, retention, pain, and failure to resolve her incontinence.The physician also told the patient that he would make his decision on the type of sling once he performed the operation and looked inside of her bladder.In the past, her bladder was consistent with radiation changes.He also gave the patient the option of a second opinion as well.After reviewing and hearing the physician's recommendation, the patient wishes to pursue the surgery on (b)(6) 2010.On (b)(6) 2017, the patient was presented to the emergency department (ed) from uro-gyn for admission for iv antibiotics due to worsening pyelonephritis after receiving a cystoscopy.The patient was admitted with urinary tract infection (uti), voiding difficulties, and multiple drug allergies.She began experiencing recurrent utis earlier this year.She had a proteus uti earlier this year and had an escherichia coli uti in july.Because of her repeated utis, she was referred to a physician from urogynecology where she underwent cystoscopy last week.Thereafter, she had ongoing dysuria and a reaction to ciprofloxacin with severe lower extremity pain which she described as ripping in her muscles in her lower legs.The patient was in for antibiotic management and pain control.She has some ongoing mild suprapubic discomfort, but dysuria has resolved and there was no incontinence.Moreover, she had urethral sling procedure about 5 years ago.She stated that her sling may be a little bit overcorrected, and she typically had a residual of approximately 40cc.The patient had an element of bladder outlet obstruction which could lead to residuals though her reported residuals was only 40cc which was acceptable.If she did have an element of bladder outlet obstruction from an overcorrected urethra from a prior sling procedure, she may have high pressure voiding which could place her at risk for repeated utis.This could be evaluated with multichannel urodynamics.Furthermore, the patient is on prophylactic therapy for utis which included cranberry supplementation and estrogen replacement.She should be considered for self-start antibiotic therapy typically consisting of one pill twice daily for 3 days as soon as patient begins experiencing symptoms but due to her multiple drug allergies, her best drug of choice in this instance would be nitrofurantoin.She did have underlying dyspareunia since the surgery and there was no known history of a urethral diverticulum.Abdominal ct was performed for generalized abdominal pain to rule out pyelonephritis and abscess status post procedure cystoscopy.No acute abnormality was noted.The assessment was complicated uti.The plan was to treat with rocephin, iv fluids, enoxaparin, and hydromorphone.On (b)(6) 2017, the patient returned to the office with her husband for follow-up of urinary tract infection (uti) and dysuria.She was discharged on macrobid which she completed last friday.She continues to have symptoms of burning, lower abdominal pain, low back pain and fatigue.She stated that she had not felt right since the cystoscopic examination.She underwent multichannel urodynamics.There was no evidence of bladder outlet obstruction.Pressure flow nomogram was consistent with absence of the obstruction.She had high flow low pressure voiding.All her urinary symptoms, lower back pain and lower abdominal pain have resolved.At the present time, she is asymptomatic.After her urodynamics, she was recommended to try estring but she developed significant reaction and she subsequently discontinued the medication with resolution of her symptoms.During assessment, the patient did not have any voiding difficulties.It took about 6 weeks for her to recover from her cystoscopy which raised the question as to whether she had an allergic reaction of some type to the prep solution or the cystoscopic sterilization process that was performed at her uro-gynecologist's office.She does not have evidence of bladder outlet obstruction from her prior sling procedure.Discussion was held as to how to manage her repeated utis.Reportedly, she remained on theragran hp, and discussed with her physician other estrogen replacements including estrace or oral tablets.In addition, they also discussed self-start therapy with antibiotics such as nitrofurantoin.She also indicated that she developed some type of facial skin reaction after being on a suppressive antibiotic which she does not recall the name.Moreover, the physician advised the patient not to be given with any additional antibiotic until they know what medication that was.She has a multitude of drug allergies making antibiotic options for treatment difficult.On (b)(6) 2020, the patient with a past medical history of stage 4 colon cancer with hemicolectomy and colostomy bag as well as hypothyroidism who presented to ed with a month history of pelvic pain with radiation to lower back constantly for a week.Also, she presented with abdominal pain and dyspareunia.She stated that she has history of bladder prolapse in 2010 where she had mesh sling placed and was evaluated by her urologist a week ago who noted that the patient had prolapse at that time and was advised to have a follow-up with a specialist.Furthermore, the patient's appointment was not until next week but due to continued pain, she came to ed for evaluation.It was also noted that the patient had occasional nausea and left shoulder pain, that was not worse with movement.The patient had taken ibuprofen.Physical exam revealed suprapubic tenderness, mildly erythematous vaginal vault, uterine prolapse, and mild tenderness to bilateral paravertebral lumbar spine.Ct was consistent with uterine prolapse.The patient was to follow up with urogyn.On (b)(6) 2020, the patient presented for physical therapy (pt) evaluation with symptoms of pudendal neuralgia following history of colon cancer/treatment, bladder suspension and frequent falls.She had high tone pelvic floor musculature r>l and reported significant pain with sitting.She will benefit from physical therapy to reduce pain symptoms and educate patient in self-care management.The patient arrived and stated that she started to have pain this winter in her vulva, lower abdomen and lower back.Her symptoms were reported as pins and needles/ burnings/coldness.She stated that she felt like there was a ball in her vagina and had been diagnosed with slight uterine prolapse.Her chief complaint was pain with sitting and had inability to have penetrative intercourse with her husband.She was then referred to physical therapy.Previously, the patient was not working due to being permanently disabled.She stopped working and was not able to walk 10 years ago.She was unable to walk currently and has boot on right foot secondary to possible metatarsal fracture.Her physical therapy (pt) evaluation revealed abnormal muscle tone, decreased strength, pain, decreased flexibility, impaired sensation resulting in self-care, home management, community/leisure limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab, patient goals and maximize prior level of function (plof) of chosen activities of daily living (adl).On (b)(6) 2020, the patient presented to emergency department (ed) for evaluation of urinary urgency, frequency, dysuria and hematuria since friday.The patient was seen on friday for evaluation of ongoing lower abdominal pain that the patient suspected may be due to implanted mesh used for repair of prolapse.The patient has had prior outpatient imaging.The patient had a straight catheterization, which she stated was traumatic and painful due to known strictures from prior radiation.The patient noted that she was especially susceptible to uti, after instrumentation and has had many previously.Additionally, she had episode of gross hematuria last night with continued urethral discomfort.Urinalysis was abnormal with moderate bacteria, blood, and leukocytes.A urine culture was submitted.The patient was diagnosed with acute cystitis with hematuria and prescribed macrobid pending culture results.On (b)(6) 2020, she had returned to physical therapy with pelvic pain.She felt her pain was associated to her cystocele repair with mesh insertion 10 years ago.She had a follow-up with a physician, had bladder installations and injections into pfm of trameel.She stated nothing was working and she continued to have pain constantly in low back, across lower abdomen and numbness in perineum.The patient reported that her interstitial cystitis was treated, and she felt that it was not the issue.Atrophic changes were noted in the vulva vestibule as was tenderness to adductors and piriformis.She had abnormal muscle tone and decreased strength.The plan was for weekly pt and therapeutic activities at home.On (b)(6) 2020, the patient had a telehealth visit regarding pelvic pain and possible pudendal and obturator neuralgia.The patient has a history of colon cancer status post low anterior resection in 2008.The patient had a recurrence and underwent a left hemicolectomy with proctectomy and total mesenteric excision in 2009.The patient also had an obtryx tvt-o sling placed in 2010 for relatively mild stress urinary incontinence.The patient did well for several years.The patient was very active with exercise, including biking.She noted the onset of symptoms approximately 5 years ago, but over the last year the patient has noted increasing pain complaints.She notes pain radiating down both of her legs.She also notes a foreign object sensation in the vagina that feels like a billiard ball.She has pain with adduction of her legs.She had burning pain where her rectum was.Her pain was increased with sitting.She did have some symptoms going back 5 years, but much worse since january of this year.She can no longer have sex due to pain.She notes bladder pain with urinary urgency.She also has slow voiding with mixed incontinence.Moreover, potential diagnoses were reviewed such as obturator neuralgia and pudendal neuralgia.The mesh itself can also be a pain trigger, especially for vaginal and bladder pain.She was also at increased risk for a pudendal nerve problem given that she has had a proctectomy.On (b)(6) 2021, she was for in-person consultation after a phone consult in december.The patient had a complicated surgical history including left hemicolectomy with proctectomy and permanent colostomy.The patient also had a mid-urethral trans obturator sling placed in 2010.Patient initially did relatively well but over the last 1-2 years was noted with progressive pain which is now quite distressing.The patient's pain complaints were consistent with both obturator and pudendal neuralgia.Physical exam revealed cystocele, mesh was tender to palpation, and levator plate tender to palpation especially over sacrospinous areas.The impression was that the patient had multiple potential reasons to have pain.The sling itself appeared to be a pain generator as well as the possibility of obturator neuralgia.The patient could have pudendal neuralgia both from the proctectomy and from the sling placement.The plan was for complete removal of the tvt-o sling including both groin components.On (b)(6) 2021, the patient underwent transvaginal mesh excision with cystocele repair and bilateral groin exploration for the treatment of her bladder pain, pelvic pain, postoperative obturator neuralgia, and pudendal neuralgia.The mesh was identified and divided in the midline.A large portion of mesh was dissected and removed from both sides up to the groin.On the left side, it was noted that the mesh must have retracted into the groin and was not in a space that could be accessed.It was felt that any further dissection would lead to further muscle loss to the adductor muscle group.A tiny bit of mesh was still palpable in the obturator muscle that could not be retrieved.On the right side, an identical groin dissection was performed and once again was unable to identify any mesh in this compartment.No mesh could be recovered from the groin, so once again, as much of the mesh from the vaginal aspect was removed as possible leaving only a tiny bit of mesh adherent to the underside of the bone and in the obturator internus muscle and membrane.The patient developed a spinal headache from the spinal anesthesia administered to augment her postoperative pain control.She underwent a blood patch on postoperative day 1.On postoperative day 2, the patient voided with a low postvoid residual.Pain control was adequate with oral oxycodone.She was considered stable for discharge.She was discharged to stay in a local hotel for follow-up with her physician next week.She was given routine instructions.On (b)(6) 2021, according to the pathology report, the vaginal mesh excision consisted with fibrous and skeletal muscle tissue with mild chronic inflammation, rare multinucleated giant cells, and foreign body consistent with mesh.On (b)(6) 2021, the patient was in for her routine post operation check-up.She was doing relatively well.Her vaginal pain was minimal and her incisional pain from groin exploration was also tolerable.She continued to have obturator nerve pain which was more difficult for her.Furthermore, she was voiding normally with no stress incontinence, and she was moving her bowels normally.Her biggest concern was pain control.The physician and the patient discussed their alternatives, and they will try switching her to hydromorphone from the oxycodone.The patient will continue with very light activity over the next few weeks.She will follow-up with her local gynecologist in 4-5 weeks for a postop check, and a new prescription for dilaudid was given by her physician.The patient will have a follow-up via telehealth visit with the physician in approximately 3 months to monitor her progress regarding her neuropathic pain.On (b)(6) 2021, the patient presented to the er with chills, nausea and weakness that started 2 days prior, increased abdominal pain that radiated to her back, distention, and hard stool.She had not been ambulatory since her surgery on february 4th which normally helps her bowel regimen.Imaging showed constipation, and the patient was going to add miralax and senna in addition to colace.On (b)(6) 2021, the patient was seen by a urologist for pelvic prolapse, cystocele, and urinary tract infections.Approximately 2 weeks ago, the patient developed symptoms of urinary tract infection with bladder pain and irritation.She described it as a sensation of suprapubic irritation.She also had some mild dysuria.A urinalysis was performed by her gynecologist which apparently revealed an e.Coli urinary tract infection.She was then placed on macrobid for 5 days.She presented with some persistent symptoms of bladder irritation and inflammation.Her symptoms have partially improved but she was completing the 5-day course of nitrofurantoin.Today, her urinalysis was normal with negative leukocytes and negative nitrites.Her antibiotics were extended for an additional 7 days, and she was given samples of uribel to be used as needed for irritation/inflammation.On (b)(6) 2021, the patient was seen by her obgyn for a follow-up on pelvic pain.Despite extensive groin dissections during mesh removal in february, no additional mesh could be retrieved from these areas.The patient continued to have symptoms of both pudendal and obturator neuralgia.Repeating her groin dissection was not recommended due to the risks and likelihood of being unsuccessful.Transgluteal pudendal nerve decompression was discussed with a potential for unilateral procedure on the left side where the patient's symptoms were worse.The patient was also advised of the protracted nature of nerve healing taking up to 2 years to see maximal improvement along with the clinical failure rate of at least 20%.The possibility of pudendal nerve cryoablation or drg stimulator which has the advantage of potentially treating more than 1 pain generator were also discussed as options.The assessment was continued obturator and pudendal neuralgia.The patient planned to consider her options.On (b)(6) 2021, the patient was in for patient evaluation for outpatient therapy for her pelvic pain, hip pain, limited hip abduction, and other symptoms and signs involving the musculoskeletal system.She had pelvic pain secondary to pelvic floor dysfunction as well as mesh removal in february.She was also deconditioned due to bed rest after surgery as she had been told to rest up due to hemorrhaging after surgery.She reported urinary frequency, incontinence with a full bladder and bending over, difficulty feeling if she has emptied her bladder, pain with initial bladder emptying, and pain with intercourse.Physical therapy evaluation reveals abnormal muscle tone, decreased flexibility, impaired coordination, decreased rom, decreased endurance, impaired balance, and pain (bladder function) resulting in limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab and patient goals and maximize plof of chosen adls.***additional information october 18, 2022*** on (b)(6) 2022, the patient was seen and examined for impaired glucose tolerance, hypothyroidism/hashimoto's, and hyperlipidemia, colon cancer status post total colectomy, chemo and radiation in 2009.The patient has had problems with a mesh placed for bladder prolapse which had nerve impingement and pain down her leg.She has been unable to exercise this year.She walks 30 min to an hour per day.She was previously very athletic.The patient has difficulty losing weight since she had bilateral oopherectomy in 2009 when she had colectomy for colon cancer.The patient has also seen several nutritionists.Upon examination the patient reported hearing loss.The patient also reported problems with urination.The patient reported alternately too hot and too cold.The patient reported easy bleeding and a tendency for easy bruising.The patient reported back pain, muscle aches, pain localized to one or more joints, and joint stiffness localized to one or more joints.The patient reported difficulty walking.The patient reported glaucoma or cataracts.The patient reported thyroid disorder.The patient reported currently wearing eyeglasses or contact lenses.A follow up was scheduled for january.Current medication: - advil 200 mg oral capsule 0 days, 0 refills - synthroid 88 mcg oral tablet once a day 0 days, 0 refills past medical/surgical history: retinal or dilated eye exam within 1 year.Pregnancy: previously pregnant 2 time(s).Social history: tobacco use: smoking status: never smoker.Alcohol: alcohol use.Habits: exercising regularly.Marital: currently married.***additional information received on november 11, 2022*** on (b)(6) 2022, the patient was seen and examined for her yearly follow up status post lower anterior resection (lar) last (b)(6) 2008, and a recent reconstructive surgery because of problems with bladder mesh in february 2021.The patient was reported to be getting physical therapy (pt) for both shoulder and pelvic pain.The patient was doing generally well, however, she still needed a colonoscopy.The patient's urinary tract infections were less common - none this past year.She continued with the same peripheral neuropathy in hands and feet.Fine motor worse.She had a reaction to eye drops with some hearing loss in the interim.Cognitively, she feels about the same, and her family agreed.She is not rowing.She walks about 1.5 miles in 30 min.She has trouble with stairs.She reports significant worsening of bilateral hip and left shoulder pain.Mri of the left shoulder showed significant soft tissue injury - there has been modest improvement with pt.Her last bowel obstruction reported was on june 25, 2015 and she was hospitalized at virtua hospital.Obstruction was resolved with bowel rest.The patient was trying to lose weight but was not succeeding due to limited by inability to exercise.Pain at worst 6/10 in the lower back associated with sciatica, sacrum and hips which was not constant.The patient did not require pain medication.Upon examination the patient was positive for cognitive defects.The patient's pain score was 8 out of 10 at worst and currently at 0 out of 10 which was mainly in felt in the hip and bladder.The patient was also depressed.The physician's impression includes: 1.Rectal cancer, well-differentiated adenocarcinoma, stage i resected 1/16/08.For genetic counseling and germline testing was done which did not identify any pathogenic or clinically significant mutations.Tumor marker remains normal.2.Recurrent rectal cancer, 1/2009, treated with pre-operative chemo rads, and followed by apr on 5/16109.Had post-op folfox 8 cycles till 11/9/09.3.Utis, pyelonephritis 4.Hypothyroidism, medically managed 5.Anxiety, depression: currently not being followed 6.Oxaliplatin neuropathy, persistent, with occasional falls 7.Cognitive sequelae of - chemotherapy - stably disabled with this 8.Knee arthritis 9.Intermittent bowel obstruction - last in 2025 10.She has had side-effects of unusual severity from chemo rads - likely dna repair defect, and they need to check germ line.As part of the patient's plan, she needed to continue with pt for ongoing neurological problems, and new pelvic floor problems.Clinically and radiographically without evidence of disease, now with an mri and ct showing no new abnormalities.Colonoscopy due - her gastroenterologist has retired, and they will ask another physician to see her.The patient needed to continue ongoing follow up and see in 1 year for clinical evaluation.***additional information received on january 4, 2023*** on (b)(6) 2021, the patient was seen and examined.The patient presented to the clinic for evaluation of abnormal uterine bleeding.The patient had a recent transvaginal mesh excision with cystocele repair and bilateral groin exploration.The mesh was reported to be located in an abnormal location.The patient also complained of occasional stress/urge incontinence which was manageable.The patient reported postoperative difficulty with hip abduction.In the physician's assessment the patient experienced a high-tone pelvic floor dysfunction, hyperlipidemia, stress incontinence, hypothyroidism, gastroesophageal reflux disease, and anxiety.The patient was also status post radiation therapy and chemotherapy.It was noted that the patient was healing well after her surgery.The patient reported that she noted a change in her pain.The physician recommended to use a small amount of premarin in the post operation period to help with vaginal healing.On (b)(6) 2022, the patient was seen and examined for her annual gynecologic examination.The patient reported that was not sexually active due to dyspareunia after surgery with mesh placement and removal.Upon examination, the patient's vagina appeared to be in atrophy and a stage 1-2 cystocele was noted.The patient also reported leakage with bending and she was wearing pads.She also had recurrent urinary tract infections with two kidney infections.

Event Description

It was reported to boston scientific corporation that an obtryx halo single system was implanted during a cystocele repair, major urethral transobturator sling and cystoscopy procedure performed on (b)(6), 2010, for the treatment of urethral hypermobility, stress urinary incontinence, and cystocele.The patient had a history of advanced colorectal cancer, had two pelvic and abdominal surgeries after chemotherapy and radiation, and had developed stress urinary incontinence in recent years.She was originally seen in the early stages of incontinence over the last few years.She was originally seen in the early part of 2010 with the recommendations for urodynamics and to consider vaginal surgery for her incontinence.She finally followed up in early november, wishing to pursue her surgery now that she has been in a state of remission for her colorectal malignancy.Urodynamics were performed, demonstrating stress urinary incontinence with a low valsalva leak point pressure, and her physical exam confirmed the presence of hypermobility and a central cystocele.There was some descent of her uterus, but not enough to call it a uterine prolapse.Moreover, the options for the patient were reviewed by the physician, which included observation, kegel exercises, collagen injection, and a sling procedure with cystocele repair.The physician explained to the patient that he would keep her procedure very basic and not pursue anything with extensive surgical intervention due to her previous pelvic radiation, chemotherapy, and previous abdominal pelvic surgery.The physician recommended a simple cystocele repair and the insertion of a mid-urethral sling either by a pubovaginal approach or a transobturator approach.The physician explained the side effects of doing this surgery, such as infection, bleeding, erosion, retention, pain, and failure to resolve her incontinence.The physician also told the patient that he would make his decision on the type of sling once he performed the operation and looked inside of her bladder.In the past, her bladder was consistent with radiation changes.He also gave the patient the option of a second opinion as well.After reviewing and hearing the physician's recommendation, the patient wishes to pursue the surgery on (b)(6), 2010.On (b)(6), 2017, the patient was presented to the emergency department (ed) from uro-gyn for admission for iv antibiotics due to worsening pyelonephritis after receiving a cystoscopy.The patient was admitted with urinary tract infection (uti), voiding difficulties, and multiple drug allergies.She began experiencing recurrent utis earlier this year.She had a proteus uti earlier this year and had an escherichia coli uti in july.Because of her repeated utis, she was referred to a physician from urogynecology where she underwent cystoscopy last week.Thereafter, she had ongoing dysuria and a reaction to ciprofloxacin with severe lower extremity pain which she described as ripping in her muscles in her lower legs.The patient was in for antibiotic management and pain control.She has some ongoing mild suprapubic discomfort, but dysuria has resolved and there was no incontinence.Moreover, she had urethral sling procedure about 5 years ago.She stated that her sling may be a little bit overcorrected, and she typically had a residual of approximately 40cc.The patient had an element of bladder outlet obstruction which could lead to residuals though her reported residuals was only 40cc which was acceptable.If she did have an element of bladder outlet obstruction from an overcorrected urethra from a prior sling procedure, she may have high pressure voiding which could place her at risk for repeated utis.This could be evaluated with multichannel urodynamics.Furthermore, the patient is on prophylactic therapy for utis which included cranberry supplementation and estrogen replacement.She should be considered for self-start antibiotic therapy typically consisting of one pill twice daily for 3 days as soon as patient begins experiencing symptoms but due to her multiple drug allergies, her best drug of choice in this instance would be nitrofurantoin.She did have underlying dyspareunia since the surgery and there was no known history of a urethral diverticulum.Abdominal ct was performed for generalized abdominal pain to rule out pyelonephritis and abscess status post procedure cystoscopy.No acute abnormality was noted.The assessment was complicated uti.The plan was to treat with rocephin, iv fluids, enoxaparin, and hydromorphone.On (b)(6) 2017, the patient returned to the office with her husband for follow-up of urinary tract infection (uti) and dysuria.She was discharged on macrobid which she completed last friday.She continues to have symptoms of burning, lower abdominal pain, low back pain and fatigue.She stated that she had not felt right since the cystoscopic examination.She underwent multichannel urodynamics.There was no evidence of bladder outlet obstruction.Pressure flow nomogram was consistent with absence of the obstruction.She had high flow low pressure voiding.All her urinary symptoms, lower back pain and lower abdominal pain have resolved.At the present time, she is asymptomatic.After her urodynamics, she was recommended to try estring but she developed significant reaction and she subsequently discontinued the medication with resolution of her symptoms.During assessment, the patient did not have any voiding difficulties.It took about 6 weeks for her to recover from her cystoscopy which raised the question as to whether she had an allergic reaction of some type to the prep solution or the cystoscopic sterilization process that was performed at her uro-gynecologist's office.She does not have evidence of bladder outlet obstruction from her prior sling procedure.Discussion was held as to how to manage her repeated utis.Reportedly, she remained on theragran hp, and discussed with her physician other estrogen replacements including estrace or oral tablets.In addition, they also discussed self-start therapy with antibiotics such as nitrofurantoin.She also indicated that she developed some type of facial skin reaction after being on a suppressive antibiotic which she does not recall the name.Moreover, the physician advised the patient not to be given with any additional antibiotic until they know what medication that was.She has a multitude of drug allergies making antibiotic options for treatment difficult.On (b)(6), 2020, the patient with a past medical history of stage 4 colon cancer with hemicolectomy and colostomy bag as well as hypothyroidism who presented to ed with a month history of pelvic pain with radiation to lower back constantly for a week.Also, she presented with abdominal pain and dyspareunia.She stated that she has history of bladder prolapse in 2010 where she had mesh sling placed and was evaluated by her urologist a week ago who noted that the patient had prolapse at that time and was advised to have a follow-up with a specialist.Furthermore, the patient's appointment was not until next week but due to continued pain, she came to ed for evaluation.It was also noted that the patient had occasional nausea and left shoulder pain, that was not worse with movement.The patient had taken ibuprofen.Physical exam revealed suprapubic tenderness, mildly erythematous vaginal vault, uterine prolapse, and mild tenderness to bilateral paravertebral lumbar spine.Ct was consistent with uterine prolapse.The patient was to follow up with urogyn.On (b)(6), 2020, the patient presented for physical therapy (pt) evaluation with symptoms of pudendal neuralgia following history of colon cancer/treatment, bladder suspension and frequent falls.She had high tone pelvic floor musculature r>l and reported significant pain with sitting.She will benefit from physical therapy to reduce pain symptoms and educate patient in self-care management.The patient arrived and stated that she started to have pain this winter in her vulva, lower abdomen and lower back.Her symptoms were reported as pins and needles/ burnings/coldness.She stated that she felt like there was a ball in her vagina and had been diagnosed with slight uterine prolapse.Her chief complaint was pain with sitting and had inability to have penetrative intercourse with her husband.She was then referred to physical therapy.Previously, the patient was not working due to being permanently disabled.She stopped working and was not able to walk 10 years ago.She was unable to walk currently and has boot on right foot secondary to possible metatarsal fracture.Her physical therapy (pt) evaluation revealed abnormal muscle tone, decreased strength, pain, decreased flexibility, impaired sensation resulting in self-care, home management, community/leisure limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab, patient goals and maximize prior level of function (plof) of chosen activities of daily living (adl).On (b)(6), 2020, the patient presented to emergency department (ed) for evaluation of urinary urgency, frequency, dysuria and hematuria since friday.The patient was seen on friday for evaluation of ongoing lower abdominal pain that the patient suspected may be due to implanted mesh used for repair of prolapse.The patient has had prior outpatient imaging.The patient had a straight catheterization, which she stated was traumatic and painful due to known strictures from prior radiation.The patient noted that she was especially susceptible to uti, after instrumentation and has had many previously.Additionally, she had episode of gross hematuria last night with continued urethral discomfort.Urinalysis was abnormal with moderate bacteria, blood, and leukocytes.A urine culture was submitted.The patient was diagnosed with acute cystitis with hematuria and prescribed macrobid pending culture results.On (b)(6), 2020, she had returned to physical therapy with pelvic pain.She felt her pain was associated to her cystocele repair with mesh insertion 10 years ago.She had a follow-up with a physician, had bladder installations and injections into pfm of trameel.She stated nothing was working and she continued to have pain constantly in low back, across lower abdomen and numbness in perineum.The patient reported that her interstitial cystitis was treated, and she felt that it was not the issue.Atrophic changes were noted in the vulva vestibule as was tenderness to adductors and piriformis.She had abnormal muscle tone and decreased strength.The plan was for weekly pt and therapeutic activities at home.On (b)(6), 2020, the patient had a telehealth visit regarding pelvic pain and possible pudendal and obturator neuralgia.The patient has a history of colon cancer status post low anterior resection in 2008.The patient had a recurrence and underwent a left hemicolectomy with proctectomy and total mesenteric excision in 2009.The patient also had an obtryx tvt-o sling placed in 2010 for relatively mild stress urinary incontinence.The patient did well for several years.The patient was very active with exercise, including biking.She noted the onset of symptoms approximately 5 years ago, but over the last year the patient has noted increasing pain complaints.She notes pain radiating down both of her legs.She also notes a foreign object sensation in the vagina that feels like a billiard ball.She has pain with adduction of her legs.She had burning pain where her rectum was.Her pain was increased with sitting.She did have some symptoms going back 5 years, but much worse since january of this year.She can no longer have sex due to pain.She notes bladder pain with urinary urgency.She also has slow voiding with mixed incontinence.Moreover, potential diagnoses were reviewed such as obturator neuralgia and pudendal neuralgia.The mesh itself can also be a pain trigger, especially for vaginal and bladder pain.She was also at increased risk for a pudendal nerve problem given that she has had a proctectomy.On (b)(6), 2021, she was for in-person consultation after a phone consult in december.The patient had a complicated surgical history including left hemicolectomy with proctectomy and permanent colostomy.The patient also had a mid-urethral trans obturator sling placed in 2010.Patient initially did relatively well but over the last 1-2 years was noted with progressive pain which is now quite distressing.The patient's pain complaints were consistent with both obturator and pudendal neuralgia.Physical exam revealed cystocele, mesh was tender to palpation, and levator plate tender to palpation especially over sacrospinous areas.The impression was that the patient had multiple potential reasons to have pain.The sling itself appeared to be a pain generator as well as the possibility of obturator neuralgia.The patient could have pudendal neuralgia both from the proctectomy and from the sling placement.The plan was for complete removal of the tvt-o sling including both groin components.On (b)(6), 2021, the patient underwent transvaginal mesh excision with cystocele repair and bilateral groin exploration for the treatment of her bladder pain, pelvic pain, postoperative obturator neuralgia, and pudendal neuralgia.The mesh was identified and divided in the midline.A large portion of mesh was dissected and removed from both sides up to the groin.On the left side, it was noted that the mesh must have retracted into the groin and was not in a space that could be accessed.It was felt that any further dissection would lead to further muscle loss to the adductor muscle group.A tiny bit of mesh was still palpable in the obturator muscle that could not be retrieved.On the right side, an identical groin dissection was performed and once again was unable to identify any mesh in this compartment.No mesh could be recovered from the groin, so once again, as much of the mesh from the vaginal aspect was removed as possible leaving only a tiny bit of mesh adherent to the underside of the bone and in the obturator internus muscle and membrane.The patient developed a spinal headache from the spinal anesthesia administered to augment her postoperative pain control.She underwent a blood patch on postoperative day 1.On postoperative day 2, the patient voided with a low postvoid residual.Pain control was adequate with oral oxycodone.She was considered stable for discharge.She was discharged to stay in a local hotel for follow-up with her physician next week.She was given routine instructions.On (b)(6), 2021, according to the pathology report, the vaginal mesh excision consisted with fibrous and skeletal muscle tissue with mild chronic inflammation, rare multinucleated giant cells, and foreign body consistent with mesh.On (b)(6), 2021, the patient was in for her routine post operation check-up.She was doing relatively well.Her vaginal pain was minimal and her incisional pain from groin exploration was also tolerable.She continued to have obturator nerve pain which was more difficult for her.Furthermore, she was voiding normally with no stress incontinence, and she was moving her bowels normally.Her biggest concern was pain control.The physician and the patient discussed their alternatives, and they will try switching her to hydromorphone from the oxycodone.The patient will continue with very light activity over the next few weeks.She will follow-up with her local gynecologist in 4-5 weeks for a postop check, and a new prescription for dilaudid was given by her physician.The patient will have a follow-up via telehealth visit with the physician in approximately 3 months to monitor her progress regarding her neuropathic pain.On (b)(6), 2021, the patient presented to the er with chills, nausea and weakness that started 2 days prior, increased abdominal pain that radiated to her back, distention, and hard stool.She had not been ambulatory since her surgery on february 4th which normally helps her bowel regimen.Imaging showed constipation, and the patient was going to add miralax and senna in addition to colace.On (b)(6), 2021, the patient was seen by a urologist for pelvic prolapse, cystocele, and urinary tract infections.Approximately 2 weeks ago, the patient developed symptoms of urinary tract infection with bladder pain and irritation.She described it as a sensation of suprapubic irritation.She also had some mild dysuria.A urinalysis was performed by her gynecologist which apparently revealed an e.Coli urinary tract infection.She was then placed on macrobid for 5 days.She presented with some persistent symptoms of bladder irritation and inflammation.Her symptoms have partially improved but she was completing the 5-day course of nitrofurantoin.Today, her urinalysis was normal with negative leukocytes and negative nitrites.Her antibiotics were extended for an additional 7 days, and she was given samples of uribel to be used as needed for irritation/inflammation.On (b)(6), 2021, the patient was seen by her obgyn for a follow-up on pelvic pain.Despite extensive groin dissections during mesh removal in february, no additional mesh could be retrieved from these areas.The patient continued to have symptoms of both pudendal and obturator neuralgia.Repeating her groin dissection was not recommended due to the risks and likelihood of being unsuccessful.Transgluteal pudendal nerve decompression was discussed with a potential for unilateral procedure on the left side where the patient's symptoms were worse.The patient was also advised of the protracted nature of nerve healing taking up to 2 years to see maximal improvement along with the clinical failure rate of at least 20%.The possibility of pudendal nerve cryoablation or drg stimulator which has the advantage of potentially treating more than 1 pain generator were also discussed as options.The assessment was continued obturator and pudendal neuralgia.The patient planned to consider her options.On (b)(6), 2021, the patient was in for patient evaluation for outpatient therapy for her pelvic pain, hip pain, limited hip abduction, and other symptoms and signs involving the musculoskeletal system.She had pelvic pain secondary to pelvic floor dysfunction as well as mesh removal in february.She was also deconditioned due to bed rest after surgery as she had been told to rest up due to hemorrhaging after surgery.She reported urinary frequency, incontinence with a full bladder and bending over, difficulty feeling if she has emptied her bladder, pain with initial bladder emptying, and pain with intercourse.Physical therapy evaluation reveals abnormal muscle tone, decreased flexibility, impaired coordination, decreased rom, decreased endurance, impaired balance, and pain (bladder function) resulting in limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab and patient goals and maximize plof of chosen adls.Additional information october 18, 2022.On (b)(6), 2022, the patient was seen and examined for impaired glucose tolerance, hypothyroidism/hashimoto's, and hyperlipidemia, colon cancer status post total colectomy, chemo and radiation in 2009.The patient has had problems with a mesh placed for bladder prolapse which had nerve impingement and pain down her leg.She has been unable to exercise this year.She walks 30 min to an hour per day.She was previously very athletic.The patient has difficulty losing weight since she had bilateral oopherectomy in 2009 when she had colectomy for colon cancer.The patient has also seen several nutritionists.Upon examination the patient reported hearing loss.The patient also reported problems with urination.The patient reported alternately too hot and too cold.The patient reported easy bleeding and a tendency for easy bruising.The patient reported back pain, muscle aches, pain localized to one or more joints, and joint stiffness localized to one or more joints.The patient reported difficulty walking.The patient reported glaucoma or cataracts.The patient reported thyroid disorder.The patient reported currently wearing eyeglasses or contact lenses.A follow up was scheduled for january.Current medication: advil 200 mg oral capsule 0 days, 0 refills, synthroid 88 mcg oral tablet once a day 0 days, 0 refills.Past medical/surgical history: retinal or dilated eye exam within 1 year.Pregnancy: previously pregnant 2 time(s).Social history: tobacco use: smoking status: never smoker.Alcohol: alcohol use.Habits: exercising regularly.Marital: currently married.Additional information received on november 11, 2022.On (b)(6), 2022, the patient was seen and1 examined for her yearly follow up status post lower anterior resection (lar) last (b)(6), 2008, and a recent reconstructive surgery because of problems with bladder mesh in (b)(6) 2021.The patient was reported to be getting physical therapy (pt) for both shoulder and pelvic pain.The patient was doing generally well, however, she still needed a colonoscopy.The patient's urinary tract infections were less common - none this past year.She continued with the same peripheral neuropathy in hands and feet.Fine motor worse.She had a reaction to eye drops with some hearing loss in the interim.Cognitively, she feels about the same, and her family agreed.She is not rowing.She walks about 1.5 miles in 30 min.She has trouble with stairs.She reports significant worsening of bilateral hip and left shoulder pain.Mri of the left shoulder showed significant soft tissue injury - there has been modest improvement with pt.Her last bowel obstruction reported was on (b)(6), 2015 and she was hospitalized at virtua hospital.Obstruction was resolved with bowel rest.The patient was trying to lose weight but was not succeeding due to limited by inability to exercise.Pain at worst 6/10 in the lower back associated with sciatica, sacrum and hips which was not constant.The patient did not require pain medication.Upon examination the patient was positive for cognitive defects.The patient's pain score was 8 out of 10 at worst and currently at 0 out of 10 which was mainly in felt in the hip and bladder.The patient was also depressed.The physician's impression includes: 1.Rectal cancer, well-differentiated adenocarcinoma, stage i resected (b)(6) 2008.For genetic counseling and germline testing was done which did not identify any pathogenic or clinically significant mutations.Tumor marker remains normal.2.Recurrent rectal cancer, 1/2009, treated with pre-operative chemo rads, and followed by (b)(6).Had post-op folfox 8 cycles till (b)(6) 2009.3.Utis, pyelonephritis 4.Hypothyroidism, medically managed 5.Anxiety, depression: currently not being followed 6.Oxaliplatin neuropathy, persistent, with occasional falls 7.Cognitive sequelae of - chemotherapy - stably disabled with this 8.Knee arthritis 9.Intermittent bowel obstruction - last in 2025 10.She has had side-effects of unusual severity from chemo rads - likely dna repair defect, and they need to check germ line.As part of the patient's plan, she needed to continue with pt for ongoing neurological problems, and new pelvic floor problems.Clinically and radiographically without evidence of disease, now with an mri and ct showing no new abnormalities.Colonoscopy due - her gastroenterologist has retired, and they will ask another physician to see her.The patient needed to continue ongoing follow up and see in 1 year for clinical evaluation.Additional information received on january 4, 2023.On (b)(6), 2021, the patient was seen and examined.The patient presented to the clinic for evaluation of abnormal uterine bleeding.The patient had a recent transvaginal mesh excision with cystocele repair and bilateral groin exploration.The mesh was reported to be located in an abnormal location.The patient also complained of occasional stress/urge incontinence which was manageable.The patient reported postoperative difficulty with hip abduction.In the physician's assessment the patient experienced a high-tone pelvic floor dysfunction, hyperlipidemia, stress incontinence, hypothyroidism, gastroesophageal reflux disease, and anxiety.The patient was also status post radiation therapy and chemotherapy.It was noted that the patient was healing well after her surgery.The patient reported that she noted a change in her pain.The physician recommended to use a small amount of premarin in the post operation period to help with vaginal healing.On (b)(6), 2022, the patient was seen and examined for her annual gynecologic examination.The patient reported that was not sexually active due to dyspareunia after surgery with mesh placement and removal.Upon examination, the patient's vagina appeared to be in atrophy and a stage 1-2 cystocele was noted.The patient also reported leakage with bending and she was wearing pads.She also had recurrent urinary tract infections with two kidney infections.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to november 29, 2010, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: (b)(6).(b)(6).Block h6: patient codes e2330, e1002, e0123, e0126, e1310, e1906, e2326, e1309, and e2328, capture the reportable events of pain (severe lower extremity pain, back pain, pelvic and perineal pain, pain in left shoulder, bladder pain, pelvic pain, incisional pain, joint pain), abdominal pain, nerve damage (pudendal and obturator neuralgia, pain radiating down both of her legs), neuropathy (neuropathic pain), urinary tract infection, infection (worsening pyelonephritis), inflammation (mild chronic inflammation, chronic cystitis), urinary retention (incomplete emptying of bladder), and obstruction (bladder outlet obstruction), respectively.Impact codes f1905, f1202, f08, f2303 and f23, capture the reportable events of device revision or replacement (transvaginal mesh excision), disability (permanently disabled), hospitalization or prolonged hospitalization, medication required (self-start antibiotic therapy, antibiotic management, topical estrogen replacement, cranberry supplementation) and unexpected medical intervention (pain control), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks b5, b7, h6, and h10 have been updated based on the additional information on october 18, 2022.Block h6: patient code e0122 was utilized to capture the reportable event of walking difficulty.Block h11: block a1 has been corrected.Blocks a4, b5, h6 and h10 have been updated based on the additional information received on november 11, 2022.Block h6: patient code e020201 captures the reportable event of anxiety.Patient code e020202 captures the reportable event of depression.Impact code f12 has been used in the light of this patient seeking legal recourse for a personal injury related to the device.Block h11: block h6 has been updated based on medical review received on december 12, 2022.Block h11: block b5 has been updated based on additional information received on january 4, 2023.Block h11: block h6 (device code) has been corrected based on the additional information received on january 23, 2023.

Event Description

It was reported to boston scientific corporation that an obtryx halo single system was implanted during a cystocele repair, major urethral transobturator sling and cystoscopy procedure performed on (b)(6) 2010, for the treatment of urethral hypermobility, stress urinary incontinence, and cystocele.The patient had a history of advanced colorectal cancer, had two pelvic and abdominal surgeries after chemotherapy and radiation, and had developed stress urinary incontinence in recent years.She was originally seen in the early stages of incontinence over the last few years.She was originally seen in the early part of 2010 with the recommendations for urodynamics and to consider vaginal surgery for her incontinence.She finally followed up in early november, wishing to pursue her surgery now that she has been in a state of remission for her colorectal malignancy.Urodynamics were performed, demonstrating stress urinary incontinence with a low valsalva leak point pressure, and her physical exam confirmed the presence of hypermobility and a central cystocele.There was some descent of her uterus, but not enough to call it a uterine prolapse.Moreover, the options for the patient were reviewed by the physician, which included observation, kegel exercises, collagen injection, and a sling procedure with cystocele repair.The physician explained to the patient that he would keep her procedure very basic and not pursue anything with extensive surgical intervention due to her previous pelvic radiation, chemotherapy, and previous abdominal pelvic surgery.The physician recommended a simple cystocele repair and the insertion of a mid-urethral sling either by a pubovaginal approach or a transobturator approach.The physician explained the side effects of doing this surgery, such as infection, bleeding, erosion, retention, pain, and failure to resolve her incontinence.The physician also told the patient that he would make his decision on the type of sling once he performed the operation and looked inside of her bladder.In the past, her bladder was consistent with radiation changes.He also gave the patient the option of a second opinion as well.After reviewing and hearing the physician's recommendation, the patient wishes to pursue the surgery on (b)(6) 2010.On (b)(6) 2017, the patient was presented to the emergency department (ed) from uro-gyn for admission for iv antibiotics due to worsening pyelonephritis after receiving a cystoscopy.The patient was admitted with urinary tract infection (uti), voiding difficulties, and multiple drug allergies.She began experiencing recurrent utis earlier this year.She had a proteus uti earlier this year and had an escherichia coli uti in (b)(6).Because of her repeated utis, she was referred to a physician from urogynecology where she underwent cystoscopy last week.Thereafter, she had ongoing dysuria and a reaction to ciprofloxacin with severe lower extremity pain which she described as ripping in her muscles in her lower legs.The patient was in for antibiotic management and pain control.She has some ongoing mild suprapubic discomfort, but dysuria has resolved and there was no incontinence.Moreover, she had urethral sling procedure about 5 years ago.She stated that her sling may be a little bit overcorrected, and she typically had a residual of approximately 40cc.The patient had an element of bladder outlet obstruction which could lead to residuals though her reported residuals was only 40cc which was acceptable.If she did have an element of bladder outlet obstruction from an overcorrected urethra from a prior sling procedure, she may have high pressure voiding which could place her at risk for repeated utis.This could be evaluated with multichannel urodynamics.Furthermore, the patient is on prophylactic therapy for utis which included cranberry supplementation and estrogen replacement.She should be considered for self-start antibiotic therapy typically consisting of one pill twice daily for 3 days as soon as patient begins experiencing symptoms but due to her multiple drug allergies, her best drug of choice in this instance would be nitrofurantoin.She did have underlying dyspareunia since the surgery and there was no known history of a urethral diverticulum.Abdominal ct was performed for generalized abdominal pain to rule out pyelonephritis and abscess status post procedure cystoscopy.No acute abnormality was noted.The assessment was complicated uti.The plan was to treat with rocephin, iv fluids, enoxaparin, and hydromorphone.On (b)(6) 2017, the patient returned to the office with her husband for follow-up of urinary tract infection (uti) and dysuria.She was discharged on macrobid which she completed last friday.She continues to have symptoms of burning, lower abdominal pain, low back pain and fatigue.She stated that she had not felt right since the cystoscopic examination.She underwent multichannel urodynamics.There was no evidence of bladder outlet obstruction.Pressure flow nomogram was consistent with absence of the obstruction.She had high flow low pressure voiding.All her urinary symptoms, lower back pain and lower abdominal pain have resolved.At the present time, she is asymptomatic.After her urodynamics, she was recommended to try estring but she developed significant reaction and she subsequently discontinued the medication with resolution of her symptoms.During assessment, the patient did not have any voiding difficulties.It took about 6 weeks for her to recover from her cystoscopy which raised the question as to whether she had an allergic reaction of some type to the prep solution or the cystoscopic sterilization process that was performed at her uro-gynecologist's office.She does not have evidence of bladder outlet obstruction from her prior sling procedure.Discussion was held as to how to manage her repeated utis.Reportedly, she remained on theragran hp, and discussed with her physician other estrogen replacements including estrace or oral tablets.In addition, they also discussed self-start therapy with antibiotics such as nitrofurantoin.She also indicated that she developed some type of facial skin reaction after being on a suppressive antibiotic which she does not recall the name.Moreover, the physician advised the patient not to be given with any additional antibiotic until they know what medication that was.She has a multitude of drug allergies making antibiotic options for treatment difficult.On (b)(6) 2020, the patient with a past medical history of stage 4 colon cancer with hemicolectomy and colostomy bag as well as hypothyroidism who presented to ed with a month history of pelvic pain with radiation to lower back constantly for a week.Also, she presented with abdominal pain and dyspareunia.She stated that she has history of bladder prolapse in 2010 where she had mesh sling placed and was evaluated by her urologist a week ago who noted that the patient had prolapse at that time and was advised to have a follow-up with a specialist.Furthermore, the patient's appointment was not until next week but due to continued pain, she came to ed for evaluation.It was also noted that the patient had occasional nausea and left shoulder pain, that was not worse with movement.The patient had taken ibuprofen.Physical exam revealed suprapubic tenderness, mildly erythematous vaginal vault, uterine prolapse, and mild tenderness to bilateral paravertebral lumbar spine.Ct was consistent with uterine prolapse.The patient was to follow up with urogyn.On (b)(6) 2020, the patient presented for physical therapy (pt) evaluation with symptoms of pudendal neuralgia following history of colon cancer/treatment, bladder suspension and frequent falls.She had high tone pelvic floor musculature r>l and reported significant pain with sitting.She will benefit from physical therapy to reduce pain symptoms and educate patient in self-care management.The patient arrived and stated that she started to have pain this winter in her vulva, lower abdomen and lower back.Her symptoms were reported as pins and needles/ burnings/coldness.She stated that she felt like there was a ball in her vagina and had been diagnosed with slight uterine prolapse.Her chief complaint was pain with sitting and had inability to have penetrative intercourse with her husband.She was then referred to physical therapy.Previously, the patient was not working due to being permanently disabled.She stopped working and was not able to walk 10 years ago.She was unable to walk currently and has boot on right foot secondary to possible metatarsal fracture.Her physical therapy (pt) evaluation revealed abnormal muscle tone, decreased strength, pain, decreased flexibility, impaired sensation resulting in self-care, home management, community/leisure limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab, patient goals and maximize prior level of function (plof) of chosen activities of daily living (adl).On (b)(6) 2020, the patient presented to emergency department (ed) for evaluation of urinary urgency, frequency, dysuria and hematuria since friday.The patient was seen on friday for evaluation of ongoing lower abdominal pain that the patient suspected may be due to implanted mesh used for repair of prolapse.The patient has had prior outpatient imaging.The patient had a straight catheterization, which she stated was traumatic and painful due to known strictures from prior radiation.The patient noted that she was especially susceptible to uti, after instrumentation and has had many previously.Additionally, she had episode of gross hematuria last night with continued urethral discomfort.Urinalysis was abnormal with moderate bacteria, blood, and leukocytes.A urine culture was submitted.The patient was diagnosed with acute cystitis with hematuria and prescribed macrobid pending culture results.On (b)(6) 2020, she had returned to physical therapy with pelvic pain.She felt her pain was associated to her cystocele repair with mesh insertion 10 years ago.She had a follow-up with a physician, had bladder installations and injections into pfm of trameel.She stated nothing was working and she continued to have pain constantly in low back, across lower abdomen and numbness in perineum.The patient reported that her interstitial cystitis was treated, and she felt that it was not the issue.Atrophic changes were noted in the vulva vestibule as was tenderness to adductors and piriformis.She had abnormal muscle tone and decreased strength.The plan was for weekly pt and therapeutic activities at home.On (b)(6) 2020, the patient had a telehealth visit regarding pelvic pain and possible pudendal and obturator neuralgia.The patient has a history of colon cancer status post low anterior resection in 2008.The patient had a recurrence and underwent a left hemicolectomy with proctectomy and total mesenteric excision in 2009.The patient also had an obtryx tvt-o sling placed in 2010 for relatively mild stress urinary incontinence.The patient did well for several years.The patient was very active with exercise, including biking.She noted the onset of symptoms approximately 5 years ago, but over the last year the patient has noted increasing pain complaints.She notes pain radiating down both of her legs.She also notes a foreign object sensation in the vagina that feels like a billiard ball.She has pain with adduction of her legs.She had burning pain where her rectum was.Her pain was increased with sitting.She did have some symptoms going back 5 years, but much worse since (b)(6) of this year.She can no longer have sex due to pain.She notes bladder pain with urinary urgency.She also has slow voiding with mixed incontinence.Moreover, potential diagnoses were reviewed such as obturator neuralgia and pudendal neuralgia.The mesh itself can also be a pain trigger, especially for vaginal and bladder pain.She was also at increased risk for a pudendal nerve problem given that she has had a proctectomy.On (b)(6) 2021, she was for in-person consultation after a phone consult in december.The patient had a complicated surgical history including left hemicolectomy with proctectomy and permanent colostomy.The patient also had a mid-urethral trans obturator sling placed in 2010.Patient initially did relatively well but over the last 1-2 years was noted with progressive pain which is now quite distressing.The patient's pain complaints were consistent with both obturator and pudendal neuralgia.Physical exam revealed cystocele, mesh was tender to palpation, and levator plate tender to palpation especially over sacrospinous areas.The impression was that the patient had multiple potential reasons to have pain.The sling itself appeared to be a pain generator as well as the possibility of obturator neuralgia.The patient could have pudendal neuralgia both from the proctectomy and from the sling placement.The plan was for complete removal of the tvt-o sling including both groin components.On (b)(6) 2021, the patient underwent transvaginal mesh excision with cystocele repair and bilateral groin exploration for the treatment of her bladder pain, pelvic pain, postoperative obturator neuralgia, and pudendal neuralgia.The mesh was identified and divided in the midline.A large portion of mesh was dissected and removed from both sides up to the groin.On the left side, it was noted that the mesh must have retracted into the groin and was not in a space that could be accessed.It was felt that any further dissection would lead to further muscle loss to the adductor muscle group.A tiny bit of mesh was still palpable in the obturator muscle that could not be retrieved.On the right side, an identical groin dissection was performed and once again was unable to identify any mesh in this compartment.No mesh could be recovered from the groin, so once again, as much of the mesh from the vaginal aspect was removed as possible leaving only a tiny bit of mesh adherent to the underside of the bone and in the obturator internus muscle and membrane.The patient developed a spinal headache from the spinal anesthesia administered to augment her postoperative pain control.She underwent a blood patch on postoperative day 1.On postoperative day 2, the patient voided with a low postvoid residual.Pain control was adequate with oral oxycodone.She was considered stable for discharge.She was discharged to stay in a local hotel for follow-up with her physician next week.She was given routine instructions.On (b)(6) 2021, according to the pathology report, the vaginal mesh excision consisted with fibrous and skeletal muscle tissue with mild chronic inflammation, rare multinucleated giant cells, and foreign body consistent with mesh.On (b)(6) 2021, the patient was in for her routine post operation check-up.She was doing relatively well.Her vaginal pain was minimal and her incisional pain from groin exploration was also tolerable.She continued to have obturator nerve pain which was more difficult for her.Furthermore, she was voiding normally with no stress incontinence, and she was moving her bowels normally.Her biggest concern was pain control.The physician and the patient discussed their alternatives, and they will try switching her to hydromorphone from the oxycodone.The patient will continue with very light activity over the next few weeks.She will follow-up with her local gynecologist in 4-5 weeks for a postop check, and a new prescription for dilaudid was given by her physician.The patient will have a follow-up via telehealth visit with the physician in approximately 3 months to monitor her progress regarding her neuropathic pain.On (b)(6) 2021, the patient presented to the er with chills, nausea and weakness that started 2 days prior, increased abdominal pain that radiated to her back, distention, and hard stool.She had not been ambulatory since her surgery on (b)(6) which normally helps her bowel regimen.Imaging showed constipation, and the patient was going to add miralax and senna in addition to colace.On (b)(6) 2021, the patient was seen by a urologist for pelvic prolapse, cystocele, and urinary tract infections.Approximately 2 weeks ago, the patient developed symptoms of urinary tract infection with bladder pain and irritation.She described it as a sensation of suprapubic irritation.She also had some mild dysuria.A urinalysis was performed by her gynecologist which apparently revealed an e.Coli urinary tract infection.She was then placed on macrobid for 5 days.She presented with some persistent symptoms of bladder irritation and inflammation.Her symptoms have partially improved but she was completing the 5-day course of nitrofurantoin.Today, her urinalysis was normal with negative leukocytes and negative nitrites.Her antibiotics were extended for an additional 7 days, and she was given samples of uribel to be used as needed for irritation/inflammation.On (b)(6) 2021, the patient was seen by her obgyn for a follow-up on pelvic pain.Despite extensive groin dissections during mesh removal in february, no additional mesh could be retrieved from these areas.The patient continued to have symptoms of both pudendal and obturator neuralgia.Repeating her groin dissection was not recommended due to the risks and likelihood of being unsuccessful.Transgluteal pudendal nerve decompression was discussed with a potential for unilateral procedure on the left side where the patient's symptoms were worse.The patient was also advised of the protracted nature of nerve healing taking up to 2 years to see maximal improvement along with the clinical failure rate of at least 20%.The possibility of pudendal nerve cryoablation or drg stimulator which has the advantage of potentially treating more than 1 pain generator were also discussed as options.The assessment was continued obturator and pudendal neuralgia.The patient planned to consider her options.On (b)(6) 2021, the patient was in for patient evaluation for outpatient therapy for her pelvic pain, hip pain, limited hip abduction, and other symptoms and signs involving the musculoskeletal system.She had pelvic pain secondary to pelvic floor dysfunction as well as mesh removal in (b)(6).She was also deconditioned due to bed rest after surgery as she had been told to rest up due to hemorrhaging after surgery.She reported urinary frequency, incontinence with a full bladder and bending over, difficulty feeling if she has emptied her bladder, pain with initial bladder emptying, and pain with intercourse.Physical therapy evaluation reveals abnormal muscle tone, decreased flexibility, impaired coordination, decreased rom, decreased endurance, impaired balance, and pain (bladder function) resulting in limitations.The patient will benefit from skilled pt services to address limitation, work towards rehab and patient goals and maximize plof of chosen adls.Additional information october 18, 2022: on (b)(6) 2022, the patient was seen and examined for impaired glucose tolerance, hypothyroidism/hashimoto's, and hyperlipidemia, colon cancer status post total colectomy, chemo and radiation in 2009.The patient has had problems with a mesh placed for bladder prolapse which had nerve impingement and pain down her leg.She has been unable to exercise this year.She walks 30 min to an hour per day.She was previously very athletic.The patient has difficulty losing weight since she had bilateral oophorectomy in 2009 when she had colectomy for colon cancer.The patient has also seen several nutritionists.Upon examination the patient reported hearing loss.The patient also reported problems with urination.The patient reported alternately too hot and too cold.The patient reported easy bleeding and a tendency for easy bruising.The patient reported back pain, muscle aches, pain localized to one or more joints, and joint stiffness localized to one or more joints.The patient reported difficulty walking.The patient reported glaucoma or cataracts.The patient reported thyroid disorder.The patient reported currently wearing eyeglasses or contact lenses.A follow up was scheduled for (b)(6).Current medication: advil 200 mg oral capsule 0 days, 0 refills.Synthroid 88 mcg oral tablet once a day 0 days, 0 refills.Past medical/surgical history: retinal or dilated eye exam within 1 year.Pregnancy: previously pregnant 2 time(s).Social history: tobacco use: smoking status: never smoker.Alcohol: alcohol use.Habits: exercising regularly.Marital: currently married.Additional information received on november 11, 2022: on (b)(6) 2022, the patient was seen and examined for her yearly follow up status post lower anterior resection (lar) last (b)(6) 2008, and a recent reconstructive surgery because of problems with bladder mesh in (b)(6) 2021.The patient was reported to be getting physical therapy (pt) for both shoulder and pelvic pain.The patient was doing generally well, however, she still needed a colonoscopy.The patient's urinary tract infections were less common - none this past year.She continued with the same peripheral neuropathy in hands and feet.Fine motor worse.She had a reaction to eye drops with some hearing loss in the interim.Cognitively, she feels about the same, and her family agreed.She is not rowing.She walks about 1.5 miles in 30 min.She has trouble with stairs.She reports significant worsening of bilateral hip and left shoulder pain.Mri of the left shoulder showed significant soft tissue injury - there has been modest improvement with pt.Her last bowel obstruction reported was on (b)(6) 2015 and she was hospitalized at (b)(6) hospital.Obstruction was resolved with bowel rest.The patient was trying to lose weight but was not succeeding due to limited by inability to exercise.Pain at worst 6/10 in the lower back associated with sciatica, sacrum and hips which was not constant.The patient did not require pain medication.Upon examination the patient was positive for cognitive defects.The patient's pain score was 8 out of 10 at worst and currently at 0 out of 10 which was mainly in felt in the hip and bladder.The patient was also depressed.The physician's impression includes: 1.Rectal cancer, well-differentiated adenocarcinoma, stage i resected (b)(6) 2008.For genetic counseling and germline testing was done which did not identify any pathogenic or clinically significant mutations.Tumor marker remains normal.2.Recurrent rectal cancer, (b)(6) 2009, treated with pre-operative chemo rads, and followed by (b)(6) 2009.Had post-op folfox 8 cycles till (b)(6) 2009.3.Utis, pyelonephritis.4.Hypothyroidism, medically managed.5.Anxiety, depression: currently not being followed.6.Oxaliplatin neuropathy, persistent, with occasional falls.7.Cognitive sequelae of - chemotherapy - stably disabled with this.8.Knee arthritis.9.Intermittent bowel obstruction - last in 2025.10.She has had side-effects of unusual severity from chemo rads - likely dna repair defect, and they need to check germ line.As part of the patient's plan, she needed to continue with pt for ongoing neurological problems, and new pelvic floor problems.Clinically and radiographically without evidence of disease, now with an mri and ct showing no new abnormalities.Colonoscopy due - her gastroenterologist has retired, and they will ask another physician to see her.The patient needed to continue ongoing follow up and see in 1 year for clinical evaluation.Additional information received on january 4, 2023: on (b)(6) 2021, the patient was seen and examined.The patient presented to the clinic for evaluation of abnormal uterine bleeding.The patient had a recent transvaginal mesh excision with cystocele repair and bilateral groin exploration.The mesh was reported to be located in an abnormal location.The patient also complained of occasional stress/urge incontinence which was manageable.The patient reported postoperative difficulty with hip abduction.In the physician's assessment the patient experienced a high-tone pelvic floor dysfunction, hyperlipidemia, stress incontinence, hypothyroidism, gastroesophageal reflux disease, and anxiety.The patient was also status post radiation therapy and chemotherapy.It was noted that the patient was healing well after her surgery.The patient reported that she noted a change in her pain.The physician recommended to use a small amount of premarin in the post operation period to help with vaginal healing.On (b)(6) 2022, the patient was seen and examined for her annual gynecologic examination.The patient reported that was not sexually active due to dyspareunia after surgery with mesh placement and removal.Upon examination, the patient's vagina appeared to be in atrophy and a stage 1-2 cystocele was noted.The patient also reported leakage with bending and she was wearing pads.She also had recurrent urinary tract infections with two kidney infections.Additional information received on september 19, 2023: on (b)(6) 2022, the patient had a follow -up visit.During that time, it was noted that the mesh implanted in the patient was disintegrated and migrated.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to november 29, 2010, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).Block h6: patient codes e2330, e1002, e0123, e0126, e1310, e1906, e2326, e1309, e2328, e0122, e020201, and e020202 capture the reportable events of pain (severe lower extremity pain, back pain, pelvic and perineal pain, pain in left shoulder, bladder pain, pelvic pain, incisional pain, joint pain), abdominal pain, nerve damage (pudendal and obturator neuralgia, pain radiating down both of her legs), neuropathy (neuropathic pain), urinary tract infection, infection (worsening pyelonephritis), inflammation (mild chronic inflammation, chronic cystitis), urinary retention (incomplete emptying of bladder), and obstruction (bladder outlet obstruction), walking difficulty, anxiety, and depression respectively.Impact codes f1905, f1202, f08, f2303 and f23, capture the reportable events of device revision or replacement (transvaginal mesh excision), disability (permanently disabled), hospitalization or prolonged hospitalization, medication required (self-start antibiotic therapy, antibiotic management, topical estrogen replacement, cranberry supplementation) and unexpected medical intervention (pain control), respectively.Device code a1502 (positioning problem) captures the observation (b)(6) 2021, that the mesh was located in an abnormal position.Block h11: block b5 and h6 have been updated based on additional information received on september 19, 2023.Block h6 - device code a04 (material integrity problem has been added to capture the event of mesh disintegrated and migrated.

• Brand Name: OBTRYX SYSTEM - HALO
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): FREUDENBERG MEDICAL MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14604995
• MDR Text Key: 293380130
• Report Number: 3005099803-2022-02999
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729718987
• UDI-Public: 08714729718987
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: M0068505000
• Device Catalogue Number: 850-500
• Device Lot Number: 1ML0062901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Disability; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White