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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Apnea (1720); Bacterial Infection (1735); Erosion (1750); Fatigue (1849); Flatus (1865); Micturition Urgency (1871); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Stenosis (2263); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Depression (2361); Numbness (2415); Obstruction/Occlusion (2422); Prolapse (2475); Sleep Dysfunction (2517); Hematuria (2558); Weight Changes (2607); Dysuria (2684); Paresthesia (4421); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2009, implant date, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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.

Event Description

It was reported to boston scientific corporation that an obtryx transobturator mid-urethral sling system device was implanted into the patient during a procedure performed on (b)(6) 2009.As reported by the patient's attorney, the patient experienced an unknown injury.

Manufacturer Narrative

Additional information: blocks b5 and h6: patient codes and impact codes.Block b3 date of event: date of event was approximated to (b)(6) 2020, based on the information that the patient had surgery due to symptom.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient codes e2006, e2328, e1309, e2330, e2311, e1310, e1405, e1301, e0123, e1901, e1605, e0127, e1401 capture the reportable events of erosion, bladder obstruction, retention, pain, discomfort, uti, dyspareunia, dysuria, nerve damage, bacterial vaginosis, muscle spasm, numbness, extensive vaginal discharge and adhesions.Impact code of f1905 and f1901 capture the reportable events of mesh release surgery; and laparoscopic bilateral salpingectomies, lysis of adhesions and urethrolysis, urethroplasty.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 that an obtryx transobturator mid-urethral sling system device was implanted into the patient during a procedure performed on (b)(6) 2009.As reported by the patient's attorney, the patient experienced an unknown injury.The device was not returned for analysis.Additional information received on august 11, 2022.It was reported to boston scientific corporation that an obtryx transobturator mid-urethral sling system device was implanted into the patient during a procedure performed on (b)(6) 2009.Office visit on (b)(6) 2020: patient reported bladder problem and wanted a full removal of pelvic mesh as it had caused her pudendal neuralgia and in 2020, patient had surgery due to bladder obstruction.It was found that the mesh implanted in 2010 had rolled up and wrapped around the urethra, strangulating and partially eroded into the bladder neck and urethra.Only released the structure and was advised to find a more qualified physician to remove the mesh and rebuild her obliterated pelvic floor.Patient also reported being bothered due to the following symptoms: prolapse symptoms of bulging in vaginal area, pressure, heaviness and feeling incomplete bladder emptying bowel symptoms of inability to completely evacuate bowel, loss of gas without control, pain with defecation, 14 bowel movements/week, but did not experience diarrhea or constipation and denies accidental bowel leakage.Urinary symptoms of voiding every hour or more, 14 times a day, and 4 times per night.It was also reported that patient had vaginal delivery weighed 9lbs and 11 ounces.Had not taken hormone replacement therapy and vaginal hormone replacement therapy.Patient was not sexually active.Review of systems showed pain in joints, lower back pain, numbness, depressed, difficulty sleeping and pelvic pain.Urogynecological examination showed levator muscle tenderness, discomfort along the anterior vaginal wall and along the pubococcygeus muscle and extensive vaginal discharge.On (b)(6) 2021, patient came for consultation of the symptoms low back pain, anal pain, and vaginal numbness with chief complaint of pelvic pain.Patient reported her pain began 10 years ago after she underwent urethral sling procedure after childbirth.Immediately following the procedure, she noted pain in her vaginal region that lasted beyond surgical pain.She had seen multiple urologic and pain specialists, ultimately had a "mesh release" procedure done in (b)(6) 2020.After this procedure, she noted the same vaginal/urethral pain, as well as new pain in her inner thigh down to her anus.Characterizing the pain is difficult and depends upon what she is doing, however light touch precipitates pain and it has caused her to take time off from work and limits her daily activities (i.E., unable to swim, sit for extended periods of time, or have sexual intercourse).She had not tried any oral medications, but she did have good results with a combination suppository (local anesthetic, valium, and some other unknown medication).Unfortunately, the suppository lasted only a few days with the pain subsequently returning.Associated symptoms include urinary incontinence and clitoral numbness.Her major concern was getting to a point where she can work to support her son with special needs.Assessment and plan: to address the muscular component of her pain: trial of baclofen po for 1 month (advised to update physician in 1 week).Advised patient to keep her appointment for pelvic pt scheduled for april.To address the neuropathic component of her pain: will schedule pudendal nerve block and sympathetic ganglion of impar block.To address the central component of her long-standing pain: advised patient to follow up with pain psychology and acupuncture.Follow up after procedure.On (b)(6) 2021, patient had a follow up visit.Had her catheter removed and post -- procedural and post -- infection pain had been resolved and back to her baseline pain that she described as inner thigh radiating midline bilaterally and was exacerbated by sitting on hard surfaces.Current pain medications: oxycodone 5 mg q6h prn.B&o suppository.Baclofen.(patient has tried but is not currently taking as it does not help and affects her cognitively.) assessment and plan: to address the muscular component of her pain: continue trial of dantrolene 25 mg tid (checked lft's today and will recheck around 3/5/3021 if working well for her).Continue oxycodone 5 mg to tid prn.Agree with trial of b&o suppository.Advised patient to keep her appointment for pelvic pt scheduled for april.To address the neuropathic component of her pain: will schedule pudendal nerve block and sympathetic ganglion of impar block for after infection has been resolved and catheter has been removed.To address the central component of her long-standing pain: continue to recommend patient to follow up with pain psychology and acupuncture.Follow up after procedure post operative visit on (b)(6) 2021, discussed regarding issues of continued pelvic pain and dysuria, pudendal nerve block which provided some temporary relief and concerned that there may be some "residual mesh" responsible for the symptoms.Symptoms included pain when she sit, burning with urination, urinary frequency, urinary urgency, pelvic floor muscle pain.Patient's bacterial vaginosis screen was positive for bacterial vaginosis.Metrogel prescribed.During a telemedicine video visit on (b)(6) 2021, discussed mri result which was consistent with presence of some residual mesh in the groin but no vaginal portions of mesh encountered on mri.Treatment plan discussed with patient: 1.Encouraged to initiate and continue with pelvic floor physical therapy.2.Will continue pain management with a physician and guided blocks.3.We discussed vaginal medication (could consider vaginal diazepam or mixed suppositories for pain management).4.I discussed that mesh removal would likely not be successful in eliminating the pain.Encountering the mesh arms in groin would be technically very challenging and i recommend against it.Office visit on (b)(6) 2021, patient reported still on gabapentin and it made her tired throughout the day.She occasionally slept through urge or urinate and wet the bed.Bilateral pudendal nerve block improved her pain temporarily.Still doing pelvic floor therapy but had been painful for her.(b)(6) 2021 cystoscopy showed urethra was normal.Bladder neck was normal.Ureteral orifice was normal size, shape, and position, effluxing clear bilaterally.Bladder mucosa was normal.Additional findings: no mesh exposure in the bladder or urethra.No foreign bodies, stones, or lesions.There was no urethral stricture.Images from her ct and mri on 1m pax reviewed.According to mri radiology report there was a hypointense band like structure which may possibly reflect residual mesh material related her prior trans-obturator sling procedure which was a possible source of her pelvic pain.Exam notable for tenderness along the obturators.We discussed surgical removal of mesh fragments.Risks and benefits discussed including bleeding, infection, injury to adjacent organs, incomplete resolution of symptoms.Discontinue gabapentin case request for obturator mesh fragment removal and bilateral pudendal nerve block.Additional information received on august 16, 2022.On (b)(6) 2020, the patient had an office visit for pelvic pain.This was post-operative day 1, status post laparoscopic bilateral salpingectomies, lysis of adhesions done, urethrolysis, removal of vaginal mesh sling and urethral repair (urethroplasty).Patient reported that she had consistent unrelenting abdominal pain since surgery.The physician who performed urethrolysis, removal of vaginal mesh and urethral repair (urethroplasty) believed the procedure was causing patient's abdominal pain.Pain was not improved with tramadol but percocet usually controls her pain.She stated that she was passing gas and tolerating regular diet.Patient was recommended to consult a gyn team to rule out underlying pathology and to offer recommendation for pain control.Patient's abdominal exam was benign and appeared to be within normal post operative state.Follow up was scheduled for february 3 and 4.Planned to return to clinic for routine post operative care.

Manufacturer Narrative

Additional information: blocks a2, a3, a4, b3, b5, b6, b7 and h6: patient codes and impact codes.Correction: g2: report source (removed company representative) block b3 date of event: date of event was approximated to (b)(6) 2020, based on the information that the patient had surgery due to symptom.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: patient codes e2006, e2328, e1309, e2330, e2311, e1310, e1405, e1301, e0123, e1901, e1605, e0127, e1401 capture the reportable events of erosion, bladder obstruction, retention, pain, discomfort, uti, dyspareunia, dysuria, nerve damage, bacterial vaginosis, muscle spasm, numbness, extensive vaginal discharge.Impact code of f1905 captures the reportable event of mesh release surgery.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 that an obtryx transobturator mid-urethral sling system device was implanted into the patient during a procedure performed on november 5, 2009.As reported by the patient's attorney, the patient experienced an unknown injury.The device was not returned for analysis.---additional information received on august 11, 2022--- it was reported to boston scientific corporation that an obtryx transobturator mid-urethral sling system device was implanted into the patient during a procedure performed on (b)(6) 2009.Office visit on (b)(6) 2020: patient reported bladder problem and wanted a full removal of pelvic mesh as it had caused her pudendal neuralgia and in 2020, patient had surgery due to bladder obstruction.It was found that the mesh implanted in 2010 had rolled up and wrapped around the urethra, strangulating and partially eroded into the bladder neck and urethra.Only released the structure and was advised to find a more qualified physician to remove the mesh and rebuild her obliterated pelvic floor.Patient also reported being bothered due to the following symptoms: prolapse symptoms of bulging in vaginal area, pressure, heaviness and feeling incomplete bladder emptying bowel symptoms of inability to completely evacuate bowel, loss of gas without control, pain with defecation, 14 bowel movements/week, but did not experience diarrhea or constipation and denies accidental bowel leakage.Urinary symptoms of voiding every hour or more, 14 times a day, and 4 times per night it was also reported that patient had vaginal delivery weighed 9lbs and 11 ounces.Had not taken hormone replacement therapy and vaginal hormone replacement therapy.Patient was not sexually active.Review of systems showed pain in joints, lower back pain, numbness, depressed, difficulty sleeping and pelvic pain.Urogynecological examination showed levator muscle tenderness, discomfort along the anterior vaginal wall and along the pubococcygeus muscle and extensive vaginal discharge.On (b)(6) 2021, patient came for consultation of the symptoms low back pain, anal pain, and vaginal numbness with chief complaint of pelvic pain.Patient reported her pain began 10 years ago after she underwent urethral sling procedure after childbirth.Immediately following the procedure, she noted pain in her vaginal region that lasted beyond surgical pain.She had seen multiple urologic and pain specialists, ultimately had a "mesh release" procedure done in (b)(6) 2020.This proceure, she noted the same vaginal/urethral pain, as well as new pain in her inner thigh down to her anus.Characterizing the pain is difficult and depends upon what she is doing, however light touch precipitates pain and it has caused her to take time off from work and limits her daily activities (i.E., unable to swim, sit for extended periods of time, or have sexual intercourse).She had not tried any oral medications, but she did have good results with a combination suppository (local anesthetic, valium, and some other unknown medication).Unfortunately, the suppository lasted only a few days with the pain subsequently returning.Associated symptoms include urinary incontinence and clitoral numbness.Her major concern was getting to a point where she can work to support her son with special needs.Assessment and plan: to address the muscular component of her pain: trial of baclofen po for 1 month (advised to update physician in 1 week) advised patient to keep her appointment for pelvic pt scheduled for april.To address the neuropathic component of her pain: will schedule pudendal nerve block and sympathetic ganglion of impar block.To address the central component of her long-standing pain: advised patient to follow up with pain psychology and acupuncture.Follow up after procedure.On february 2, 2021, patient had a follow up visit.Had her catheter removed and post -- procedural and post -- infection pain had been resolved and back to her baseline pain that she describds as inner thigh radiating midline bilaterally and was exacerbated by sitting on hard surfaces.Current pain medications: oxycodone 5 mg q6h prn.B&o suppository.Baclofen (patient has tried but is not currently taking as it does not help and affects her cognitively.) assessment and plan: to address the muscular component of her pain: continue trial of dantrolene 25 mg tid (checked lft's today and will recheck around 3/5/3021 if working well for her).Continue oxycodone 5 mg to tid prn.Agree with trial of b&o suppository.Advised patient to keep her appointment for pelvic pt scheduled for april.To address the neuropathic component of her pain: will schedule pudendal nerve block and sympathetic ganglion of impar block for after infection has been resolved and catheter has been removed.To address the central component of her long-standing pain: continue to recommend patient to follow up with pain psychology and acupuncture.Follow up after procedure post operative visit on march 8, 2021, discussed regarding issues of continued pelvic pain and dysuria, pudendal nerve block which provided some temporary relief and concerned that there may be some "residual mesh" responsible for the symptoms.Symptoms included pain when she sit, burning with urination, urinary frequency, urinary urgency, pelvic floor muscle pain.Patient's bacterial vaginosis screen was positive for bacterial vaginosis.Metrogel prescribed.During a telemedicine video visit on april 1, 2021, discussed mri result which was consistent with presence of some residual mesh in the groin but no vaginal portions of mesh encountered on mri.Treatment plan discussed with patient: 1.Encouraged to initiate and continue with pelvic floor physical therapy.2.Will continue pain management with a physician and guided blocks.3.We discussed vaginal medication (could consider vaginal diazepam or mixed suppositories for pain management) 4.I discussed that mesh removal would likely not be successful in eliminating the pain.Encountering the mesh arms in groin would be technically very challenging and i recommend against it.Office visit on (b)(6) 2021, patient reported still on gabapentin and it made her tired throughout the day.She occasionally slept through urge or urinate and wet the bed.Bilateral pudendal nerve block improved her pain temporarily.Still doing pelvic floor therapy but had been painful for her (b)(6) 2021 cystoscopy showed urethra was normal.Bladder neck was normal.Ureteral orifice was normal size, shape, and position, effluxing clear bilaterally.Bladder mucosa was normal.Additional findings: no mesh exposure in the bladder or urethra.No foreign bodies, stones, or lesions.There was no urethral stricture.Images from her ct and mri on 1m pax reviewed.According to mri radiology report there was a hypointense band like structure which may possibly reflect residual mesh material related her prior trans-obturator sling procedure which was a possible source of her pelvic pain.Exam notable for tenderness along the obturators.We discussed surgical removal of mesh fragments.Risks and benefits discussed including bleeding, infection, injury to adjacent organs, incomplete resolution of symptoms.Discontinue gabapentin.Case request for obturator mesh fragment removal and bilateral pudendal nerve block.

Event Description

It was reported to boston scientific corporation that an obtryx transobturator mid-urethral sling system device was implanted into the patient during a laparoscopic lysis of adhesions, left ovarian cystectomy, anterior and posterior vaginal prolapse repair, and transobturator tape procedure performed on (b)(6), 2009 for the diagnoses of chronic pelvic pain, cystocele, rectocele, stress urinary incontinence, pelvic adhesions, and left simple ovarian cyst.On an unspecified date following the surgery, the patient developed recurrent stress urinary incontinence, urge incontinence, obstructive voiding symptoms, and urinary tract infection.On (b)(6) 2013, the patient was diagnosed with interstitial cystitis and had to self-catheterize.Urodynamics demonstrated detrusor overactivity consistent with bladder outlet obstruction.Additionally, cystoscopy had noted inflammatory changes in the bladder that had resolved by cystoscopy in october 2019.More recently, the patient had gross hematuria associated with mixed urinary incontinence episodes, and urinalysis showed trace red blood cells.She denied dysuria or irritative voiding symptoms.Exam revealed scarring at the mid and proximal urethra that was mildly tender to palpation.The patient requested removal of the mesh.On (b)(6) 2020, the patient underwent diagnostic laparoscopy, lysis of adhesions, bilateral salpingectomies, removal of vaginal sling, urethrolysis, and urethral repair (urethroplasty) for the preoperative diagnoses of mixed urinary incontinence, bladder outlet obstruction, mechanical complication of the genitourinary device, and pelvic pain.Exam under anesthesia noted significant scarring in the midline extending from the distal urethra to the level of the trigone of the bladder.There was also thick scarring in the anterior vaginal wall.Scar tissue and banding extended laterally to the urethra on both sides of the midline.The sling was identified to be embedded in the tissue and compressing the proximal urethra.The scar tissue, banding, and sling were carefully dissected and excised.It was noted that the urethral wall where the sling had been embedded in the tissue and compressing appeared very thin.The integrity was confirmed and closer inspection revealed a membrane-like stricture at the midurethra with some proximal urethral dilation.The urethra was reinforced in two layers to provide support and prevent any extravasation.On (b)(6) 2020, the patient had an office visit for pelvic pain.This was post-operative day 1, status post laparoscopic bilateral salpingectomies, lysis of adhesions done, urethrolysis, removal of vaginal mesh sling and urethral repair (urethroplasty).Patient reported that she had consistent unrelenting abdominal pain since surgery.The physician who performed urethrolysis, removal of vaginal mesh and urethral repair (urethroplasty) believed the procedure was causing patient's abdominal pain.Pain was not improved with tramadol but percocet usually controls her pain.She stated that she was passing gas and tolerating regular diet.Patient was recommended to consult a gyn team to rule out underlying pathology and to offer recommendation for pain control.Patient's abdominal exam was benign and appeared to be within normal post operative state.Follow up was scheduled for february 3 and 4.Planned to return to clinic for routine post operative care.On (b)(6) 2020, the patient was evaluated for pelvic pain, urinary incontinence, and sleep apnea with associated weight gain.The pelvic pain was sharp, moderate-severe in the perineal area.Associated symptoms included back pain, hematuria, vaginal discharge, and bladder spasms.Urinary incontinence was described as painful and continuous leakage of urine.Medications for bladder spasms did not help.The patient's diagnoses included bladder outlet obstruction and continuous leakage of urine for which she was to see urology; and entrapment of the obturator nerve.On (b)(6) 2020, the patient had a visit for evaluation of pelvic pain and possible pudendal neuralgia.The patient had previously been found to have mesh erosion and underwent mesh excision in january 2020 where the vaginal portion of the sling was removed.The patient reported that since the sling removal surgery, she developed incontinence and cannot feel when she urinates.The clitoris and urethral areas are numb.She also developed pain at the perineum and in the groin area that is worse with sitting on hard surfaces.She also experiences the symptoms when she is walking up hills.Even though she has incontinence, she has trouble emptying her bladder and may have to sit first minute or so.It was found that the patient was having numbness in the distribution of the dorsal branch of the pudendal nerve which may have been affected from her prior surgery or possibly from the mesh.Given her new symptoms of groin pain, it was believed she could potentially be having a side effect from continued pain from the retained mesh.She may have also had entrapment of the pudendal nerves.For further evaluation, the patient was to be scheduled for an mri of the pelvis for evaluation of the pudendal nerves as well as an evaluation by a physical therapist.The patient was also having continued vaginal bleeding since her surgery, and the plan was to evaluate the healing of the vaginal tissue and possibly perform a revision if necessary.On (b)(6) 2020 the patient presented for disability extension related to pelvic pain and discomfort on standing and walking for periods of time.She also reported fatigue and anxiety.On the same day, she was seen at a center for chronic pelvic pain for the chief complaints of pelvic pain, pudendal neuralgia, abstract voiding, and urinary urgency.The pain affected the following areas: suprapubic, mons pubis, right and left groin, right and left labia, clitoris, urethra, perineum, right and left inner ischial tuberosity, and entire anus.The pain was described as sharp, burning, tingling, sensation of foreign body in vagina, and continuous and worse with sitting and physical activity.She was not sexually active due to severe pain during and after intercourse.She also described hesitancy, urinating 3 x per night, and feeling like she is not completely emptying her bladder.She has significant pain in the crease lines where her underwear is which is consistent with allodynia which means that she has to wear loose clothing and often is unable to wear underwear.Her pain is mostly located in the perineal area consistent with the area of innervation of the pudendal nerve.She also has some groin pain bilaterally.Patient continues to have recurrent urinary tract infection with e.Coli which are confirmed by microbiology.Exam revealed right and left levators and right and left obturators were severely tender, and her right and left adductor were mildly tender.She had mild tenderness on both sides of her back.The assessment included pelvic and perineal pain, urge urinary incontinence, dyspareunia, and pudendal nerve neuropathy.The plan was for pudendal nerve block, botox to the pelvic floor, cystoscopy, and bilateral groin mesh removal.Office visit on december 8, 2020: patient reported bladder problem and wanted a full removal of pelvic mesh as it had caused her pudendal neuralgia and in 2020, patient had surgery due to bladder obstruction.It was found that the mesh implanted in 2010 had rolled up and wrapped around the urethra, strangulating and partially eroded into the bladder neck and urethra.Only released the structure and was advised to find a more qualified physician to remove the mesh and rebuild her obliterated pelvic floor.Patient also reported being bothered due to the following symptoms: prolapse symptoms of bulging in vaginal area, pressure, heaviness and feeling incomplete bladder emptying bowel symptoms of inability to completely evacuate bowel, loss of gas without control, pain with defecation, 14 bowel movements/week, but did not experience diarrhea or constipation and denies accidental bowel leakage.Urinary symptoms of voiding every hour or more, 14 times a day, and 4 times per night it was also reported that patient had vaginal delivery weighed 9lbs and 11 ounces.Had not taken hormone replacement therapy and vaginal hormone replacement therapy.Patient was not sexually active.Review of systems showed pain in joints, lower back pain, numbness, depressed, difficulty sleeping and pelvic pain.Urogynecological examination showed levator muscle tenderness, discomfort along the anterior vaginal wall and along the pubococcygeus muscle and extensive vaginal discharge.On (b)(6) 2021, patient came for consultation of the symptoms low back pain, anal pain, and vaginal numbness with chief complaint of pelvic pain.Patient reported her pain began 10 years ago after she underwent urethral sling procedure after childbirth.Immediately following the procedure, she noted pain in her vaginal region that lasted beyond surgical pain.She had seen multiple urologic and pain specialists, ultimately had a "mesh release" procedure done in 01/2020.After this procedure, she noted the same vaginal/urethral pain, as well as new pain in her inner thigh down to her anus.Characterizing the pain is difficult and depends upon what she is doing, however light touch precipitates pain and it has caused her to take time off from work and limits her daily activities (i.E., unable to swim, sit for extended periods of time, or have sexual intercourse).She had not tried any oral medications, but she did have good results with a combination suppository (local anesthetic, valium, and some other unknown medication).Unfortunately, the suppository lasted only a few days with the pain subsequently returning.Associated symptoms include urinary incontinence and clitoral numbness.Her major concern was getting to a point where she can work to support her son with special needs.Assessment and plan: to address the muscular component of her pain: - trial of baclofen po for 1 month (advised to update physician in 1 week) - advised patient to keep her appointment for pelvic pt scheduled for april to address the neuropathic component of her pain: - will schedule pudendal nerve block and sympathetic ganglion of impar block to address the central component of her long-standing pain: - advised patient to follow up with pain psychology and acupuncture - follow up after procedure.On (b)(6) 2021, patient had a follow up visit.Had her catheter removed and post -- procedural and post -- infection pain had been resolved and back to her baseline pain that she described as inner thigh radiating midline bilaterally and was exacerbated by sitting on hard surfaces.Current pain medications: -oxycodone 5 mg q6h prn -b&o suppository -baclofen (patient has tried but is not currently taking as it does not help and affects her cognitively.) assessment and plan: to address the muscular component of her pain: - continue trial of dantrolene 25 mg tid (checked lft's today and will recheck around (b)(6) 2021 if working well for her) - continue oxycodone 5 mg to tid prn - agree with trial of b&o suppository - advised patient to keep her appointment for pelvic pt scheduled for april to address the neuropathic component of her pain: - will schedule pudendal nerve block and sympathetic ganglion of impar block for after infection has been resolved and catheter has been removed.To address the central component of her long-standing pain: - continue to recommend patient to follow up with pain psychology and acupuncture.Follow up after procedure post operative visit on (b)(6) 2021, discussed regarding issues of continued pelvic pain and dysuria, pudendal nerve block which provided some temporary relief and concerned that there may be some "residual mesh" responsible for the symptoms.Symptoms included pain when she sits, burning with urination, urinary frequency, urinary urgency, pelvic floor muscle pain.Patient's bacterial vaginosis screen was positive for bacterial vaginosis.Metrogel prescribed.During a telemedicine video visit on april 1, 2021, discussed mri result which was consistent with presence of some residual mesh in the groin but no vaginal portions of mesh encountered on mri.Treatment plan discussed with patient: 1.Encouraged to initiate and continue with pelvic floor physical therapy 2.Will continue pain management with a physician and guided blocks 3.We discussed vaginal medication (could consider vaginal diazepam or mixed suppositories for pain management) 4.I discussed that mesh removal would likely not be successful in eliminating the pain.Encountering the mesh arms in groin would be technically very challenging and i recommend against it.Office visit on (b)(6) 2021, patient reported still on gabapentin and it made her tired throughout the day.She occasionally slept through urge or urinate and wet the bed.Bilateral pudendal nerve block improved her pain temporarily.Still doing pelvic floor therapy but had been painful for her (b)(6) 2021 cystoscopy showed urethra was normal.Bladder neck was normal.Ureteral orifice was normal size, shape, and position, effluxing clear bilaterally.Bladder mucosa was normal.Additional findings: no mesh exposure in the bladder or urethra.No foreign bodies, stones, or lesions.There was no urethral stricture.Images from her ct and mri on 1m pax reviewed.According to mri radiology report there was a hypointense band like structure which may possibly reflect residual mesh material related her prior trans-obturator sling procedure which was a possible source of her pelvic pain.Exam notable for tenderness along the obturators.We discussed surgical removal of mesh fragments.Risks and benefits discussed including bleeding, infection, injury to adjacent organs, incomplete resolution of symptoms.-discontinue gabapentin -case request for obturator mesh fragment removal and bilateral pudendal nerve block on (b)(6) 2022, the patient was seen for preoperative counseling.It was discussed that her symptoms may be consistent with pain related to the sling arms.She had a discussion with her healthcare provider about the surgical removal of the sling arms.The plan is to remove the arms through a groin incision.Given her multiple surgeries around the urethra, they would not be performing any mesh exploration or removal in the areas adjacent to the urethra.Therefore, the sling arms may be only removed up to the point of the obturator foramen/obturator membrane.Mesh medial to the obturator membrane would not be removed, and the patient may still have remnant mesh after this procedure.After discussing the risk of the procedure including injury to the muscles, nerves, including the obturator nerve, causing weakness to the medial thigh and or numbness, including paralysis, worsening pain, worsening incontinence, the patient understands these risks and signed a consent for the procedure.The patient had also been seen by a physical therapist that day ((b)(6) 2022) and was diagnosed with spastic pelvic floor syndrome.In regards to her pelvic floor muscle spasms which were identified by her physical therapist, the risk and benefits of botox injections to the pelvic floor was discussed.Botox could help relax the pelvic floor muscles and last for up to 4 to 6 months.They discussed the risk of botox including worsening pain, constipation, stool incontinence, urinary retention, urinary incontinence, muscle injury, bleeding, infection, and the patient understands that some side effects may improve when the botox starts wearing off in 4 to 6 months.The plan was to perform a pelvic floor examination on the day of the procedure to guide the injection of the botox.

Manufacturer Narrative

Block b3 date of event: date of event was approximated to (b)(6) 2020, based on the information that the patient had surgery due to symptom.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) second mesh revision surgeon is: (b)(6) block h6: patient codes e2006, e2328, e1309, e2330, e2311, e1310, e1405, e1301, e0123, e1901, e1605, e0127, e1401, e1715, e2337 and e2337 capture the reportable events of erosion, bladder obstruction, retention, pain, discomfort, uti, dyspareunia, dysuria, nerve damage, bacterial vaginosis, muscle spasm, numbness, extensive vaginal discharge, adhesions, scar tissue extending lateral to the urethra and thickening scarring in the anterior vaginal wall, urethra appeared to be a urethral stricture membrane-like and interstitial cystitis.Impact code of f1905, f1901 and f1202 capture the reportable events of mesh release surgery; and laparoscopic bilateral salpingectomies; lysis of adhesions and urethrolysis, urethroplasty; and disability.Block 11: b5, b7 and h6 patient codes and impact codes have been corrected.B5 has also been updated with additional information received october 4, 2022 regarding office visits on (b)(6) 2020 and (b)(6) 2022.

Manufacturer Narrative

Additional information: b5, e1, h6: impact code.Block e1: (b)(6).Block h6: impact code f1903 captures the reportable event of removing the mesh arms.Block b3 date of event: date of event was approximated to (b)(6) 2020, based on the information that the patient had surgery due to symptom.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Second mesh revision surgeon is: (b)(6).Block h6: patient codes e2006, e2328, e1309, e2330, e2311, e1310, e1405, e1301, e0123, e1901, e1605, e0127, e1401, e1715, e2337 and e2337 capture the reportable events of erosion, bladder obstruction, retention, pain, discomfort, uti, dyspareunia, dysuria, nerve damage, bacterial vaginosis, muscle spasm, numbness, extensive vaginal discharge, adhesions, scar tissue extending lateral to the urethra and thickening scarring in the anterior vaginal wall, urethra appeared to be a urethral stricture membrane-like and interstitial cystitis.Impact code of f1905, f1901 and f1202 capture the reportable events of mesh release surgery; and laparoscopic bilateral salpingectomies; lysis of adhesions and urethrolysis, urethroplasty; and disability.Block 11: b5, b7 and h6 patient codes and impact codes have been corrected.B5 has also been updated with additional information received october 4, 2022 regarding office visits on may 18, 2020 and july 5, 2022.

Event Description

It was reported to boston scientific corporation that an obtryx transobturator mid-urethral sling system device was implanted into the patient during a laparoscopic lysis of adhesions, left ovarian cystectomy, anterior and posterior vaginal prolapse repair, and transobturator tape procedure performed on (b)(6) 2009 for the diagnoses of chronic pelvic pain, cystocele, rectocele, stress urinary incontinence, pelvic adhesions, and left simple ovarian cyst.On an unspecified date following the surgery, the patient developed recurrent stress urinary incontinence, urge incontinence, obstructive voiding symptoms, and urinary tract infection.On (b)(6) 2013, the patient was diagnosed with interstitial cystitis and had to self-catheterize.Urodynamics demonstrated detrusor overactivity consistent with bladder outlet obstruction.Additionally, cystoscopy had noted inflammatory changes in the bladder that had resolved by cystoscopy in october 2019.More recently, the patient had gross hematuria associated with mixed urinary incontinence episodes, and urinalysis showed trace red blood cells.She denied dysuria or irritative voiding symptoms.Exam revealed scarring at the mid and proximal urethra that was mildly tender to palpation.The patient requested removal of the mesh.On (b)(6) 2020, the patient underwent diagnostic laparoscopy, lysis of adhesions, bilateral salpingectomies, removal of vaginal sling, urethrolysis, and urethral repair (urethroplasty) for the preoperative diagnoses of mixed urinary incontinence, bladder outlet obstruction, mechanical complication of the genitourinary device, and pelvic pain.Exam under anesthesia noted significant scarring in the midline extending from the distal urethra to the level of the trigone of the bladder.There was also thick scarring in the anterior vaginal wall.Scar tissue and banding extended laterally to the urethra on both sides of the midline.The sling was identified to be embedded in the tissue and compressing the proximal urethra.The scar tissue, banding, and sling were carefully dissected and excised.It was noted that the urethral wall where the sling had been embedded in the tissue and compressing appeared very thin.The integrity was confirmed and closer inspection revealed a membrane-like stricture at the midurethra with some proximal urethral dilation.The urethra was reinforced in two layers to provide support and prevent any extravasation.On (b)(6) 2020, the patient had an office visit for pelvic pain.This was post-operative day 1, status post laparoscopic bilateral salpingectomies, lysis of adhesions done, urethrolysis, removal of vaginal mesh sling and urethral repair (urethroplasty).Patient reported that she had consistent unrelenting abdominal pain since surgery.The physician who performed urethrolysis, removal of vaginal mesh and urethral repair (urethroplasty) believed the procedure was causing patient's abdominal pain.Pain was not improved with tramadol but percocet usually controls her pain.She stated that she was passing gas and tolerating regular diet.Patient was recommended to consult a gyn team to rule out underlying pathology and to offer recommendation for pain control.Patient's abdominal exam was benign and appeared to be within normal post operative state.Follow up was scheduled for february 3 and 4.Planned to return to clinic for routine post operative care.On (b)(6) 2020, the patient was evaluated for pelvic pain, urinary incontinence, and sleep apnea with associated weight gain.The pelvic pain was sharp, moderate-severe in the perineal area.Associated symptoms included back pain, hematuria, vaginal discharge, and bladder spasms.Urinary incontinence was described as painful and continuous leakage of urine.Medications for bladder spasms did not help.The patient's diagnoses included bladder outlet obstruction and continuous leakage of urine for which she was to see urology; and entrapment of the obturator nerve.On (b)(6) 2020, the patient had a visit for evaluation of pelvic pain and possible pudendal neuralgia.The patient had previously been found to have mesh erosion and underwent mesh excision in january 2020 where the vaginal portion of the sling was removed.The patient reported that since the sling removal surgery, she developed incontinence and cannot feel when she urinates.The clitoris and urethral areas are numb.She also developed pain at the perineum and in the groin area that is worse with sitting on hard surfaces.She also experiences the symptoms when she is walking up hills.Even though she has incontinence, she has trouble emptying her bladder and may have to sit first minute or so.It was found that the patient was having numbness in the distribution of the dorsal branch of the pudendal nerve which may have been affected from her prior surgery or possibly from the mesh.Given her new symptoms of groin pain, it was believed she could potentially be having a side effect from continued pain from the retained mesh.She may have also had entrapment of the pudendal nerves.For further evaluation, the patient was to be scheduled for an mri of the pelvis for evaluation of the pudendal nerves as well as an evaluation by a physical therapist.The patient was also having continued vaginal bleeding since her surgery, and the plan was to evaluate the healing of the vaginal tissue and possibly perform a revision if necessary.On (b)(6) 2020, the patient presented for disability extension related to pelvic pain and discomfort on standing and walking for periods of time.She also reported fatigue and anxiety.On the same day, she was seen at a center for chronic pelvic pain for the chief complaints of pelvic pain, pudendal neuralgia, abstract voiding, and urinary urgency.The pain affected the following areas: suprapubic, mons pubis, right and left groin, right and left labia, clitoris, urethra, perineum, right and left inner ischial tuberosity, and entire anus.The pain was described as sharp, burning, tingling, sensation of foreign body in vagina, and continuous and worse with sitting and physical activity.She was not sexually active due to severe pain during and after intercourse.She also described hesitancy, urinating 3 x per night, and feeling like she is not completely emptying her bladder.She has significant pain in the crease lines where her underwear is which is consistent with allodynia which means that she has to wear loose clothing and often is unable to wear underwear.Her pain is mostly located in the perineal area consistent with the area of innervation of the pudendal nerve.She also has some groin pain bilaterally.Patient continues to have recurrent urinary tract infection with e.Coli which are confirmed by microbiology.Exam revealed right and left levators and right and left obturators were severely tender, and her right and left adductor were mildly tender.She had mild tenderness on both sides of her back.The assessment included pelvic and perineal pain, urge urinary incontinence, dyspareunia, and pudendal nerve neuropathy.The plan was for pudendal nerve block, botox to the pelvic floor, cystoscopy, and bilateral groin mesh removal.Office visit on (b)(6) 2020: patient reported bladder problem and wanted a full removal of pelvic mesh as it had caused her pudendal neuralgia and in 2020, patient had surgery due to bladder obstruction.It was found that the mesh implanted in 2010 had rolled up and wrapped around the urethra, strangulating and partially eroded into the bladder neck and urethra.Only released the structure and was advised to find a more qualified physician to remove the mesh and rebuild her obliterated pelvic floor.Patient also reported being bothered due to the following symptoms: prolapse symptoms of bulging in vaginal area, pressure, heaviness and feeling incomplete bladder emptying.Bowel symptoms of inability to completely evacuate bowel, loss of gas without control, pain with defecation, 14 bowel movements/week, but did not experience diarrhea or constipation and denies accidental bowel leakage.Urinary symptoms of voiding every hour or more, 14 times a day, and 4 times per night.It was also reported that patient had vaginal delivery weighed 9lbs and 11 ounces.Had not taken hormone replacement therapy and vaginal hormone replacement therapy.Patient was not sexually active.Review of systems showed pain in joints, lower back pain, numbness, depressed, difficulty sleeping and pelvic pain.Urogynecological examination showed levator muscle tenderness, discomfort along the anterior vaginal wall and along the pubococcygeus muscle and extensive vaginal discharge.On (b)(6) 2021, patient came for consultation of the symptoms low back pain, anal pain, and vaginal numbness with chief complaint of pelvic pain.Patient reported her pain began 10 years ago after she underwent urethral sling procedure after childbirth.Immediately following the procedure, she noted pain in her vaginal region that lasted beyond surgical pain.She had seen multiple urologic and pain specialists, ultimately had a "mesh release" procedure done in 01/2020.After this procedure, she noted the same vaginal/urethral pain, as well as new pain in her inner thigh down to her anus.Characterizing the pain is difficult and depends upon what she is doing, however light touch precipitates pain and it has caused her to take time off from work and limits her daily activities (i.E., unable to swim, sit for extended periods of time, or have sexual intercourse).She had not tried any oral medications, but she did have good results with a combination suppository (local anesthetic, valium, and some other unknown medication).Unfortunately, the suppository lasted only a few days with the pain subsequently returning.Associated symptoms include urinary incontinence and clitoral numbness.Her major concern was getting to a point where she can work to support her son with special needs.Assessment and plan: to address the muscular component of her pain: - trial of baclofen po for 1 month (advised to update physician in 1 week) - advised patient to keep her appointment for pelvic pt scheduled for april.To address the neuropathic component of her pain: - will schedule pudendal nerve block and sympathetic ganglion of impar block.To address the central component of her long-standing pain: advised patient to follow up with pain psychology and acupuncture.Follow up after procedure.On (b)(6) 2021, patient had a follow up visit.Had her catheter removed and post -- procedural and post -- infection pain had been resolved and back to her baseline pain that she described as inner thigh radiating midline bilaterally and was exacerbated by sitting on hard surfaces.Current pain medications: -oxycodone 5 mg q6h prn -b&o suppository -baclofen (patient has tried but is not currently taking as it does not help and affects her cognitively.) assessment and plan: to address the muscular component of her pain: - continue trial of dantrolene 25 mg tid (checked lft's today and will recheck around (b)(6) 3021 if working well for her) - continue oxycodone 5 mg to tid prn - agree with trial of b&o suppository - advised patient to keep her appointment for pelvic pt scheduled for april.To address the neuropathic component of her pain: - will schedule pudendal nerve block and sympathetic ganglion of impar block for after infection has been resolved and catheter has been removed.To address the central component of her long-standing pain: - continue to recommend patient to follow up with pain psychology and acupuncture.Follow up after procedure post operative visit on (b)(6) 2021, discussed regarding issues of continued pelvic pain and dysuria, pudendal nerve block which provided some temporary relief and concerned that there may be some "residual mesh" responsible for the symptoms.Symptoms included pain when she sits, burning with urination, urinary frequency, urinary urgency, pelvic floor muscle pain.Patient's bacterial vaginosis screen was positive for bacterial vaginosis.Metrogel prescribed.During a telemedicine video visit on (b)(6) 2021, discussed mri result which was consistent with presence of some residual mesh in the groin but no vaginal portions of mesh encountered on mri.Treatment plan discussed with patient: 1.Encouraged to initiate and continue with pelvic floor physical therapy.2.Will continue pain management with a physician and guided blocks.3.We discussed vaginal medication (could consider vaginal diazepam or mixed suppositories for pain management).4.I discussed that mesh removal would likely not be successful in eliminating the pain.Encountering the mesh arms in groin would be technically very challenging and i recommend against it.Office visit on (b)(6) 2021, patient reported still on gabapentin and it made her tired throughout the day.She occasionally slept through urge or urinate and wet the bed.Bilateral pudendal nerve block improved her pain temporarily.Still doing pelvic floor therapy but had been painful for her (b)(6) 2021 cystoscopy showed urethra was normal.Bladder neck was normal.Ureteral orifice was normal size, shape, and position, effluxing clear bilaterally.Bladder mucosa was normal.Additional findings: no mesh exposure in the bladder or urethra.No foreign bodies, stones, or lesions.There was no urethral stricture.Images from her ct and mri on 1m pax reviewed.According to mri radiology report there was a hypointense band like structure which may possibly reflect residual mesh material related her prior trans-obturator sling procedure which was a possible source of her pelvic pain.Exam notable for tenderness along the obturators.We discussed surgical removal of mesh fragments.Risks and benefits discussed including bleeding, infection, injury to adjacent organs, incomplete resolution of symptoms.Discontinue gabapentin.Case request for obturator mesh fragment removal and bilateral pudendal nerve block.On (b)(6) 2022, the patient was seen for preoperative counseling.It was discussed that her symptoms may be consistent with pain related to the sling arms.She had a discussion with her healthcare provider about the surgical removal of the sling arms.The plan is to remove the arms through a groin incision.Given her multiple surgeries around the urethra, they would not be performing any mesh exploration or removal in the areas adjacent to the urethra.Therefore, the sling arms may be only removed up to the point of the obturator foramen/obturator membrane.Mesh medial to the obturator membrane would not be removed, and the patient may still have remnant mesh after this procedure.After discussing the risk of the procedure including injury to the muscles, nerves, including the obturator nerve, causing weakness to the medial thigh and or numbness, including paralysis, worsening pain, worsening incontinence, the patient understands these risks and signed a consent for the procedure.The patient had also been seen by a physical therapist that day ((b)(6) 2022) and was diagnosed with spastic pelvic floor syndrome.In regards to her pelvic floor muscle spasms which were identified by her physical therapist, the risk and benefits of botox injections to the pelvic floor was discussed.Botox could help relax the pelvic floor muscles and last for up to 4 to 6 months.They discussed the risk of botox including worsening pain, constipation, stool incontinence, urinary retention, urinary incontinence, muscle injury, bleeding, infection, and the patient understands that some side effects may improve when the botox starts wearing off in 4 to 6 months.The plan was to perform a pelvic floor examination on the day of the procedure to guide the injection of the botox.Additional information received on november 3, 2022.On (b)(6) 2021, the patient was encountered in the preoperative holding area, where the procedure was again reviewed with the patient, as it had been in clinic when informed consent was obtained.The patient was then brought into the operating room where she underwent a smooth induction of general anesthesia.The patient was placed in the dorsal lithotomy position with all pressure points padded.Iv ancef was administered.The procedure began by performing a vaginal ultrasound.The bladder, urethra, and foley balloon were identified, but the team was not able to locate any area consistent with residual mesh.An area was identified with extensive echogenicity consistent with previous scarring and a midline vaginal inicision was made there.A flap of vaginal epithelium was created, exposing an area incorporating the urethra which was incised to complete a urethrolysis.This was circumferentially dissected off and repaired with 4-0 vicryl suture.The vaginal flap was extended to the pubic bone bilaterally and no mesh was encountered.The periurethral fascia was closed over this in a non-overlapping manner with 4-0 vicryl running suture.The vaginal epithelial flap was then closed over the defect with a running 4-0 vicryl.Cystourethroscopy was performed by surveying the bladder which was unremarkable.The urethral defect was closed and watertight, later confirmed with retrograde instillation of methylene blue.A foley catheter was replaced, with plans for void trial in 7-10 days.The patient was taken out of the dorsal lithotomy position and awoken from her general anesthetic without incident.The patient was then given post-operative pain medications.On (b)(6) 2021, during a follow-up check, the ganglion impar block fixed the low back and inside the meat.Pudendal block helped with lower genitalia.The patient's pain is at a constant dull ache.If she sits too long it becomes loud.If she is standing too long then it goes into the pelvis.Walking uphill is a not allowed and walking downhill is fine.She cannot sit on the concrete or hard benches.She feels like these pains are intertwined.Since the last visit in pain clinic patient reports 100% improvement in their pain from pain procedures.Patient reports 40% improvement in their pain with use of their current pain medications.The patient has seen a physical therapist to treat the current problem.Over the last 12 months, they have done 1-7 sessions and over the last 6 months they have done 8-10 sessions.Physical therapy did not help.The patient is not doing a home exercise program has stated that the pain currently is at pain score: 7/10.Over the past week, the patient's pain has been at its worst at 10/10, at best at 5/10 and average is at 7/10.During the past week, it has interfered with enjoyment of life at 7/10 and general activity at 7/10.Pain treatments are the following on these dates: (b)(6) 2021 ganglion impar block, 2 days relief, 100% relief.(b)(6) 2021 pudendal nerve block, 2 days relief, 100% relief.On (b)(6) 2021, the patient had an mdr pelvis soft tissue with and without contrast.The t2 hypointense band like structure is noted posterior to the pubic symphysis just to the left of midline extending towards the region of the left obturator foramen.Additional linear t2 hypointense bandlike area is noted extending towards the right obturator foramen.On (b)(6) 2021, the patient underwent an initial urethrolysis but she continued to experience bothersome symptoms.An mri was performed that did not demonstrate any residual mesh in the patient's groins but did demonstrate two areas of enhancement that could be suspicious for retained mesh fragments.The patient was encountered in the preoperative holding area, where the procedure was again reviewed with the patient, as it had been in clinic when informed consent was obtained.She was then brought into the operating room where she underwent a smooth induction of general anesthesia.She was placed in the dorsal lithotomy position with all pressure points padded.Iv ancef and flagyl were administered.An extensive exam under anesthesia was performed, and two areas of nodularity were felt, more so on the left than on the right.A midline inicsion of approximately 2.5cm proximal to the urethral meatus was made - this area was proximal to the area of previous urethrolysis but retained some induration and appeared to extend towards the nodularity felt laterally.After a combination of sharp and blunt dissection, encountered the area of induration which appeared to be incorporating the urethra.This area was incised and sent for pathologic specimen.A cystoscopy confirmed the urethral defect but the bladder neck, trigone and ureteral orifices were intact.After this area of nodularity was resected and sent for pathologic specimen, proceeded to repair the urethral defect.Additionally, obtained a few segments of the urethra and sent these for biopsy as well.I did not encounter any area of scarring that was consistent with mesh.However, at the completion of the procedure we had explored extensively behind the pubic bone and i did not think it would be beneficial to explore the groins further, given the mri findings and the findings on vaginal exploration.A foley was left in place and will be removed in 10 days via vcug.We then proceed to perform the bilateral pudendal nerve blocks.We encountered both ischial spines bilaterally, and proceeded to inject 10cc of 0.5% bupivacaine / 2% lidocaine mixture bilaterally.The patient tolerated the procedure well and without complication.Patient has contacted us via mychart to express complaint about the change in her surgical time.Surgical time has been changed because there is a different case scheduled that has to be moved to first case.This decision was made on thursday after careful review and discussion of the operating room schedule.Patient being moved from 720am start to 11 am start.Patient is expressing frustration and anger regarding change in surgical time due to her prior arrangements.Note is being made of her frustration but we cannot accommodate the request given the clinical needs of moving a different case to first start.Additionally, each patient is different and recovery period in afternoon may differ by several hours in certain circumstances.Arrangements made must be flexible and this has been expressed to patient by scheduling staff.Patient experience emailed as well by physician and scheduler.On (b)(6) 2022, the patient had the mesh arms removed via groin incisions in arizona with dr.(b)(6) at st.Joseph's.Since the surgery, the patient felt like the pain of pulling has been relieved.Patient still feels pain in places people shouldn't have any pain but she is pleased that the nagging, constant pain is gone.She stated that the pudendal nerve block she received on (b)(6) 2022 was very beneficial.According to the patient, the blocks wear off every 3 to 4 months.In additional, she stated that she feels the vaginal valium is also working well.Interdisciplinary by (b)(6) nurse at (b)(6) 2022.Patient was seen in clinic today by (b)(6) dr.Avs instructions were provided.Plan: pfpt valium for vaginal suppository case request for pudendal nerve block in 12/2022 patient verbalized understanding and agrees with the plan.

Event Description

It was reported that an obtryx transobturator mid-urethral sling system device was implanted into the patient during a procedure performed on (b)(6) 2009.As reported by the patient's attorney, the patient experienced an unknown injury.The device was not returned for analysis.Additional information received on august 11, 2022: it was reported to boston scientific corporation that an obtryx transobturator mid-urethral sling system device was implanted into the patient during a procedure performed on (b)(6) 2009.Office visit on (b)(6) 2020: patient reported bladder problem and wanted a full removal of pelvic mesh as it had caused her pudendal neuralgia and in 2020, patient had surgery due to bladder obstruction.It was found that the mesh implanted in 2010 had rolled up and wrapped around the urethra, strangulating and partially eroded into the bladder neck and urethra.Only released the structure and was advised to find a more qualified physician to remove the mesh and rebuild her obliterated pelvic floor.Patient also reported being bothered due to the following symptoms: prolapse symptoms of bulging in vaginal area, pressure, heaviness and feeling incomplete bladder emptying bowel symptoms of inability to completely evacuate bowel, loss of gas without control, pain with defecation, 14 bowel movements/week, but did not experience diarrhea or constipation and denies accidental bowel leakage.Urinary symptoms of voiding every hour or more, 14 times a day, and 4 times per night.It was also reported that patient had vaginal delivery weighed 9lbs and 11 ounces.Had not taken hormone replacement therapy and vaginal hormone replacement therapy.Patient was not sexually active.Review of systems showed pain in joints, lower back pain, numbness, depressed, difficulty sleeping and pelvic pain.Urogynecological examination showed levator muscle tenderness, discomfort along the anterior vaginal wall and along the pubococcygeus muscle and extensive vaginal discharge.On (b)(6) 2021, patient came for consultation of the symptoms low back pain, anal pain, and vaginal numbness with chief complaint of pelvic pain.Patient reported her pain began 10 years ago after she underwent urethral sling procedure after childbirth.Immediately following the procedure, she noted pain in her vaginal region that lasted beyond surgical pain.She had seen multiple urologic and pain specialists, ultimately had a "mesh release" procedure done in (b)(6) 2020.After this procedure, she noted the same vaginal/urethral pain, as well as new pain in her inner thigh down to her anus.Characterizing the pain is difficult and depends upon what she is doing, however light touch precipitates pain and it has caused her to take time off from work and limits her daily activities (i.E., unable to swim, sit for extended periods of time, or have sexual intercourse).She had not tried any oral medications, but she did have good results with a combination suppository (local anesthetic, valium, and some other unknown medication).Unfortunately, the suppository lasted only a few days with the pain subsequently returning.Associated symptoms include urinary incontinence and clitoral numbness.Her major concern was getting to a point where she can work to support her son with special needs.Assessment and plan: to address the muscular component of her pain: trial of baclofen po for 1 month (advised to update physician in 1 week).Advised patient to keep her appointment for pelvic pt scheduled for (b)(6).To address the neuropathic component of her pain: will schedule pudendal nerve block and sympathetic ganglion of impar block.To address the central component of her long-standing pain: advised patient to follow up with pain psychology and acupuncture.Follow up after procedure.On (b)(6) 2021, patient had a follow up visit.Had her catheter removed and post -- procedural and post -- infection pain had been resolved and back to her baseline pain that she describes as inner thigh radiating midline bilaterally and was exacerbated by sitting on hard surfaces.Current pain medications: oxycodone 5 mg q6h prn.B&o suppository.Baclofen (patient has tried but is not currently taking as it does not help and affects her cognitively.) assessment and plan: to address the muscular component of her pain: continue trial of dantrolene 25 mg tid (checked lft's today and will recheck around (b)(6) 3021 if working well for her).Continue oxycodone 5 mg to tid prn.Agree with trial of b&o suppository.Advised patient to keep her appointment for pelvic pt scheduled for (b)(6).To address the neuropathic component of her pain: will schedule pudendal nerve block and sympathetic ganglion of impar block for after infection has been resolved and catheter has been removed.To address the central component of her long-standing pain: continue to recommend patient to follow up with pain psychology and acupuncture.Follow up after procedure.Post operative visit on (b)(6) , 2021, discussed regarding issues of continued pelvic pain and dysuria, pudendal nerve block which provided some temporary relief and concerned that there may be some "residual mesh" responsible for the symptoms.Symptoms included pain when she sit, burning with urination, urinary frequency, urinary urgency, pelvic floor muscle pain.Patient's bacterial vaginosis screen was positive for bacterial vaginosis.Metrogel prescribed.During a telemedicine video visit on (b)(6) 2021, discussed mri result which was consistent with presence of some residual mesh in the groin but no vaginal portions of mesh encountered on mri.Treatment plan discussed with patient: 1.Encouraged to initiate and continue with pelvic floor physical therapy.2.Will continue pain management with a physician and guided blocks.3.We discussed vaginal medication (could consider vaginal diazepam or mixed suppositories for pain management).4.I discussed that mesh removal would likely not be successful in eliminating the pain.Encountering the mesh arms in groin would be technically very challenging and i recommend against it.Office visit on (b)(6) 2021, patient reported still on gabapentin and it made her tired throughout the day.She occasionally slept through urge or urinate and wet the bed.Bilateral pudendal nerve block improved her pain temporarily.Still doing pelvic floor therapy but had been painful for her (b)(6) 2021 cystoscopy showed urethra was normal.Bladder neck was normal.Ureteral orifice was normal size, shape, and position, effluxing clear bilaterally.Bladder mucosa was normal.Additional findings: no mesh exposure in the bladder or urethra.No foreign bodies, stones, or lesions.There was no urethral stricture.Images from her ct and mri on 1m pax reviewed.According to mri radiology report there was a hypointense band like structure which may possibly reflect residual mesh material related her prior trans-obturator sling procedure which was a possible source of her pelvic pain.Exam notable for tenderness along the obturators.We discussed surgical removal of mesh fragments.Risks and benefits discussed including bleeding, infection, injury to adjacent organs, incomplete resolution of symptoms.Discontinue gabapentin.Case request for obturator mesh fragment removal and bilateral pudendal nerve block.Additional information received on august 16, 2022: on (b)(6) 2020, the patient had an office visit for pelvic pain.Status post laparoscopic bilateral salpingectomies, lysis of adhesions done, urethrolysis, removal of vaginal mesh sling and urethral repair (urethroplasty) done, patient reported that she had consistent unrelenting abdominal pain since surgery.The physician who performed urethrolysis, removal of vaginal mesh and urethral repair (urethroplasty) believed the procedure was causing patient's abdominal pain.Pain was not improved with tramadol but percocet usually controls her pain.She stated that she was passing gas and tolerating regular diet.Patient was recommended to consult a gyn team to rule out underlying pathology and to offer recommendation for pain control.Patient's abdominal exam was benign and appeared to be within normal post operative state.Follow up was scheduled for february 3 and 4.Planned to return to clinic for routine post operative care.Additional information received on august 8, 2022: it was reported to boston scientific corporation that an obtryx transobturator mid-urethral sling system device was implanted into the patient during a laparoscopic lysis of adhesions + left ovarian cystotomy + anterior and posterior vaginal prolapse repair + trans-obturator tape procedure performed on (b)(6) 2009 for chronic pelvic pain, cystocele, rectocele and stress urinary incontinence.Postoperatively, the patient was diagnosed with pelvic adhesions and left simple ovarian cyst.Patient was taken to the pacu in stable condition with no complications reported.On (b)(6) 2020, the patient had to undergo surgery of urethrolysis, removal of vaginal mesh and urethroplasty due to mixed urinary incontinence, bladder outlet obstruction, mechanical complication of the genitourinary device and pelvic pain.During procedure, there was thickening scarring in the anterior vaginal wall so initially the anterior vaginal infiltrated with saline and longitudinal midline incision was then made from the distal ureter approximately starting 1cm proximal to the meatus all the way through the full length of the urethra up to the level and just beyond the bladder neck region.The vaginal wall on both sides of the midline was dissected.When the urethra was fully exposed, there was significant scarring especially in the proximal urethra and at the level of the bladder neck with scar band and scar tissue extending lateral to the urethra on both sides of the midline.Mesh sling was identified which appeared to be well embedded into the tissue and compressing the proximal urethra.After complete removal of the mesh sling and the scar tissue associated with it, the indention between the proximal urethra and bladder neck was now released and the urethral vesicle angle was more in normal alignment.The bladder neck was closely inspected through the vaginal incision and there was no evidence of extravasation.The urethra was closely inspected and appeared to be a urethral stricture membrane-like at the mid urethra.After the removal of the mesh and all of the scar tissue and the completion of the urethrolysis, the urethral wall was reinforced the urethral wall by approximating the remanence of the pubocervical fascia in 2 layers.The first layer being horizontal and the second being longitudinal to provide support for the urethra and prevent any urethral extravasation.Patient was taken to recovery room in satisfactory condition.Later, on (b)(6) 2020, patient came for pelvic pain, urine incontinence and sleep apnea.Sleep apnea symptoms began 9 months ago and reported as being severe.The context of the symptoms includes weight gain.Associated symptoms include daytime somnolence, swelling in bilateral legs.Symptoms are chronic and are poorly controlled.Last surgery in (b)(6) 2020 where middle part of mesh was unstrangled from the urethra and patient has continued symptoms which need further assessment.They performed imaging of kidneys and pelvis.Has had bladder spasms in the past with multiple medications used before that did not help.Review of systems showed positive for hematuria and vaginal discharge.Assessment/plan: 1.Assessment -- bladder outlet obstruction.Patient plan - please let us know if symptoms worsen while you wait to see the urologist.2.Assessment -- continuous leakage of urine.Patient plan -- referral to urology for management.3.Assessment -- complication of implanted vaginal mesh, unspecified complication, sequela.4.Assessment -- entrapment, obturator nerve, unspecified laterally.Patient plan -- referral to urology.Please go to er if worsening symptoms.5.Assessment -- swelling of lower extremity.Plan orders - further diagnostic evaluations ordered today include(s) duplex scan venous lower leg bilateral to be performed on bilateral and ecg to be performed.6.Assessment -- sleep apnea, unspecified type.Impression -- severe symptoms.Patient plan -- please urgently get sleep study done so we can get sleep apnea under control and prevent heart attacks, strokes.Follow up with pcp (primary care physician) in 2-4 weeks for 30 minutes visit (sleep apnea, swelling in legs).On (b)(6) 2020, patient came for disability ext.The symptoms are reported as being moderate.The symptoms occur daily.The location is pelvic pain.Aggravating factors include recent surgical procedure / complicated.Associated symptoms include pelvic pain, discomfort on standing / walking for periods of time.She states the symptoms are chronic and are poorly controlled.Continuing pelvic pain here to request more time off until can get her pain settled off.Review of systems showed patient was positive for fatigue, anxiety and pelvic pain.Assessment/plan: 1.Assessment -- pelvic pain in female.Patient plan -- persistent pelvic pain, unable to stand, walk, sit for long periods of time.Always needing to change positions.2.Assessment -- complications of implanted mesh, unspecified complication, sequela.Patient plan -- still having mesh issues which is thought to have migrated or may have entrapped some fibers of obturator nerve; continued disability written.3.Assessment -- entrapment, obturator nerve, unspecified laterality.On september 9, 2020, pain note stated patient developed significant abstract avoiding any pain after placement of obtryx mesh in (b)(6) 2009.Because of her significant obstruction she was told she has interstitial cystitis and had to self-catheterized.She would also frequently see blood in her urine.Patient developed pain with intercourse to the point where her marriage fell apart.Eventually she saw a urologist dr.(b)(6) in (b)(6) removed rebated to a 0.5 cm piece of vaginal portion of the mesh in (b)(6) 2020.This has somewhat improved her voiding it she continues to be insignificant pain.She continues to have very significant pain with intercourse heading for approximately two days after.She is nocturia getting up at night 3 to 4 times.She still has difficulty emptying her bladder.She has significant pain when she is walking up the hill.She has significant pain in the crease lines where her underwear is which is consistent with allodynia which means that she has to wear loose clothing and often is unable to wear underwear.Her pain is mostly located in the perineal area consistent with the area of innervation of the pudendal nerve.She also has some groin pain bilaterally.Patient continues to have recurrent urinary tract infection with e.Coli which are confirmed by microbiology.Patient also has noticed that she has occasional swelling of her feet for the past one and 1/2 years and she has developed source inside her nose.She questions whether this is autoimmune.Assessment: pain in pelvis (finding) - pelvic and perineal pain started (b)(6) 2009 modified (b)(6) 2020.Urge urinary incontinence (finding) - urge incontinence started (b)(6) 2009 modified (b)(6) 2020.Delay when starting to pass urine (finding) - hesitancy of micturition started (b)(6) 2009 modified (b)(6) 2020.Dyspareunia - non-psychogenic (finding) - dyspareunia started (b)(6) 2009 modified (b)(6) 2020.Pudendal nerve neuropathy (disorder) - other specified mononeuropathies started (b)(6) 2009 - pudendal neuralgia resulting from implantation of obtryx modified (b)(6) 2020 patient may also have autoimmune condition related to the misplacement.Plan: pudendal nerve block.Botox to pelvic floor 400u.Cystoscopy.Bilateral groin mesh removal.On (b)(6) 2021, physician's documentation stated patient presented with bladder spasms and debris in foley catheter.The patient had bladder surgery done in 2020 and a revision 7 days prior to arrival with urogynecology for mesh revision and urethral repair.A foley catheter was put in at surgery.She was doing well until today when she developed bladder spasms and noticed debris in the foley catheter.A note stated that patient had bladder spasms occasional leaking around the tube when spasming and some debris in the foley, but the foley is draining.She is well-appearing without flank pain fever, abdominal exam is benign.Sent urine and it is suggestive of infection with nitrite positive with many whites and many bacteria, treating with ceftriaxone, keflex.Deferred foley exchange given this was placed in for surgery and there was urethral surgery done as well and thus this may be a difficult replacement, recommended she discuss possible foley exchange with her surgeon.Otherwise gave her medications that were planned by her surgeon with improvement of her symptoms, she will fill their prescription, suspect symptoms related to bladder spasm and urinary tract infection, catheter associated.She does not appear septic, discharge, the patient follow-up with her surgeon and return precautions she agrees.Impression and plan: diagnosis -- catheter associated urinary tract infection.Condition -- improved, stable.Dispositioned -- discharge to home.On (b)(6) 2021, patient came for er follow up and dysphagia.The symptoms were reported as being moderate.The location was pelvic floor pain/urine leak.She stated the symptoms were acute and had improved.Seen er for leaking urine/uti.Had pelvic floor surgery with intention to remove remaining mesh this surgery at (b)(6) ended up transected her urethra and that needed repair.Mesh, as what told to patient, was lost and unable to be found.Patient wanted second opinion by another gyne for her complicated case of chronic pelvic pain.Referral will be given.Assessment/plan: complication of implanted vaginal mesh, unspecified complication, sequela.Plan: complicated procedure done at (b)(6), unfinished removal of vaginal mesh.Patient seeking 2nd opinion, will send to another pelvic floor specialist.Patient had an office visit on (b)(6) 2021 for follow up endoscopy, nodules right lung, not able to work since (b)(6) 2020, pelvic floor referral and depression.Hpi: 1.Follow up endoscopy - biopsy was done and patient will meet with gi for discussion of symptoms.2.Nodules right lung -- ct scan lung nodule without contract patient low risk as non-smoker.3.Not able to work since (b)(6) 2020 - due to ongoing pelvic pain, pudendal nerve, unable sit / stand for long periods of time.4.Pelvic floor referral - referral to a physician (b)(6) - pelvic floor and reconstructive surgery.5.Depression.Lastly, on (b)(6) 2021, a visit note stated pelvic pain as chief complaint.Patient had 2 attempts to remove mesh, unfortunately, she had her urethra and transected the first time as well as the second time and no mesh was removed.Patient continued to be in significant pain.Physician believed that her mesh which was dislodged in pelvic floor muscles was causing them to spasm.Patient had botox injection which gave her some minor temporary relief but as long as mesh still in the muscles she could not have the full relief.Patient went to proceed with groin removal of the mesh, bilateral pudendal nerve block and botox injection into pelvic floor muscles 400 units.This procedure was discussed in detail with the patient.Patient understood that there are no guarantees that this will relieve her pain and that there are risks associated with surgery.

Manufacturer Narrative

Block b3 date of event was approximated to january 1, 2020, based on the information that the patient had surgery due to symptom.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Second mesh revision surgeon is: dr.(b)(6).Block h6: patient codes e2006, e2328, e1309, e2330, e2311, e1310, e1405, e1301, e0123, e1901, e1605, e0127, e1401, e1715, e2337 and e2337 capture the reportable events of erosion, bladder obstruction, retention, pain, discomfort, uti, dyspareunia, dysuria, nerve damage, bacterial vaginosis, muscle spasm, numbness, extensive vaginal discharge, adhesions, scar tissue extending lateral to the urethra and thickening scarring in the anterior vaginal wall, urethra appeared to be a urethral stricture membrane-like and interstitial cystitis.Impact code of f1905 and f1901 capture the reportable events of mesh release surgery; and laparoscopic bilateral salpingectomies, lysis of adhesions and urethrolysis, urethroplasty.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the removed mesh is not expected to be returned for evaluation; therefore, a problem 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 transobturator mid-urethral sling system device was implanted into the patient during a laparoscopic lysis of adhesions, left ovarian cystectomy, anterior and posterior vaginal prolapse repair, and transobturator tape procedure performed on (b)(6), 2009 for the diagnoses of chronic pelvic pain, cystocele, rectocele, stress urinary incontinence, pelvic adhesions, and left simple ovarian cyst.On an unspecified date following the surgery, the patient developed recurrent stress urinary incontinence, urge incontinence, obstructive voiding symptoms, and urinary tract infection.On (b)(6) 2013, the patient was diagnosed with interstitial cystitis and had to self-catheterize.Urodynamics demonstrated detrusor overactivity consistent with bladder outlet obstruction.Additionally, cystoscopy had noted inflammatory changes in the bladder that had resolved by cystoscopy in (b)(6) 2019.More recently, the patient had gross hematuria associated with mixed urinary incontinence episodes, and urinalysis showed trace red blood cells.She denied dysuria or irritative voiding symptoms.Exam revealed scarring at the mid and proximal urethra that was mildly tender to palpation.The patient requested removal of the mesh.On (b)(6) 2020, the patient underwent diagnostic laparoscopy, lysis of adhesions, bilateral salpingectomies, removal of vaginal sling, urethrolysis, and urethral repair (urethroplasty) for the preoperative diagnoses of mixed urinary incontinence, bladder outlet obstruction, mechanical complication of the genitourinary device, and pelvic pain.Exam under anesthesia noted significant scarring in the midline extending from the distal urethra to the level of the trigone of the bladder.There was also thick scarring in the anterior vaginal wall.Scar tissue and banding extended laterally to the urethra on both sides of the midline.The sling was identified to be embedded in the tissue and compressing the proximal urethra.The scar tissue, banding, and sling were carefully dissected and excised.It was noted that the urethral wall where the sling had been embedded in the tissue and compressing appeared very thin.The integrity was confirmed and closer inspection revealed a membrane-like stricture at the midurethra with some proximal urethral dilation.The urethra was reinforced in two layers to provide support and prevent any extravasation.On (b)(6) 2020, the patient had an office visit for pelvic pain.This was post-operative day 1, status post laparoscopic bilateral salpingectomies, lysis of adhesions done, urethrolysis, removal of vaginal mesh sling and urethral repair (urethroplasty).Patient reported that she had consistent unrelenting abdominal pain since surgery.The physician who performed urethrolysis, removal of vaginal mesh and urethral repair (urethroplasty) believed the procedure was causing patient's abdominal pain.Pain was not improved with tramadol but percocet usually controls her pain.She stated that she was passing gas and tolerating regular diet.Patient was recommended to consult a gyn team to rule out underlying pathology and to offer recommendation for pain control.Patient's abdominal exam was benign and appeared to be within normal post operative state.Follow up was scheduled for february 3 and 4.Planned to return to clinic for routine post operative care.On (b)(6) 2020, the patient was evaluated for pelvic pain, urinary incontinence, and sleep apnea with associated weight gain.The pelvic pain was sharp, moderate-severe in the perineal area.Associated symptoms included back pain, hematuria, vaginal discharge, and bladder spasms.Urinary incontinence was described as painful and continuous leakage of urine.Medications for bladder spasms did not help.The patient's diagnoses included bladder outlet obstruction and continuous leakage of urine for which she was to see urology; and entrapment of the obturator nerve.On (b)(6) 2020, the patient had a visit for evaluation of pelvic pain and possible pudendal neuralgia.The patient had previously been found to have mesh erosion and underwent mesh excision in (b)(6) 2020 where the vaginal portion of the sling was removed.The patient reported that since the sling removal surgery, she developed incontinence and cannot feel when she urinates.The clitoris and urethral areas are numb.She also developed pain at the perineum and in the groin area that is worse with sitting on hard surfaces.She also experiences the symptoms when she is walking up hills.Even though she has incontinence, she has trouble emptying her bladder and may have to sit first minute or so.It was found that the patient was having numbness in the distribution of the dorsal branch of the pudendal nerve which may have been affected from her prior surgery or possibly from the mesh.Given her new symptoms of groin pain, it was believed she could potentially be having a side effect from continued pain from the retained mesh.She may have also had entrapment of the pudendal nerves.For further evaluation, the patient was to be scheduled for an mri of the pelvis for evaluation of the pudendal nerves as well as an evaluation by a physical therapist.The patient was also having continued vaginal bleeding since her surgery, and the plan was to evaluate the healing of the vaginal tissue and possibly perform a revision if necessary.On (b)(6) 2020, the patient presented for disability extension related to pelvic pain and discomfort on standing and walking for periods of time.She also reported fatigue and anxiety.On the same day, she was seen at a center for chronic pelvic pain for the chief complaints of pelvic pain, pudendal neuralgia, abstract voiding, and urinary urgency.The pain affected the following areas: suprapubic, mons pubis, right and left groin, right and left labia, clitoris, urethra, perineum, right and left inner ischial tuberosity, and entire anus.The pain was described as sharp, burning, tingling, sensation of foreign body in vagina, and continuous and worse with sitting and physical activity.She was not sexually active due to severe pain during and after intercourse.She also described hesitancy, urinating 3 x per night, and feeling like she is not completely emptying her bladder.She has significant pain in the crease lines where her underwear is which is consistent with allodynia which means that she has to wear loose clothing and often is unable to wear underwear.Her pain is mostly located in the perineal area consistent with the area of innervation of the pudendal nerve.She also has some groin pain bilaterally.Patient continues to have recurrent urinary tract infection with e.Coli which are confirmed by microbiology.Exam revealed right and left levators and right and left obturators were severely tender, and her right and left adductor were mildly tender.She had mild tenderness on both sides of her back.The assessment included pelvic and perineal pain, urge urinary incontinence, dyspareunia, and pudendal nerve neuropathy.The plan was for pudendal nerve block, botox to the pelvic floor, cystoscopy, and bilateral groin mesh removal.Office visit on (b)(6) 2020: patient reported bladder problem and wanted a full removal of pelvic mesh as it had caused her pudendal neuralgia and in 2020, patient had surgery due to bladder obstruction.It was found that the mesh implanted in 2010 had rolled up and wrapped around the urethra, strangulating and partially eroded into the bladder neck and urethra.Only released the structure and was advised to find a more qualified physician to remove the mesh and rebuild her obliterated pelvic floor.Patient also reported being bothered due to the following symptoms: prolapse symptoms of bulging in vaginal area, pressure, heaviness and feeling incomplete bladder emptying bowel symptoms of inability to completely evacuate bowel, loss of gas without control, pain with defecation, 14 bowel movements/week, but did not experience diarrhea or constipation and denies accidental bowel leakage.Urinary symptoms of voiding every hour or more, 14 times a day, and 4 times per night it was also reported that patient had vaginal delivery weighed 9lbs and 11 ounces.Had not taken hormone replacement therapy and vaginal hormone replacement therapy.Patient was not sexually active.Review of systems showed pain in joints, lower back pain, numbness, depressed, difficulty sleeping and pelvic pain.Urogynecological examination showed levator muscle tenderness, discomfort along the anterior vaginal wall and along the pubococcygeus muscle and extensive vaginal discharge.On (b)(6) 2021, patient came for consultation of the symptoms low back pain, anal pain, and vaginal numbness with chief complaint of pelvic pain.Patient reported her pain began 10 years ago after she underwent urethral sling procedure after childbirth.Immediately following the procedure, she noted pain in her vaginal region that lasted beyond surgical pain.She had seen multiple urologic and pain specialists, ultimately had a "mesh release" procedure done in (b)(6) 2020.After this procedure, she noted the same vaginal/urethral pain, as well as new pain in her inner thigh down to her anus.Characterizing the pain is difficult and depends upon what she is doing, however light touch precipitates pain and it has caused her to take time off from work and limits her daily activities (i.E., unable to swim, sit for extended periods of time, or have sexual intercourse).She had not tried any oral medications, but she did have good results with a combination suppository (local anesthetic, valium, and some other unknown medication).Unfortunately, the suppository lasted only a few days with the pain subsequently returning.Associated symptoms include urinary incontinence and clitoral numbness.Her major concern was getting to a point where she can work to support her son with special needs.Assessment and plan: to address the muscular component of her pain: trial of baclofen po for 1 month (advised to update physician in 1 week) - advised patient to keep her appointment for pelvic pt scheduled for april to address the neuropathic component of her pain: - will schedule pudendal nerve block and sympathetic ganglion of impar block to address the central component of her long-standing pain: - advised patient to follow up with pain psychology and acupuncture - follow up after procedure.On (b)(6) 2021, patient had a follow up visit.Had her catheter removed and post -- procedural and post -- infection pain had been resolved and back to her baseline pain that she described as inner thigh radiating midline bilaterally and was exacerbated by sitting on hard surfaces.Current pain medications: -oxycodone 5 mg q6h prn.-b&o suppository.-baclofen (patient has tried but is not currently taking as it does not help and affects her cognitively.) assessment and plan: to address the muscular component of her pain: - continue trial of dantrolene 25 mg tid (checked lft's today and will recheck around (b)(6) 2021 if working well for her).- continue oxycodone 5 mg to tid prn.- agree with trial of b&o suppository.- advised patient to keep her appointment for pelvic pt scheduled for april.To address the neuropathic component of her pain: - will schedule pudendal nerve block and sympathetic ganglion of impar block for after infection has been resolved and catheter has been removed.To address the central component of her long-standing pain: - continue to recommend patient to follow up with pain psychology and acupuncture.Follow up after procedure.Post operative visit on (b)(6) 2021, discussed regarding issues of continued pelvic pain and dysuria, pudendal nerve block which provided some temporary relief and concerned that there may be some "residual mesh" responsible for the symptoms.Symptoms included pain when she sits, burning with urination, urinary frequency, urinary urgency, pelvic floor muscle pain.Patient's bacterial vaginosis screen was positive for bacterial vaginosis.Metrogel prescribed.During a telemedicine video visit on (b)(6) 2021, discussed mri result which was consistent with presence of some residual mesh in the groin but no vaginal portions of mesh encountered on mri.Treatment plan discussed with patient: 1.Encouraged to initiate and continue with pelvic floor physical therapy 2.Will continue pain management with a physician and guided blocks 3.We discussed vaginal medication (could consider vaginal diazepam or mixed suppositories for pain management) 4.I discussed that mesh removal would likely not be successful in eliminating the pain.Encountering the mesh arms in groin would be technically very challenging and i recommend against it.Office visit on (b)(6) 2021, patient reported still on gabapentin and it made her tired throughout the day.She occasionally slept through urge or urinate and wet the bed.Bilateral pudendal nerve block improved her pain temporarily.Still doing pelvic floor therapy but had been painful for her.(b)(6) 2021 cystoscopy showed urethra was normal.Bladder neck was normal.Ureteral orifice was normal size, shape, and position, effluxing clear bilaterally.Bladder mucosa was normal.Additional findings: no mesh exposure in the bladder or urethra.No foreign bodies, stones, or lesions.There was no urethral stricture.Images from her ct and mri on 1m pax reviewed.According to mri radiology report there was a hypointense band like structure which may possibly reflect residual mesh material related her prior trans-obturator sling procedure which was a possible source of her pelvic pain.Exam notable for tenderness along the obturators.We discussed surgical removal of mesh fragments.Risks and benefits discussed including bleeding, infection, injury to adjacent organs, incomplete resolution of symptoms.Discontinue gabapentin -case request for obturator mesh fragment removal and bilateral pudendal nerve block on (b)(6) 2022, the patient was seen for preoperative counseling.It was discussed that her symptoms may be consistent with pain related to the sling arms.She had a discussion with her healthcare provider about the surgical removal of the sling arms.The plan is to remove the arms through a groin incision.Given her multiple surgeries around the urethra, they would not be performing any mesh exploration or removal in the areas adjacent to the urethra.Therefore, the sling arms may be only removed up to the point of the obturator foramen/obturator membrane.Mesh medial to the obturator membrane would not be removed, and the patient may still have remnant mesh after this procedure.After discussing the risk of the procedure including injury to the muscles, nerves, including the obturator nerve, causing weakness to the medial thigh and or numbness, including paralysis, worsening pain, worsening incontinence, the patient understands these risks and signed a consent for the procedure.The patient had also been seen by a physical therapist that day ((b)(6), 2022) and was diagnosed with spastic pelvic floor syndrome.In regards to her pelvic floor muscle spasms which were identified by her physical therapist, the risk and benefits of botox injections to the pelvic floor was discussed.Botox could help relax the pelvic floor muscles and last for up to 4 to 6 months.They discussed the risk of botox including worsening pain, constipation, stool incontinence, urinary retention, urinary incontinence, muscle injury, bleeding, infection, and the patient understands that some side effects may improve when the botox starts wearing off in 4 to 6 months.The plan was to perform a pelvic floor examination on the day of the procedure to guide the injection of the botox.Additional information received on november 3, 2022: on (b)(6) 2021, the patient was encountered in the preoperative holding area, where the procedure was again reviewed with the patient, as it had been in the clinic when informed consent was obtained.The patient was then brought into the operating room where she underwent a smooth induction of general anesthesia.The patient was placed in the dorsal lithotomy position with all pressure points padded.Iv ancef was administered.The procedure began by performing a vaginal ultrasound.The bladder, urethra, and foley balloon were identified, but the team was not able to locate any area consistent with residual mesh.An area was identified with extensive echogenicity consistent with previous scarring and a midline vaginal incision was made there.A flap of vaginal epithelium was created, exposing an area incorporating the urethra which was incised to complete a urethrolysis.This was circumferentially dissected off and repaired with 4-0 vicryl suture.The vaginal flap was extended to the pubic bone bilaterally and no mesh was encountered.The periurethral fascia was closed over this in a non-overlapping manner with 4-0 vicryl running suture.The vaginal epithelial flap was then closed over the defect with a running 4-0 vicryl.Cystourethroscopy was performed by surveying the bladder which was unremarkable.The urethral defect was closed and watertight, later confirmed with retrograde instillation of methylene blue.A foley catheter was replaced, with plans for void trial in 7-10 days.The patient was taken out of the dorsal lithotomy position and awoken from her general anesthetic without incident.The patient was then given post-operative pain medications.On (b)(6) 2021, during a follow-up check, the ganglion impar block fixed the low back and inside the meat.Pudendal block helped with lower genitalia.The patient's pain is at a constant dull ache.If she sits too long it becomes loud.If she is standing too long then it goes into the pelvis.Walking uphill is a not allowed and walking downhill is fine.She cannot sit on the concrete or hard benches.She feels like these pains are intertwined.Since the last visit in pain clinic patient reports 100% improvement in their pain from pain procedures.Patient reports 40% improvement in their pain with use of their current pain medications.The patient has seen a physical therapist to treat the current problem.Over the last 12 months, they have done 1-7 sessions and over the last 6 months they have done 8-10 sessions.Physical therapy did not help.The patient is not doing a home exercise program has stated that the pain currently is at pain score: 7/10.Over the past week, the patient's pain has been at its worst at 10/10, at best at 5/10 and average is at 7/10.During the past week, it has interfered with enjoyment of life at 7/10 and general activity at 7/10.Pain treatments are the following on these dates: (b)(6) 2021 ganglion impar block, 2 days relief, 100% relief (b)(6), 2021 pudendal nerve block, 2 days relief, 100% relief on (b)(6) 2021, the patient had an mdr pelvis soft tissue with and without contrast.The t2 hypointense band like structure is noted posterior to the pubic symphysis just to the left of midline extending towards the region of the left obturator foramen.Additional linear t2 hypointense bandlike area is noted extending towards the right obturator foramen.On (b)(6) 2021, the patient underwent an initial ureterolysis but she continued to experience bothersome symptoms.An mri was performed that did not demonstrate any residual mesh in the patient's groins but did demonstrate two areas of enhancement that could be suspicious for retained mesh fragments.The patient was encountered in the preoperative holding area, where the procedure was again reviewed with the patient, as it had been in clinic when informed consent was obtained.She was then brought into the operating room where she underwent a smooth induction of general anesthesia.She was placed in the dorsal lithotomy position with all pressure points padded.Iv ancef and flagyl were administered.An extensive exam under anesthesia was performed, and two areas of nodularity were felt, more so on the left than on the right.A midline incision of approximately 2.5cm proximal to the urethral meatus was made - this area was proximal to the area of previous urethrolysis but retained some induration and appeared to extend towards the nodularity felt laterally.After a combination of sharp and blunt dissection, encountered the area of induration which appeared to be incorporating the urethra.This area was incised and sent for pathologic specimen.A cystoscopy confirmed the urethral defect but the bladder neck, trigone and ureteral orifices were intact.After this area of nodularity was resected and sent for pathologic specimen, proceeded to repair the urethral defect.Additionally, obtained a few segments of the urethra and sent these for biopsy as well.I did not encounter any area of scarring that was consistent with mesh.However, at the completion of the procedure we had explored extensively behind the pubic bone and the physician did not think it would be beneficial to explore the groins further, given the mri findings and the findings on vaginal exploration.A foley was left in place and will be removed in 10 days via vcug.The bilateral pudendal nerve blocks was then performed.Both ischial spines bilaterally were encountered and proceeded to inject 10cc of 0.5% bupivacaine / 2% lidocaine mixture bilaterally.The patient tolerated the procedure well and without complication.On (b)(6) 2022, the patient had the mesh arms removed via groin incision.Since the surgery, the patient felt like the pain of pulling has been relieved.Patient still feels pain in places people shouldn't have any pain but she is pleased that the nagging, constant pain is gone.She stated that the pudendal nerve block she received on (b)(6), 2022 was very beneficial.According to the patient, the blocks wear off every 3 to 4 months.In addition, she stated that she feels the vaginal valium is also working well.The patient was seen in clinic on (b)(6) 2022.Avs instructions were provided.Plan: pfpt (pelvic floor physical therapy).Valium for vaginal suppository.Case request for pudendal nerve block in (b)(6) 2022 patient verbalized understanding and agreed with the plan.Additional information received on august 9, 2023: on (b)(6) 2020, the patient had an office visit and was diagnosed with pudendal neuralgia due to previous mesh inserted.During the visit, some medications had been recommended to the patient.A physical exam was also performed and showed normal findings.Assessment/plan: complication for implanted vaginal mesh needs to be removed, and repair of a nerve involving mesh migration needs to have a surgery itself.- for pudendal neuralgia, the patient will undergo surgical treatment.On (b)(6) 2022, the patient had an online consultation due to extreme pain when working uphill, swimming, and doing physical activities.Assessment/plan: - for class 3 severe obesity due to excess calories with body mass, the patient needs to lose weight through lifestyle changes such as healthier choices and meal plans, increased daily activity, and an exercise plan.- for the patient's excessive daytime sleepiness, she needs a follow-up for evaluation and management.Patient was also assessed for premature surgical menopause.

Manufacturer Narrative

Blocks b5 and b7 have been updated based on the additional information received on august 9, 2023.Additional information: b5, e1, h6: impact code.Block e1: this event was reported by the patient's legal representation.Primary surgeon: (b)(6), md.Block h6: impact code f1903 captures the reportable event of removing the mesh arms.Block b3 date of event: date of event was approximated to january 1, 2020, based on the information that the patient had surgery due to symptom.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient codes e2006, e2328, e1309, e2330, e2311, e1310, e1405, e1301, e0123, e1901, e1605, e0127, e1401, e1715, e2337 and e2337 capture the reportable events of erosion, bladder obstruction, retention, pain, discomfort, uti, dyspareunia, dysuria, nerve damage, bacterial vaginosis, muscle spasm, numbness, extensive vaginal discharge, adhesions, scar tissue extending lateral to the urethra and thickening scarring in the anterior vaginal wall, urethra appeared to be a urethral stricture membrane-like and interstitial cystitis.Impact code of f1905, f1901 and f1202 capture the reportable events of mesh release surgery; and laparoscopic bilateral salpingectomies; lysis of adhesions and urethrolysis, urethroplasty; and disability.Block 11: b5, b7 and h6 patient codes and impact codes have been corrected.B5 has also been updated with additional information received october 4, 2022 regarding office visits on may (b)(6) 2022.

• Brand Name: LYNX SYSTEM
• 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): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12121407
• MDR Text Key: 260051229
• Report Number: 3005099803-2021-03278
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 104 KG