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BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Fall (1848); Fatigue (1849); Fever (1858); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Inflammation (1932); Muscle Weakness (1967); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Depression (2361); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)
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| Event Date 05/01/2018 |
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Event Type
Injury
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Event Description
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It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed on (b)(6) 2008.On (b)(6) 2018, patient underwent urethrolysis, cystoscopy and sling removal procedure due to vaginal pain and frequent urinary tract infections.Reportedly, patient had a bmi of 36.65 kg/sq.M.Reportedly, this was a complex case of deep sling placement and was quite friable, therefore an extra time was needed by the surgeon to carefully remove the sling in its entirety.However, the mesh was not completely removed.Procedure went without complications.Patient went for a follow-up with physical therapy on (b)(6) 2019 for pelvic and perineal pain, neuralgia and neuritis, as well as pain in the right and left hip.She also reported dyspareunia and an overactive bladder.Cystoscopy showed the bladder looked fine, however the physician observed that the mesh was eroded.A week later, patient made a follow-up with physical therapy.In the pt setting, her pain and disability related to her pelvic floor, bladder and bowel, and pudendal neuralgia were addressed.Some of her functional limitations identified are the following: daily care of herself, urinating approximately 10 to 14 times during the day and 4 times at night on average, if she has to wait to urinate her pain escalates in her bladder, pain with both urination and bowel movements, sleep limited by pain as well as bladder urgency, sitting limited to 5min in an upright position, walking limited to necessary amount and cannot tolerate walking 2 blocks (using a crutch on left side due to weakness in her low left extremities), travelling limited to necessary journeys due to pain, intercourse causes pain, unable to tolerate any recreational activity or exercises, cannot tolerate going to most social functions, cannot perform household chores, cannot return to work.Patient also reported she had been hospitalized for 5 days due to urinary tract infection which was difficult to treat and that she had an abscess on her bladder which had to be drained.On (b)(6) 2019, patient underwent mesh removal surgery of the left and right groin, ultrasound-guided bilateral nerve block, cystoscopy with bladder hydrodistention x 6 minutes due to long history of chronic pelvic pain.During the procedure, portions of the right and left groin mesh were removed and were noted to be densely embedded in the muscles.Pathology report of the mesh specimens noted foreign body inflammatory reaction surrounding the mesh material embedded in fibromuscular background.Patient passed voiding trial and was discharged in stable condition the following day.Following the surgery, patient was still reporting feeling the pain has returned even stronger as the nerve blocks wore off.She has also worn tens unit, tried vaginal suppositories and had acupuncture.She also underwent urodynamic analyzer testing with findings of stress urinary incontinence, underactive detrusor and incomplete bladder emptying.Patient had several follow-up visits due to urinary issues, infection and pain.Patient was also diagnosed with irritable bowel syndrome with constipation.Patient also received botox injections and nerve blocks for her spastic pelvic syndrome and pudendal neuralgia.She reported some improvement after these treatments.She had also discussed with her physician other treatment options such as robotic obturator nerve neurolysis and sola therapy.As of (b)(6) 2021, patient continues to present with varying and rather severe symptoms related to pelvic floor, the mesh and its removal.She reports having high urgency of her bladder that is aggravated by pain, stress, bowel habits and intercourse.This report was originally submitted via asr.Report identification number: 10848278, submission period: march 1, 2019 to may 14, 2019, asr exemption number: e2013036, pro code: otn,.
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Manufacturer Narrative
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Date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2018 was chosen as a best estimate based on the date of the first sling removal surgery.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.Sling removal surgeon (2008): (b)(6).Mesh removal surgeons (2019): (b)(6).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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Manufacturer Narrative
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Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2018 was chosen as a best estimate based on the date of the first sling removal surgery.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.Sling removal surgeon (2008): (b)(6).Mesh removal surgeons (2019): (b)(6).(b)(6) hospital and medical center.Block h6: patient codes e1405, e2326, e0126, e2006, e2101, e2330, e1309, e1310 and e172001 capture the reportable events of dyspareunia, inflammation, neuropathy, erosion, adhesion, pain, urinary retention, urinary tract infection and abscess.Impact codes f1202, f1903 and f2303 capture the reportable events of disability, mesh removal and medications.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.
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Event Description
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It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed on (b)(6) 2008.Medical and surgical history also included hysterectomy for heavy periods and ovarian cysts.The patient was diagnosed with pudendal neuralgia using mri and neurogram in (b)(6) 2018.On (b)(6) 2018, the patient was seen for physical therapy for persistent pain at the pelvic floor region.She had undergone right hip arthroscopic labral repair and debridement on (b)(6) 2018 which had reduced her hip pain but it had not improved her pelvic pain.On (b)(6) 2018, patient underwent urethrolysis, cystoscopy and sling removal procedure due to vaginal pain and frequent urinary tract infections.Reportedly, patient had a bmi of 36.65 kg/sq.M.Reportedly, this was a complex case of deep sling placement and was quite friable, therefore an extra time was needed by the surgeon to carefully remove the sling in its entirety.The mesh was invading the periurethral tissue and was adherent to the urethra, which required urethrolysis.However, the mesh was not completely removed.Procedure went without complications.The patient reported being pain-free for 48 hours postoperatively until she developed a fever due to uti.Patient went for a follow-up with physical therapy on (b)(6) 2019 for pelvic and perineal pain, neuralgia and neuritis, as well as pain in the right and left hip.She also reported dyspareunia and an overactive bladder (urgency).She reported -urinating approximately 10 to 14 times during the day and 4 times at night on average, doesn't always empty bladder well, burning sensation, frequent utis, complete incontinence following surgery which is improving but still has high urinary frequency.Additional symptoms included some difficulty with bowel movements, especially if she is using pain meds, for which she was using linzess and eating fruits and vegetables; vulvar and perineal pain that worsened with clothes rubbing or sitting but was better with gabapentin use; left hip pain increased; pudendal nerve pain increased with stretching; pain in inner and anterior thighs especially with increased activity; unable to drive as she cannot tolerate sitting at a 90 degree angle; and obturator pain.The assessment was noted as including a high level of muscular tension-tenderness in the perineal, suprapubic regions with poor coordination of her pelvic floor (pf) during attempts at active relaxation; pelvic floor shortened, tight, and in spasm; nocturia; increased urinary frequency; increased pain with sitting and walking; and pudendal neuralgia.The plan was physical therapy weekly for 12 weeks using various modalities.A week later, patient made a follow-up with physical therapy.In the pt setting, her pain and disability related to her pelvic floor, bladder and bowel, and pudendal neuralgia were addressed.Some of her functional limitations identified are the following: - daily care of herself - urinating approximately 10 to 14 times during the day and 4 times at night on average - if she has to wait to urinate her pain escalates in her bladder - pain with both urination and bowel movements - sleep limited by pain as well as bladder urgency - sitting limited to 5min in an upright position - walking limited to necessary amount and cannot tolerate walking 2 blocks (using a crutch on left side due to weakness in her low left extremities) - travelling limited to necessary journeys due to pain - intercourse causes pain - unable to tolerate any recreational activity or exercises - cannot tolerate going to most social functions - cannot perform household chores - cannot return to work patient also reported she had been hospitalized for 5 days due to urinary tract infection which was difficult to treat and that she had an abscess on her bladder which had to be drained.On (b)(6) 2019, patient underwent mesh removal surgery of the left and right groin, ultrasound-guided bilateral nerve block, cystoscopy with bladder hydrodistention x 6 minutes due to long history of chronic pelvic pain.During the procedure, portions of the right and left groin mesh were removed and were noted to be densely embedded in the muscles.Cystoscopy showed trabeculations and hypervascularity.Diffusely pathology report of the mesh specimens noted foreign body inflammatory reaction surrounding the mesh material embedded in fibromuscular background.Patient passed voiding trial and was discharged in stable condition the following day.On (b)(6) 2019, the patient returned to pt.She reported that she had recovered well after surgery until (b)(6) when she had increased pain and underwent a second nerve block.At the time of the pt appointment, the patient was still reporting feeling the pain has returned even stronger as the nerve blocks wore off.She has also worn tens unit, tried vaginal suppositories and had acupuncture.On (b)(6) 2020, the patient had a urodynamics study (uds) for urinary incontinence with findings of stress urinary incontinence, underactive detrusor and incomplete bladder emptying.On (b)(6) 20202, she presented for pt.It was noted that the patient continues to struggle with pain symptoms in her pelvic floor suggestive of nerve irritation at the femoral and obturator nerves as well as the pudendal nerve.Manual physical therapy interventions help to reduce her symptoms, allowing some improvement in the severity which allows her to have improved tolerance for functional activities such as driving to appointments.Her symptoms are chronic in nature.Skilled pt interventions continue to be indicated to assist her in gradual functional gains and improved pain management.Patient had several follow-up visits due to urinary issues, interstitial cystitis, infection and pain.Patient was also diagnosed with irritable bowel syndrome with constipation.Patient also received botox injections and nerve blocks for her spastic pelvic syndrome and pudendal neuralgia.She reported some improvement after these treatments.She had also discussed with her physician other treatment options such as robotic obturator nerve neurolysis and sola therapy.As of (b)(6) 2021, the patient was having flares of pain related to her pelvic floor 2-4x/month.They seem to be related to stress responses, intercourse, sitting on a harder surface and any straining related to bm.Overall the recent surgeries/procedures/injections have helped her pain but she is unable to achieve self-management due to the symptoms being highly irritable.She also reported having high urgency of her bladder that is aggravated by pain, stress, bowel habits and intercourse.It was noted that pt has been highly beneficial for her as part of medical interventions to calm her pain at least intermittently.She is improving her tolerance for walking and performing light household tasks such as preparing an easy meal.Both her pudendal and obturator nerves are impinged and are a factor in her continued symptoms.Physical therapy was to continue.This report was originally submitted via asr.- report identification number: (b)(4) - submission period: (b)(6), 2019 to (b)(6), 2019 - asr exemption number: e2013036 - pro code: otn.
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Event Description
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It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed on (b)(6) 2008.Medical and surgical history also included hysterectomy for heavy periods and ovarian cysts.The patient was diagnosed with pudendal neuralgia using mri and neurogram in may 2018.On (b)(6) 2018, the patient was seen for physical therapy for persistent pain at the pelvic floor region.She had undergone right hip arthroscopic labral repair and debridement on (b)(6) 2018 which had reduced her hip pain but it had not improved her pelvic pain.On november 28, 2018, patient underwent urethrolysis, cystoscopy and sling removal procedure due to vaginal pain and frequent urinary tract infections.Reportedly, patient had a bmi of 36.65 kg/sq.M.Reportedly, this was a complex case of deep sling placement and was quite friable, therefore an extra time was needed by the surgeon to carefully remove the sling in its entirety.The mesh was invading the periurethral tissue and was adherent to the urethra, which required urethrolysis.However, the mesh was not completely removed.Procedure went without complications.The patient reported being pain-free for 48 hours postoperatively until she developed a fever due to uti.Patient went for a follow-up with physical therapy on (b)(6) 2019 for pelvic and perineal pain, neuralgia and neuritis, as well as pain in the right and left hip.She also reported dyspareunia and an overactive bladder (urgency).She reported -urinating approximately 10 to 14 times during the day and 4 times at night on average, doesn't always empty bladder well, burning sensation, frequent utis, complete incontinence following surgery which is improving but still has high urinary frequency.Additional symptoms included some difficulty with bowel movements, especially if she is using pain meds, for which she was using linzess and eating fruits and vegetables; vulvar and perineal pain that worsened with clothes rubbing or sitting but was better with gabapentin use; left hip pain increased; pudendal nerve pain increased with stretching; pain in inner and anterior thighs especially with increased activity; unable to drive as she cannot tolerate sitting at a 90 degree angle; and obturator pain.The assessment was noted as including a a high level of muscular tension-tenderness in the perineal, suprapubic regions with poor coordination of her pelvic floor (pf) during attempts at active relaxation; pelvic floor shortened, tight, and in spasm; nocturia; increased urinary frequency; increased pain with sitting and walking; and pudendal neuralgia.The plan was physical therapy weekly for 12 weeks using various modalities.A week later, patient made a follow-up with physical therapy.In the pt setting, her pain and disability related to her pelvic floor, bladder and bowel, and pudendal neuralgia were addressed.Some of her functional limitations identified are the following: daily care of herself.Urinating approximately 10 to 14 times during the day and 4 times at night on average.If she has to wait to urinate her pain escalates in her bladder.Pain with both urination and bowel movements.Sleep limited by pain as well as bladder urgency.Sitting limited to 5min in an upright position.Walking limited to necessary amount and cannot tolerate walking 2 blocks (using a crutch on left side due to weakness in her low left extremities).Travelling limited to necessary journeys due to pain.Intercourse causes pain.Unable to tolerate any recreational activity or exercises.Cannot tolerate going to most social functions.Cannot perform household chores.Cannot return to work.Patient also reported she had been hospitalized for 5 days due to urinary tract infection which was difficult to treat and that she had an abscess on her bladder which had to be drained.On (b)(6) 2019, patient underwent mesh removal surgery of the left and right groin, ultrasound-guided bilateral nerve block, cystoscopy with bladder hydrodistention x 6 minutes due to long history of chronic pelvic pain.During the procedure, portions of the right and left groin mesh were removed and were noted to be densely embedded in the muscles.Cystoscopy showed trabeculations and hypervascularity.Diffusely pathology report of the mesh specimens noted foreign body inflammatory reaction surrounding the mesh material embedded in fibromuscular background.Patient passed voiding trial and was discharged in stable condition the following day.On (b)(6) 2019, the patient returned to pt.She reported that she had recovered well after surgery until september when she had increased pain and underwent a second nerve block.At the time of the pt appointment, the patient was still reporting feeling the pain has returned even stronger as the nerve blocks wore off.She has also worn tens unit, tried vaginal suppositories and had acupuncture.On (b)(6) 2020, the patient had a urodynamics study (uds) for urinary incontinence with findings of stress urinary incontinence, underactive detrusor and incomplete bladder emptying.On (b)(6) 2020, she presented for pt.It was noted that the patient continues to struggle with pain symptoms in her pelvic floor suggestive of nerve irritation at the femoral and obturator nerves as well as the pudendal nerve.Manual physical therapy interventions help to reduce her symptoms, allowing some improvement in the severity which allows her to have improved tolerance for functional activities such as driving to appointments.Her symptoms are chronic in nature.Skilled pt interventions continue to be indicated to assist her in gradual functional gains and improved pain management.Patient had several follow-up visits due to urinary issues, interstitial cystitis, infection and pain.Patient was also diagnosed with irritable bowel syndrome with constipation.Patient also received botox injections and nerve blocks for her spastic pelvic syndrome and pudendal neuralgia.She reported some improvement after these treatments.She had also discussed with her physician other treatment options such as robotic obturator nerve neurolysis and sola therapy.As of (b)(6) 2021, the patient was having flares of pain related to her pelvic floor 2-4x/month.They seem to be related to stress responses, intercourse, sitting on a harder surface and any straining related to bm.Overall the recent surgeries/procedures/injections have helped her pain but she is unable to achieve self-management due to the symptoms being highly irritable.She also reported having high urgency of her bladder that is aggravated by pain, stress, bowel habits and intercourse.It was noted that pt has been highly beneficial for her as part of medical interventions to calm her pain at least intermittently.She is improving her tolerance for walking and performing light household tasks such as preparing an easy meal.Both her pudendal and obturator nerves are impinged and are a factor in her continued symptoms.Physical therapy was to continue.This report was originally submitted via asr.Report identification number: (b)(4).Submission period: march 1, 2019 to may 14, 2019.Asr exemption number: e2013036.Pro code: otn.Additional information received on april 08, 2022: on (b)(6) 2019, the patient underwent vaginal mesh removal surgery.The patient reported to have done bpnb well overnight, post vaginal mesh removal.She reported minimal pain and noted good pain control especially with robaxin.The patient has been tolerating po foods and fluids.She was able to urinate; however, the patient has not passed gas or had any bowel movements yet.The patient did not note any abdominal discomfort or pain.Nausea and vomiting, light headedness, dizziness, and fevers were not noted.The patient was scheduled for discharge in the morning of (b)(6) 2019.Additional information received on november 3, 2022 and november 8, 2022: on (b)(6) 2019, the patient still experienced much pain from her pudendal nerve impingement due to complications of pelvic mesh.She recently saw a pain management specialist, but for now, she wanted to proceed with surgery to remove the mesh.Review of systems: gastrointestinal: positive for heartburn and nausea.Lack of appetite.Assessment and plan: 1.Preoperative clearance; 2.Obese; 3.Pudendal neuralgia; 4.Vaginosis; 5.H/o total hysterectomy with bilateral salpingo-oophorectomy (bso); 6.Interstitial cystitis; 7.Irritable bowel syndrome; 8.Recurrent uti; 9.Chronic constipation; 10.Urge incontinence; 11.Fatigue due to depression.To complete exam and forward to indicated site a week before surgery date.On (b)(6) 2019, the patient presented with urinary tract infection signs/symptoms which included burning sensation.She also reported having rash in skin folds.Review of systems: gastrointestinal: positive for nausea.Negative for abdominal pain, constipation, diarrhea and vomiting.1.Urethralgia.Bland urine during the visit, and chronic cystitis symptoms.Awaiting clearance prior to treatment: poct (point-of-care-test) urinalysis, urine culture 2.Intertrigo.To stop otc creams and start nystatin (mycostatin); apply to cleansed and dry skin in groin and under abdomen.3.Pudendal neuralgia, baseline per pt.To continue robaxin and gabapentin.On (b)(6) 2020, the patient presented with pain in the lower abdomen.She reported that it felt like pressure.She reported multiple bladder problems, recurrent utis, feeling like there is abdominal swelling and discomfort, and unable to urinate but feels like she needs to urinate badly.Assessment and plan: 1.Dysuria.Urine normal.Send for urine culture.Patient to call urology to move up appt if possible.Ibuprofen 600 for suprapubic pain.Follow-up 1 month.2.Recurrent uti.Send ua for culture.3.Interstitial cystitis.4.Umbilical hernia without obstruction and without gangrene seen on ct done in er.Possible etiology of periumbilical pain.5.Class 3 severe obesity.On (b)(6) 2020, the patient presented for a follow-up and for her lab results.She now has bilateral leg pain and recurrent utis.She goes to pelvic floor physical therapy twice a week.Review of systems: gastrointestinal: negative.Assessments: 1.Vitamin d insufficiency.2.Morbid obesity.3.Recurrent uti (urinary tract infection).4.Enthesopathy of right hip.5.Pudendal neuralgia.6.Postoperative obturator neuralgia.Plan: 1.Increase vitamin d supplementation.2.Pt should consider keto diet to drop large amount of weight before focusing on exercise but gastric bypass is being considered.On (b)(6) 2020, the patient presented with complaints of having a lot pelvic muscle spasms which she feels is causing bladder urgency.She has been taking methocarbonyl 500mg.Plan: to do botox injection of obturator and nerve blocks of genitofemoral nerve and obturator nerve to help spasm.If that doesn't work, next step is neuromodulation.The patient also has gastric bypass scheduled on (b)(6) 2022.On (b)(6) 2020, the patient presented in the clinic with the following current complaints: 1.Urination.10-14x/during day.She reported she doesn't always empty her bladder well.Most days, she can go 1-1.25 hours between voids.She still has difficulty delaying the urge as this causes bladder pain.She reported that her left side seems worse.Nocturia; struggles with sudden urgency (mild-severe); difficult to fully empty, often wiggles around or double voids.She can void a little easier as physical therapy has helped her relax more effectively.Mild urinary incontinence with laughter and coughing.She wears a light pad.Her urethra has been painful.She still has the pressure and a burning feeling at the urethra.She can have spasms around the bladder, but not the bladder itself.Overall, these are calming.2.Bowel habits : using linzess daily, allows her to have less strain with bowel movement.Painful bowel movement which can last a few minutes to several hours.Patient problems noted during the visit: vulvar pain ;pelvic floor is shortened-tight and appears to be in spasm.Pf strength is impaired due to pf being tight and shortened.Decreased strength b hips.Tension in pf musculature is moderate to severe b; nocturia; increased urinary frequency both day and night; increased pain with sitting, walking, general activity; pudendal neuralgia.Notes during the visit stated that on (b)(6) 2018, the patient returned to pt due to persistent pain at the pelvic floor region.She underwent a r hip arthroscopic labral repair and debridement on (b)(6) 2018.This reduced her hip pain and improved her mobility, but it did not reduce pelvic pain.She had pt at another local office but could not tolerate the exercise due to increased pain in the pelvic floor.She had a fall during this time due to le pain.Cystoscopy in 2018 showed a normal bladder lining but she does have symptoms of oab and is taking oxybutinin with some benefit.She was diagnosed with pudendal neuralgia using an mri and neurogram in (b)(6) 2018.Her b hip pain began approximately 1 year ago without a specific injury.Her pudendal nerve pain began 5 years after her surgery without a specific incident.Assessment/diagnosis: the patient continues to struggle with symptoms of bladder irritability, pudendal nerve irritation and possibly obturator nerve irritation.Pt has proven to be very helpful in keeping her symptoms at a more manageable level, helping her balance her symptoms more effectively.Unfortunately, she continues to have a high level of dysfunction with limitations in functional status and quality of life.She is unable to tolerate driving and most household tasks with her tolerance for sitting limiting most family and social events.Treatment to be provided: procedures: therapeutic exercises (rom, strength, stability), neuromuscular rehabilitation (muscle re-education), manual theraqy (soft tissue mobilization, myofascial release, visceral manipulation), patient education (home exercise program, postural raining, ergonomics, lifting mechanics, tens use, activity modification).On (b)(6) 2021, the patient presented for a follow-up visit.She reported that she was doing well at that time.She had not noticed any improvement thus far, but does reported she had not flared since starting physical therapy/pilates/massage.She reported improvement in tightness and pain.She stated hesitancy to use the wand for self-internal treatment as she experienced flaring herself previously when attempting to use the wand.Alleviators: gabapentin.The patient noted she has not attempted any exercises or stretches to alleviate her pain.Worsening factors: bowel movements, sexual intercourse, sitting, walking, long periods of standing, being confined to one position at a time, laying supine makes oi worse.Assessment: physical therapist advised the patient to continue working scar tissue at home.On (b)(6) 2022, the patient presented for preoperative counseling prior to surgery later this week for botox injection of pelvic floor muscles and bilateral pudendal nerve block.This is her fourth botox procedure overall.Review of systems: gastrointestinal: normal.Genitourinary: negative for blood in urine, positive for frequent urination, burning with urination, loss of urine or dribbling.Ob/gyn: normal.Physical exam: pelvic: external genitalia: normal.Bimanual: pelvic floor musculature increased tone and tenderness, left >> right, similar between left ol and left levator ani.Somewhat impaired conscious contraction/relaxation.The rest is normal.Assessment/plan: 1.Spastic pelvic floor syndrome.Injection therapeutic agent trigger point.2.Chronic pelvic pain.3.Neuralgia of both pudendal nerves.4.Urinary urgency.5.Urinary frequency.6.Complication of implanted vaginal mesh.On (b)(6) 2022, the patient underwent pudendal nerve block - transvaginal and botox injection procedures due to severe pelvic floor spasm and pain symptoms.Her pre and postoperative diagnoses included: urinary urgency, complication of implanted vaginal mesh, chronic pelvic pain, overactive bladder, spastic pelvic floor syndrome, neuralgia of both pudendal nerves and urinary frequency.
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Manufacturer Narrative
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H6: patient codes and impact codes have been updated based on the new information received on november 3, 2022 and november 8, 2022.The exact event onset date is unknown.The provided event date of may 1, 2018 was chosen as a best estimate based on the date when pudendal neuralgia was diagnosed.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.This event was reported by the patient's legal representation.Sling removal surgeon (2008): (b)(6).Mesh removal surgeons (2019): (b)(6).The following imdrf patient codes capture the reportable events below: e1405 :dyspareunia; e2326 :inflammation; e0126 :neuropathy; e2006 :erosion; e2101 :adhesion; e2330 :pain; e1309 :urinary retention; e1310 :urinary tract infection; e172001 :abscess; e1705 :burning sensation; e1002 :abdominal pain; e1301 :dysuria; e0123 :neuralgia and neuritis; e0506 :urethrorrhagia.Imdrf impact codes f1202, f1903 and f2303 capture the reportable events of disability, mesh removal and medications.
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Event Description
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It was reported to boston scientific corporation that an obtryx system device was implanted into the patient during a procedure performed on (b)(6), 2008.Medical and surgical history also included hysterectomy for heavy periods and ovarian cysts.The patient was diagnosed with pudendal neuralgia using mri and neurogram in may 2018.On (b)(6) 2018, the patient was seen for physical therapy for persistent pain at the pelvic floor region.She had undergone right hip arthroscopic labral repair and debridement on june 1, 2018 which had reduced her hip pain but it had not improved her pelvic pain.On (b)(6) 2018, patient underwent urethrolysis, cystoscopy and sling removal procedure due to vaginal pain and frequent urinary tract infections.Reportedly, patient had a bmi of 36.65 kg/sq.M.Reportedly, this was a complex case of deep sling placement and was quite friable, therefore an extra time was needed by the surgeon to carefully remove the sling in its entirety.The mesh was invading the periurethral tissue and was adherent to the urethra, which required urethrolysis.However, the mesh was not completely removed.Procedure went without complications.The patient reported being pain-free for 48 hours postoperatively until she developed a fever due to uti.Patient went for a follow-up with physical therapy on (b)(6) 2019 for pelvic and perineal pain, neuralgia and neuritis, as well as pain in the right and left hip.She also reported dyspareunia and an overactive bladder (urgency).She reported -urinating approximately 10 to 14 times during the day and 4 times at night on average, doesn't always empty bladder well, burning sensation, frequent utis, complete incontinence following surgery which is improving but still has high urinary frequency.Additional symptoms included some difficulty with bowel movements, especially if she is using pain meds, for which she was using linzess and eating fruits and vegetables; vulvar and perineal pain that worsened with clothes rubbing or sitting but was better with gabapentin use; left hip pain increased; pudendal nerve pain increased with stretching; pain in inner and anterior thighs especially with increased activity; unable to drive as she cannot tolerate sitting at a 90 degree angle; and obturator pain.The assessment was noted as including a a high level of muscular tension-tenderness in the perineal, suprapubic regions with poor coordination of her pelvic floor (pf) during attempts at active relaxation; pelvic floor shortened, tight, and in spasm; nocturia; increased urinary frequency; increased pain with sitting and walking; and pudendal neuralgia.The plan was physical therapy weekly for 12 weeks using various modalities.A week later, patient made a follow-up with physical therapy.In the pt setting, her pain and disability related to her pelvic floor, bladder and bowel, and pudendal neuralgia were addressed.Some of her functional limitations identified are the following: - daily care of herself - urinating approximately 10 to 14 times during the day and 4 times at night on average - if she has to wait to urinate her pain escalates in her bladder - pain with both urination and bowel movements - sleep limited by pain as well as bladder urgency - sitting limited to 5min in an upright position - walking limited to necessary amount and cannot tolerate walking 2 blocks (using a crutch on left side due to weakness in her low left extremities) - travelling limited to necessary journeys due to pain - intercourse causes pain - unable to tolerate any recreational activity or exercises - cannot tolerate going to most social functions - cannot perform household chores - cannot return to work patient also reported she had been hospitalized for 5 days due to urinary tract infection which was difficult to treat and that she had an abscess on her bladder which had to be drained.On (b)(6), 2019, patient underwent mesh removal surgery of the left and right groin, ultrasound-guided bilateral nerve block, cystoscopy with bladder hydrodistention x 6 minutes due to long history of chronic pelvic pain.During the procedure, portions of the right and left groin mesh were removed and were noted to be densely embedded in the muscles.Cystoscopy showed trabeculations and hypervascularity.Diffusely pathology report of the mesh specimens noted foreign body inflammatory reaction surrounding the mesh material embedded in fibromuscular background.Patient passed voiding trial and was discharged in stable condition the following day.On (b)(6) 2019, the patient returned to pt.She reported that she had recovered well after surgery until september when she had increased pain and underwent a second nerve block.At the time of the pt appointment, the patient was still reporting feeling the pain has returned even stronger as the nerve blocks wore off.She has also worn tens unit, tried vaginal suppositories and had acupuncture.On (b)(6)2020, the patient had a urodynamics study (uds) for urinary incontinence with findings of stress urinary incontinence, underactive detrusor and incomplete bladder emptying.On (b)(6), 2020, she presented for pt.It was noted that the patient continues to struggle with pain symptoms in her pelvic floor suggestive of nerve irritation at the femoral and obturator nerves as well as the pudendal nerve.Manual physical therapy interventions help to reduce her symptoms, allowing some improvement in the severity which allows her to have improved tolerance for functional activities such as driving to appointments.Her symptoms are chronic in nature.Skilled pt interventions continue to be indicated to assist her in gradual functional gains and improved pain management.Patient had several follow-up visits due to urinary issues, interstitial cystitis, infection and pain.Patient was also diagnosed with irritable bowel syndrome with constipation.Patient also received botox injections and nerve blocks for her spastic pelvic syndrome and pudendal neuralgia.She reported some improvement after these treatments.She had also discussed with her physician other treatment options such as robotic obturator nerve neurolysis and sola therapy.As of (b)(6) 2021, the patient was having flares of pain related to her pelvic floor 2-4x/month.They seem to be related to stress responses, intercourse, sitting on a harder surface and any straining related to bm.Overall the recent surgeries/procedures/injections have helped her pain but she is unable to achieve self-management due to the symptoms being highly irritable.She also reported having high urgency of her bladder that is aggravated by pain, stress, bowel habits and intercourse.It was noted that pt has been highly beneficial for her as part of medical interventions to calm her pain at least intermittently.She is improving her tolerance for walking and performing light household tasks such as preparing an easy meal.Both her pudendal and obturator nerves are impinged and are a factor in her continued symptoms.Physical therapy was to continue.This report was originally submitted via asr.- report identification number: 10848278 - submission period: march 1, 2019 to may 14, 2019 - asr exemption number: e2013036 - pro code: otn ***additional information received on april 08, 2022*** on (b)(6), 2019, the patient underwent vaginal mesh removal surgery.The patient reported to have done bpnb well overnight, post vaginal mesh removal.She reported minimal pain and noted good pain control especially with robaxin.The patient has been tolerating po foods and fluids.She was able to urinate; however, the patient has not passed gas or had any bowel movements yet.The patient did not note any abdominal discomfort or pain.Nausea and vomiting, light headedness, dizziness, and fevers were not noted.The patient was scheduled for discharge in the morning of (b)(6), 2019.***additional information received on november 3, 2022 and november 8, 2022*** on (b)(6) 2019, the patient still experienced much pain from her pudendal nerve impingement due to complications of pelvic mesh.She recently saw a pain management specialist, but for now, she wanted to proceed with surgery to remove the mesh.Review of systems gastrointestinal: positive for heartburn and nausea.Lack of appetite assessment and plan: 1.Preoperative clearance 2.Obese 3.Pudendal neuralgia 4.Vaginosis 5.H/o total hysterectomy with bilateral salpingo-oophorectomy (bso) 6.Interstitial cystitis 7.Irritable bowel syndrome 8.Recurrent uti 9.Chronic constipation 10.Urge incontinence 11.Fatigue due to depression to complete exam and forward to indicated site a week before surgery date.On (b)(6) 2019, the patient presented with urinary tract infection signs/symptoms which included burning sensation.She also reported having rash in skin folds.Review of systems: gastrointestinal: positive for nausea.Negative for abdominal pain, constipation, diarrhea and vomiting.1.Urethralgia.Bland urine during the visit, and chronic cystitis symptoms.Awaiting clearance prior to treatment: poct (point-of-care-test) urinalysis, urine culture 2.Intertrigo.To stop otc creams and start nystatin (mycostatin); apply to cleansed and dry skin in groin and under abdomen.3.Pudendal neuralgia, baseline per pt.To continue robaxin and gabapentin.On (b)(6), 2020, the patient presented with pain in the lower abdomen.She reported that it felt like pressure.She reported multiple bladder problems, recurrent utis, feeling like there is abdominal swelling and discomfort, and unable to urinate but feels like she needs to urinate badly.Assessment and plan: 1.Dysuria urine normal.Send for urine culture.Patient to call urology to move up appt if possible.Ibuprofen 600 for suprapubic pain.Follow-up 1 month.2.Recurrent uti send ua for culture 3.Interstitial cystitis 4.Umbilical hernia without obstruction and without gangrene seen on ct done in er.Possible etiology of periumbilical pain.5.Class 3 severe obesity on (b)(6) 2020, the patient presented for a follow-up and for her lab results.She now has bilateral leg pain and recurrent utis.She goes to pelvic floor physical therapy twice a week.Review of systems: gastrointestinal: negative assessments: 1.Vitamin d insufficiency 2.Morbid obesity 3.Recurrent uti (urinary tract infection) 4.Enthesopathy of right hip 5.Pudendal neuralgia 6.Postoperative obturator neuralgia plan: 1.Increase vitamin d supplementation.2.Pt should consider keto diet to drop large amount of weight before focusing on exercise but gastric bypass is being considered.On (b)(6), 2020, the patient presented with complaints of having a lot pelvic muscle spasms which she feels is causing bladder urgency.She has been taking methocarbonyl 500mg.Plan: to do botox injection of obturator and nerve blocks of genitofemoral nerve and obturator nerve to help spasm.If that doesn't work, next step is neuromodulation.The patient also has gastric bypass scheduled on (b)(6), 2022.On (b)(6), 2020, the patient presented in the clinic with the following current complaints: 1.Urination.- 10-14x/during day.She reported she doesn't always empty her bladder well.Most days, she can go 1-1.25 hours between voids.She still has difficulty delaying the urge as this causes bladder pain.She reported that her left side seems worse.- nocturia - struggles with sudden urgency (mild-severe) - difficult to fully empty, often wiggles around or double voids.She can void a little easier as physical therapy has helped her relax more effectively.- mild urinary incontinence with laughter and coughing.She wears a light pad.- her urethra has been painful.She still has the pressure and a burning feeling at the urethra - can have spasms around the bladder, but not the bladder itself.Overall, these are calming.2.Bowel habits - using linzess daily, allows her to have less strain with bowel movement.- painful bowel movement which can last a few minutes to several hours.Patient problems noted during the visit: - vulvar pain - pelvic floor is shortened-tight and appears to be in spasm.- pf strength is impaired due to pf being tight and shortened.- decreased strength b hips.- tension in pf musculature is moderate to severe b - nocturia - increased urinary frequency both day and night - increased pain with sitting, walking, general activity - pudendal neuralgia notes during the visit stated that on october 17, 2018, the patient returned to pt due to persistent pain at the pelvic floor region.She underwent a r hip arthroscopic labral repair and debridement on june 1, 2018.This reduced her hip pain and improved her mobility, but it did not reduce pelvic pain.She had pt at another local office but could not tolerate the exercise due to increased pain in the pelvic floor.She had a fall during this time due to le pain.Cystoscopy in 2018 showed a normal bladder lining but she does have symptoms of oab and is taking oxybutinin with some benefit.She was diagnosed with pudendal neuralgia using an mri and neurogram in may 2018.Her b hip pain began approximately 1 year ago without a specific injury.Her pudendal nerve pain began 5 years after her surgery without a specific incident.Assessment/diagnosis: the patient continues to struggle with symptoms of bladder irritability, pudendal nerve irritation and possibly obturator nerve irritation.Pt has proven to be very helpful in keeping her symptoms at a more manageable level, helping her balance her symptoms more effectively.Unfortunately, she continues to have a high level of dysfunction with limitations in functional status and quality of life.She is unable to tolerate driving and most household tasks with her tolerance for sitting limiting most family and social events.Treatment to be provided: procedures: therapeutic exercises (rom, strength, stability), neuromuscular rehabilitation (muscle re-education), manual theraqy (soft tissue mobilization, myofascial release, visceral manipulation), patient education (home exercise program, postural raining, ergonomics, lifting mechanics, tens use, activity modification) on (b)(6)2021, the patient presented for a follow-up visit.She reported that she was doing well at that time.She had not noticed any improvement thus far, but does reported she had not flared since starting physical therapy/pilates/massage.She reported improvement in tightness and pain.She stated hesitancy to use the wand for self-internal treatment as she experienced flaring herself previously when attempting to use the wand.Alleviators: gabapentin.The patient noted she has not attempted any exercises or stretches to alleviate her pain.Worsening factors: bowel movements, sexual intercourse, sitting, walking, long periods of standing, being confined to one position at a time, laying supine makes oi worse.Assessment: physical therapist advised the patient to continue working scar tissue at home.On (b)(6) 2022, the patient presented for preoperative counseling prior to surgery later this week for botox injection of pelvic floor muscles and bilateral pudendal nerve block.This is her fourth botox procedure overall.Review of systems: gastrointestinal: normal genitourinary: negative for blood in urine, positive for frequent urination, burning with urination, loss of urine or dribbling ob/gyn: normal physical exam: pelvic: external genitalia: normal bimanual: pelvic floor musculature increased tone and tenderness, left >> right, similar between left ol and left levator ani.Somewhat impaired conscious contraction/relaxation.The rest is normal.Assessment/plan: 1.Spastic pelvic floor syndrome injection therapeutic agent trigger point 2.Chronic pelvic pain 3.Neuralgia of both pudendal nerves 4.Urinary urgency 5.Urinary frequency 6.Complication of implanted vaginal mesh on (b)(6) 2022, the patient underwent pudendal nerve block - transvaginal and botox injection procedures due to severe pelvic floor spasm and pain symptoms.Her pre and postoperative diagnoses included: urinary urgency, complication of implanted vaginal mesh, chronic pelvic pain, overactive bladder, spastic pelvic floor syndrome, neuralgia of both pudendal nerves and urinary frequency.***additional information received on february 7, 2023*** according to the report, in 2017, the patient developed labial pain and was treated for a variety of vulvovaginal infections, including bacterial vaginosis and candidiasis.She continued to have intermittent bilateral labial burning, and this was ultimately attributed to hormonal imbalances for which she underwent a laparoscopic right oophorectomy in 2017.Following this intervention, bilateral labial burning became constant rather than intermittent.Recently, the patient's pain has been over her bilateral labia as well as her inner thigh and legs.She describes the leg and thigh pain as weakness and tenderness in the labial pain as burning.The pain is aggravated by sitting for longer than 30 minutes on a padded surface, and she is unable to tolerate any sitting on hard surfaces.The pain is also aggravated by wearing tight clothing.Pain is alleviated by lying down.The pain intermittently radiates to her bilateral lower quadrants.Patient denies dyspareunia however she has significant residual soreness following intercourse since the vaginal mesh removal.She also has increased pain following an orgasm.Additionally, the patient voids over 20 times daily.She has at least four episodes of nocturia per night.She denies urinary hesitancy.She believes that she has incomplete bladder emptying.The patient has no dysuria or hematuria.She reports pain with bladder filling that is relieved with urination.The patient also has constipation.She reports a significant increase in pain following bowel movements.She denies melena or hematochezia.She has never undergone a colonoscopy.Subsequently, the patient had physical therapy on (b)(6) 2019 with the potential for rehabilitation and the diagnosis of pudendal irritation and pelvic floor tension.The patient describes pudendal pain as radiating into both labia majora on either side, urethral burning, coccyx pain, anterior and medial bilateral thigh pain and weakness, and right-to-left electric pain down the posterior thigh to the knee during undergoing care.The patient claims that sitting and prolonged walking are the worst, that driving is impossible for her, and that the pain is never-ending.According to patient reports, lying down is not worse; reclining actually feels a little better.Moreover, the patient denies taking suppositories for pain relief.According to reports, she is extremely sensitive to various vulvar creams, including baclofen cream and lidocaine gel in the past.The patient is also using a hormone patch.The patient is still taking gabapentin for pain, which is beneficial.Pelvic exam/palpation: the patient reports coccyx tenderness and denies pain in the bilateral sacroiliac joints, low back, outer hips, sacrotuberous ligaments, alcock's canal, and ischial tuberosities.The patient denies having pain in the lower abdomen.On examination of the bilateral anterior and medial thighs, the patient had no significant pain, although there was a decreased sensation and slight tension in the left-sided adductors.Patient has tenderness and reproduction of palpation with palpation of bilateral labia majora and denies pain across perineum.She also denies any major pain at the vaginal entry or across the pelvic floor, with the exception of bilateral obturator muscles.She also denies reproducing pain with palpation of bilateral ischial spines.The patient may perform a pelvic floor contraction with limited excursion, a slightly sluggish release, and a bulge.Assessment: the patient demonstrates mild-moderate pelvic floor tension in bilateral obturator muscles; otherwise, the pelvic floor muscles are not reproducing her pain overall.Patient with hypersensitivity and pain reproduction into bilateral labia majora.Patient would benefit from medical intervention to address possible contribution of retained mesh to her continued pain as well as nerve interventions to address irritation in conjunction with continued pfpt and suppositories if needed.Review of systems: constitutional: weight gain and fatigue musculoskeletal: muscle weakness neurological: difficulty walking psychiatric: depression hematologic/lymphatic: iymphadenopathy endocrine: dry skin immunologic: allergies plan of care: 1.Complications of implanted vaginal mesh -discussed the option for removal of bilateral groin mesh and that the patient very much desires this intervention.Thus, they will plan for the resection of bilateral groin mesh.They also discussed that there was no guarantee that we would find her mesh, be able to remove it, or improve her pain.She is also aware that her pain may worsen following surgery.They also discussed hospital post-operative expectations, including post-op pain control, diet, and discharge planning.The patient verbalized her understanding, and all questions were answered.2.Pudendal neuralgia -the patient will undergo a guided pudendal nerve block.This was reviewed with the patient, who understood that this is a diagnostic test and that they will need to evaluate if she has numbness associated with the block as well as whether or not she has pain relief immediately following the block.3.Spastic pelvic floor syndrome -plan to continue pelvic floor pt with her current physical therapist.-plan for botox injections into the pelvic floor muscles at the time of mesh removal.-prescription for valium baclofen ketamine suppositories provided.4.Interstitial cystitis -patient will get a urine culture with her primary care doctor who manage her chronic urinary tract infection and will pursue adequate treatment.-plan for bladder hydro distention every six minutes at the time of the patient's mesh removal.It was discussed in detail with the patient that if she had any signs of a urinary tract infection on a urinalysis at the time of her presentation for surgery, they would not proceed with the hydro distention.
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Manufacturer Narrative
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Block h2: additional information blocks b5, b7 and h6: patient codes have been updated based on the new information received on february 7, 2023.Block b3: the exact event onset date is unknown.The provided event date of (b)(6) 2018, was chosen as a best estimate based on the date when pudendal neuralgia was diagnosed.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.Sling removal surgeon (2008): lisa rogo-gupta mesh removal surgeons (2019): michael hibner and elizabeth banks st.Joseph hospital and medical center block h6: the following imdrf patient codes capture the reportable events below: e1405 - dyspareunia e2326 - inflammation e0126 - neuropathy e2006 - erosion e2101 - adhesion e2330 - pain e1309 - urinary retention e1310 - urinary tract infection e172001 - abscess e1705 - burning sensation e1002 - abdominal pain e1301 - dysuria e0123 - neuralgia and neuritis e0506 - urethrorrhagia e020202 - depression e1309 - urinary retention the following imdrf impact codes capture the reportable events of: f1202, f1903 and f2303 capture the reportable events of disability, mesh removal and medications.
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