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

BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

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Model Number M0068505000

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

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Erosion (1750); Diarrhea (1811); Purulent Discharge (1812); Micturition Urgency (1871); Headache (1880); Hemorrhage/Bleeding (1888); Inflammation (1932); Nausea (1970); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Deformity/ Disfigurement (2360); Prolapse (2475); Dysuria (2684); Constipation (3274); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Insufficient Information (4580)

Event Date 07/04/2019

Event Type Injury

Manufacturer Narrative

Date of event was approximated to (b)(6) 2019, implant date, as no event date was reported.This event was reported by the patient's legal representation.The surgeon is: (b)(6).(b)(4).The complaint device 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

Manufacturer Narrative

Additional information: blocks a2, a3, b2: outcomes attrib to adv event, b3, b5, e1, h6: patient codes and h6: impact codes block b3 date of event: date of event was approximated to (b)(6) 2019, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The surgeon is: (b)(4).Block h6: patient codes e2006, e2308, e2330, e1405 and e1002 capture the reportable events of mesh erosion, disfigurement, pain, dyspareunia and abdominal pain.Impact codes f1202, f1903, f1905, and f2303 capture the reportable events of physical impairment, device explantation, device revision and treatments.Block h10: the complaint device 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

Manufacturer Narrative

Additional information: blocks b3, b5, d6b, e1 (below) h6: patient codes and h6: impact codes.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Sling removal surgeon: (b)(6).Block h6: patient codes e2006, e2308, e2330, e1405, e1002, e1715, e1310, e0123,capture the reportable events of mesh erosion, disfigurement, pain, dyspareunia, abdominal pain, scar tissue, urinary tract infections and pudendal neuralgia.Impact codes f1202, f1903, f1905, f1901 and f2303 capture the reportable events of physical impairment, device explantation, device revision, other surgical interventions, and treatments.Block h10: the complaint device 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 system - halo device was used during a procedure performed on (b)(6), 2019.As reported by the patient's attorney, the patient has experienced an unspecified injury.**additional information received on december 8, 2021** it was reported that as a result of the implant, the patient has suffered abdominal and pelvic pain, dyspareunia, erosion of mesh, urinary problems, bladder and groin pain, neurological pain, and past and future physical impairment and disfigurement, past and future emotional distress, past and future physical pain and suffering, and recommended future revision or explant surgery.Reportedly, the patient is still receiving treatment so this list is subject to change as her condition develops and diagnoses are received in the future.**additional information received on january 12.2022** the patient underwent a robotic assisted laparoscopic total hysterectomy, bilateral salpingectomy, cystoscopy with trans-obturator urethropexy procedure on (b)(6), 2019 due to menorrhagia with regular cycle, severe dysmenorrhea, dyspareunia due to medical condition in female and stress incontinence.Medical history included smoking (1 pack per day for 24 years), depression, irritable bowel syndrome.On (b)(6), 2019, the patient presented to emergency department with lower abdominal and pelvic pain, diarrhea off-and-on for the past week and nausea.She reported that she noticed a large cup of pus in the toilet and had been on macrobid twice for utis since the implant surgery.The patient had seen her primary care physician on (b)(6), 2019, and she was sent for blood work and an abdominal ct scan which showed mild colitis with liquid stool.She was prescribed flagyl.Exam on (b)(6), 2019, revealed purulent material in the vaginal vault, an opening in the vaginal vault with some white tissue, and tenderness to this area and upon suprapubic palpation.Ct and wet prep were consistent with vaginitis.The patient was prescribed vaginal suppository clindamycin for bacterial vaginitis.On (b)(6), 2019, the patient presented with the preoperative diagnoses of erosion of implanted vaginal mesh to surrounding tissue, pelvic pain, lower abdominal pain and pelvic pressure, status post laparoscopic hysterectomy and transobturator sling with cystoscopy.The patient reported that since the 2019 procedure, she has experienced severe pain in the left lateral fornices of the vagina suburethrally specifically when the bladder fills and on certain movements and sitting for long periods of time.The patient underwent cystoscopy and urethroscopy.On examination, the patient did not have any evidence of any extrusion of the sling; however, she did have some discomfort along the arms and the lateral fornices and suburethral areas as well as a levator myalgia when palpating the levator muscles in the pelvis.The patient underwent cystoscopy and urethroscopy.No evidence of any lesions or erosions into the bladder and both ureters were effluxing urine.With the bladder filled to approximately 300 ml, gentle palpation in the suburethral area, midurethral, suburethral and lateral fornices was performed and revealed there was more pain on the left than the right and the suburethral area seemed to be the most significantly painful right under where the sling would sit.Both levators were again tender; however, the left seemed to be more tender than the right.At this point, the rest of the procedure was completed and she was sent to recovery room and discharged in good condition and will follow up in the office.On (b)(6), 2020, the patient reported that she experienced stabbing pains in rectum, clitoris and bilateral groins since her 2019 procedure.She also reported pain when sitting, pain with full bladder, pelvic pain, painful intercourse, urinary incontinence with urgency, urinary frequency, and nocturia.The physician and patient discussed possible mesh removal.On (b)(6), 2020, the patient presented with vaginal pain, dyspareunia, muscular groin pain, leg pain, and foreign material in vagina.She then underwent complete removal of the obtryx vaginal sling, removal of vulvar mesh with exploration of the obturator space, urethral lysis, vaginal paravaginal dissection and mesh removal from the deep obturator internus muscles and anterior colporrhaphy.The operative report notes that it was a very difficult surgery due to scarring from the previous surgery and the dissection required to remove the mesh that was very deeply implanted.On (b)(6), 2020, the patient presented for a new patient consultation.She reported low back and pelvic pain that started in (b)(6) 2019 and had gradually worsened which she feels was worsened by her hysterectomy and mesh placement.She reported bilateral thigh pain accompanied by swelling and extreme pressure around her tailbone.The pain was worsened with sitting, increased walking and intercourse, and she was off work since (b)(6), 2020 and concerned about the pain affecting her work upon her return due to prolonged sitting that is required at her job.The pain was also impacting her activities of daily living.Since mesh removal 5 weeks prior, she did have less pressure in the urethral and vaginal area, but the other pain was not improved.On (b)(6), 2020, the patient presented with pudendal neuralgia and underwent left pudendal nerve block with fluoroscopic guidance.It was noted the patient had not responded to more than 3 months of conservative therapy including activity modification, physical therapy, exercise program, and medications.On (b)(6), 2020, the patient presented for a preoperative assessment to address her with bilateral pudendal neuralgia.Reportedly, her obturator and pudendal neuralgia started since her total vaginal hysterectomy with tvt-o placement in (b)(6) 2019 and did not resolve after the complete removal of the mesh.There was some reduction in the groin and thigh pain since mesh removal, but the pudendal type symptoms and pain were still present and included poor sitting tolerance, rectal pain, clitoral pain, vaginal pressure pain, pain with intercourse and orgasm, and pain with bowel movements.The pudendal blocks provided excellent temporary pain relief.On (b)(6), 2020, the patient underwent bilateral transgluteal pudendal nerve decompression.It was found that the patient had congenital pudendal nerve entrapment; a branch of the pudendal nerve was found to be perforating the sacrospinous ligament.There was some bleeding associated with the procedure that was controlled with packing, surgiflo, and cautery.The patient was admitted to the hospital for pain control and was transitioned to oral medications.On (b)(6), 2020, the patient was discharged with pain medications.

Manufacturer Narrative

Correction to blocks b5 and h6: patient codes.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Sling removal surgeon: (b)(6), md.(b)(6).Block h6: patient codes e2006, e2308, e2330, e1405, e1002, e1715, e1310, e0123, e0506, e1901 and e2326 capture the reportable events of mesh erosion, disfigurement, pain, dyspareunia, abdominal pain, scar tissue, urinary tract infections, pudendal neuralgia, bleeding and bacterial vaginitis (captured under e1901 and e2326).Impact codes f1202, f1903, f1905, f1901 and f2303 capture the reportable events of physical impairment, device explantation, device revision, other surgical interventions, and treatments.Block h10: the complaint device 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.

Manufacturer Narrative

Additional information: blocks b5, b7 and h6: patient codes block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Sling removal surgeon: (b)(6) md (b)(6).Block h6: patient codes e2006, e2308, e2330, e1405, e1002, e1715, e1310, e0123, e0506, e1901, e2326, e1301 and e020201 capture the reportable events of mesh erosion, disfigurement, pain, dyspareunia, abdominal pain, scar tissue, urinary tract infections, pudendal neuralgia, bleeding, bacterial vaginitis (captured under e1901 and e2326), dysuria and anxiety.Impact codes f1202, f1903, f1905, f1901 and f2303 capture the reportable events of physical impairment, device explantation, device revision, other surgical interventions, and treatments.Block h10: the complaint device 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 system - halo device was used during a procedure performed on (b)(6) 2019.As reported by the patient's attorney, the patient has experienced an unspecified injury.**additional information received on december 8, 2021** it was reported that as a result of the implant, the patient has suffered abdominal and pelvic pain, dyspareunia, erosion of mesh, urinary problems, bladder and groin pain, neurological pain, and past and future physical impairment and disfigurement, past and future emotional distress, past and future physical pain and suffering, and recommended future revision or explant surgery.Reportedly, the patient is still receiving treatment so this list is subject to change as her condition develops and diagnoses are received in the future.**additional information received on january 12, 2022** the patient underwent a robotic assisted laparoscopic total hysterectomy, bilateral salpingectomy, cystoscopy with trans-obturator urethropexy procedure on (b)(6), 2019 due to menorrhagia with regular cycle, severe dysmenorrhea, dyspareunia due to medical condition in female and stress incontinence.Medical history included smoking (1 pack per day for 24 years), depression, irritable bowel syndrome.On (b)(6) 2019, the patient presented to emergency department with lower abdominal and pelvic pain, diarrhea off-and-on for the past week and nausea.She reported that she noticed a large cup of pus in the toilet and had been on macrobid twice for utis since the implant surgery.The patient had seen her primary care physician on (b)(6), 2019, and she was sent for blood work and an abdominal ct scan which showed mild colitis with liquid stool.She was prescribed flagyl.Exam on (b)(6), 2019, revealed purulent material in the vaginal vault, an opening in the vaginal vault with some white tissue, and tenderness to this area and upon suprapubic palpation.Ct and wet prep were consistent with vaginitis.The patient was prescribed vaginal suppository clindamycin for bacterial vaginitis.On (b)(6), 2019, the patient presented with the preoperative diagnoses of erosion of implanted vaginal mesh to surrounding tissue, pelvic pain, lower abdominal pain and pelvic pressure, status post laparoscopic hysterectomy and transobturator sling with cystoscopy.The patient reported that since the 2019 procedure, she has experienced severe pain in the left lateral fornices of the vagina suburethrally specifically when the bladder fills and on certain movements and sitting for long periods of time.The patient underwent cystoscopy and urethroscopy.On examination, the patient did not have any evidence of any extrusion of the sling; however, she did have some discomfort along the arms and the lateral fornices and suburethral areas as well as a levator myalgia when palpating the levator muscles in the pelvis.The patient underwent cystoscopy and urethroscopy.No evidence of any lesions or erosions into the bladder and both ureters were effluxing urine.With the bladder filled to approximately 300 ml, gentle palpation in the suburethral area, midurethral, suburethral and lateral fornices was performed and revealed there was more pain on the left than the right and the suburethral area seemed to be the most significantly painful right under where the sling would sit.Both levators were again tender; however, the left seemed to be more tender than the right.At this point, the rest of the procedure was completed and she was sent to recovery room and discharged in good condition and will follow up in the office.On (b)(6), 2020, the patient reported that she experienced stabbing pains in rectum, clitoris and bilateral groins since her 2019 procedure.She also reported pain when sitting, pain with full bladder, pelvic pain, painful intercourse, urinary incontinence with urgency, urinary frequency, and nocturia.The physician and patient discussed possible mesh removal.On (b)(6) 2020, the patient presented with vaginal pain, dyspareunia, muscular groin pain, leg pain, and foreign material in vagina.She then underwent complete removal of the obtryx vaginal sling, removal of vulvar mesh with exploration of the obturator space, urethral lysis, vaginal paravaginal dissection and mesh removal from the deep obturator internus muscles and anterior colporrhaphy.The operative report notes that it was a very difficult surgery due to scarring from the previous surgery and the dissection required to remove the mesh that was very deeply implanted.On (b)(6) 2020, the patient presented for a new patient consultation.She reported low back and pelvic pain that started in june 2019 and had gradually worsened which she feels was worsened by her hysterectomy and mesh placement.She reported bilateral thigh pain accompanied by swelling and extreme pressure around her tailbone.The pain was worsened with sitting, increased walking and intercourse, and she was off work since (b)(6) 2020 and concerned about the pain affecting her work upon her return due to prolonged sitting that is required at her job.The pain was also impacting her activities of daily living.Since mesh removal 5 weeks prior, she did have less pressure in the urethral and vaginal area, but the other pain was not improved.On (b)(6) 2020, the patient presented with pudendal neuralgia and underwent left pudendal nerve block with fluoroscopic guidance.It was noted the patient had not responded to more than 3 months of conservative therapy including activity modification, physical therapy, exercise program, and medications.On (b)(6) 2020, the patient presented for a preoperative assessment to address her with bilateral pudendal neuralgia.Reportedly, her obturator and pudendal neuralgia started since her total vaginal hysterectomy with tvt-o placement in june 2019 and did not resolve after the complete removal of the mesh.There was some reduction in the groin and thigh pain since mesh removal, but the pudendal type symptoms and pain were still present and included poor sitting tolerance, rectal pain, clitoral pain, vaginal pressure pain, pain with intercourse and orgasm, and pain with bowel movements.The pudendal blocks provided excellent temporary pain relief.On (b)(6), 2020, the patient underwent bilateral transgluteal pudendal nerve decompression.It was found that the patient had congenital pudendal nerve entrapment; a branch of the pudendal nerve was found to be perforating the sacrospinous ligament.There was some bleeding associated with the procedure that was controlled with packing, surgiflo, and cautery.The patient was admitted to the hospital for pain control and was transitioned to oral medications.On (b)(6), 2020, the patient was discharged with pain medications.**additional information received on (b)(6) 2022** on (b)(6), 2020, the patient presented with complaints of pain consistent with pudendal and obturator neuralgia.She reported pressure in vagina and rectum and has had nerve blocks which were effective but the effects were not lasting.She also complained of still having very poor sitting tolerance, lancinating rectal pain, pressure pain in the vagina with lancinating clitoral pain, extreme painful intercourse, painful clitoral stimulation, painful orgasm and painful bowel movements.Her urination has improved since the sling removal.The plan at that time was for the patient to make an appointment for an in-person consultation with physical examination and to review treatment options.On (b)(6) 2022, she presented for evaluation of pelvic pain, bladder spasms and pain with bowel movements.On physical exam: vagina: positive cystocele rectocele relatively small, positive levator tenderness bilaterally with no significant hypertonus.Rectal: the coccyx is minimally tender, both sacrospinous ligament complexes are very tender with a positive tinel's sign.Impression: bilateral pudendal neuralgia for which the patient opted to proceed with bilateral transgluteal pudendal nerve decompression.On (b)(6), 2021, the patient had a follow-up in regards to her s/p bilateral transgluteal pudendal nerve decompression.She reported still having significant pudendal nerve symptoms of left much greater than right.Her right-sided pain was fairly mild.The character of her pain on the left was described as somewhat different, not as sharp and lancinating as it had been before.However, the patient was still quite uncomfortable.She spent most of her time lying down.She was seeing pain specialist and was getting pain management treatment which she did find somewhat helpful.She does not have adequately trained physical therapy in her community.She continued to note groin pain radiating down the inner aspect of the thigh especially on the left.Impression: continued pudendal and obturator neuralgia with good improvement on her right side but minimal improvement on her left.Plan: to continue pudendal protection and medical pain management.She was encouraged to try to get further pudendal nerve blocks as sometimes these are more effective after nerve decompression.She was to follow-up in 4-5 months for another telehealth visit to monitor her progress.**additional information received on july 8, 2022** on (b)(6), 2019, the patient presented due to ongoing pelvic pain.She wanted to discuss pain while waiting to see the pain specialist on (b)(6), 2020.She reported that at times, she experienced burning intense pain in the vaginal area.At other times, the pain can radiate into the bilateral upper thighs and into the rectal area.The pain was determined to be due to erosion of vaginal mesh into the surrounding structures.She reported taking ibuprofen every 3 hours without relief of her pain and desired to explore other treatment options.Physical exam showed normal findings.Review of systems gastrointestinal: positive for constipation and diarrhea genitourinary: positive for frequency and pelvic pain assessment and plan: pelvic pain nortriptyline (pamelor) 25 mg oral capsule; take 1 cap by mouth nightly.Diclofenac (vol taren) 50 mg oral tablet, delayed release (e.C.); take 1 tab by mouth 3 times daily (with meals).It was recommended to start nortriptyline for the neuropathic pain which would possibly help with irritable bowel and bladder spasm type symptoms that she was experiencing.To stop ibuprofen and to try on diclofenac.For follow-up in the next 2-4 weeks to evaluate the effect of the medication relieving her pain.For any significant side effects from the medication, she was advised to contact the office immediately.On (b)(6), 2020, the patient presented with complaints of anxiety and pain.She wanted to follow-up on stratification of pamelor.She reported that she could not tolerate the side effect of the medication and only took it for 2 weeks.Moreover, she reported ongoing chronic pelvic pain related to nerve entrapment from pelvic mesh.She continued to have pinprick sensation in the legs and her legs felt weak at times due to pain.Prozac was working well for depression/anxiety.Her physical exam at that time was noted as normal.Review of systems: genitourinary: positive for pelvic pain psychiatric/behavioral: positive for dysphoric mood.The patient is nervous/anxious.Assessment ad plan: pelvic pain pregabalin (lyrica) 50 mg oral capsule; take 1 cap by mouth 3 times daily to start with one daily and increase by one dose every 2 days until up to three times a day.To follow-up in thirty days.Surgery in april.On (b)(6) 2020, the patient presented for follow-up on pain.She reported that lyrica was making her very tired throughout the day and she could not sleep at night due to the pain.She added that the medication did not help with her pain especially in the evening hours.Her pain was a 7 out of 10 n the pain scale in the evening.Assessment and plan: pelvic pain tramadol (ultram) 50 mg oral tablet; take 1 tab by mouth 2 times daily as needed for pain for up to 14 days.Postoperative surgical complication involving genitourinary system associated with genitourinary procedure, unspecified complication tramadol (ultram) 50 mg oral tablet; take 1 tab by mouth 2 times daily as needed for pain for up to 14 days.Referral to pain clinic on (b)(6) 2020, the patient returned for a follow-up on pelvic pain for which she requested refill of tramadol.She had mesh removal 3 weeks ago ((b)(6), 2020).She had been on augmentin for seven days since (b)(6), 2020.She reported having chills and hot flashes; diarrhea and nausea for the past week; and unchanged pain described as burning and throbbing.She rated her pain 7 out of 10 and 4 out of 10 when least severe.Functional limitations include pain with standing and off work until (b)(6), 2020 due to the surgery.On physical exam, the patient had abdominal tenderness (suprapubic).She was advised to return if symptoms worsen or fail to improve; otherwise, she was to follow-up with the surgeon the following month as scheduled.On (b)(6), 2020, the patient presented for follow-up on her mood disorder and refill on prozac.She reported the medication was working "so-so." she also wanted to follow-up on tramadol, but was uncertain whether she would like to have a refill or change in medication.She had nerve blocks on the same day.Assessment: mood disorder (hcc) (chronic) - venlafaxine (effexor-xr) 75 mg oral capsule, sust.Release 24 hr; take 1 cap by mouth daily.Dispense: 30 cap; refill: 2 - discontinue prozac chronic nonintractable headache, unspecified headache type - venlafaxine (effexor-xr) 75 mg oral capsule, sust.Release 24 hr; take 1 cap by mouth daily.Dispense: 30 cap; refill: 2 pelvic pain syndrome - tramadol (ultram) 50mg oral table; take 1 tab by mouth 2 times daily as needed for pain.Dispense: 28 tab; refill: 0 - discussed will need to follow-up with paradigm pain management for further refills of tramadol.Cervicalgia of occipito-atlanto-axial region - xr cervical spine ap and lateral; future - suggested omt therapy for neck pain as well as headache bladder prolapse the patient was advised to return in about four weeks for follow-up on effexor xr.On (b)(6), 2020, the patient returned to the clinic and desired going back on prozac medication for anxiety.She reported having irritability and anxiousness.It was also discussed getting forms completed for long term disability.She had been off work form her surgery until (b)(6).She was under the care of pain management to get nerve block/ablation done for ongoing pelvic pain.She reported that it was uncomfortable for her to sit after approximately 5 hours at work.Her pain management doctor did not recommend long-term disability at this time.They offered to send her for functional capacity evaluation.She stated that she was able to work, but she did not prefer to until the nerve ablations were done.Assessment: pelvic pain a request to return to work note from her surgeon was requested.Long-term disability not supported at this time.She was again offered referral for functional capacity evaluation.Mood disorder (hcc) fluoxetine (prozac) 20 mg oral capsule; take 1 cap by mouth daily.

Manufacturer Narrative

Additional information: blocks b5, b7 and h6: patient codes correction to block g2 block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6) sling removal surgeon: (b)(6) block h6: patient codes e2006, e2308, e2330, e1405, e1002, e1715, e1310, e0123, e0506, e1901, e2326 and e1301 capture the reportable events of mesh erosion, disfigurement, pain, dyspareunia, abdominal pain, scar tissue, urinary tract infections, pudendal neuralgia, bleeding, bacterial vaginitis (captured under e1901 and e2326) and dysuria.Impact codes f1202, f1903, f1905, f1901 and f2303 capture the reportable events of physical impairment, device explantation, device revision, other surgical interventions, and treatments.Block h10: the complaint device 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 system - halo device was used during a procedure performed on (b)(6) 2019.As reported by the patient's attorney, the patient has experienced an unspecified injury.**additional information received on december 8, 2021** it was reported that as a result of the implant, the patient has suffered abdominal and pelvic pain, dyspareunia, erosion of mesh, urinary problems, bladder and groin pain, neurological pain, and past and future physical impairment and disfigurement, past and future emotional distress, past and future physical pain and suffering, and recommended future revision or explant surgery.Reportedly, the patient is still receiving treatment so this list is subject to change as her condition develops and diagnoses are received in the future.**additional information received on january 12.2022** the patient underwent a robotic assisted laparoscopic total hysterectomy, bilateral salpingectomy, cystoscopy with trans-obturator urethropexy procedure on (b)(6) 2019 due to menorrhagia with regular cycle, severe dysmenorrhea, dyspareunia due to medical condition in female and stress incontinence.Medical history included smoking (1 pack per day for 24 years), depression, irritable bowel syndrome.On (b)(6) 2019, the patient presented to emergency department with lower abdominal and pelvic pain, diarrhea off-and-on for the past week and nausea.She reported that she noticed a large cup of pus in the toilet and had been on macrobid twice for utis since the implant surgery.The patient had seen her primary care physician on (b)(6) 2019, and she was sent for blood work and an abdominal ct scan which showed mild colitis with liquid stool.She was prescribed flagyl.Exam on (b)(6) 2019, revealed purulent material in the vaginal vault, an opening in the vaginal vault with some white tissue, and tenderness to this area and upon suprapubic palpation.Ct and wet prep were consistent with vaginitis.The patient was prescribed vaginal suppository clindamycin for bacterial vaginitis.On (b)(6) 2019, the patient presented with the preoperative diagnoses of erosion of implanted vaginal mesh to surrounding tissue, pelvic pain, lower abdominal pain and pelvic pressure, status post laparoscopic hysterectomy and transobturator sling with cystoscopy.The patient reported that since the 2019 procedure, she has experienced severe pain in the left lateral fornices of the vagina suburethrally specifically when the bladder fills and on certain movements and sitting for long periods of time.The patient underwent cystoscopy and urethroscopy.On examination, the patient did not have any evidence of any extrusion of the sling; however, she did have some discomfort along the arms and the lateral fornices and suburethral areas as well as a levator myalgia when palpating the levator muscles in the pelvis.The patient underwent cystoscopy and urethroscopy.No evidence of any lesions or erosions into the bladder and both ureters were effluxing urine.With the bladder filled to approximately 300 ml, gentle palpation in the suburethral area, midurethral, suburethral and lateral fornices was performed and revealed there was more pain on the left than the right and the suburethral area seemed to be the most significantly painful right under where the sling would sit.Both levators were again tender; however, the left seemed to be more tender than the right.At this point, the rest of the procedure was completed and she was sent to recovery room and discharged in good condition and will follow up in the office.On (b)(6) 2020, the patient reported that she experienced stabbing pains in rectum, clitoris and bilateral groins since her 2019 procedure.She also reported pain when sitting, pain with full bladder, pelvic pain, painful intercourse, urinary incontinence with urgency, urinary frequency, and nocturia.The physician and patient discussed possible mesh removal.On (b)(6) 2020, the patient presented with vaginal pain, dyspareunia, muscular groin pain, leg pain, and foreign material in vagina.She then underwent complete removal of the obtryx vaginal sling, removal of vulvar mesh with exploration of the obturator space, urethral lysis, vaginal paravaginal dissection and mesh removal from the deep obturator internus muscles and anterior colporrhaphy.The operative report notes that it was a very difficult surgery due to scarring from the previous surgery and the dissection required to remove the mesh that was very deeply implanted.On (b)(6) 2020, the patient presented for a new patient consultation.She reported low back and pelvic pain that started in (b)(6) 2019 and had gradually worsened which she feels was worsened by her hysterectomy and mesh placement.She reported bilateral thigh pain accompanied by swelling and extreme pressure around her tailbone.The pain was worsened with sitting, increased walking and intercourse, and she was off work since (b)(6) 2020 and concerned about the pain affecting her work upon her return due to prolonged sitting that is required at her job.The pain was also impacting her activities of daily living.Since mesh removal 5 weeks prior, she did have less pressure in the urethral and vaginal area, but the other pain was not improved.On (b)(6) 2020, the patient presented with pudendal neuralgia and underwent left pudendal nerve block with fluoroscopic guidance.It was noted the patient had not responded to more than 3 months of conservative therapy including activity modification, physical therapy, exercise program, and medications.On (b)(6) 2020, the patient presented for a preoperative assessment to address her with bilateral pudendal neuralgia.Reportedly, her obturator and pudendal neuralgia started since her total vaginal hysterectomy with tvt-o placement in (b)(6) 2019 and did not resolve after the complete removal of the mesh.There was some reduction in the groin and thigh pain since mesh removal, but the pudendal type symptoms and pain were still present and included poor sitting tolerance, rectal pain, clitoral pain, vaginal pressure pain, pain with intercourse and orgasm, and pain with bowel movements.The pudendal blocks provided excellent temporary pain relief.On (b)(6) 2020, the patient underwent bilateral transgluteal pudendal nerve decompression.It was found that the patient had congenital pudendal nerve entrapment; a branch of the pudendal nerve was found to be perforating the sacrospinous ligament.There was some bleeding associated with the procedure that was controlled with packing, surgiflo, and cautery.The patient was admitted to the hospital for pain control and was transitioned to oral medications.On (b)(6) 2020, the patient was discharged with pain medications.**additional information received on june 30, 2022** on (b)(6) 2020, the patient presented with complaints of pain consistent with pudendal and obturator neuralgia.She reported pressure in vagina and rectum and has had nerve blocks which were effective but the effects were not lasting.She also complained of still having very poor sitting tolerance, lancinating rectal pain, pressure pain in the vagina with lancinating clitoral pain, extreme painful intercourse, painful clitoral stimulation, painful orgasm and painful bowel movements.Her urination has improved since the sling removal.The plan at that time was for the patient to make an appointment for an in-person consultation with physical examination and to review treatment options.On (b)(6) 2020, she presented for evaluation of pelvic pain, bladder spasms and pain with bowel movements.On physical exam: vagina: positive cystocele rectocele relatively small, positive levator tenderness bilaterally with no significant hypertonus.Rectal: the coccyx is minimally tender, both sacrospinous ligament complexes are very tender with a positive tinel's sign.Impression: bilateral pudendal neuralgia for which the patient opted to proceed with bilateral transgluteal pudendal nerve decompression.On (b)(6) 2021, the patient had a follow-up in regards to her s/p bilateral transgluteal pudendal nerve decompression on (b)(6) 2020.She reported still having significant pudendal nerve symptoms of left much greater than right.Her right-sided pain was fairly mild.The character of her pain on the left was described as somewhat different, not as sharp and lancinating as it had been before.However, the patient was still quite uncomfortable.She spent most of her time lying down.She was seeing pain specialist and was getting pain management treatment which she did find somewhat helpful.She does not have adequately trained physical therapy in her community.She continued to note groin pain radiating down the inner aspect of the thigh especially on the left.Impression: continued pudendal and obturator neuralgia with good improvement on her right side but minimal improvement on her left.Plan: to continue pudendal protection and medical pain management.She was encouraged to try to get further pudendal nerve blocks as sometimes these are more effective after nerve decompression.She was to follow-up in 4-5 months for another telehealth visit to monitor her progress.On (b)(6) 2021, the patient had a televisit for follow up.She noted significant reduction in her rectal and clitoral pain but reported some new pain in the outer labia area, some shooting pain from her incision areas on her buttock, and vaginal/pelvic floor muscle spasms which increase her pain.Her obturator nerve symptoms were unchanged.The patient had a chronic history of ibs-d now with some fecal incontinence.The patient was advised she may still see significant improvement regarding her pudendal nerve symptoms going forward as she was currently approximately 8 months out from her surgery, and maximal nerve recovery can take up to 2 years or longer.In the meantime the patient could consider medications to reduce neuropathic pain, botox treatment with physical therapy regarding her pelvic floor muscle spasms, and/or a drg stimulator.**additional information received on july 8.2022** on (b)(6) 2019, the patient presented due to ongoing pelvic pain.She wanted to discuss pain while waiting to see the pain specialist on (b)(6) 2020.She reported that at times, she experienced burning intense pain in the vaginal area.At other times, the pain can radiate into the bilateral upper thighs and into the rectal area.The pain was determined to be due to erosion of vaginal mesh into the surrounding structures.She reported taking ibuprofen every 3 hours without relief of her pain and desired to explore other treatment options.Physical exam showed normal findings.Review of systems gastrointestinal: positive for constipation and diarrhea genitourinary: positive for frequency and pelvic pain assessment and plan: pelvic pain - nortriptyline (pamelor) 25 mg oral capsule; take 1 cap by mouth nightly.- diclofenac (vol taren) 50 mg oral tablet, delayed release (e.C.); take 1 tab by mouth 3 times daily (with meals).- it was recommended to start nortriptyline for the neuropathic pain which would possibly help with irritable bowel and bladder spasm type symptoms that she was experiencing.- to stop ibuprofen and to try on diclofenac.For follow-up in the next 2-4 weeks to evaluate the effect of the medication relieving her pain.For any significant side effects from the medication, she was advised to contact the office immediately.On january 6, 2020, the patient presented with complaints of anxiety and pain.She wanted to follow-up on stratification of pamelor.She reported that she could not tolerate the side effect of the medication and only took it for 2 weeks.Moreover, she reported ongoing chronic pelvic pain related to nerve entrapment from pelvic mesh.She continued to have pinprick sensation in the legs and her legs felt weak at times due to pain.Prozac was working well for depression/anxiety.Her physical exam at that time was noted as normal.Review of systems: genitourinary: positive for pelvic pain psychiatric/behavioral: positive for dysphoric mood.The patient is nervous/anxious.Assessment and plan: pelvic pain - pregabalin (lyrica) 50 mg oral capsule; take 1 cap by mouth 3 times daily - to start with one daily and increase by one dose every 2 days until up to three times a day.- to follow-up in thirty days.- surgery in april.On (b)(6) 2020, the patient presented for follow-up on pain.She reported that lyrica was making her very tired throughout the day and she could not sleep at night due to the pain.She added that the medication did not help with her pain especially in the evening hours.Her pain was a 7 out of 10 on the pain scale in the evening.She had been scheduled to have her mesh removed, but the procedure was cancelled because of the pandemic.Assessment and plan: pelvic pain - tramadol (ultram) 50 mg oral tablet; take 1 tab by mouth 2 times daily as needed for pain for up to 14 days.Postoperative surgical complication involving genitourinary system associated with genitourinary procedure, unspecified complication - tramadol (ultram) 50 mg oral tablet; take 1 tab by mouth 2 times daily as needed for pain for up to 14 days.- referral to pain clinic on (b)(6) , the patient returned for a follow-up on pelvic pain for which she requested refill of tramadol.She had mesh removal 3 weeks ago (b)(6) 2020).She had been on augmentin for seven days since (b)(6) 2020.She reported having chills and hot flashes; diarrhea and nausea for the past week; and unchanged pain described as burning and throbbing.She rated her pain 7 out of 10 and 4 out of 10 when least severe.Functional limitations include pain with standing and off work until (b)(6) 2020 due to the surgery.On physical exam, the patient had abdominal tenderness (suprapubic).She was advised to return if symptoms worsen or fail to improve; otherwise, she was to follow-up with the surgeon the following month as scheduled.On (b)(6) 2020 reported the medication was working "so-so." she also wanted to follow-up on tramadol, but was uncertain whether she would like to have a refill or change in medication.She had nerve blocks on the same day.Assessment: mood disorder (hcc) (chronic) - venlafaxine (effexor-xr) 75 mg oral capsule, sust.Release 24 hr; take 1 cap by mouth daily.Dispense: 30 cap; refill: 2 - discontinue prozac chronic nonintractable headache, unspecified headache type - venlafaxine (effexor-xr) 75 mg oral capsule, sust.Release 24 hr; take 1 cap by mouth daily.Dispense: 30 cap; refill: 2 pelvic pain syndrome - tramadol (ultram) 50mg oral table; take 1 tab by mouth 2 times daily as needed for pain.Dispense: 28 tab; refill: 0 - discussed will need to follow-up with paradigm pain management for further refills of tramadol.Cervicalgia of occipito-atlanto-axial region - xr cervical spine ap and lateral; future - suggested omt therapy for neck pain as well as headache bladder prolapse the patient was advised to return in about four weeks for follow-up on effexor xr.On september 1, 2020, the patient returned to the clinic and desired going back on prozac medication for anxiety.She reported having irritability and anxiousness.It was also discussed getting forms completed for long term disability.She had been off work form her surgery until august 31.She was under the care of pain management to get nerve block/ablation done for ongoing pelvic pain.She reported that it was uncomfortable for her to sit after approximately 5 hours at work.Her pain management doctor did not recommend long-term disability at this time.They offered to send her for functional capacity evaluation.She stated that she was able to work, but she did not prefer to until the nerve ablations were done.Assessment: pelvic pain a request to return to work note from her surgeon was requested.Long-term disability not supported at this time.She was again offered referral for functional capacity evaluation.Mood disorder (hcc) fluoxetine (prozac) 20 mg oral capsule; take 1 cap by mouth daily.

Manufacturer Narrative

Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Sling removal surgeon: dionysios veronikis, md mercy clinic tower b block h6: patient codes e2006, e2308, e2330, e1405, e1002, e1715, e1310, e0123, e0506, e1901, e2326, e1301 and e020201 capture the reportable events of mesh erosion, disfigurement, pain, dyspareunia, abdominal pain, scar tissue, urinary tract infections, pudendal neuralgia, bleeding, bacterial vaginitis (captured under e1901 and e2326), dysuria and anxiety.Impact codes f1202, f1903, f1905, f1901 and f2303 capture the reportable events of physical impairment, device explantation, device revision, other surgical interventions, and treatments.

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Brand Name

OBTRYX SYSTEM - HALO

Type of Device

MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Manufacturer (Section D)

BOSTON SCIENTIFIC CORPORATION

300 boston scientific way

marlborough MA 01752

Manufacturer (Section G)

BOSTON SCIENTIFIC CORPORATION

780 brookside drive

spencer IN 47460

Manufacturer Contact

carole morley

300 boston scientific way

marlborough, MA 01752

5086834015

MDR Report Key

12962679

MDR Text Key

282203647

Report Number

3005099803-2021-07771

Device Sequence Number

Product Code

OTN

UDI-Device Identifier

08714729718987

UDI-Public

08714729718987

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K040787

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer,Company Representative

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Health Professional

Device Expiration Date

10/21/2021

Device Model Number

M0068505000

Device Catalogue Number

850-500

Device Lot Number

0022824702

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Initial Date Manufacturer Received

11/16/2021

Initial Date FDA Received

12/08/2021

Supplement Dates Manufacturer Received

12/08/2021
01/12/2022
03/18/2022
06/30/2022
07/08/2022
08/04/2022

Supplement Dates FDA Received

01/06/2022
02/09/2022
04/14/2022
07/29/2022
08/05/2022
08/31/2022

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Date Device Manufactured

10/22/2018

Is the Device Single Use?

Yes

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Other; Required Intervention;

Patient Age

39 YR

Patient Sex

Female

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

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