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BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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| Model Number M0068502111 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abscess (1690); Adhesion(s) (1695); Erosion (1750); Fatigue (1849); Fever (1858); Micturition Urgency (1871); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Laceration(s) (1946); Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Chills (2191); Hernia (2240); Urinary Frequency (2275); Anxiety (2328); Discomfort (2330); Depression (2361); Numbness (2415); Prolapse (2475); Weight Changes (2607); Dysuria (2684); Fibrosis (3167); Constipation (3274); Urethral Stenosis/Stricture (4501); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580)
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| Event Date 12/22/2014 |
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Event Type
Injury
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6) 2014, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant 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.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2014.As reported by the patient's attorney, the patient experienced an unknown injury.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on december 22, 2014.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on july 18, 2022: it was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a total vaginal hysterectomy with cystocele and rectocele repair + tvt placement + bilateral uterosacral suspension procedure performed on december 22, 2014 for the treatment of chronic pelvic pain syndrome, vaginismus, pelvic floor hypertonia with pudendal nerve involvement.It was reported that the patient had a post operative fever and small mesh erosion which was excised in office.The patient reported that she has been plagued by pain complaints following device implant.On (b)(6) 2020 the patient was seen by a physician for pelvic pain.Upon examination, no cystocele or rectocele was present and there were no signs of erosion or infection.An ultrasound performed on that date showed a 4.4cm by 4.1cm cyst on the right ovary and multiple cysts, the largest being 2.3 by 2cm, on the left ovary.The physician recommended follow up in three months.The patient underwent a complete tvt mesh excision including the retropubic mesh via a pfannenstiel incision in (b)(6) 2021, pain worsened after surgery.On (b)(6) 2021, a ct scan of abdomen and pelvis with contrast showed development of symmetric tubular cystic foci on each side of the bladder, each of which measure approximately 4.8x 2.1 x 3.5cm.Differential considerations include obstructing glands/ducts of the bartholin's or skene's gland, or less likely abscess or hydrosalpinx however this does not appear to be in the anatomic area of the fallopian tubes.Clinical correlation was recommended.The patient reported improved pelvic pain signs and symptoms since (b)(6) 2021 due to injections and 7 months of pfpt.During an office visit on (b)(6) 2022, the physician assessed the patient's pain as consistent with both obturator and pudendal neuralgia.The patient noted persistent pain complaints but also new pain possibly consistent with ilioinguinal neuralgia.The patient also noted recurrent stress urinary incontinence, which is quite significant.Physical examination showed positive tenderness noted at the lateral edges of the incisions, left greater than right, consistent with ilioinguinal neuralgia and positive point tenderness along the inferior pubic rami.The patient underwent a diagnostic ilioinguinal nerve block, which gave temporary pain relief.This appeared to be more affected on the left than the right.Reviewed treatment options going forward at length.The patient decided to undergo a bilateral ilioinguinal/iliohypogastric neurectomy; burch procedure, and removal of the uterosacral suspension sutures due to pudendal neuralgia, stress urinary incontinence, and ilioinguinal neuralgia.The patient was placed in the supine position, awakened in the operating room, brought to recovery room awake, alert, in apparent stable condition.No complications reported.Pelvic/perineal pain recurred after the procedure.The patient also reported significant pelvic nerve irritation, mild-mod pelvic muscle spasms but low vaginal vault tone, with that, patients chronic pelvic pain syndrome (cpps) etiology appears to be multifactorial.Some improved/resolved cases include pain at right labia and vagina, occasional pain with vaginal penetration, bilateral groin pain, urinary urgency, constipation.On (b)(6) 2022, the patient reported chronic pelvic pain and discomfort rated 8 out of 10.Some urgency, frequency, burning with urination, pain during intercourse, pain while walking, sleeping, and sitting for long periods of time.The patient was incapable of doing running and lifting.The pain is localized to lower abdomen, pelvis, lumbosacral back or buttocks.The pain is of sufficient severity to cause functional disability.Previous treatments include a course of nsaids for 6 weeks, and a course of physical therapy for 6 weeks.The patient was assessed as having pelvic pain likely secondary to neuropathic pain and myofascial pain syndrome with both central sensitization and peripheral sensitization leading to membrane hyperexcitability and upregulation of both the central nervous system and peripheral nervous system with a sympathetic component to pain.Patient continues to have pain despite the conservative therapy.Some improved/resolved cases include pain at right labia and vagina, occasional pain with vaginal penetration, bilateral groin pain, urinary urgency, constipation.Treatment for other chronic pain: - valium tablet, 5 mg, - diclofenac tablet, 75mg, - valium tablet, 2 mg, - diclofenac sodium tablet delayed release, 75 mg.Additional information received on august 16, 2022 and september 1, 2022: it was reported during an office visit on march 11, 2021 that the symptoms of mesh problems began one year ago and lasted generally for one year.Patient stated the symptoms located in vagina and are chronic and stable.She had an advantage fit retropubic sling placed in 2014, and in 2015, she had an outpatient visit where she reported prolene sutures were trimmed.Since february 2020, she had had generalized fatigue, fever, chills, pelvic pain.Had deep dyspareunia during and after intercourse since initial surgery.She also reported that she had a postoperative fever and had a prolonged course postoperatively in the hospital requiring antibiotics.Patient reported urge incontinence and is sexually active with dyspareunia; stress incontinence was improved since surgery.Review of systems: positive: chills, fatigue, fever, weight gain, abdominal pain, nocturia, prolapsed uterus, urge incontinence, urgency, depression, back pain, joint pain, muscle weakness, dyspareunia, fibroids.On (b)(6) 2021, the patient had surgery for advantage sling removal, urethral lysis, anterior colporrhaphy, abdominal paravaginal, removal of abdominal mesh due to vaginal pain, pelvic pain, pain with coitus and urinary stricture.Hemostasis was excellent.The anterior vaginal wall was closed with running suture of#2-0 dexon.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.No complications reported.In a pathology report, it showed the mesh contains a small amount of adherent pink soft tissue.Two days after the surgery, patient reported right sided groin pain.Medication was not relieving her pain.Prescribed gabapentin for pain along with a steroid and muscle relaxer.If no improvement, patient will be referred to neurology.On (b)(6) 2021, the patient presented at the emergency department with numbness on the right side of her pelvis after mesh removal procedure on march 16, 2021.Patient continued to have groin pain despite being put on steroids, neurontin, and robaxin.Patient stated that her surgeon told her they "might have cut her nerve", there could be an obturator nerve cut during sling removal.On (b)(6) 2021, patient returned for follow up.Since sling removal, she is no longer having fevers and joint pains have resolved.She had some pain in groin that was quite severe after surgery.She went to the er and had a ct scan done.Since then, she has seen a specialist in maryland who can inject her groin which has been a "miracle" treatment and has really helped.On (b)(6) 2021 the patient reported that she saw gyn for spotting six weeks ago.The patient reports extreme pain when her bladder is full.On (b)(6) 2021, patient presented due to nerve pain from surgery, swollen abdomen but was doing better.The neve pain started about 5 weeks ago and she went to pelvic therapy.Pain was still shooting down from left side down to pelvic area, she complained of numbness on the surface of the skin and nerve pain beneath.She had a specialist appointment in (b)(6) 2021.Over the past 2 weeks, the previous pain had got worse - it seems to be radiating to the incision side and is now making a bulge or hernia.The left side is not as bad as the right side.The physician reports that the patient may have ilioinguinal nerve issue or maybe nerve entrapment.The patient reports an increase in urgency.A nerve block is planned after christmas.Assessment/plan: 1.Bladder pain frequency is new.Feels like she is still retaining urine.Doubt inguinal issue as the whole pelvic area is swollen.She also has left flank pain.Will obtain renal ultrasound.Will try her on flomax and see if this may relax the bladder.She has an appt at uva for pudendal nerve injection.- chronic bladder pain.2.Bilateral pain of inguinal region may have inguinal hernia on the right side vs scar tissue.- right and left lower quadrant; urinalysis, dipstick *results: nitrite: positive.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to february 1, 2020, the date when symptoms first started.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6) at (b)(6) hospital.Sling removal surgeon is: dr.(b)(6).Block h6: patient codes e2006, e2311, e2330, e172001, e1906, e1405, e1715, e1301, e232402, e0505, e2401, e0127, e1720, e1605, e1307, e0123, e2101, e2009, e2319 capture the reportable events of: 9099: erosion - small mesh erosion treated with excision in office 9205: pain - obturator and pudendal neuralgia, ilioinguinal neuralgia; pain while walking, sitting for long periods of time and sleeping; chronic pelvic pain; pain in lower abdomen, pelvis, lumbosacral back or buttocks; pain at right labia and vagina.9000: abscess - obstructing glands/ducts of the bartholin's or skene's gland, or less likely abscess or hydrosalpinx.9151: infection - cystic foci on each side of the bladder.9069: discomfort.9247: scarring - significant scar; surgical scar to pubic bone.9075: dyspareunia - pain during intercourse.9081: dysuria - burning with urination.9158: injury (nos) - vaginismus.9161: irritation - significant pelvic nerve irritation.9198: numbness - persistent numbness from umbilicus.9124: hematoma - post-op 300cc bleeding/hematoma.9177: muscle spasm - mild-mod pelvic muscle spasms.9148: urinary incontinence - recurrent stress urinary incontinence.9391: urethral stenosis/stricture - urinary stricture.9004: adhesions - mesh contains a small amount of adherent pink soft tissue; urethral lysis.9168: laceration - obturator nerve cut.9349: hernia - bulge or hernia like.9189: nerve damage - ilioinguinal nerve issue.Impact codes f1202, f1903, f1901 and f2303 capture the reportable events of incapable of doing running and lifting and pain is of sufficient severity to cause functional disability; complete tvt mesh excision; bilateral ilioinguinal/iliohypogastric neurectomy; burch procedure, and removal of the uterosacral suspension sutures and diagnostic ilioinguinal nerve block; and medications taken, injections and pelvic floor physical therapy.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to march 1, 2021, the date the mesh was completely excised.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6), (b)(6) hospital.Block h6: patient codes e2006, e2311, e2330, e172001, e1906, e1405, e1715, e1301, e232402, e0505, e2401, e0127, e1720, e1605 capture the reportable events of: 9099: erosion - small mesh erosion treated with excision in office 9205: pain - obturator and pudendal neuralgia, ilioinguinal neuralgia; pain while walking, sitting for long periods of time and sleeping; chronic pelvic pain; pain in lower abdomen, pelvis, lumbosacral back or buttocks; pain at right labia and vagina.9000: abscess - obstructing glands/ducts of the bartholin's or skene's gland, or less likely abscess or hydrosalpinx , 9151: infection - cystic foci on each side of the bladder, 9069: discomfort, 9247: scarring - significant scar; surgical scar to pubic bone, 9075: dyspareunia - pain during intercourse, 9081: dysuria - burning with urination, 9158: injury (nos) - vaginismus, 9161: irritation - significant pelvic nerve irritation, 9198: numbness - persistent numbness from umbilicus, 9124: hematoma - post-op 300cc bleeding/hematoma, 9177: muscle spasm - mild-mod pelvic muscle spasms, 9148: urinary incontinence - recurrent stress urinary incontinence.Impact codes f1202, f1903, f1901 and f2303 capture the reportable events of incapable of doing running and lifting and pain is of sufficient severity to cause functional disability; complete tvt mesh excision; bilateral ilioinguinal/iliohypogastric neurectomy; burch procedure, and removal of the uterosacral suspension sutures and diagnostic ilioinguinal nerve block; and medications taken, injections and pelvic floor physical therapy.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.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.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2014.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on july 18, 2022: it was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a total vaginal hysterectomy with cystocele and rectocele repair + tvt placement + bilateral uterosacral suspension procedure performed on (b)(6) 2014 for the treatment of chronic pelvic pain syndrome, vaginismus, pelvic floor hypertonia with pudendal nerve involvement.It was reported that the patient had a post operative fever and small mesh erosion which was excised in office.The patient reported that she has been plagued by pain complaints following device implant.On (b)(6) 2020 the patient was seen by a physician for pelvic pain.Upon examination, no cystocele or rectocele was present and there were no signs of erosion or infection.An ultrasound performed on that date showed a 4.4cm by 4.1cm cyst on the right ovary and multiple cysts, the largest being 2.3 by 2cm, on the left ovary.The physician recommended follow up in three months.The patient underwent a complete tvt mesh excision including the retropubic mesh via a pfannenstiel incision in (b)(6) 2021, pain worsened after surgery.On (b)(6) 2021, a ct scan of abdomen and pelvis with contrast showed development of symmetric tubular cystic foci on each side of the bladder, each of which measure approximately 4.8x 2.1 x 3.5cm.Differential considerations include obstructing glands/ducts of the bartholin's or skene's gland, or less likely abscess or hydrosalpinx however this does not appear to be in the anatomic area of the fallopian tubes.Clinical correlation was recommended.The patient reported improved pelvic pain signs and symptoms since (b)(6) 2021 due to injections and 7 months of pfpt.During an office visit on (b)(6) 2022, the physician assessed the patient's pain as consistent with both obturator and pudendal neuralgia.The patient noted persistent pain complaints but also new pain possibly consistent with ilioinguinal neuralgia.The patient also noted recurrent stress urinary incontinence, which is quite significant.Physical examination showed positive tenderness noted at the lateral edges of the incisions, left greater than right, consistent with ilioinguinal neuralgia and positive point tenderness along the inferior pubic rami.The patient underwent a diagnostic ilioinguinal nerve block, which gave temporary pain relief.This appeared to be more affected on the left than the right.Reviewed treatment options going forward at length.The patient decided to undergo a bilateral ilioinguinal/iliohypogastric neurectomy; burch procedure, and removal of the uterosacral suspension sutures due to pudendal neuralgia, stress urinary incontinence, and ilioinguinal neuralgia.The patient was placed in the supine position, awakened in the operating room, brought to recovery room awake, alert, in apparent stable condition.No complications reported.Pelvic/perineal pain recurred after the procedure.The patient also reported significant pelvic nerve irritation, mild-mod pelvic muscle spasms but low vaginal vault tone, with that, patients chronic pelvic pain syndrome (cpps) etiology appears to be multifactorial.Some improved/resolved cases include pain at right labia and vagina, occasional pain with vaginal penetration, bilateral groin pain, urinary urgency, constipation.On (b)(6) 2022, the patient reported chronic pelvic pain and discomfort rated 8 out of 10.Some urgency, frequency, burning with urination, pain during intercourse, pain while walking, sleeping, and sitting for long periods of time.The patient was incapable of doing running and lifting.The pain is localized to lower abdomen, pelvis, lumbosacral back or buttocks.The pain is of sufficient severity to cause functional disability.Previous treatments include a course of nsaids for 6 weeks, and a course of physical therapy for 6 weeks.The patient was assessed as having pelvic pain likely secondary to neuropathic pain and myofascial pain syndrome with both central sensitization and peripheral sensitization leading to membrane hyperexcitability and upregulation of both the central nervous system and peripheral nervous system with a sympathetic component to pain.Patient continues to have pain despite the conservative therapy.Some improved/resolved cases include pain at right labia and vagina, occasional pain with vaginal penetration, bilateral groin pain, urinary urgency, constipation.Treatment for other chronic pain: valium tablet, 5 mg; diclofenac tablet, 75mg; valium tablet, 2 mg; diclofenac sodium tablet delayed release, 75 mg.
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Manufacturer Narrative
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Additional information: blocks b3, b5 and h6: patient codes have been updated based on additional information received on september 12, 15 and 16, 2022.Block b3 date of event: date of event was approximated to december 22, 2014, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: patient codes e2006, e2311, e2330, e172001, e1906, e1405, e1715, e1301, e232402, e0505, e2401, e0127, e1720, e1605, e1307, e0123, e2101, e2009, e2319 capture the reportable events of: 9106: extrusion - small mesh erosion treated with excision in office 9205: pain - obturator and pudendal neuralgia, ilioinguinal neuralgia; pain while walking, sitting for long periods of time and sleeping; chronic pelvic pain; pain in lower abdomen, pelvis, lumbosacral back or buttocks; pain at right labia and vagina.9000: abscess - obstructing glands/ducts of the bartholin's or skene's gland, or less likely abscess or hydrosalpinx.9158: injury (nos) - cystic foci on each side of the bladder.9069: discomfort.9247: scarring - significant scar and surgical scar to pubic bone.9075: dyspareunia - pain during intercourse.9081: dysuria - burning with urination.9161: irritation - significant pelvic nerve irritation.9198: numbness - persistent numbness from umbilicus.9124: hematoma - post-op 300cc bleeding/hematoma.9177: muscle spasm - mild-mod pelvic muscle spasms and vaginismus.9148: urinary incontinence - recurrent stress urinary incontinence.9391: urethral stenosis/stricture - urinary stricture.9004: adhesions - mesh contains a small amount of adherent pink soft tissue; urethral lysis.9168: laceration - obturator nerve cut.9349: hernia - bulge or hernia like.9189: nerve damage - ilioinguinal nerve issue and pudendal nerve involvement.Impact codes f1202, f1903, f1901 and f2303 capture the reportable events of incapable of doing running and lifting and pain is of sufficient severity to cause functional disability; complete tvt mesh excision; bilateral ilioinguinal/iliohypogastric neurectomy; burch procedure, and removal of the uterosacral suspension sutures and diagnostic ilioinguinal nerve block; and medications taken, injections and pelvic floor physical therapy.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2014.As reported by the patient's attorney, the patient experienced an unknown injury.Additional information received on july 18, 2022.It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a total vaginal hysterectomy with cystocele and rectocele repair + tvt placement + bilateral uterosacral suspension procedure performed on (b)(6) 2014.It was reported that the patient had a post operative fever and small mesh erosion which was excised in office.The patient reported that she has been plagued by pain complaints following device implant.The patient experienced chronic pelvic pain syndrome, vaginismus, and pelvic floor hypertonia with pudendal nerve involvement with an onset date documented as (b)(6) 2014.On (b)(6) 2020 the patient was seen by a physician for pelvic pain.She also reported persistent low-grade fevers since february and had had several work-ups to find the cause.Associated symptoms included achiness and muscle spasms.She was diagnosed with rocky mountain spotted fever and treated without improvement in symptoms.She was borderline positive for epstein-barr.Upon examination, no cystocele or rectocele was present and there were no signs of erosion or infection.An ultrasound performed on that date showed a 4.4cm by 4.1cm cyst on the right ovary and multiple cysts, the largest being 2.3 by 2cm, on the left ovary.The assessment included incomplete uterovaginal prolapse, fever of unknown origin, chronic pelvic and perineal pain, and bilateral hemorrhagic ovarian cysts.Urinalysis was negative.The physician recommended follow up in three months.The patient underwent a complete tvt mesh excision including the retropubic mesh via a pfannenstiel incision in (b)(6) 2021, pain worsened after surgery.On (b)(6) 2021, a ct scan of abdomen and pelvis with contrast showed development of symmetric tubular cystic foci on each side of the bladder, each of which measure approximately 4.8x 2.1 x 3.5cm.Differential considerations include obstructing glands/ducts of the bartholin's or skene's gland, or less likely abscess or hydrosalpinx however this does not appear to be in the anatomic area of the fallopian tubes.Clinical correlation was recommended.The patient reported improved pelvic pain signs and symptoms since (b)(6) 2021 due to injections and 7 months of pfpt.During an office visit on (b)(6) 2022, the physician assessed the patient's pain as consistent with both obturator and pudendal neuralgia.The patient noted persistent pain complaints but also new pain possibly consistent with ilioinguinal neuralgia.The patient also noted recurrent stress urinary incontinence, which is quite significant.Physical examination showed positive tenderness noted at the lateral edges of the incisions, left greater than right, consistent with ilioinguinal neuralgia and positive point tenderness along the inferior pubic rami.The patient underwent a diagnostic ilioinguinal nerve block, which gave temporary pain relief.This appeared to be more affected on the left than the right.Reviewed treatment options going forward at length.The patient decided to undergo a bilateral ilioinguinal/iliohypogastric neurectomy; burch procedure, and removal of the uterosacral suspension sutures due to pudendal neuralgia, stress urinary incontinence, and ilioinguinal neuralgia.There was some fibrosis in the retropubic space secondary to the prior procedures.Dissection to the fixation sutures was challenging and the right side suture was scarred down.The sutures were cut, but there was some arterial type bleeding that was relatively difficult to control as the vessel retracted.Ligasure was used and bleeding was controlled, though it was noted that the patient lost approximately 300-350 cc of blood.The patient was placed in the supine position, awakened in the operating room, brought to recovery room awake, alert, in apparent stable condition.Pelvic/perineal pain recurred after the procedure.She also had a hematoma post-operatively.The patient also reported significant pelvic nerve irritation, mild-mod pelvic muscle spasms but low vaginal vault tone, with that, patients chronic pelvic pain syndrome (cpps) etiology appears to be multifactorial.Some improved/resolved cases include pain at right labia and vagina, occasional pain with vaginal penetration, bilateral groin pain, urinary urgency, constipation.On (b)(6) 2022, the patient reported chronic pelvic pain and discomfort rated 8 out of 10.Some urgency, frequency, burning with urination, pain during intercourse, pain while walking, sleeping, and sitting for long periods of time.The patient was incapable of doing running and lifting.The pain is localized to lower abdomen, pelvis, lumbosacral back or buttocks.The pain is of sufficient severity to cause functional disability.Previous treatments include a course of nsaids for 6 weeks, and a course of physical therapy for 6 weeks.The patient was assessed as having pelvic pain likely secondary to neuropathic pain and myofascial pain syndrome with both central sensitization and peripheral sensitization leading to membrane hyperexcitability and upregulation of both the central nervous system and peripheral nervous system with a sympathetic component to pain.Patient continues to have pain despite the conservative therapy.Some improved/resolved cases include pain at right labia and vagina, occasional pain with vaginal penetration, bilateral groin pain, urinary urgency, constipation.Treatment for other chronic pain: - valium tablet, 5 mg - diclofenac tablet, 75mg - valium tablet, 2 mg - diclofenac sodium tablet delayed release, 75 mg.Additional information received on august 16, 2022 and september 1, 2022.It was reported during an office visit on (b)(6) 2021 that the symptoms of mesh problems began one year ago and lasted generally for one year.Patient stated the symptoms located in vagina and are chronic and stable.She had an advantage fit retropubic sling placed in 2014, and in 2015, she had an outpatient visit where she reported prolene sutures were trimmed.Since (b)(6) 2020, she had had generalized fatigue, fever, chills, pelvic pain.Had deep dyspareunia during and after intercourse since initial surgery.She also reported that she had a postoperative fever and had a prolonged course postoperatively in the hospital requiring antibiotics.Patient reported urge incontinence and is sexually active with dyspareunia; stress incontinence was improved since surgery.Review of systems: positive: chills, fatigue, fever, weight gain, abdominal pain, nocturia, prolapsed uterus, urge incontinence, urgency, depression, back pain, joint pain, muscle weakness, dyspareunia, fibroids.On (b)(6) 2021, the patient had surgery for advantage sling removal, urethral lysis, anterior colporrhaphy, abdominal paravaginal, removal of abdominal mesh due to vaginal pain, pelvic pain, pain with coitus and urinary stricture.Hemostasis was excellent.The anterior vaginal wall was closed with running suture of#2-0 dexon.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.No complications reported.In a pathology report, it showed the mesh contains a small amount of adherent pink soft tissue.Two days after the surgery, patient reported right sided groin pain.Medication was not relieving her pain.Prescribed gabapentin for pain along with a steroid and muscle relaxer.If no improvement, patient will be referred to neurology.On (b)(6) 2021, the patient presented at the emergency department with numbness on the right side of her pelvis after mesh removal procedure on (b)(6) 2021.Patient continued to have groin pain despite being put on steroids, neurontin, and robaxin.Patient stated that her surgeon told her they "might have cut her nerve", there could be an obturator nerve cut during sling removal.On (b)(6) 2021, patient returned for follow up.Since sling removal, she is no longer having fevers and joint pains have resolved.She had some pain in groin that was quite severe after surgery.She went to the er and had a ct scan done.Since then, she has seen a specialist in maryland who can inject her groin which has been a "miracle" treatment and has really helped.On (b)(6) 2021 the patient reported that she saw gyn for spotting six weeks ago.The patient reports extreme pain when her bladder is full.On (b)(6) 2021, patient presented due to nerve pain from surgery, swollen abdomen but was doing better.The neve pain started about 5 weeks ago and she went to pelvic therapy.Pain was still shooting down from left side down to pelvic area, she complained of numbness on the surface of the skin and nerve pain beneath.She had a specialist appointment in dec 2021.Over the past 2 weeks, the previous pain had got worse - it seems to be radiating to the incision side and is now making a bulge or hernia.The left side is not as bad as the right side.The physician reports that the patient may have ilioinguinal nerve issue or maybe nerve entrapment.The patient reports an increase in urgency.A nerve block is planned after christmas.Assessment/plan: 1.Bladder pain.Frequency is new.Feels like she is still retaining urine.Doubt inguinal issue as the whole pelvic area is swollen.She also has left flank pain.Will obtain renal ultrasound.Will try her on flomax and see if this may relax the bladder.She has an appt at uva for pudendal nerve injection.- chronic bladder pain 2.Bilateral pain of inguinal region may have inguinal hernia on the right side vs scar tissue.- right and left lower quadrant; urinalysis, dipstick results: nitrite: positive.Additional information received on september 12, 15 and 16, 2022.A documentation on october 28, 2020 stated that an encounter with the patient on september 29, 2020 reported that the patient had a tick bite and was then provided medication.Review of systems showed muscle aches and weakness, neck pain and back pain, skin rash.Visit diagnose on (b)(6) 2021 was ilioinguinal neuralgia of left and right side, neurologic cause of groin pain.Pain continued in her pelvic area between pubic bones that was separate from the pain she experienced in the pudendal area.Was shooting down from the bilateral labial region to inguinal and upper anterior thigh.With exertion, pain worsened and shot down to knees.She also reported her pelvic area was numb superficially with pain felt more deeply.She also had bulges on either side of her pelvic area.Bulges did not increase with exertion.She was evaluated for hernias previously, but us and ct abdomen/pelvis were negative.She also reported left mid-back pain that was intermittent.During pelvic therapy exercises, it improved with palpation.She tried topamax and gabapentin in the past for neuropath pain, but medications made her sleepy and preferred not to be on sedative medication.Motrin worked.She was having urinary urgency, needed to use the bathroom every hour and developed bladder pain if unable to do it quickly.Also reported stress incontinence with laughing/coughing.Gastrointestinal review was moderate pain on palpation approximately pelvic area.Assessment and plan: patient presented with numbness and chronic pain in her pelvic area with radiating pain to her anterior thighs that started after a gynecologic surgical procedure.Neurologic exam is notable for allodynia in dermatome levels t12, l 1, s2/s3; notably, no upper motor neuron umn signs or weakness present on exam.Her symptoms were consistent with neuropathic pain that seemed to be most within the territory of the bilateral ilioinguinal nerve, which innervated the labia and inguinal region, the upper anterior and medial thigh, and part of the genitalia.The medial femoral cutaneous nerve, a superficial femoral nerve, may also be implicated in some pain in the upper thigh as well, but less likely to be solely responsible.Discussed with patient the use of lidocaine patches and starting duloxetine for nerve pain; it is non-sedating and may also help with anxiety.1.Discussed with patient that she continues seeing ob/gyn neuralgia specialists.2.Start duloxetine 30 mg daily.Discussed that there is room to go up on the medication if needed.3.Start lidocaine patch as needed for nerve pain.Progress note: nerve block specialist in (b)(6) 2021.Pudendal nerve injections improved groin pain but could not separate her legs.Had trigger point injections and saw pain specialist.On (b)(6) 2021, patient presented for consultation in diagnostic nerve block.Procedure: under aseptic conditions bilateral ilioinguinal nerve block was performed with a total of 12 cc of 0.5% marcaine, negative aspiration was obtained prior to infiltration, the patient noted paresthesia on the left extending into the groin, she did not note the same degree of extension of paresthesia on the right, there were no complications, she tolerated the procedure well, she was given routine instructions.Office notes on (b)(6) 2021: assessment/plan 1.Right groin pain - nerve stabilizer: she is on low dose of gabapentin but stated that even at the low dose she felt "drugged".Discussed trying to increase this but she will not tolerate it.Discontinue gabapentin and start topamax 50mg.2.Follow up in 2 months.Light counseling on (b)(6) 2021, patient had an appointment scheduled at uva for bladder repair consult.Experiencing groin and bladder pain.Mesh removal surgery was march 2021, but there has been no follow-up because she was unable to reach the surgeon.Patient feared surgery and possible intense pain that will follow like last time, but she's ready to be healthy.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2014.As reported by the patient's attorney, the patient experienced an unknown injury.---additional information received on july 18, 2022--- it was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a total vaginal hysterectomy with cystocele and rectocele repair + tvt placement + bilateral uterosacral suspension procedure performed on (b)(6) 2014.It was reported that the patient had a post operative fever and small mesh erosion which was excised in office.The patient reported that she has been plagued by pain complaints following device implant.The patient experienced chronic pelvic pain syndrome, vaginismus, and pelvic floor hypertonia with pudendal nerve involvement with an onset date documented as (b)(6) 2014.On (b)(6) 2020 the patient was seen by a physician for pelvic pain.She also reported persistent low-grade fevers since february and had had several work-ups to find the cause.Associated symptoms included achiness and muscle spasms.She was diagnosed with rocky mountain spotted fever and treated without improvement in symptoms.She was borderline positive for epstein-barr.Upon examination, no cystocele or rectocele was present and there were no signs of erosion or infection.An ultrasound performed on that date showed a 4.4cm by 4.1cm cyst on the right ovary and multiple cysts, the largest being 2.3 by 2cm, on the left ovary.The assessment included incomplete uterovaginal prolapse, fever of unknown origin, chronic pelvic and perineal pain, and bilateral hemorrhagic ovarian cysts.Urinalysis was negative.The physician recommended follow up in three months.The patient underwent a complete tvt mesh excision including the retropubic mesh via a pfannenstiel incision in (b)(6) 2021, pain worsened after surgery.On (b)(6) 2021, a ct scan of abdomen and pelvis with contrast showed development of symmetric tubular cystic foci on each side of the bladder, each of which measure approximately 4.8x 2.1 x 3.5cm.Differential considerations include obstructing glands/ducts of the bartholin's or skene's gland, or less likely abscess or hydrosalpinx however this does not appear to be in the anatomic area of the fallopian tubes.Clinical correlation was recommended.The patient reported improved pelvic pain signs and symptoms since (b)(6) 2021 due to injections and 7 months of pfpt.During an office visit on (b)(6) 2022, the physician assessed the patient's pain as consistent with both obturator and pudendal neuralgia.The patient noted persistent pain complaints but also new pain possibly consistent with ilioinguinal neuralgia.The patient also noted recurrent stress urinary incontinence, which is quite significant.Physical examination showed positive tenderness noted at the lateral edges of the incisions, left greater than right, consistent with ilioinguinal neuralgia and positive point tenderness along the inferior pubic rami.The patient underwent a diagnostic ilioinguinal nerve block, which gave temporary pain relief.This appeared to be more affected on the left than the right.Reviewed treatment options going forward at length.The patient decided to undergo a bilateral ilioinguinal/iliohypogastric neurectomy; burch procedure, and removal of the uterosacral suspension sutures due to pudendal neuralgia, stress urinary incontinence, and ilioinguinal neuralgia.There was some fibrosis in the retropubic space secondary to the prior procedures.Dissection to the fixation sutures was challenging and the right side suture was scarred down.The sutures were cut, but there was some arterial type bleeding that was relatively difficult to control as the vessel retracted.Ligasure was used and bleeding was controlled, though it was noted that the patient lost approximately 300-350 cc of blood.The patient was placed in the supine position, awakened in the operating room, brought to recovery room awake, alert, in apparent stable condition.Pelvic/perineal pain recurred after the procedure.She also had a hematoma post-operatively.The patient also reported significant pelvic nerve irritation, mild-mod pelvic muscle spasms but low vaginal vault tone, with that, patients chronic pelvic pain syndrome (cpps) etiology appears to be multifactorial.Some improved/resolved cases include pain at right labia and vagina, occasional pain with vaginal penetration, bilateral groin pain, urinary urgency, constipation.On (b)(6) 2022, the patient reported chronic pelvic pain and discomfort rated 8 out of 10.Some urgency, frequency, burning with urination, pain during intercourse, pain while walking, sleeping, and sitting for long periods of time.The patient was incapable of doing running and lifting.The pain is localized to lower abdomen, pelvis, lumbosacral back or buttocks.The pain is of sufficient severity to cause functional disability.Previous treatments include a course of nsaids for 6 weeks, and a course of physical therapy for 6 weeks.The patient was assessed as having pelvic pain likely secondary to neuropathic pain and myofascial pain syndrome with both central sensitization and peripheral sensitization leading to membrane hyperexcitability and upregulation of both the central nervous system and peripheral nervous system with a sympathetic component to pain.Patient continues to have pain despite the conservative therapy.Some improved/resolved cases include pain at right labia and vagina, occasional pain with vaginal penetration, bilateral groin pain, urinary urgency, constipation.Treatment for other chronic pain: - valium tablet, 5 mg - diclofenac tablet, 75mg - valium tablet, 2 mg - diclofenac sodium tablet delayed release, 75 mg --additional information received on august 16, 2022 and september 1, 2022--- it was reported during an office visit on (b)(6) 2021 that the symptoms of mesh problems began one year ago and lasted generally for one year.Patient stated the symptoms located in vagina and are chronic and stable.She had an advantage fit retropubic sling placed in 2014, and in 2015, she had an outpatient visit where she reported prolene sutures were trimmed.Since (b)(6) 2020, she had had generalized fatigue, fever, chills, pelvic pain.Had deep dyspareunia during and after intercourse since initial surgery.She also reported that she had a postoperative fever and had a prolonged course postoperatively in the hospital requiring antibiotics.Patient reported urge incontinence and is sexually active with dyspareunia; stress incontinence was improved since surgery.Review of systems: positive: chills, fatigue, fever, weight gain, abdominal pain, nocturia, prolapsed uterus, urge incontinence, urgency, depression, back pain, joint pain, muscle weakness, dyspareunia, fibroids.On (b)(6) 2021, the patient had surgery for advantage sling removal, urethral lysis, anterior colporrhaphy, abdominal paravaginal, removal of abdominal mesh due to vaginal pain, pelvic pain, pain with coitus and urinary stricture.Hemostasis was excellent.The anterior vaginal wall was closed with running suture of#2-0 dexon.The patient tolerated the procedure well and was transferred to the recovery room in excellent condition.No complications reported.In a pathology report, it showed the mesh contains a small amount of adherent pink soft tissue.Two days after the surgery, patient reported right sided groin pain.Medication was not relieving her pain.Prescribed gabapentin for pain along with a steroid and muscle relaxer.If no improvement, patient will be referred to neurology.On (b)(6) 2021, the patient presented at the emergency department with numbness on the right side of her pelvis after mesh removal procedure on (b)(6) 2021.Patient continued to have groin pain despite being put on steroids, neurontin, and robaxin.Patient stated that her surgeon told her they "might have cut her nerve", there could be an obturator nerve cut during sling removal.On (b)(6) 2021, patient returned for follow up.Since sling removal, she is no longer having fevers and joint pains have resolved.She had some pain in groin that was quite severe after surgery.She went to the er and had a ct scan done.Since then, she has seen a specialist in maryland who can inject her groin which has been a "miracle" treatment and has really helped.On (b)(6) 2021 the patient reported that she saw gyn for spotting six weeks ago.The patient reports extreme pain when her bladder is full.On (b)(6) 2021, patient presented due to nerve pain from surgery, swollen abdomen but was doing better.The neve pain started about 5 weeks ago and she went to pelvic therapy.Pain was still shooting down from left side down to pelvic area, she complained of numbness on the surface of the skin and nerve pain beneath.She had a specialist appointment in (b)(6) 2021.Over the past 2 weeks, the previous pain had got worse - it seems to be radiating to the incision side and is now making a bulge or hernia.The left side is not as bad as the right side.The physician reports that the patient may have ilioinguinal nerve issue or maybe nerve entrapment.The patient reports an increase in urgency.A nerve block is planned after christmas.Assessment/plan: 1.Bladder pain frequency is new.Feels like she is still retaining urine.Doubt inguinal issue as the whole pelvic area is swollen.She also has left flank pain.Will obtain renal ultrasound.Will try her on flomax and see if this may relax the bladder.She has an appt at uva for pudendal nerve injection.- chronic bladder pain.2.Bilateral pain of inguinal region may have inguinal hernia on the right side vs scar tissue.- right and left lower quadrant; urinalysis, dipstick.*results: nitrite: positive.---additional information received on september 12, 15 and 16, 2022--- a documentation on (b)(6) 2020 stated that an encounter with the patient on (b)(6) 2020 reported that the patient had a tick bite and was then provided medication.Review of systems showed muscle aches and weakness, neck pain and back pain, skin rash.On (b)(6) 2021, the patient had a virtual visit for pain from possible pudendal neuralgia.The patient had undergone a vaginal hysterectomy with a&p repair, tvt, bilateral uterosacral suspension for pelvic organ prolapse and sui.The suspension was done with a total four prolene sutures.The patient had significant pain ever since that procedure.She also would get intermittent infections requiring antibiotics.She noted pain in both groin areas as well as vaginal pain.She also had significant urinary urgency and frequency.Eventually she underwent a complete mesh excision with cystocele repair including a retropubic dissection in (b)(6) 2021.The patient notes continued pain complaints.Some of the groin pain has improved but she now notes pain extending from the low pubic bone area near the edges of her pfannenstiel scar extending into the groin and upper leg.This is worse on the left than the right.She also notes numbness associated with her abdominal incision.She notes the pain to be increased with sitting.She also notes some in her vaginal pain.She denies any rectal or perineal pain.There is pain at the introitus along the sides of the vaginal opening.She notes some clitoral numbness but also some pain.Orgasm is painful.She notes recurrent sui with urinary urgency.Should she delay urination she will get a flare-up of pain even after voiding.She generally does not have dysuria.Bowel movement is normal.She notes some deep dyspareunia and also has pain if she adducts her legs widely.She still notes sitting pain.She has had pudendal nerve blocks which have reduced her pudendal pain significantly.She is getting some physical therapy which is somewhat helpful.Possible diagnoses of a pudendal neuralgia as well as possible ilioinguinal neuralgia with recurrent sui were reviewed in addition to possible treatments including ilioinguinal neurectomy after diagnostic nerve block and burch procedure.The patient also might benefit from removal of the permanent uterosacral suspension sutures verses a pudendal nerve decompression surgery.The patient was advised she needs to have an in person consultation with physical exam.Visit diagnoses on (b)(6) 2021 included ilioinguinal neuralgia of left and right side, neurologic cause of groin pain.Pain continued in her pelvic area between pubic bones that was separate from the pain she experienced in the pudendal area.Was shooting down from the bilateral labial region to inguinal and upper anterior thigh.With exertion, pain worsened and shot down to knees.She also reported her pelvic area was numb superficially with pain felt more deeply.She also had bulges on either side of her pelvic area.Bulges did not increase with exertion.She was evaluated for hernias previously, but us and ct abdomen/pelvis were negative.She also reported left mid-back pain that was intermittent.During pelvic therapy exercises, it improved with palpation.She tried topamax and gabapentin in the past for neuropath pain, but medications made her sleepy and preferred not to be on sedative medication.Motrin worked.She was having urinary urgency, needed to use the bathroom every hour and developed bladder pain if unable to do it quickly.Also reported stress incontinence with laughing/coughing.Gastrointestinal review was moderate pain on palpation approximately pelvic area.Assessment and plan: patient presented with numbness and chronic pain in her pelvic area with radiating pain to her anterior thighs that started after a gynecologic surgical procedure.Neurologic exam is notable for allodynia in dermatome levels t12, l 1, s2/s3; notably, no upper motor neuron umn signs or weakness present on exam.Her symptoms were consistent with neuropathic pain that seemed to be most within the territory of the bilateral ilioinguinal nerve, which innervated the labia and inguinal region, the upper anterior and medial thigh, and part of the genitalia.The medial femoral cutaneous nerve, a superficial femoral nerve, may also be implicated in some pain in the upper thigh as well, but less likely to be solely responsible.Discussed with patient the use of lidocaine patches and starting duloxetine for nerve pain; it is non-sedating and may also help with anxiety.1.Discussed with patient that she continues seeing ob/gyn neuralgia specialists.2.Start duloxetine 30 mg daily.Discussed that there is room to go up on the medication if needed.3.Start lidocaine patch as needed for nerve pain.Progress note: nerve block specialist in (b)(6) 2021.Pudendal nerve injections improved groin pain but could not separate her legs.Had trigger point injections and saw pain specialist.On (b)(6) 2021, patient presented for consultation in diagnostic nerve block.Procedure: under aseptic conditions bilateral ilioinguinal nerve block was performed with a total of 12 cc of 0.5% marcaine, negative aspiration was obtained prior to infiltration, the patient noted paresthesia on the left extending into the groin, she did not note the same degree of extension of paresthesia on the right, there were no complications, she tolerated the procedure well, she was given routine instructions.Office notes on (b)(6) 2021: assessment/plan 1.Right groin pain since mesh removal 3 weeks prior described as intermittent, shooting, numbness, tingling and hypersensitivity to touch in the right groin.The pain was somewhat better with rest and worse with certain movement.She has tried gabapentin, robaxin, and steroids.- nerve stabilizer: she is on low dose of gabapentin but stated that even at the low dose she felt "drugged".Discussed trying to increase this but she will not tolerate it.Discontinue gabapentin and start topamax 50mg.2.Follow up in 2 months.Light counseling on (b)(6) 2021, patient had an appointment scheduled at uva for bladder repair consult.Experiencing groin and bladder pain.Mesh removal surgery was (b)(6) 2021, but there has been no follow-up because she was unable to reach the surgeon.Patient feared surgery and possible intense pain that will follow like last time, but she's ready to be healthy.The diagnostic impression was adjustment disorder with anxiety.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to (b)(6) 2014, implant date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6) hospital (b)(6) sling removal surgeon is: dr.(b)(6).Block h6: patient codes e2006, e2311, e2330, e172001, e1906, e1405, e1715, e1301, e232402, e0505, e2401, e0127, e1720, e1605, e1307, e0123, e2101, e2009, e2319 capture the reportable events of: 9106: extrusion - small mesh erosion treated with excision in office 9205: pain - obturator and pudendal neuralgia, ilioinguinal neuralgia; pain while walking, sitting for long periods of time and sleeping; chronic pelvic pain; pain in lower abdomen, pelvis, lumbosacral back or buttocks; pain at right labia and vagina.9000: abscess - obstructing glands/ducts of the bartholin's or skene's gland, or less likely abscess or hydrosalpinx 9158: injury (nos) - cystic foci on each side of the bladder 9069: discomfort 9247: scarring - significant scar and surgical scar to pubic bone 9075: dyspareunia - pain during intercourse 9081: dysuria - burning with urination 9161: irritation - significant pelvic nerve irritation 9198: numbness - persistent numbness from umbilicus 9124: hematoma - post-op 300cc bleeding/hematoma 9177: muscle spasm - mild-mod pelvic muscle spasms and vaginismus 9148: urinary incontinence - recurrent stress urinary incontinence 9391: urethral stenosis/stricture - urinary stricture 9004: adhesions - mesh contains a small amount of adherent pink soft tissue; urethral lysis 9168: laceration - obturator nerve cut 9349: hernia - bulge or hernia like 9189: nerve damage - ilioinguinal nerve issue and pudendal nerve involvement impact codes f1202, f1903, f1901 and f2303 capture the reportable events of incapable of doing running and lifting and pain is of sufficient severity to cause functional disability; complete tvt mesh excision; bilateral ilioinguinal/iliohypogastric neurectomy; burch procedure, and removal of the uterosacral suspension sutures and diagnostic ilioinguinal nerve block; and medications taken, injections and pelvic floor physical therapy.Block 11: blocks b5 and h6 patient codes have been corrected.
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Search Alerts/Recalls
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