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BOSTON SCIENTIFIC CORPORATION OBTRYX SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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| Model Number M0068505001 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Erosion (1750); Calcium Deposits/Calcification (1758); Fatigue (1849); Flatus (1865); Headache (1880); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Discomfort (2330); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Weight Changes (2607); Dysuria (2684); Paresthesia (4421); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559); Urinary Incontinence (4572); Swelling/ Edema (4577); Insufficient Information (4580)
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| Event Date 01/16/2014 |
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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 - halo device was implanted into the patient during a trans-obturator mid-urethral sling with polypropylene mesh material + cystoscopy procedure performed on (b)(6) 2014 for the treatment of stress urinary incontinence.As reported by the patient's attorney, the patient claimed to experience the following injuries as a result of the implantation of the prior designated pelvic mesh product: dyspareunia, chronic pain, urinary, dysfunction, infections, revision surgeries, scarring, and loss of enjoyment of life.The plaintiff also claimed to have suffered damages including physical pain, physical impairment and mental anguish sustained in the past and will sustain in the future additional information received on august 18, 2022: the implant procedure went well; however, the patient had issues with pain control and discomfort from the catheter and chose to stay overnight in the hospital for observation.Discharged home in the morning of (b)(6) 2014, with pain medication of norco, antibiotics and levofloxacin for home use.Medication reconciliation followed and continued previous home medications including ambien, bumex, cymbalta, klonopin, klor-con, lisinopril, oxycodone, prilosec, saphris, simvastatin, soma, valium, and vesicare.Follow up in one week.Office visit on (b)(6) 2020: the patient complained of pelvic pain that is described as throbbing and is always having it since 2015.Menses stopped about 2 years ago and has not had any bleeding since then.Did not have any bad cramping when she was bleeding.Had not had a pap smear done in a long time.Last ultrasound was (b)(6) 2019 and patient said she did have an ovarian cyst.Had not been on estrogen since going through menopause.Patient reported to have hot flashes.During this visit, the patient was indeed diagnosed with pelvic pain and also cervicitis.Discussed options of possible mesh removal.Office visit on (b)(6) 2020: patient presented for mesh erosion exam.Started having problems with the implanted sling in 2016.Had a 5-month-long uti which required iv treatment.Sex made her feel like she had a uti.Stopped having intercourse long ago.At night, sometimes felt she was being beaten between her legs with a bat.Some nights felt nerves tingling and burning.Perineal body was red burning and throbbing and pain went from rectum to vagina, to clitoris to urethra.Lots of bladder pain.When she had gas, it hurt her bladder.Leaking also happened at times.She did not feel the urge to void, only signal to void was nausea if waited too long.Stream dribbled, if full leaks with cough, laugh, sneeze.Patient was positive for dyspareunia, pelvic pain, vaginal pain and bladder pain per review of systems.Assessment: 1.Chronic bladder pain, 2.Pelvic pain, 3.Exposure of implanted urethral mesh.Discussed removing her mesh - all the vaginal portions of the mesh but not following it out into the leg.Patient wanted complete removal.Office visit on (b)(6) 2020: same chief complaint - pelvic pain.Problems began in 2016 since the implant procedure.Patient first suffered a symptomatic urinary tract infection and it took about 5 months for the symptoms to resolve.Required iv antibiotics.Shortly after that, began to develop a burning sensation in vagina and feelings similar to urinary tract infection even though it was culture negative.Over the next 6-12 months, those symptoms progressed.The vibratory sensation decreased but pain increased, and the feeling of stabbing burning pins and needles type pain started which was located in the vagina, under the bladder, and bilaterally in the groin.Started experiencing pain associated with bowel movements.Also, was unable to have intercourse secondary to pain.Stress incontinence was initially cured but more recently started to experience a recurrence of stress urinary incontinence.Based on the symptoms described, the trans-obturator sling was possibly the cause of the pain.According to the patient, she had a cystoscopy in 2017 which did not show any erosion of sling into the bladder or urethra.Patient had a trans-obturator sling placed in 2014 and shortly after surgery, she developed a burning sensation and feeling similar to a uti in the vaginal area.Eventually, the patient underwent surgery for mesh removal on (b)(6) 2020.Examination revealed about a 2.5cm segment of mesh was exposed mostly on the right side, going from the right fornix to the midline.A transverse incision was made above the sling.The sling was mobilized and cut in midline after clamping each end.The epithelialized tissue that was under the sling was removed.The sling was then dissected toward the obturator membrane on both sides.Most of the exposure was on the right side and the end of the sling was identified and dissected.The sling on the left side was removed in its entirety.A 10cc of 0.5% marcaine was injected into the muscle and subcutaneous tissues of the groin dissection.Cystourethroscopy was performed and showed no evidence of injury to the bladder or urethra.The patient tolerated the procedure well, was returned to the recovery room in stable condition.No complications reported.Office visit on (b)(6) 2020: no chief complaint reported during this visit.The patient reports that she no longer has throbbing pain around the urethra and previous perirectal and pelvic pain seems to have disappeared.Her current pain is due to incision involving her left groin.There is no significant increase in incontinence, pins and needles sensation in vagina and pulling in rectal the rectal area are both gone.However, voiding volitionally, pvr (post void residual) was zero even though there was some feeling of incomplete emptying.Instructed to start baby aspirin (81mg) daily for vte ppx (venous thromboembolism, propoxyphene) given imminent travel.Follow up in 2-3 weeks.Office visit on (b)(6) 2020: patient reported to have a sticking pain intermittently in clitoris since mesh was removed.Also, complaining of bloating and fluid retention from mid abdomen to thighs.Physical examination showed bilateral, inner labia minora and space between clitoris and urethra remarkable for leukoplakia and erythema which was consistent with lichens sclerosis.Also, noted blunting of the clitoral hood.Diagnosis: clitoral pain and lichens sclerosis plan: recommended clobetasol bid for 30days with follow up if not improved.Continue to follow up with primary surgeon and primary care physician as directed.Office visit to (b)(6) 2020: patient developed new symptoms of having discomfort in her groin which she feels radiates over the pubic bone and to the other cysts groin area.Her gynecologist diagnosed her of leukoplakia involving the labia minora, blunting of the clitoral hood, and vaginal atrophy.She was given triamcinolone ointment 0.5% but finds that this is uncomfortable and causes worsening of a burning sensation.Discussed potential alternative treatment and suggested clobetasol for lichen sclerosis and pelvic floor physical therapy for residual symptoms which could be related to pelvic floor dysfunction.Additionally, it was also reported that: pins and needles pain gone.Rare sui only with full bladder and cough -- getting better.Patient was overall happy with results of surgery.Pelvic floor physical therapy session on (b)(6) 2021: patient was evaluated in pfpt for pelvic pain.It was reported that she was unable to continue working as a truck driver after becoming disabled.She had severe pain and spasming diffusely throughout hip, pelvic and sacral region affecting daily activities.Patient had pain with all testing performed actively and with palpation.The patient required skilled physical therapy to address pain, decreased motion, strength, and functional activity tolerance to increasing ability to lift or carry.The patient also reported she was a truck driver before coming disabled.Lastly, office visit on (b)(6) 2022, patient was reportedly positive for weakness, fatigue, decreased activity, weight gain, swelling in legs, abdominal pain, bloating, increased gas, numbness, tingling, headaches, back pain, joint pain, muscle pain/weakness, muscle cramps.Due to patient's complaints of periumbilical pain and lower abdominal pain with increased gassiness and bloating, ct of abdomen and pelvis recommended with positive oral contrast to further evaluate for any fascial defects or intra-abdominal processes.Follow up after ct scan to discuss results.
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Manufacturer Narrative
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Initial reporter name and address: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) surgeon for mesh excision is : (b)(6) (b)(4).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 obtryx system - halo device was implanted into the patient during a trans-obturator mid-urethral sling with polypropylene mesh material + cystoscopy procedure performed on (b)(6) 2014 for the treatment of stress urinary incontinence.As reported by the patient's attorney, the patient claimed to experience the following injuries as a result of the implantation of the prior designated pelvic mesh product: dyspareunia, chronic pain, urinary, dysfunction, infections, revision surgeries, scarring, and loss of enjoyment of life.The plaintiff also claimed to have suffered damages including physical pain, physical impairment and mental anguish sustained in the past and will sustain in the future ---additional information received on august 18, 2022--- the implant procedure went well; however, the patient had issues with pain control and discomfort from the catheter and chose to stay overnight in the hospital for observation.Discharged home in the morning of (b)(6) 2014, with pain medication of norco, antibiotics and levofloxacin for home use.Medication reconciliation followed and continued previous home medications including ambien, bumex, cymbalta, klonopin, klor-con, lisinopril, oxycodone, prilosec, saphris, simvastatin, soma, valium, and vesicare.Follow up in one week.Office visit on (b)(6) 2020: the patient complained of pelvic pain that is described as throbbing and is always having it since 2015.Menses stopped about 2 years ago and has not had any bleeding since then.Did not have any bad cramping when she was bleeding.Had not had a pap smear done in a long time.Last ultrasound was april 2019 and patient said she did have an ovarian cyst.Had not been on estrogen since going through menopause.Patient reported to have hot flashes.During this visit, the patient was indeed diagnosed with pelvic pain and also cervicitis.Discussed options of possible mesh removal.Office visit on (b)(6) 2020: patient presented for mesh erosion exam.Started having problems with the implanted sling in 2016.Had a 5-month-long uti which required iv treatment.Sex made her feel like she had a uti.Stopped having intercourse long ago.At night, sometimes felt she was being beaten between her legs with a bat.Some nights felt nerves tingling and burning.Perineal body was red burning and throbbing and pain went from rectum to vagina, to clitoris to urethra.Lots of bladder pain.When she had gas, it hurt her bladder.Leaking also happened at times.She did not feel the urge to void, only signal to void was nausea if waited too long.Stream dribbled, if full leaks with cough, laugh, sneeze.Patient was positive for dyspareunia, pelvic pain, vaginal pain and bladder pain per review of systems.Exam revealed pain at the perineal body and at vestibule, suprapubic pain, pain over posterior vaginal wall, superficial mesh on the left, exposed mesh on the right that was very painful to touch.* assessment: 1.Chronic bladder pain 2.Pelvic pain 3.Exposure of implanted urethral mesh the patient was advised that her pain is probably multifactorial and that the exposed mesh is a significant part of her pain.She was advised that the bladder, posterior wall, and perineal body pain may be unrelated.Discussed removing her mesh - all the vaginal portions of the mesh but not following it out into the leg.Patient wanted complete removal and was provided names of physicians who perform complete mesh removal.Telehealth visit on (b)(6) 2020: same chief complaint - pelvic pain.Problems began in 2016, about 2 years after the implant procedure.Patient first suffered a symptomatic urinary tract infection and it took about 5 months for the symptoms to resolve.Required iv antibiotics.Shortly after that, began to develop a burning sensation in vagina and feelings similar to urinary tract infection even though it was culture negative.Over the next 6-12 months, those symptoms progressed.The vibratory sensation decreased but pain increased, and the feeling of stabbing burning pins and needles type pain started which was located in the vagina, under the bladder, and bilaterally in the groin.Started experiencing pain associated with bowel movements.Also, was unable to have intercourse secondary to pain.Stress incontinence was initially cured but more recently started to experience a recurrence of stress urinary incontinence.Based on the symptoms described, the trans-obturator sling was possibly the cause of the pain.According to the patient, she had a cystoscopy in 2017 which did not show any erosion of sling into the bladder or urethra.The plan was for the patient to travel for a preoperative exam, cystoscopy to make sure there was no erosion, and sling removal pending the exam findings.Eventually, the patient underwent surgery for mesh removal on (b)(6) 2020.Examination revealed about a 2.5cm segment of mesh was exposed mostly on the right side, going from the right fornix to the midline.A transverse incision was made above the sling.The sling was mobilized and cut in midline after clamping each end.The epithelialized tissue that was under the sling was removed.The sling was then dissected toward the obturator membrane on both sides.Most of the exposure was on the right side and the end of the sling was identified and dissected.The sling on the left side was removed in its entirety.A 10cc of 0.5% marcaine was injected into the muscle and subcutaneous tissues of the groin dissection.Cystourethroscopy was performed and showed no evidence of injury to the bladder or urethra.The patient tolerated the procedure well, was returned to the recovery room in stable condition.No complications reported.Pathology of the excised sling showed benign fibromuscular tissue and bacterial colonies with morphologic features suggestive of actinomyces.Office visit on (b)(6) 2020: no chief complaint reported during this visit.It was noted that the patient had experienced recurrent utis, vaginitis, dysuria, and progressive pelvic pain following her tot sling placement in 2014 and was found to have extrusion of mesh with calcifications.The patient reports that she no longer has throbbing pain around the urethra and previous perirectal and pelvic pain seems to have disappeared.Her current pain is due to incision involving her left groin.She was able to sense the need to urinate but had dysuria and needed to sit forward and relax the pelvic floor in order to go.There is no significant increase in incontinence, pins and needles sensation in vagina and pulling in rectal the rectal area are both gone.However, voiding volitionally, pvr (post void residual) was zero even though there was some feeling of incomplete emptying.Instructed to start baby aspirin (81mg) daily for vte ppx (venous thromboembolism, propoxyphene) given imminent travel.Follow up in 2-3 weeks.Office visit on (b)(6) 2020: patient reported to have a sticking pain intermittently in clitoris since mesh was removed.Also, complaining of bloating and fluid retention from mid abdomen to thighs.Physical examination showed bilateral, inner labia minora and space between clitoris and urethra remarkable for leukoplakia and erythema which was consistent with lichens sclerosis.Also, noted blunting of the clitoral hood.* diagnosis: clitoral pain and lichens sclerosis * plan: recommended clobetasol bid for 30days with follow up if not improved.Continue to follow up with primary surgeon and primary care physician as directed.Telehealth visit (b)(6) 2020: patient developed new symptoms of having discomfort in her groin which she feels radiates over the pubic bone and to the other cysts groin area.Her gynecologist diagnosed her of leukoplakia involving the labia minora, blunting of the clitoral hood, and vaginal atrophy.She was given triamcinolone ointment 0.5% but finds that this is uncomfortable and causes worsening of a burning sensation.Discussed potential alternative treatment and suggested clobetasol for lichen sclerosis and pelvic floor physical therapy for residual symptoms which could be related to pelvic floor dysfunction.Additionally, it was also reported that: - pins and needles pain gone.- rare sui only with full bladder and cough -- getting better.- patient was overall happy with results of surgery.Pelvic floor physical therapy session on (b)(6) 2021: patient was evaluated in pfpt for pelvic pain.It was reported that she was unable to continue working as a truck driver after becoming disabled.She had severe pain and spasming diffusely throughout hip, pelvic and sacral region affecting daily activities.She reported strong pain, muscle weakness, and pulling from her l groin to up to her clitoris, across to other side of groin.Some pins and needles from front to back.Can't tolerate any tight clothes or pants along groin.Deep inside feels spasm and throbbing.Can't sleep or rest because it is always going on.Electric shock from clitoris through vaginal canal towards bladder.Sacrum lights up red hot and makes her nauseous when she lies on it.Also has bilateral hip pain.Pain ranges 4-9/10.Patient had pain with all testing performed actively and with palpation.The patient required skilled physical therapy to address pain, decreased motion, strength, and functional activity tolerance to increasing ability to lift or carry.Lastly, office visit on (b)(6) 2022, patient was reportedly positive for weakness, fatigue, decreased activity, weight gain, swelling in legs, abdominal pain, bloating, increased gas, numbness, tingling, headaches, back pain, joint pain, muscle pain/weakness, muscle cramps.Due to patient's complaints of periumbilical pain and lower abdominal pain with increased gassiness and bloating, ct of abdomen and pelvis recommended with positive oral contrast to further evaluate for any fascial defects or intra-abdominal processes.Follow up after ct scan to discuss results.
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Manufacturer Narrative
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Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) surgeon for mesh excision is : (b)(6) block h6: patient codes of e2006, e1309, e1720, e1715, e0127, e2311, e1002, e1405, e1301, e1310, e1906, e1401, e2326, e1720, e1720, e1621, e2015 and e230901 capture the reportable events of mesh exposure, urinary retention, pain, abdominal pain, scar tissue, numbness, discomfort, dyspareunia, dysuria, uti, infection, vaginal discharge, inflammation, irritation, voiding dysfunction, muscle weakness, atrophy and calcifications.Impact code f1905 captures the reportable event of excision of exposed mesh.Impact code f1202 captures the reportable event of patient becoming disabled.Block h11: blocks b5, b7 and h6: patient codes have been corrected.
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Event Description
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It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during a trans-obturator mid-urethral sling with polypropylene mesh material + cystoscopy procedure performed on january 15, 2014 for the treatment of stress urinary incontinence.As reported by the patient's attorney, the patient claimed to experience the following injuries as a result of the implantation of the prior designated pelvic mesh product: dyspareunia, chronic pain, urinary, dysfunction, infections, revision surgeries, scarring, and loss of enjoyment of life.The plaintiff also claimed to have suffered damages including physical pain, physical impairment and mental anguish sustained in the past and will sustain in the future.Additional information received on august 18, 2022: the implant procedure went well; however, the patient had issues with pain control and discomfort from the catheter and chose to stay overnight in the hospital for observation.Discharged home in the morning of january 16, 2014, with pain medication of norco, antibiotics and levofloxacin for home use.Medication reconciliation followed and continued previous home medications including ambien, bumex, cymbalta, klonopin, klor-con, lisinopril, oxycodone, prilosec, saphris, simvastatin, soma, valium, and vesicare.Follow up in one week.Office visit on (b)(6) 2020: the patient complained of pelvic pain that is described as throbbing and is always having it since 2015.Menses stopped about 2 years ago and has not had any bleeding since then.Did not have any bad cramping when she was bleeding.Had not had a pap smear done in a long time.Last ultrasound was (b)(6) 2019 and patient said she did have an ovarian cyst.Had not been on estrogen since going through menopause.Patient reported to have hot flashes.During this visit, the patient was indeed diagnosed with pelvic pain and also cervicitis.Discussed options of possible mesh removal.Office visit on june 18, 2020: patient presented for mesh erosion exam.Started having problems with the implanted sling in 2016.Had a 5-month-long uti which required iv treatment.Sex made her feel like she had a uti.Stopped having intercourse long ago.At night, sometimes felt she was being beaten between her legs with a bat.Some nights felt nerves tingling and burning.Perineal body was red burning and throbbing, and pain went from rectum to vagina, to clitoris to urethra.Lots of bladder pain.When she had gas, it hurt her bladder.Leaking also happened at times.She did not feel the urge to void, only signal to void was nausea if waited too long.Stream dribbled, if full leaks with cough, laugh, sneeze.Patient was positive for dyspareunia, pelvic pain, vaginal pain and bladder pain per review of systems.Exam revealed pain at the perineal body and at vestibule, suprapubic pain, pain over posterior vaginal wall, superficial mesh on the left, exposed mesh on the right that was very painful to touch.* assessment: 1.Chronic bladder pain.2.Pelvic pain.3.Exposure of implanted urethral mesh.The patient was advised that her pain is probably multifactorial and that the exposed mesh is a significant part of her pain.She was advised that the bladder, posterior wall, and perineal body pain may be unrelated.Discussed removing her mesh - all the vaginal portions of the mesh but not following it out into the leg.Patient wanted complete removal and was provided names of physicians who perform complete mesh removal.Telehealth visit on july 15, 2020: same chief complaint - pelvic pain.Problems began in 2016, about 2 years after the implant procedure.Patient first suffered a symptomatic urinary tract infection and it took about 5 months for the symptoms to resolve.Required iv antibiotics.Shortly after that, began to develop a burning sensation in vagina and feelings similar to urinary tract infection even though it was culture negative.Over the next 6-12 months, those symptoms progressed.The vibratory sensation decreased but pain increased, and the feeling of stabbing burning pins and needles type pain started which was located in the vagina, under the bladder, and bilaterally in the groin.Started experiencing pain associated with bowel movements.Also, was unable to have intercourse secondary to pain.Stress incontinence was initially cured but more recently started to experience a recurrence of stress urinary incontinence.Based on the symptoms described, the trans-obturator sling was possibly the cause of the pain.According to the patient, she had a cystoscopy in 2017 which did not show any erosion of sling into the bladder or urethra.The plan was for the patient to travel for a preoperative exam, cystoscopy to make sure there was no erosion, and sling removal pending the exam findings.On (b)(6) 2020, the patient came for the plan of preop antibiotics on call to or and consented cystoscopy, explant of transobturator sling and groin dissection.Eventually, the patient underwent surgery for mesh removal on (b)(6) 2020.Examination revealed about a 2.5cm segment of mesh was exposed mostly on the right side, going from the right fornix to the midline.A transverse incision was made above the sling.The sling was mobilized and cut in midline after clamping each end.The epithelialized tissue that was under the sling was removed.The sling was then dissected toward the obturator membrane on both sides.Most of the exposure was on the right side and the end of the sling was identified and dissected.The sling on the left side was removed in its entirety.A 10cc of 0.5% marcaine was injected into the muscle and subcutaneous tissues of the groin dissection.Cystourethroscopy was performed and showed no evidence of injury to the bladder or urethra.The patient tolerated the procedure well, was returned to the recovery room in stable condition.No complications reported.Pathology of the excised sling showed benign fibromuscular tissue and bacterial colonies with morphologic features suggestive of actinomyces.She was discharged home on (b)(6) 2020, without any untoward events.Office visit on (b)(6) 2020: no chief complaint reported during this visit.It was noted that the patient had experienced recurrent utis, vaginitis, dysuria, and progressive pelvic pain following her tot sling placement in 2014 and was found to have extrusion of mesh with calcifications.The patient reports that she no longer has throbbing pain around the urethra and previous perirectal and pelvic pain seems to have disappeared.Her current pain is due to incision involving her left groin.She was able to sense the need to urinate but had dysuria and needed to sit forward and relax the pelvic floor in order to go.There is no significant increase in incontinence, pins and needles sensation in vagina and pulling in rectal the rectal area are both gone.However, voiding volitionally, pvr (post void residual) was zero even though there was some feeling of incomplete emptying.Instructed to start baby aspirin (81mg) daily for vte ppx (venous thromboembolism, propoxyphene) given imminent travel.Follow up in 2-3 weeks.A progress notes on september 2, 2020 stated that the patient continues to heal.Vaginal bleeding stopped at two weeks post operation.Urinating is better -- easier to empty, usually a full stream.Getting normal signals to void.Pain gone in leg and pelvic area.Pins and needles pain gone.Rare sui only with full bladder and cough is getting better.Overall, she was happy with the results of surgery and telemedicine visit was scheduled in 3 months' time.Office visit on (b)(6) 2020: patient reported to have a sticking pain intermittently in clitoris since mesh was removed.Also, complaining of bloating and fluid retention from mid abdomen to thighs.Physical examination showed bilateral, inner labia minora and space between clitoris and urethra remarkable for leukoplakia and erythema which was consistent with lichens sclerosis.Also, noted blunting of the clitoral hood.Diagnosis: clitoral pain and lichens sclerosis.Plan: recommended clobetasol bid for 30days with follow up if not improved.Continue to follow up with primary surgeon and primary care physician as directed.Telehealth visit (b)(6) 2020: patient developed new symptoms of having discomfort in her groin which she feels radiates over the pubic bone and to the other cysts groin area.Her gynecologist diagnosed her of leukoplakia involving the labia minora, blunting of the clitoral hood, and vaginal atrophy.She was given triamcinolone ointment 0.5% but finds that this is uncomfortable and causes worsening of a burning sensation.Discussed potential alternative treatment and suggested clobetasol for lichen sclerosis and pelvic floor physical therapy for residual symptoms which could be related to pelvic floor dysfunction.Additionally, it was also reported that: pins and needles pain gone.Rare sui only with full bladder and cough -- getting better.Patient was overall happy with results of surgery.Pelvic floor physical therapy session on (b)(6) 2021: patient was evaluated in pfpt for pelvic pain.It was reported that she was unable to continue working as a truck driver after becoming disabled.She had severe pain and spasming diffusely throughout hip, pelvic and sacral region affecting daily activities.She reported strong pain, muscle weakness, and pulling from her l groin to up to her clitoris, across to other side of groin.Some pins and needles from front to back.Can't tolerate any tight clothes or pants along groin.Deep inside feels spasm and throbbing.Can't sleep or rest because it is always going on.Electric shock from clitoris through vaginal canal towards bladder.Sacrum lights up red hot and makes her nauseous when she lies on it.Also has bilateral hip pain.Pain ranges 4-9/10.Patient had pain with all testing performed actively and with palpation.The patient required skilled physical therapy to address pain, decreased motion, strength, and functional activity tolerance to increasing ability to lift or carry.An office visit on (b)(6) 2022, patient was reportedly positive for weakness, fatigue, decreased activity, weight gain, swelling in legs, abdominal pain, bloating, increased gas, numbness, tingling, headaches, back pain, joint pain, muscle pain/weakness, muscle cramps.Due to patient's complaints of periumbilical pain and lower abdominal pain with increased gassiness and bloating, ct of abdomen and pelvis recommended with positive oral contrast to further evaluate for any fascial defects or intra-abdominal processes.Follow up after ct scan to discuss results.Doctor's letter on (b)(6) 2022: found out that the patient eventually needed to have the mesh removed because of complications.The physician reported that they were disappointed that they had not seen the patient since (b)(6) 2014, when she stated that she no longer had leakage and that she was happy with the result.The surgeon stated that they were puzzled as to why they did not follow up when the patient started having problems.
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Manufacturer Narrative
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Block b5 has been updated based on the information received on september 16 and 19, 2022.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).Surgeon for mesh excision is: dr.(b)(6).Block h6: patient codes of e2006, e1309, e1720, e1715, e0127, e2311, e1002, e1405, e1301, e1310, e1906, e1401, e2326, e1720, e1720, e1621, e2015 and e230901 capture the reportable events of mesh exposure, urinary retention, pain, abdominal pain, scar tissue, numbness, discomfort, dyspareunia, dysuria, uti, infection, vaginal discharge, inflammation, irritation, voiding dysfunction, muscle weakness, atrophy and calcifications.Impact code f1905 captures the reportable event of excision of exposed mesh.Impact code f1202 captures the reportable event of patient becoming disabled.Block h11: blocks b5, b7 and h6: patient codes have been corrected.
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Event Description
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It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during a transobturator midurethral sling with polypropylene mesh material + cystoscopy procedure performed on january 15, 2014 for the treatment of stress urinary incontinence.As reported by the patient attorney, the patient claimed to experience the following injuries as a result of the implantation of the prior designated pelvic mesh product: dyspareunia, chronic pain, urinary, dysfunction, infections, revision surgeries, scarring, and loss of enjoyment of life.The plaintiff also claimed to have suffered damages including physical pain, physical impairment and mental anguish sustained in the past and will sustain in the future additional information received on august 18, 2022 the implant procedure went well; however, the patient had issues with pain control and discomfort from the catheter and chose to stay overnight in the hospital for observation.Discharged home in the morning of (b)(6) 2014, with pain medication of norco, antibiotics and levofloxacin for home use.Medication reconciliation followed and continued previous home medications including ambien, bumex, cymbalta, klonopin, klor - con, lisinopril, oxycodone, prilosec, saphris, simvastatin, soma, valium, and vesicare.Follow up in one week.Office visit on (b)(6) 2020: the patient complained of pelvic pain that is described as throbbing and is always having it since 2015.Menses stopped about 2 years ago and has not had any bleeding since then.Did not have any bad cramping when she was bleeding.Had not had a pap smear done in a long time.Last ultrasound was on (b)(6) 2019 and patient said she did have an ovarian cyst.Had not been on estrogen since going through menopause.Patient reported to have hot flashes.During this visit, the patient was indeed diagnosed with pelvic pain and also cervicitis.Discussed options of possible mesh removal.Office visit on (b)(6) 2020: patient presented for mesh erosion exam.Started having problems with the implanted sling in 2016.Had a 5 - month - long uti which required iv treatment.Sex made her feel like she had a uti.Stopped having intercourse long ago.At night, sometimes felt she was being beaten between her legs with a bat.Some nights felt nerves tingling and burning.Perineal body was red burning and throbbing, and pain went from rectum to vagina, to clitoris to urethra.Lots of bladder pain.When she had gas, it hurt her bladder.Leaking also happened at times.She did not feel the urge to void, only signal to void was nausea if waited too long.Stream dribbled, if full leaks with cough, laugh, sneeze.Patient was positive for dyspareunia, pelvic pain, vaginal pain and bladder pain per review of systems.Exam revealed pain at the perineal body and at vestibule, suprapubic pain, pain over posterior vaginal wall, superficial mesh on the left, exposed mesh on the right that was very painful to touch.* assessment: 1.Chronic bladder pain 2.Pelvic pain 3.Exposure of implanted urethral mesh.The patient was advised that her pain is probably multifactorial and that the exposed mesh is a significant part of her pain.She was advised that the bladder, posterior wall, and perineal body pain may be unrelated.Discussed removing her mesh - all the vaginal portions of the mesh but not following it out into the leg.Patient wanted complete removal and was provided names of physicians who perform complete mesh removal.Telehealth visit on (b)(6) 2020: same chief complaint - pelvic pain.Problems began in 2016, about 2 years after the implant procedure.Patient first suffered a symptomatic urinary tract infection and it took about 5 months for the symptoms to resolve.Required iv antibiotics.Shortly after that, began to develop a burning sensation in vagina and feelings similar to urinary tract infection even though it was culture negative.Over the next 6 - 12 months, those symptoms progressed.The vibratory sensation decreased but pain increased, and the feeling of stabbing burning pins and needles type pain started which was located in the vagina, under the bladder, and bilaterally in the groin.Started experiencing pain associated with bowel movements.Also, was unable to have intercourse secondary to pain.Stress incontinence was initially cured but more recently started to experience a recurrence of stress urinary incontinence.Based on the symptoms described, the transobturator sling was possibly the cause of the pain.According to the patient, she had a cystoscopy in 2017 which did not show any erosion of sling into the bladder or urethra.The plan was for the patient to travel for a preoperative exam, cystoscopy to make sure there was no erosion, and sling removal pending the exam findings.On (b)(6) 2020, the patient came for the plan of preop antibiotics on call to or and consented cystoscopy, explant of transobturator sling and groin dissection.Eventually, the patient underwent surgery for mesh removal on (b)(6) 2020.Examination revealed about a 2.5cm segment of mesh was exposed mostly on the right side, going from the right fornix to the midline.A transverse incision was made above the sling.The sling was mobilized and cut in midline after clamping each end.The epithelialized tissue that was under the sling was removed.The sling was then dissected toward the obturator membrane on both sides.Most of the exposure was on the right side and the end of the sling was identified and dissected.The sling on the left side was removed in its entirety.A 10cc of 0.5 percent marcaine was injected into the muscle and subcutaneous tissues of the groin dissection.Cystourethroscopy was performed and showed no evidence of injury to the bladder or urethra.The patient tolerated the procedure well, was returned to the recovery room in stable condition.No complications reported.Pathology of the excised sling showed benign fibromuscular tissue and bacterial colonies with morphologic features suggestive of actinomyces.She was discharged home on (b)(6) 2020, without any untoward events.Office visit on (b)(6) 2020: no chief complaint reported during this visit.It was noted that the patient had experienced recurrent utis, vaginitis, dysuria, and progressive pelvic pain following her tot sling placement in 2014 and was found to have extrusion of mesh with calcifications.The patient reports that she no longer has throbbing pain around the urethra and previous perirectal and pelvic pain seems to have disappeared.Her current pain is due to incision involving her left groin.She was able to sense the need to urinate but had dysuria and needed to sit forward and relax the pelvic floor in order to go.There is no significant increase in incontinence, pins and needles sensation in vagina and pulling in rectal the rectal area are both gone.However, voiding volitionally, pvr (post void residual) was zero even though there was some feeling of incomplete emptying.Instructed to start baby aspirin (81mg) daily for vte ppx (venous thromboembolism, propoxyphene) given imminent travel.Follow up in 2 - 3 weeks.A progress notes on (b)(6) 2020 stated that the patient continues to heal.Vaginal bleeding stopped at two weeks post operation.Urinating is better - easier to empty, usually a full stream.Getting normal signals to void.Pain gone in leg and pelvic area.Pins and needles pain gone.Rare sui only with full bladder and cough is getting better.Overall, she was happy with the results of surgery and telemedicine visit was scheduled in 3 months time.Office visit on (b)(6) 2020: patient reported to have a sticking pain intermittently in clitoris since mesh was removed.Also, complaining of bloating and fluid retention from mid abdomen to thighs.Physical examination showed bilateral, inner labia minora and space between clitoris and urethra remarkable for leukoplakia and erythema which was consistent with lichens sclerosis.Also, noted blunting of the clitoral hood.Diagnosis: clitoral pain and lichens sclerosis plan: recommended clobetasol bid for 30days with follow up if not improved.Continue to follow up with primary surgeon and primary care physician as directed.Telehealth visit (b)(6) 2020: patient developed new symptoms of having discomfort in her groin which she feels radiates over the pubic bone and to the other cysts groin area.Her gynecologist diagnosed her of leukoplakia involving the labia minora, blunting of the clitoral hood, and vaginal atrophy.She was given triamcinolone ointment 0.5 percent but finds that this is uncomfortable and causes worsening of a burning sensation.Discussed potential alternative treatment and suggested clobetasol for lichen sclerosis and pelvic floor physical therapy for residual symptoms which could be related to pelvic floor dysfunction.Additionally, it was also reported that: pins and needles pain gone.Rare sui only with full bladder and cough - getting better.Patient was overall happy with results of surgery.Pelvic floor physical therapy session on (b)(6) 2021: patient was evaluated in pfpt for pelvic pain.It was reported that she was unable to continue working as a truck driver after becoming disabled.She had severe pain and spasming diffusely throughout hip, pelvic and sacral region affecting daily activities.She reported strong pain, muscle weakness, and pulling from her l groin to up to her clitoris, across to other side of groin.Some pins and needles from front to back.Cannot tolerate any tight clothes or pants along groin.Deep inside feels spasm and throbbing.Cannot sleep or rest because it is always going on.Electric shock from clitoris through vaginal canal towards bladder.Sacrum lights up red hot and makes her nauseous when she lies on it.Also has bilateral hip pain.Pain ranges 4 - 9/10.Patient had pain with all testing performed actively and with palpation.The patient required skilled physical therapy to address pain, decreased motion, strength, and functional activity tolerance to increasing ability to lift or carry.An office visit on (b)(6) 2022, patient was reportedly positive for weakness, fatigue, decreased activity, weight gain, swelling in legs, abdominal pain, bloating, increased gas, numbness, tingling, headaches, back pain, joint pain, muscle pain/weakness, muscle cramps.Due to patient complaints of periumbilical pain and lower abdominal pain with increased gassiness and bloating, ct of abdomen and pelvis recommended with positive oral contrast to further evaluate for any fascial defects or intra - abdominal processes.Follow up after ct scan to discuss results.Doctor letter on (b)(6) 2022: found out that the patient eventually needed to have the mesh removed because of complications.The physician reported that they were disappointed that they had not seen the patient since (b)(6) 2014, when she stated that she no longer had leakage and that she was happy with the result.The surgeon stated that they were puzzled as to why they did not follow up when the patient started having problems.Additional information received on november 16, 2022 on (b)(6) 2019, patient presented for examination.She reported that she had had increasing lower and pelvic pain for the last 13 to 14 days with a stabbing to pin prickling sensation to her lower groin and rectal area.Patient felt that her bladder mesh may have migrated.She was concerned that she may have cancer as she attempted to see a gynecologist several years ago but no pap smear or any testing was done at that time.She was also convinced that her bladder mesh was migrating.Lastly, she was having bilateral flank pain that was fleeting lasting only a second or 2 at a time.She stated it was an electric shock to her back that resolved very quickly, it happened when she was walking mostly.Also, she was having worsening rectal and vaginal pain with laying down but not with walking.She was in the emergency department to figure out what may be going on.She had been having intermittent symptoms for the last several years but worse in the last 13 to 14 days.
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Manufacturer Narrative
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Blocks b5 has been updated based on the information received on november 16, 2022.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) dr.(b)(6) center( b)(6).Surgeon for mesh excision is: (b)(6) dr.(b)(6) center.(b)(6) block h6: patient codes of e2006, e1309, e1720, e1715, e0127, e2311, e1002, e1405, e1301, e1310, e1906, e1401, e2326, e1720, e1720, e1621, e2015 and e230901 capture the reportable events of mesh exposure, urinary retention, pain, abdominal pain, scar tissue, numbness, discomfort, dyspareunia, dysuria, uti, infection, vaginal discharge, inflammation, irritation, voiding dysfunction, muscle weakness, atrophy and calcifications.Impact code f1905 captures the reportable event of excision of exposed mesh.Impact code f1202 captures the reportable event of patient becoming disabled.
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Event Description
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It was reported to boston scientific corporation that an obtryx system - halo device was implanted into the patient during a transobturator midurethral sling with polypropylene mesh material + cystoscopy procedure performed on (b)(6) 2014 for the treatment of stress urinary incontinence.As reported by the patient attorney, the patient claimed to experience the following injuries as a result of the implantation of the prior designated pelvic mesh product: dyspareunia, chronic pain, urinary, dysfunction, infections, revision surgeries, scarring, and loss of enjoyment of life.The plaintiff also claimed to have suffered damages including physical pain, physical impairment and mental anguish sustained in the past and will sustain in the future.Additional information received on august 18, 2022.The implant procedure went well; however, the patient had issues with pain control and discomfort from the catheter and chose to stay overnight in the hospital for observation.Discharged home in the morning of (b)(6) 2014, with pain medication of norco, antibiotics and levofloxacin for home use.Medication reconciliation followed and continued previous home medications including ambien, bumex, cymbalta, klonopin, klor - con, lisinopril, oxycodone, prilosec, saphris, simvastatin, soma, valium, and vesicare.Follow up in one week.Office visit on (b)(6) 2020: the patient complained of pelvic pain that is described as throbbing and is always having it since 2015.Menses stopped about 2 years ago and has not had any bleeding since then.Did not have any bad cramping when she was bleeding.Had not had a pap smear done in a long time.Last ultrasound was (b)(6) 2019 and patient said she did have an ovarian cyst.Had not been on estrogen since going through menopause.Patient reported to have hot flashes.During this visit, the patient was indeed diagnosed with pelvic pain and also cervicitis.Discussed options of possible mesh removal.Office visit on (b)(6) 2020: patient presented for mesh erosion exam.Started having problems with the implanted sling in 2016.Had a 5 - month - long uti which required iv treatment.Sex made her feel like she had a uti.Stopped having intercourse long ago.At night, sometimes felt she was being beaten between her legs with a bat.Some nights felt nerves tingling and burning.Perineal body was red burning and throbbing, and pain went from rectum to vagina, to clitoris to urethra.Lots of bladder pain.When she had gas, it hurt her bladder.Leaking also happened at times.She did not feel the urge to void, only signal to void was nausea if waited too long.Stream dribbled, if full leaks with cough, laugh, sneeze.Patient was positive for dyspareunia, pelvic pain, vaginal pain and bladder pain per review of systems.Exam revealed pain at the perineal body and at vestibule, suprapubic pain, pain over posterior vaginal wall, superficial mesh on the left, exposed mesh on the right that was very painful to touch.Assessment: 1.Chronic bladder pain.2.Pelvic pain.3.Exposure of implanted urethral mesh.The patient was advised that her pain is probably multifactorial and that the exposed mesh is a significant part of her pain.She was advised that the bladder, posterior wall, and perineal body pain may be unrelated.Discussed removing her mesh - all the vaginal portions of the mesh but not following it out into the leg.Patient wanted complete removal and was provided names of physicians who perform complete mesh removal.Telehealth visit on (b)(6) 2020: same chief complaint - pelvic pain.Problems began in 2016, about 2 years after the implant procedure.Patient first suffered a symptomatic urinary tract infection and it took about 5 months for the symptoms to resolve.Required iv antibiotics.Shortly after that, began to develop a burning sensation in vagina and feelings similar to urinary tract infection even though it was culture negative.Over the next 6 - 12 months, those symptoms progressed.The vibratory sensation decreased but pain increased, and the feeling of stabbing burning pins and needles type pain started which was located in the vagina, under the bladder, and bilaterally in the groin.Started experiencing pain associated with bowel movements.Also, was unable to have intercourse secondary to pain.Stress incontinence was initially cured but more recently started to experience a recurrence of stress urinary incontinence.Based on the symptoms described, the transobturator sling was possibly the cause of the pain.According to the patient, she had a cystoscopy in 2017 which did not show any erosion of sling into the bladder or urethra.The plan was for the patient to travel for a preoperative exam, cystoscopy to make sure there was no erosion, and sling removal pending the exam findings.On (b)(6) 2020, the patient came for the plan of preop antibiotics on call to or and consented cystoscopy, explant of transobturator sling and groin dissection.Eventually, the patient underwent surgery for mesh removal on (b)(6) 2020.Examination revealed about a 2.5cm segment of mesh was exposed mostly on the right side, going from the right fornix to the midline.A transverse incision was made above the sling.The sling was mobilized and cut in midline after clamping each end.The epithelialized tissue that was under the sling was removed.The sling was then dissected toward the obturator membrane on both sides.Most of the exposure was on the right side and the end of the sling was identified and dissected.The sling on the left side was removed in its entirety.A 10cc of 0.5 percent marcaine was injected into the muscle and subcutaneous tissues of the groin dissection.Cystourethroscopy was performed and showed no evidence of injury to the bladder or urethra.The patient tolerated the procedure well, was returned to the recovery room in stable condition.No complications reported.Pathology of the excised sling showed benign fibromuscular tissue and bacterial colonies with morphologic features suggestive of actinomyces.She was discharged home on (b)(6) 2020, without any untoward events.Office visit on (b)(6) 2020: no chief complaint reported during this visit.It was noted that the patient had experienced recurrent utis, vaginitis, dysuria, and progressive pelvic pain following her tot sling placement in 2014 and was found to have extrusion of mesh with calcifications.The patient reports that she no longer has throbbing pain around the urethra and previous perirectal and pelvic pain seems to have disappeared.Her current pain is due to incision involving her left groin.She was able to sense the need to urinate but had dysuria and needed to sit forward and relax the pelvic floor in order to go.There is no significant increase in incontinence, pins and needles sensation in vagina and pulling in rectal the rectal area are both gone.However, voiding volitionally, pvr (post void residual) was zero even though there was some feeling of incomplete emptying.Instructed to start baby aspirin (81mg) daily for vte ppx (venous thromboembolism, propoxyphene) given imminent travel.Follow up in 2 - 3 weeks.A progress notes on (b)(6) 2020 stated that the patient continues to heal.Vaginal bleeding stopped at two weeks post operation.Urinating is better - easier to empty, usually a full stream.Getting normal signals to void.Pain gone in leg and pelvic area.Pins and needles pain gone.Rare sui only with full bladder and cough is getting better.Overall, she was happy with the results of surgery and telemedicine visit was scheduled in 3 months time.Office visit on (b)(6) 2020: patient reported to have a sticking pain intermittently in clitoris since mesh was removed.Also, complaining of bloating and fluid retention from mid abdomen to thighs.Physical examination showed bilateral, inner labia minora and space between clitoris and urethra remarkable for leukoplakia and erythema which was consistent with lichens sclerosis.Also, noted blunting of the clitoral hood.Diagnosis: clitoral pain and lichens sclerosis.Plan: recommended clobetasol bid for 30days with follow up if not improved.Continue to follow up with primary surgeon and primary care physician as directed.Telehealth visit (b)(6) 2020: patient developed new symptoms of having discomfort in her groin which she feels radiates over the pubic bone and to the other cysts groin area.Her gynecologist diagnosed her of leukoplakia involving the labia minora, blunting of the clitoral hood, and vaginal atrophy.She was given triamcinolone ointment 0.5 percent but finds that this is uncomfortable and causes worsening of a burning sensation.Discussed potential alternative treatment and suggested clobetasol for lichen sclerosis and pelvic floor physical therapy for residual symptoms which could be related to pelvic floor dysfunction.Additionally, it was also reported that: pins and needles pain gone.Rare sui only with full bladder and cough - getting better.Patient was overall happy with results of surgery.Pelvic floor physical therapy session on (b)(6) 2021: patient was evaluated in pfpt for pelvic pain.It was reported that she was unable to continue working as a truck driver after becoming disabled.She had severe pain and spasming diffusely throughout hip, pelvic and sacral region affecting daily activities.She reported strong pain, muscle weakness, and pulling from her l groin to up to her clitoris, across to other side of groin.Some pins and needles from front to back.Cannot tolerate any tight clothes or pants along groin.Deep inside feels spasm and throbbing.Cannot sleep or rest because it is always going on.Electric shock from clitoris through vaginal canal towards bladder.Sacrum lights up red hot and makes her nauseous when she lies on it.Also has bilateral hip pain.Pain ranges 4 - 9/10.Patient had pain with all testing performed actively and with palpation.The patient required skilled physical therapy to address pain, decreased motion, strength, and functional activity tolerance to increasing ability to lift or carry.An office visit on (b)(6) 2022, patient was reportedly positive for weakness, fatigue, decreased activity, weight gain, swelling in legs, abdominal pain, bloating, increased gas, numbness, tingling, headaches, back pain, joint pain, muscle pain/weakness, muscle cramps.Due to patient complaints of periumbilical pain and lower abdominal pain with increased gassiness and bloating, ct of abdomen and pelvis recommended with positive oral contrast to further evaluate for any fascial defects or intra - abdominal processes.Follow up after ct scan to discuss results.Doctor letter on (b)(6) 2022: found out that the patient eventually needed to have the mesh removed because of complications.The physician reported that they were disappointed that they had not seen the patient since (b)(6) 2014, when she stated that she no longer had leakage and that she was happy with the result.The surgeon stated that they were puzzled as to why they did not follow up when the patient started having problems.Additional information received on november 16, 2022.On (b)(6) 2019, patient presented for examination.She reported that she had had increasing lower and pelvic pain for the last 13 to 14 days with a stabbing to pin prickling sensation to her lower groin and rectal area.Patient felt that her bladder mesh may have migrated.She was concerned that she may have cancer as she attempted to see a gynecologist several years ago but no pap smear or any testing was done at that time.She was also convinced that her bladder mesh was migrating.Lastly, she was having bilateral flank pain that was fleeting lasting only a second or 2 at a time.She stated it was an electric shock to her back that resolved very quickly, it happened when she was walking mostly.Also, she was having worsening rectal and vaginal pain with laying down but not with walking.She was in the emergency department to figure out what may be going on.She had been having intermittent symptoms for the last several years but worse in the last 13 to 14 days.Additional information received on december 16, 2022.The patient presented for a cystourethroscopy and vaginoscopy on (b)(6) 2020 for eroded midurethral sling and bladder pain, chronic pelvic, and groin pain.The patient reports the pain began two years after placement of transobturator sling.Vaginoscopy was performed which showed a significant segment of exposed mesh across the suburethral space, approximately 2 - 3 cm with calcification.Cystoscopy was normal and did not show any intravesical component.The patient history was reviewed as follows: problems began in 2016.She first suffered urinary tract infection which was quite symptomatic, and it took about five months for the symptoms to resolve.Required iv antibiotics.Shortly after that, she began to develop a burning sensation and feelings similar to urinary tract infection even though she was culture negative.This sensation was in the vaginal area.It progressed to a constant vibration which was in the vagina and in the area under the bladder.Over the next 6 - 12 months those symptoms progressed.Eventually, the vibratory sensation decreased but pain increased and she experienced a stabbing burning pins and needles type of pain which was located in the vagina, under the bladder, and bilaterally in her groin.It progressed at times included her entire genital area.She also started experiencing pain associated with bowel movements.Pain in the rectal area and the groins increased a lot when she would need to have a bowel movement.Also, she was unable to have intercourse secondary to pain.Even vaginal examination was painful and she could be in quite severe pain for several days after that.When she saw a gynecologist, it was felt that the pain was related to her sling.
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Manufacturer Narrative
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Blocks b5 and h6 patient codes below have been updated based on the information received on december 16, 2022.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Surgeon for mesh excision is: (b)(6).Block h6: patient codes of e2006, e1309, e1720, e1715, e0127, e2311, e1002, e1405, e1301, e1310, e1906, e1401, e2326, e1720, e1720, e1621, e2015 and e230901 capture the reportable events of exposed mesh across the suburethral space, significant suburethral erosion and mesh exposure, urinary retention, pain, abdominal pain, scar tissue, numbness, discomfort, dyspareunia, dysuria, uti, infection, vaginal discharge, inflammation, irritation, voiding dysfunction, muscle weakness, atrophy and calcifications.Impact code f1905 captures the reportable event of excision of exposed mesh.Impact code f1202 captures the reportable event of patient becoming disabled.
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Search Alerts/Recalls
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