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| Device Problems
Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Anemia (1706); Erosion (1750); Fever (1858); Fistula (1862); Micturition Urgency (1871); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Tachycardia (2095); Abnormal Vaginal Discharge (2123); Dizziness (2194); Urinary Frequency (2275); Anxiety (2328); Malaise (2359); Obstruction/Occlusion (2422); Prolapse (2475); Constipation (3274); Unspecified Heart Problem (4454); Urinary Incontinence (4572); Insufficient Information (4580)
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| Event Date 03/01/2018 |
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Event Type
Injury
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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) 2020 was chosen as a best estimate based on the date of the mesh removal surgery.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Initial reporter name and address: this event was reported by the patient's legal representation.The device was implanted at: (b)(6) hospital (b)(6).(b)(4).The removed mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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Note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that advantage fit system and upsylon y mesh devices were implanted into the patient during a procedure performed on (b)(6) 2018.After the procedure, the patient has experienced an unknown injury.Subsequently, both devices were removed from the patient on (b)(6) 2020.
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Event Description
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Note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an advantage fit system and an upsylon y mesh devices were implanted into the patient during a robotic sacrocolpopexy with hysterectomy and pubovaginal sling with advantage matrix mesh procedure performed on (b)(6) 2018, for the treatment of pelvic prolapse with stress urinary incontinence.On (b)(6) 2018, the patient came in for overnight recovery status post robotic hysterectomy and sacrocolpopexy, however, she had continued pain and significant bleeding with the pubovaginal sling.She was symptomatic with hypotension and dizziness had a hemoglobin of 9.8.The patient was held overnight and admitted for continued blood pressure monitoring and monitoring of her hemoglobin (hgb) and hematocrit (hct) over the 48-hour.The patient continued to improve, and the hemoglobin and hematocrit stabilized at 9 and 27.The patient's dizziness was resolved, and she was able to ambulate with assistance.Reportedly, the foley catheter and vaginal packing were removed on postoperative day 1.Also, she had been able to urinate and tolerate diet.On (b)(6) 2018, the patient came in for septic work-up for the chief complaints of palpitations, vaginal bleeding, fever of 101.3 fahrenheit yesterday, and increasing abdominal pain.The course/ duration of symptoms was constant and worsening.The patient also reported constipation, weakness, and general malaise.She had been taking laxatives and stool softeners without relief.The patient also stated that she did have some foul-smelling vaginal discharge, which was normal per the physician.She mentioned that she had mild bleeding 3 days ago.The patient had hysterectomy, bladder sling and colpopexy procedure 1 week ago.She had been taking tylenol with codeine for pain, and last taken was around bedtime.It was found that there was a vaginal cuff with a ribbon shaped 35mm long radiopaque object, this may represent a hemostatic device but the possibility of retained operative sponge was considered.Moreover, there was a 4cm surrounding fluid collection which could represent seroma hematoma or abscess.On (b)(6) 2019, the patient stated that she was having some pressure, and her incontinence had improved for about 80%.She also mentioned that ever since her surgery, she had been having problems with constipation.She had to take laxatives to go to the bathroom.She still had problems with bowels and stated she was leaking all the time with minimal movement.She had tension free vaginal tape for surgical treatment of her stress incontinence, and it only improved slightly over 6 months.Additionally, she leaks urine with exercising, sneezing, coughing, and laughing.She does have problems getting to the bathroom in time and after she also had the urge to urinate.She wears 2-3 pads per day.She does urinate more frequently than once every 4 hours in the daytime.She had tried time voiding and kegel exercises for the treatment of her stress incontinence.She had undergone surgery for treatment.She is willing to undergo surgical treatment for her stress incontinence.On (b)(6) 2019, she had a follow-up visit for her stress incontinence.The patient had been having worsening incontinence over last year after the sacrocolpopexy.Moreover, during the flexible cystoscopy, it was observed that there was a squamous metaplasia in her bladder.On (b)(6) 2019, the patient had a follow-up visit for her laboratory results, which showed ldl (low-density lipoprotein) cholesterol was 150, hdl (high-density lipoprotein) cholesterol was 61, triglyceride was 79 and her total cholesterol was 227.Furthermore, her thyroid stimulating hormone (tsh) was elevated at 6.52, wherein she denied history of thyroid disease.On (b)(6) 2020, she had a follow-up visit and came in for her pelvic pain.On her vaginal exam, it was observed that there was scaring of the midurethra from the sling with fixation of the sling against the pubic ramus.There was a moderate cystourethrocele with significant rotational descent of the bladder neck cephalad to the sling.Q-tip test was positive, and the stress test was also positive.Residual urine was less than 10 cc.Cuff showed a large erosion of the y-mesh at the cuff with foul smelling yellow green discharge coming from the mesh.In addition, the adnexa were clear, and the posterior wall was unremarkable.The physician's impression that the patient had y-mesh erosion, infection, pain, partial bowel compression/obstruction from the y-mesh, partial bladder outlet obstruction from the sling requiring double voiding, sling urgency, stress urinary incontinence and a cystocele.Furthermore, the physician and the patient had a long discussion regarding her options available for therapy including nonsurgical versus surgical therapies.After considering the therapies, the patient would like to go for a surgical correction, and the physician agreed that the patient would be an excellent candidate for a transvaginal resection of the sling.On (b)(6) 2020, the patient had undergone transvaginal excision of sling, laparoscopic excision of y-mesh with partial vaginectomy, laparoscopic burch procedure, and cystourethroscopy for the treatment of her mesh erosion, partial bowel obstruction, partial bladder outlet obstruction, mesh infection, pelvic pain, and stress urinary incontinence.According to the surgical pathology report, it was found the foreign material was consistent with the sling identified, and the mesh material identified was with dense fibrosis, acute and chronically inflamed granulation tissue and erosion.
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Manufacturer Narrative
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Block a4: patient's weight: 76.2 kgs block b3 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 the first symptom was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Blocks h6: patient codes e2006, e1715, e2328, e2340, e1906, e2330, e1002, e2326, e0506, e230101, e0505, e172001, and e020201, capture the reportable events of extrusion (mesh erosion), scar tissue (cicatrix) for scaring of the midurethra from the sling with fixation of the sling, ureter/urethra obstruction (partial bowel compression/obstruction from the y-mesh, partial bladder outlet obstruction from the sling requiring double voiding), bowel obstruction, dehiscence (vaginal cuff there is a ribbon shaped 35mm long radiopaque object), infection (pelvic infection), pain (pelvic, vagina, rectum), pain, abdominal, inflammation (patchy mild chronic inflammation), hemorrhage, major (significant bleeding with the pubovaginal sling/vaginal bleeding), fever, hematoma (seroma hematoma), abscess, and anxiety (chronic), respectively.Impact codes f1903, f19, f22 and f2303, capture the reportable events of device explantation (vaginal mesh material excision), surgical intervention (transvaginal excision of sling, laparoscopic excision of y-mesh with partial vaginectomy, laparoscopic burch procedure), unexpected diagnostic intervention (cystourethroscopy, flexible cystoscopy), and medication required (tylenol with codeine for pain), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the excised mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Manufacturer Narrative
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Correction to blocks b3: date of event, b5, and h6: patient and device codes.Block a4: patient's weight: 76.2 kgs.Block b3 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 the first symptom was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The device was implanted at: dr.(b)(6).Dr.(b)(6).Dr.(b)(6).Blocks h6: patient codes e2006, e1715, e2328, e2101, e1906, e2330, e1002, e2326, e0506, e0505, e172001, and e020201, capture the reportable events of extrusion (mesh erosion), scar tissue (cicatrix) for scaring of the midurethra from the sling with fixation of the sling, bowel obstruction (partial bowel compression/obstruction from the y-mesh), adhesions, infection (pelvic infection), pain (pelvic, vagina, rectum), pain, abdominal, inflammation (patchy mild chronic inflammation), hemorrhage, major (significant bleeding with the pubovaginal sling/vaginal bleeding), hematoma (seroma hematoma), abscess, and anxiety (chronic), respectively.Impact codes f1903, f19, f22 and f2303, capture the reportable events of device explantation (vaginal mesh material excision), surgical intervention (transvaginal excision of sling, laparoscopic excision of y-mesh with partial vaginectomy, laparoscopic burch procedure), unexpected diagnostic intervention (cystourethroscopy, flexible cystoscopy), and medication required (tylenol with codeine for pain), respectively.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the excised mesh is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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Note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an advantage fit system and an upsylon y mesh devices were implanted into the patient during a robotic sacrocolpopexy with hysterectomy and pubovaginal sling with advantage matrix mesh procedure performed on (b)(6) 2018, for the treatment of pelvic prolapse with stress urinary incontinence.Relevant medical and surgical history included cesarean section.Postoperative, the patient had continued pain and significant bleeding with the pubovaginal sling.She was symptomatic with hypotension and dizziness had a hemoglobin of 9.8.The patient was held overnight and admitted for continued blood pressure monitoring and monitoring of her hemoglobin (hgb) and hematocrit (hct) over the 48-hour.The patient continued to improve, and the hemoglobin and hematocrit stabilized at 9 and 27.The patient's dizziness was resolved, and she was able to ambulate with assistance.Reportedly, the foley catheter and vaginal packing were removed on postoperative day 1.Also, she had been able to urinate and tolerate diet.On (b)(6) 2018, the patient presented to the emergency department from her physician's office for septic work-up for the chief complaints of palpitations, vaginal bleeding, fever of 101.3 fahrenheit yesterday, and increasing abdominal pain.The course/ duration of symptoms was constant and worsening.The patient also reported constipation, weakness, and general malaise.She had been taking laxatives and stool softeners without relief.The patient also stated that she did have some foul-smelling vaginal discharge, which was normal per the physician she saw earlier in the day and her pelvic exam was reportedly normal then as well.She mentioned that she had mild bleeding 3 days ago.She had been taking tylenol with codeine for pain, and last taken was around bedtime.Exam revealed mild tenderness in mid-lower abdomen, the surgical incisions looked good.Complete blood count (cbc), comprehensive metabolic panel (cmp), lactic acid, urinalysis (ua), chest x-ray (cxr) and computed tomography (ct) scan were done, all with "normal findings".However, the ct report in the medical records noted an impression of "vaginal cuff there is a ribbon shaped 35 mm long radiopaque object.With a 4 cm surrounding fluid collection, it may represent a hemostatic device but the possibility of retained operative sponge should be considered.Surrounding fluid collection is nonspecific and could represent seroma hematoma or abscess".The plan was intravenous (iv) ceftriaxone with keflex 500 mg tid for the next 7 days.The patient was discharged later that day.On (b)(6) 2019, the patient stated that she was having some pressure, and her incontinence had improved about 80%.She also mentioned that ever since her surgery, she had been having problems with constipation.She had to take laxatives to go to the bathroom.She still had problems with bowels and stated she was leaking all the time with minimal movement.She had tension free vaginal tape for surgical treatment of her stress incontinence, and it only improved slightly over 6 months.Additionally, she leaks urine with exercising, sneezing, coughing, and laughing.She does have problems getting to the bathroom in time and after she also had the urge to urinate.She wears 2-3 pads per day.She does urinate more frequently than once every 4 hours in the daytime.She had tried time voiding and kegel exercises for the treatment of her stress incontinence.The assessment was sui and slow transit constipation.The plan was cystoscopy, pelvic exam, and urodynamics (uds).On (b)(6) 2019, she had a follow-up visit for her stress incontinence.Vaginal exam revealed a small rectocele and a small cystocele.Flexible cystoscopy revealed squamous metaplasia in her bladder.Medical records note that there was "no evidence of stress incontinence or cystocele on pelvic exam" and it was thought the patient was having urge incontinence.Uds was planned for the following week.On (b)(6) 2020, she had a follow-up visit and came in for her pelvic pain, vaginal pain, and rectal pain.She reported difficulty evacuating her bowels.She had undergone a barium enema and colonoscopy, both of which were unremarkable.She had both sui and urgency symptoms.Urodynamics performed on an unspecified date showed overflow incontinence though she had a normal post void residual (pvr); her first sensation to void was reportedly 600 cc.She reported vaginal bleeding and foul-smelling discharge in the past 3 months.On her vaginal exam, it was observed that there was scarring of the midurethra from the sling with fixation of the sling against the pubic ramus.There was a moderate cystourethrocele with significant rotational descent of the bladder neck cephalad to the sling.Q-tip test was positive, and the stress test was also positive.Residual urine was less than 10 cc.Cuff showed a large erosion of the y-mesh at the cuff with foul smelling yellow green discharge coming from the mesh.In addition, the adnexa were clear, and the posterior wall was unremarkable.The physician's impression that the patient had y-mesh erosion and infection with pain, partial bowel compression/obstruction from the y-mesh, partial bladder outlet obstruction from the sling requiring double voiding, sling urgency, stress urinary incontinence and a cystocele.Furthermore, the physician and the patient had a long discussion regarding her options available for therapy including nonsurgical versus surgical therapies.After considering the therapies, the patient would like to go for a surgical correction, and the physician agreed that the patient would be an excellent candidate for a transvaginal resection of the sling.On (b)(6) 2020, the patient underwent transvaginal excision of sling, laparoscopic excision of y-mesh with partial vaginectomy, laparoscopic burch procedure, and cystourethroscopy for the treatment of her mesh erosion, partial bowel obstruction, partial bladder outlet obstruction, mesh infection, pelvic pain, and stress urinary incontinence.Intraoperative findings included: scarring in the mid urethra with obvious partial bladder outlet obstruction from the sling; the sling was contracted with a decrease in pore size, scar plating, and bridging fibrosis over the sling; the sling was tight up against the urethra; once the sling was excised, the urethral obstruction was clearly freed; some adhesions of the omentum were found to the anterior abdominal wall adjacent to the suprapubic incision; the sacrocolpopexy mesh was found to be contracted, rolled, and curled, and its width was diminished to approximately 1 to 2 cm width, with obvious bridging fibrosis and scar plating around the mesh; the mesh was nearly completely eroded through the apex of the vagina with associated pus and a marked anaerobic odor; a partial vaginectomy was needed to remove the infected mesh.According to the surgical pathology report, it was found the foreign material was consistent with the sling identified, and the mesh material identified was with dense fibrosis, acute and chronically inflamed granulation tissue, and erosion.
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Event Description
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Note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an advantage fit system and an upsylon y mesh devices were implanted into the patient during a robotic sacrocolpopexy with hysterectomy and pubovaginal sling with advantage matrix mesh procedure performed on february 27, 2018, for the treatment of pelvic prolapse with stress urinary incontinence.Relevant medical and surgical history included cesarean section.Postoperative, the patient had continued pain and significant bleeding with the pubovaginal sling.She was symptomatic with hypotension and dizziness had a hemoglobin of 9.8.The patient was held overnight and admitted for continued blood pressure monitoring and monitoring of her hemoglobin (hgb) and hematocrit (hct) over the 48-hour.The patient continued to improve, and the hemoglobin and hematocrit stabilized at 9 and 27.The patient's dizziness was resolved, and she was able to ambulate with assistance.Reportedly, the foley catheter and vaginal packing were removed on postoperative day 1.Also, she had been able to urinate and tolerate diet.On (b)(6) 2018, the patient presented to the emergency department from her physician's office for septic work-up for the chief complaints of palpitations, vaginal bleeding, fever of 101.3 fahrenheit yesterday, and increasing abdominal pain.The course/ duration of symptoms was constant and worsening.The patient also reported constipation, weakness, and general malaise.She had been taking laxatives and stool softeners without relief.The patient also stated that she did have some foul-smelling vaginal discharge, which was normal per the physician she saw earlier in the day and her pelvic exam was reportedly normal then as well.She mentioned that she had mild bleeding 3 days ago.She had been taking tylenol with codeine for pain, and last taken was around bedtime.Exam revealed mild tenderness in mid-lower abdomen, the surgical incisions looked good.Complete blood count (cbc), comprehensive metabolic panel (cmp), lactic acid, urinalysis (ua), chest x-ray (cxr) and computed tomography (ct) scan were done, all with "normal findings".However, the ct report in the medical records noted an impression of "vaginal cuff there is a ribbon shaped 35 mm long radiopaque object.With a 4 cm surrounding fluid collection, it may represent a hemostatic device but the possibility of retained operative sponge should be considered.Surrounding fluid collection is nonspecific and could represent seroma hematoma or abscess".The plan was intravenous (iv) ceftriaxone with keflex 500 mg tid for the next 7 days.The patient was discharged later that day.On (b)(6) 2019, the patient stated that she was having some pressure, and her incontinence had improved about 80%.She also mentioned that ever since her surgery, she had been having problems with constipation.She had to take laxatives to go to the bathroom.She still had problems with bowels and stated she was leaking all the time with minimal movement.She had tension free vaginal tape for surgical treatment of her stress incontinence, and it only improved slightly over 6 months.Additionally, she leaks urine with exercising, sneezing, coughing, and laughing.She does have problems getting to the bathroom in time and after she also had the urge to urinate.She wears 2-3 pads per day.She does urinate more frequently than once every 4 hours in the daytime.She had tried time voiding and kegel exercises for the treatment of her stress incontinence.The assessment was sui and slow transit constipation.The plan was cystoscopy, pelvic exam, and urodynamics (uds).On (b)(6) 2019, she had a follow-up visit for her stress incontinence.Vaginal exam revealed a small rectocele and a small cystocele.Flexible cystoscopy revealed squamous metaplasia in her bladder.Medical records note that there was "no evidence of stress incontinence or cystocele on pelvic exam" and it was thought the patient was having urge incontinence.Uds was planned for the following week.On (b)(6) 2020, she had a follow-up visit and came in for her pelvic pain, vaginal pain, and rectal pain.She reported difficulty evacuating her bowels.She had undergone a barium enema and colonoscopy, both of which were unremarkable.She had both sui and urgency symptoms.Urodynamics performed on an unspecified date showed overflow incontinence though she had a normal post void residual (pvr); her first sensation to void was reportedly 600 cc.She reported vaginal bleeding and foul-smelling discharge in the past 3 months.On her vaginal exam, it was observed that there was scarring of the midurethra from the sling with fixation of the sling against the pubic ramus.There was a moderate cystourethrocele with significant rotational descent of the bladder neck cephalad to the sling.Q-tip test was positive, and the stress test was also positive.Residual urine was less than 10 cc.Cuff showed a large erosion of the y-mesh at the cuff with foul smelling yellow green discharge coming from the mesh.In addition, the adnexa were clear, and the posterior wall was unremarkable.The physician's impression that the patient had y-mesh erosion and infection with pain, partial bowel compression/obstruction from the y-mesh, partial bladder outlet obstruction from the sling requiring double voiding, sling urgency, stress urinary incontinence and a cystocele.Furthermore, the physician and the patient had a long discussion regarding her options available for therapy including nonsurgical versus surgical therapies.After considering the therapies, the patient would like to go for a surgical correction, and the physician agreed that the patient would be an excellent candidate for a transvaginal resection of the sling.On (b)(6) 2020, the patient underwent transvaginal excision of sling, laparoscopic excision of y-mesh with partial vaginectomy, laparoscopic burch procedure, and cystourethroscopy for the treatment of her mesh erosion, partial bowel obstruction, partial bladder outlet obstruction, mesh infection, pelvic pain, and stress urinary incontinence.Intraoperative findings included: scarring in the mid urethra with obvious partial bladder outlet obstruction from the sling; the sling was contracted with a decrease in pore size, scar plating, and bridging fibrosis over the sling; the sling was tight up against the urethra; once the sling was excised, the urethral obstruction was clearly freed; some adhesions of the omentum were found to the anterior abdominal wall adjacent to the suprapubic incision; the sacrocolpopexy mesh was found to be contracted, rolled, and curled, and its width was diminished to approximately 1 to 2 cm width, with obvious bridging fibrosis and scar plating around the mesh; the mesh was nearly completely eroded through the apex of the vagina with associated pus and a marked anaerobic odor; a partial vaginectomy was needed to remove the infected mesh.According to the surgical pathology report, it was found the foreign material was consistent with the sling identified, and the mesh material identified was with dense fibrosis, acute and chronically inflamed granulation tissue, and erosion.***additional information received on september 1, 2022*** on (b)(6) 2022, the patient was seen for evaluation of mesh complications.She had developed chronic constipation which she described as most likely due to the upsylon mesh.She had to take laxatives on a daily basis.She also had occasional air per the vagina.No stool or blood per the vagina and no rectal bleeding or prolapse.The physician did not think she has colovaginal fistula but said that it is a possibility.
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Manufacturer Narrative
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H2: additional information: block b5, h6 patient code added.Block a4: patient's weight: 76.2 kgs.Block b3 date of event: the exact event onset date is unknown.The provided event date of february 27, 2018 was chosen as a best estimate based on the date the first symptom was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Blocks h6: patient codes e2006, e1715, e2328, e2101, e1906, e2330, e1002, e2326, e0506, e0505, e172001, and e020201, capture the reportable events of extrusion (mesh erosion), scar tissue (cicatrix) for scaring of the midurethra from the sling with fixation of the sling, bowel obstruction (partial bowel compression/obstruction from the y-mesh), adhesions, infection (pelvic infection), pain (pelvic, vagina, rectum), pain, abdominal, inflammation (patchy mild chronic inflammation), hemorrhage, major (significant bleeding with the pubovaginal sling/vaginal bleeding), hematoma (seroma hematoma), abscess, and anxiety (chronic), respectively.Impact codes f1903, f19, f22 and f2303, capture the reportable events of device explantation (vaginal mesh material excision), surgical intervention (transvaginal excision of sling, laparoscopic excision of y-mesh with partial vaginectomy, laparoscopic burch procedure), unexpected diagnostic intervention (cystourethroscopy, flexible cystoscopy), and medication required (tylenol with codeine for pain), respectively.
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Event Description
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Note: this manufacturer report pertains to the second of two devices used during the same procedure.It was reported to boston scientific corporation that an advantage fit system and an upsylon y mesh devices were implanted into the patient during a robotic sacrocolpopexy with hysterectomy and pubovaginal sling with advantage matrix mesh procedure performed on (b)(6) 2018, for the treatment of pelvic prolapse with stress urinary incontinence.Relevant medical and surgical history included cesarean section.Postoperative, the patient had continued pain and significant bleeding with the pubovaginal sling.She was symptomatic with hypotension and dizziness had a hemoglobin of 9.8.The patient was held overnight and admitted for continued blood pressure monitoring and monitoring of her hemoglobin (hgb) and hematocrit (hct) over the 48-hour.The patient continued to improve, and the hemoglobin and hematocrit stabilized at 9 and 27.The patient's dizziness was resolved, and she was able to ambulate with assistance.Reportedly, the foley catheter and vaginal packing were removed on postoperative day 1.Also, she had been able to urinate and tolerate diet.On (b)(6) 2018, the patient presented to the emergency department from her physician's office for septic work-up for the chief complaints of palpitations, vaginal bleeding, fever of 101.3 fahrenheit yesterday, and increasing abdominal pain.The course/ duration of symptoms was constant and worsening.The patient also reported constipation, weakness, and general malaise.She had been taking laxatives and stool softeners without relief.The patient also stated that she did have some foul-smelling vaginal discharge, which was normal per the physician she saw earlier in the day and her pelvic exam was reportedly normal then as well.She mentioned that she had mild bleeding 3 days ago.She had been taking tylenol with codeine for pain, and last taken was around bedtime.Exam revealed mild tenderness in mid-lower abdomen, the surgical incisions looked good.Complete blood count (cbc), comprehensive metabolic panel (cmp), lactic acid, urinalysis (ua), chest x-ray (cxr) and computed tomography (ct) scan were done, all with "normal findings".However, the ct report in the medical records noted an impression of "vaginal cuff there is a ribbon shaped 35 mm long radiopaque object.With a 4 cm surrounding fluid collection, it may represent a hemostatic device but the possibility of retained operative sponge should be considered.Surrounding fluid collection is nonspecific and could represent seroma hematoma or abscess".The plan was intravenous (iv) ceftriaxone with keflex 500 mg tid for the next 7 days.The patient was discharged later that day.On (b)(6) 2019, the patient stated that she was having some pressure, and her incontinence had improved about 80%.She also mentioned that ever since her surgery, she had been having problems with constipation.She had to take laxatives to go to the bathroom.She still had problems with bowels and stated she was leaking all the time with minimal movement.She had tension free vaginal tape for surgical treatment of her stress incontinence, and it only improved slightly over 6 months.Additionally, she leaks urine with exercising, sneezing, coughing, and laughing.She does have problems getting to the bathroom in time and after she also had the urge to urinate.She wears 2-3 pads per day.She does urinate more frequently than once every 4 hours in the daytime.She had tried time voiding and kegel exercises for the treatment of her stress incontinence.The assessment was sui and slow transit constipation.The plan was cystoscopy, pelvic exam, and urodynamics (uds).On (b)(6) 2019, she had a follow-up visit for her stress incontinence.Vaginal exam revealed a small rectocele and a small cystocele.Flexible cystoscopy revealed squamous metaplasia in her bladder.Medical records note that there was "no evidence of stress incontinence or cystocele on pelvic exam" and it was thought the patient was having urge incontinence.Uds was planned for the following week.On (b)(6) 2020, she had a follow-up visit and came in for her pelvic pain, vaginal pain, and rectal pain.She reported difficulty evacuating her bowels.She had undergone a barium enema and colonoscopy, both of which were unremarkable.She had both sui and urgency symptoms.Urodynamics performed on an unspecified date showed overflow incontinence though she had a normal post void residual (pvr); her first sensation to void was reportedly 600 cc.She reported vaginal bleeding and foul-smelling discharge in the past 3 months.On her vaginal exam, it was observed that there was scarring of the midurethra from the sling with fixation of the sling against the pubic ramus.There was a moderate cystourethrocele with significant rotational descent of the bladder neck cephalad to the sling.Q-tip test was positive, and the stress test was also positive.Residual urine was less than 10 cc.Cuff showed a large erosion of the y-mesh at the cuff with foul smelling yellow green discharge coming from the mesh.In addition, the adnexa were clear, and the posterior wall was unremarkable.The physician's impression that the patient had y-mesh erosion and infection with pain, partial bowel compression/obstruction from the y-mesh, partial bladder outlet obstruction from the sling requiring double voiding, sling urgency, stress urinary incontinence and a cystocele.Furthermore, the physician and the patient had a long discussion regarding her options available for therapy including nonsurgical versus surgical therapies.After considering the therapies, the patient would like to go for a surgical correction, and the physician agreed that the patient would be an excellent candidate for a transvaginal resection of the sling.On (b)(6) 2020, the patient underwent transvaginal excision of sling, laparoscopic excision of y-mesh with partial vaginectomy, laparoscopic burch procedure, and cystourethroscopy for the treatment of her mesh erosion, partial bowel obstruction, partial bladder outlet obstruction, mesh infection, pelvic pain, and stress urinary incontinence.Intraoperative findings included: scarring in the mid urethra with obvious partial bladder outlet obstruction from the sling; the sling was contracted with a decrease in pore size, scar plating, and bridging fibrosis over the sling; the sling was tight up against the urethra; once the sling was excised, the urethral obstruction was clearly freed; some adhesions of the omentum were found to the anterior abdominal wall adjacent to the suprapubic incision; the sacrocolpopexy mesh was found to be contracted, rolled, and curled, and its width was diminished to approximately 1 to 2 cm width, with obvious bridging fibrosis and scar plating around the mesh; the mesh was nearly completely eroded through the apex of the vagina with associated pus and a marked anaerobic odor; a partial vaginectomy was needed to remove the infected mesh.According to the surgical pathology report, it was found the foreign material was consistent with the sling identified, and the mesh material identified was with dense fibrosis, acute and chronically inflamed granulation tissue, and erosion.Additional information received on september 1, 2022: on (b)(6) 2022, the patient was seen for evaluation of mesh complications.She had developed chronic constipation which she described as most likely due to the upsylon mesh.She had to take laxatives on a daily basis.She also had occasional air per the vagina.No stool or blood per the vagina and no rectal bleeding or prolapse.The physician did not think she has colovaginal fistula but said that it is a possibility.
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Manufacturer Narrative
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H2: additional information: block b5, h6 patient code added.Block a4: patient's weight: 76.2 kgs.Block b3 date of event: the exact event onset date is unknown.The provided event date of february 27, 2018 was chosen as a best estimate based on the date the first symptom was reported.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: this event was reported by the patient's legal representation.The device was implanted at: (b)(6).Blocks h6: patient codes e2006, e1715, e2328, e2101, e1906, e2330, e1002, e2326, e0506, e0505, e172001, and e020201, capture the reportable events of extrusion (mesh erosion), scar tissue (cicatrix) for scaring of the midurethra from the sling with fixation of the sling, bowel obstruction (partial bowel compression/obstruction from the y-mesh), adhesions, infection (pelvic infection), pain (pelvic, vagina, rectum), pain, abdominal, inflammation (patchy mild chronic inflammation), hemorrhage, major (significant bleeding with the pubovaginal sling/vaginal bleeding), hematoma (seroma hematoma), abscess, and anxiety (chronic), respectively.Impact codes f1903, f19, f22 and f2303, capture the reportable events of device explantation (vaginal mesh material excision), surgical intervention (transvaginal excision of sling, laparoscopic excision of y-mesh with partial vaginectomy, laparoscopic burch procedure), unexpected diagnostic intervention (cystourethroscopy, flexible cystoscopy), and medication required (tylenol with codeine for pain), respectively.Block h11: block d1 has been corrected from "colpassist" to "upsylon".Block e1 has been updated with the initial reporter information.
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