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| Model Number M0068402400 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Adhesion(s) (1695); Erosion (1750); Inflammation (1932); Scar Tissue (2060); Injury (2348); Fibrosis (3167); Insufficient Information (4580)
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| Event Date 05/29/2009 |
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Event Type
Injury
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6) 2009 (implant date) as no event date was reported.This complaint was reported by the patient's lawyer.The device was implanted at (b)(6).(b)(4).The complainant indicated that the device is not available for return; 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 implanted during the same procedure.It was reported to boston scientific corporation that a polyform synthetic mesh was implanted on (b)(6) 2009.As reported by the patient's attorney, the patient experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.
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Manufacturer Narrative
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Correction to block e1: initial reporter city.Block b3: date of event: date of event was approximated to (b)(6) 2009 (implant date) as no event date was reported.Block e1: this complaint was reported by the patient's lawyer.The device was implanted at (b)(6).Implanting surgeon: dr.(b)(6).Block h6: patient code e2401 and f12 capture the reportable event of unspecified injury.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device is not available for return; 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 implanted during the same procedure.It was reported to boston scientific corporation that a polyform synthetic mesh was implanted on (b)(6), 2009.As reported by the patient's attorney, the patient experienced an unknown injury.***additional information received on 20jan2022*** it was reported that the patient had been diagnosed with vaginal vault prolapse and stress urinary incontinence.On (b)(6), 2009, she underwent laparoscopic sacrocolpopexy (using da vinci robotics), laparoscopic bilateral salpingo-oophorectomy (using da vinci robotics) and suburethral sling placement (using obtryx transobturator tape) with cystoscopy.Both a polyform and obtryx mesh were used during the procedure.Patient tolerated the procedure well and was taken into recovery in stable condition.
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Manufacturer Narrative
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Blocks b5, d6b, h6 have been updated based on the additional information received on september 23, 2022.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2009 was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).The explanting surgeon: dr.(b)(6), (b)(6) hospital.United states.Block h6: patient code e2006, e2313, e2326, e1715, e2101 capture the reportable events of erosion, fibrosis, inflammation, scar tissue and adhesions.Impact code f1905 and f1901 capture the reportable events of device revision and additional surgery.
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Event Description
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Please refer to mfr report 3005099803-2020-01564 for the associated device.It was reported to boston scientific corporation that a polyform synthetic mesh was implanted on (b)(6) 2009.As reported by the patient's attorney, the patient experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.Additional information received on 20jan2022: it was reported that the patient had been diagnosed with vaginal vault prolapse and stress urinary incontinence.On (b)(6) 2009, she underwent laparoscopic sacrocolpopexy (using da vinci robotics), laparoscopic bilateral salpingo-oophorectomy (using da vinci robotics) and suburenthral sling placement (using obtryx transobturator tape) with cystoscopy.Patient tolerated the procedure well and was taken into recovery in stable condition.Additional information received on 23sep2022: it was reported to boston scientific corporation that a polyform synthetic mesh and obtryx system devices were implanted into the patient during robotic assisted laparoscopic colpopexy, bilateral salpingo-oophorectomy, suburethral sling and cystoscopy on (b)(6) 2009 for the treatment of vaginal prolapse, rectocele, cystocele and urinary incontinence.Operative findings are as follows: the right lower quadrant and pelvis have dense abdominal adhesions, yet the bowel is adherent to the cul-de-sac.The appendix was completely normal.At the end of the case, there was a significant amount of support.There was no evidence of tumor, carcinoma in situ, stones, or foreign bodies in the body on cystoscopy at the end of the procedure, with bilateral efflux of dye from anatomically normally located ureteral orifices.The ovaries were found to be completely normal and were removed at the patient's request.Reportedly, the patient tolerated the procedure well and was taken to the recovery room in stable condition.On (b)(6) 2018, the patient had been diagnosed with vaginal mesh erosion.Subsequently, the patient underwent a cystourethroscopy and a vaginal mesh excision procedure.Her outpatient examination revealed definite heaped up erosion in the anterior vaginal wall, which has been confirmed through vaginal inspection.A foley catheter was left to drain normally.The surgeon identified the area of erosion and used a sharp dissection to slowly open up the vaginal incision and carefully dissect this out and mobilize it.The surgeon moved it toward the 9 o'clock position, clamped it, divided it, and slowly dissected it out from under the urethra.The mesh appeared to be quite tight, leaving a notable indentation in the periurethral tissues.He excised from the 4 o'clock to the 9 o'clock position after mobilizing the tape.The specimen was freeze sectioned and returned to the department of pathology to identify mesh fibers within the specimen.The surgeon examined the vagina, which had some urethral tissue compression.Over this, he was able to reapproximate periurethral tissues by bringing the lower fascial edge up and approximating it with interrupted 2-0 vicryl.By buttressing this thinning area, an excellent cosmetic appearance was obtained.The surgeon then meticulously clipped the vaginal epithelium before closing it with interrupted 2-0 vicryl.This was a class 2 incision.The patient was well tolerated by this point, and a vaginal pack was retained in place.Pathology noted chronic inflammation.On (b)(6) 2018, the patient had the insertion of an autologous fascia pubovaginal sling and cystoscopy for the treatment of urinary incontinence.Reportedly, the patient tolerated the procedure well and was sent to the postoperative recovery room in stable condition.On (b)(6) 2020, the patient underwent a sigmoidoscopy with endoscopic cutting of mesh and foreign body removal for the treatment of transmural mesh extruding through the rectosigmoid and anus.During the procedure, it was observed that the patient had a sigmoid diverticulosis.Up to 30-40 cm, the mucosa was normal.The area of mesh extruding from the pelvis into the rectosigmoid was identified at about 12 cm.Copious irrigation was used.The mesh was discovered to be fastened and could not be withdrawn using rat-tooth forceps.The mesh was cut with endoscopic scissors (ensizor/slater endoscopy).The mesh looked to be traversing the colon at two sites, separated by fibrosis/granulation tissue.The entire mesh was eventually cut and removed.A 10 cm length of mesh mixed with calcified stool was removed.There were no immediate complications during the procedure.On (b)(6) 2021, she underwent a low anterior resection with a true low pelvic anastomosis, partial en bloc vaginectomy with closure of the vagina, omental pedicle flap, diverting proximal transverse loop colostomy, appendectomy, and extensive enterolysis for the treatment of mesh erosion of the rectosigmoid colon.Operative findings are as follows: the patient had a significant number of pelvic adhesions.The uterus and ovaries had been surgically removed.The appendix dangled in the pelvis.There was extensive scarring between the rectum's mesentery and the top portion of the sacrum, with obliteration of the usual avascular planes.These planes were regained further afield.The doctor could palpate the mesh within the bowel and between the bowel and the vagina since the rectum and vagina were totally connected.They soon found a few sutures connecting the mesh to the vagina.There was no evidence of hydronephrosis.There was no evidence of cancer.There was no evidence of an obstruction.There was sigmoid colon diverticulosis present, but no pus or fecal contamination outside the bowel lumen.The left side of the liver was normal and easily palpable.Adhesions to the diaphragm hid the right side of the liver.The esophageal hiatus fit perfectly.There was a distal ileum loop that was highly adherent to the base of the sigmoid colon mesentery, which appeared to be related to her previous pelvic operation.There was no fistula present.Following exploration, the incision was taken down to the neo-cul-de-sac.On the right side, the planes were less distinct due to scarring from previous surgery; however, the plane of the fascia propria was able to be entered in the presacral space and was extended down to the cul-de-sac as well.Dissection continued until the only area of adherence was the anterior mid which was where the problem with the mesh appeared to be.The vagina was dissected away from the bladder without any injury to the bladder but the vagina and rectum were fused in the area of the mesh.A small portion of the vaginal cuff was removed so the mesh could be completely excised and also included a small portion of the posterior vaginal wall.After this, dissection continued well beyond the fibrotic changes in the rectovaginal septum.The vagina was reconstructed with running locking 2-0 vicryl suture.The rectal mesentery was cleared about 6-7 cm above the anal verge and the bowel was transected with the green contour stapler.The entire fibrotic portion of the rectum was elevated out of the pelvis, and a low ligation of the inferior mesenteric vascular pedicle was performed.The sigmoid colon was then transected at the junction of the proximal and middle thirds between the automatic pursestring device and an isolation clamp.The specimen was handed off the table and opened to confirm the entire mesh was removed before submitting to the pathology department.An end-to-end anastomosis was performed using the double staple technique and was airtight.An omental pedicle flap was constructed based on the left gastroepiploic arcade and was run down the left colonic gutter into the pelvis interposed between the rectal anastomosis and the suture in the vagina.A drain was also placed through the lower left quadrant stab wound and sewn to the skin.Because of the distal level of the anastomosis and the presence of another hollow viscus repair in the immediate vicinity, a temporary transverse loop colostomy was performed as a form of fecal diversion to allow the anastomosis to heal without any intraluminal pressure.The abdomen was trephinated at a previously designated site though the right belly of the rectus muscle and the proximal transverse colon was delivered through the aperture supported on a bar.The site was closed over a large sheet of seprafilm with running looped pds suture.The skin was irrigated and closed with staples, the main incision was quarantined, and the colostomy was sutured with interrupted 3-0 chromic suture, and the appliance was pasted to the skin.The patient tolerated the procedure well.
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Manufacturer Narrative
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Block h2: additional information.Block b5 have been updated based on the additional information received on november 3, 2022.Block b3 date of event: the exact event onset date is unknown.The provided event date of may 29, 2009 was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).(b)(6).(b)(6), united states the explanting surgeon: dr.(b)(6).(b)(6) hospital united states block h6: patient code e2006, e2313, e2326, e1715, e2101 capture the reportable events of erosion, fibrosis, inflammation, scar tissue and adhesions.Impact code f1905 and f1901 capture the reportable events of device revision and additional surgery.
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Event Description
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Please refer to mfr report 3005099803-2020-01564 for the associated device.It was reported to boston scientific corporation that a polyform synthetic mesh was implanted on (b)(6) 2009.As reported by the patient's attorney, the patient experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.Additional information received on 20jan2022.It was reported that the patient had been diagnosed with vaginal vault prolapse and stress urinary incontinence.On (b)(6) 2009, she underwent laparoscopic sacrocolpopexy (using da vinci robotics), laparoscopic bilateral salpingo-oophorectomy (using da vinci robotics) and suburenthral sling placement (using obtryx transobturator tape) with cystoscopy.Patient tolerated the procedure well and was taken into recovery in stable condition.Additional information received on 23sep2022.It was reported to boston scientific corporation that a polyform synthetic mesh and obtryx system devices were implanted into the patient during robotic assisted laparoscopic colpopexy, bilateral salpingo-oophorectomy, suburethral sling and cystoscopy on (b)(6) 2009 for the treatment of vaginal prolapse, rectocele, cystocele and urinary incontinence.Operative findings are as follows: the right lower quadrant and pelvis have dense abdominal adhesions, yet the bowel is adherent to the cul-de-sac.The appendix was completely normal.At the end of the case, there was a significant amount of support.There was no evidence of tumor, carcinoma in situ, stones, or foreign bodies in the body on cystoscopy at the end of the procedure, with bilateral efflux of dye from anatomically normally located ureteral orifices.The ovaries were found to be completely normal and were removed at the patient's request.Reportedly, the patient tolerated the procedure well and was taken to the recovery room in stable condition.On (b)(6) 2018, the patient had been diagnosed with vaginal mesh erosion.Subsequently, the patient underwent a cystourethroscopy and a vaginal mesh excision procedure.Her outpatient examination revealed definite heaped up erosion in the anterior vaginal wall, which has been confirmed through vaginal inspection.A foley catheter was left to drain normally.The surgeon identified the area of erosion and used a sharp dissection to slowly open up the vaginal incision and carefully dissect this out and mobilize it.The surgeon moved it toward the 9 o'clock position, clamped it, divided it, and slowly dissected it out from under the urethra.The mesh appeared to be quite tight, leaving a notable indentation in the periurethral tissues.He excised from the 4 o'clock to the 9 o'clock position after mobilizing the tape.The specimen was freeze sectioned and returned to the department of pathology to identify mesh fibers within the specimen.The surgeon examined the vagina, which had some urethral tissue compression.Over this, he was able to reapproximate periurethral tissues by bringing the lower fascial edge up and approximating it with interrupted 2-0 vicryl.By buttressing this thinning area, an excellent cosmetic appearance was obtained.The surgeon then meticulously clipped the vaginal epithelium before closing it with interrupted 2-0 vicryl.This was a class 2 incision.The patient was well tolerated by this point, and a vaginal pack was retained in place.Pathology noted chronic inflammation.On (b)(6) 2018, the patient had the insertion of an autologous fascia pubovaginal sling and cystoscopy for the treatment of urinary incontinence.Reportedly, the patient tolerated the procedure well and was sent to the postoperative recovery room in stable condition.On (b)(6) 2020, the patient underwent a sigmoidoscopy with endoscopic cutting of mesh and foreign body removal for the treatment of transmural mesh extruding through the rectosigmoid and anus.During the procedure, it was observed that the patient had a sigmoid diverticulosis.Up to 30-40 cm, the mucosa was normal.The area of mesh extruding from the pelvis into the rectosigmoid was identified at about 12 cm.Copious irrigation was used.The mesh was discovered to be fastened and could not be withdrawn using rat-tooth forceps.The mesh was cut with endoscopic scissors (ensizor/slater endoscopy).The mesh looked to be traversing the colon at two sites, separated by fibrosis/granulation tissue.The entire mesh was eventually cut and removed.A 10 cm length of mesh mixed with calcified stool was removed.There were no immediate complications during the procedure.On (b)(6) 2021, she underwent a low anterior resection with a true low pelvic anastomosis, partial en bloc vaginectomy with closure of the vagina, omental pedicle flap, diverting proximal transverse loop colostomy, appendectomy, and extensive enterolysis for the treatment of mesh erosion of the rectosigmoid colon.Operative findings are as follows: the patient had a significant number of pelvic adhesions.The uterus and ovaries had been surgically removed.The appendix dangled in the pelvis.There was extensive scarring between the rectum's mesentery and the top portion of the sacrum, with obliteration of the usual avascular planes.These planes were regained further afield.The doctor could palpate the mesh within the bowel and between the bowel and the vagina since the rectum and vagina were totally connected.They soon found a few sutures connecting the mesh to the vagina.There was no evidence of hydronephrosis.There was no evidence of cancer.There was no evidence of an obstruction.There was sigmoid colon diverticulosis present, but no pus or fecal contamination outside the bowel lumen.The left side of the liver was normal and easily palpable.Adhesions to the diaphragm hid the right side of the liver.The esophageal hiatus fit perfectly.There was a distal ileum loop that was highly adherent to the base of the sigmoid colon mesentery, which appeared to be related to her previous pelvic operation.There was no fistula present.Following exploration, the incision was taken down to the neo-cul-de-sac.On the right side, the planes were less distinct due to scarring from previous surgery; however, the plane of the fascia propria was able to be entered in the presacral space and was extended down to the cul-de-sac as well.Dissection continued until the only area of adherence was the anterior mid which was where the problem with the mesh appeared to be.The vagina was dissected away from the bladder without any injury to the bladder but the vagina and rectum were fused in the area of the mesh.A small portion of the vaginal cuff was removed so the mesh could be completely excised and also included a small portion of the posterior vaginal wall.After this, dissection continued well beyond the fibrotic changes in the rectovaginal septum.The vagina was reconstructed with running locking 2-0 vicryl suture.The rectal mesentery was cleared about 6-7 cm above the anal verge and the bowel was transected with the green contour stapler.The entire fibrotic portion of the rectum was elevated out of the pelvis, and a low ligation of the inferior mesenteric vascular pedicle was performed.The sigmoid colon was then transected at the junction of the proximal and middle thirds between the automatic pursestring device and an isolation clamp.The specimen was handed off the table and opened to confirm the entire mesh was removed before submitting to the pathology department.An end-to-end anastomosis was performed using the double staple technique and was airtight.An omental pedicle flap was constructed based on the left gastroepiploic arcade and was run down the left colonic gutter into the pelvis interposed between the rectal anastomosis and the suture in the vagina.A drain was also placed through the lower left quadrant stab wound and sewn to the skin.Because of the distal level of the anastomosis and the presence of another hollow viscus repair in the immediate vicinity, a temporary transverse loop colostomy was performed as a form of fecal diversion to allow the anastomosis to heal without any intraluminal pressure.The abdomen was trephinated at a previously designated site though the right belly of the rectus muscle and the proximal transverse colon was delivered through the aperture supported on a bar.The site was closed over a large sheet of seprafilm with running looped pds suture.The skin was irrigated and closed with staples, the main incision was quarantined, and the colostomy was sutured with interrupted 3-0 chromic suture, and the appliance was pasted to the skin.The patient tolerated the procedure well.Additional information received on 03nov20220.On (b)(6) 2021, the patient underwent a colonoscopy with biopsy and cold biopsy forceps polypectomy.During the procedure, the patient was placed in the left lateral decubitus position, and a pediatric flexible colonoscope was inserted through the anus and advanced to the cecum without difficulty.The cecum was identified by the location of the appendiceal orifice and ileocecal valve.A retroflexed exam of the rectum was performed.At approximately 10--12 centimeters from the anus, a large amount of retained stool was present, caught up in retained mesh.The surrounding area was inflamed.The remaining colonic mucosa was normal.Biopsies were obtained from the ascending and descending colons.Within the distal transverse colon, a 4-millimeter flat polyp was present and was excised by cold biopsy forceps polypectomy.Mild-to-moderate diverticular disease was noted throughout the colon.On retroflexed exam, grade 1 internal hemorrhoids were present.Moreover, the estimated blood loss was minimal.The time to cecum was 8 minutes, and the scope withdrawal time was 8 minutes.
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Manufacturer Narrative
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Block h2: additional information block b5 have been updated based on the additional information received on january 25, 2023.Block b3 date of event: the exact event onset date is unknown.The provided event date of may 29, 2009 was chosen as a best estimate based on the date of the mesh was implanted.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).
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Event Description
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Please refer to mfr report 3005099803-2020-01564 for the associated device.It was reported to boston scientific corporation that a polyform synthetic mesh was implanted on may 29, 2009.As reported by the patient's attorney, the patient experienced an unknown injury.Boston scientific has been unable to obtain additional information regarding the event to date.***additional information received on 20jan2022*** it was reported that the patient had been diagnosed with vaginal vault prolapse and stress urinary incontinence.On (b)(6) 2009, she underwent laparoscopic sacrocolpopexy (using da vinci robotics), laparoscopic bilateral salpingo-oophorectomy (using da vinci robotics) and suburenthral sling placement (using obtryx transobturator tape) with cystoscopy.Patient tolerated the procedure well and was taken into recovery in stable condition.***additional information received on 23sep2022*** it was reported to boston scientific corporation that a polyform synthetic mesh and obtryx system devices were implanted into the patient during robotic assisted laparoscopic colpopexy, bilateral salpingo-oophorectomy, suburethral sling and cystoscopy on (b)(6) 2009 for the treatment of vaginal prolapse, rectocele, cystocele and urinary incontinence.Operative findings are as follows: the right lower quadrant and pelvis have dense abdominal adhesions, yet the bowel is adherent to the cul-de-sac.The appendix was completely normal.At the end of the case, there was a significant amount of support.There was no evidence of tumor, carcinoma in situ, stones, or foreign bodies in the body on cystoscopy at the end of the procedure, with bilateral efflux of dye from anatomically normally located ureteral orifices.The ovaries were found to be completely normal and were removed at the patient's request.Reportedly, the patient tolerated the procedure well and was taken to the recovery room in stable condition.On (b)(6) 2018, the patient had been diagnosed with vaginal mesh erosion.Subsequently, the patient underwent a cystourethroscopy and a vaginal mesh excision procedure.Her outpatient examination revealed definite heaped up erosion in the anterior vaginal wall, which has been confirmed through vaginal inspection.A foley catheter was left to drain normally.The surgeon identified the area of erosion and used a sharp dissection to slowly open up the vaginal incision and carefully dissect this out and mobilize it.The surgeon moved it toward the 9 o'clock position, clamped it, divided it, and slowly dissected it out from under the urethra.The mesh appeared to be quite tight, leaving a notable indentation in the periurethral tissues.He excised from the 4 o'clock to the 9 o'clock position after mobilizing the tape.The specimen was freeze sectioned and returned to the department of pathology to identify mesh fibers within the specimen.The surgeon examined the vagina, which had some urethral tissue compression.Over this, he was able to reapproximate periurethral tissues by bringing the lower fascial edge up and approximating it with interrupted 2-0 vicryl.By buttressing this thinning area, an excellent cosmetic appearance was obtained.The surgeon then meticulously clipped the vaginal epithelium before closing it with interrupted 2-0 vicryl.This was a class 2 incision.The patient was well tolerated by this point, and a vaginal pack was retained in place.Pathology noted chronic inflammation.On (b)(6) 2018, the patient had the insertion of an autologous fascia pubovaginal sling and cystoscopy for the treatment of urinary incontinence.Reportedly, the patient tolerated the procedure well and was sent to the postoperative recovery room in stable condition.On (b)(6) 2020, the patient underwent a sigmoidoscopy with endoscopic cutting of mesh and foreign body removal for the treatment of transmural mesh extruding through the rectosigmoid and anus.During the procedure, it was observed that the patient had a sigmoid diverticulosis.Up to 30-40 cm, the mucosa was normal.The area of mesh extruding from the pelvis into the rectosigmoid was identified at about 12 cm.Copious irrigation was used.The mesh was discovered to be fastened and could not be withdrawn using rat-tooth forceps.The mesh was cut with endoscopic scissors (ensizor/slater endoscopy).The mesh looked to be traversing the colon at two sites, separated by fibrosis/granulation tissue.The entire mesh was eventually cut and removed.A 10 cm length of mesh mixed with calcified stool was removed.There were no immediate complications during the procedure.On (b)(6) 2021, she underwent a low anterior resection with a true low pelvic anastomosis, partial en bloc vaginectomy with closure of the vagina, omental pedicle flap, diverting proximal transverse loop colostomy, appendectomy, and extensive enterolysis for the treatment of mesh erosion of the rectosigmoid colon.Operative findings are as follows: the patient had a significant number of pelvic adhesions.The uterus and ovaries had been surgically removed.The appendix dangled in the pelvis.There was extensive scarring between the rectum's mesentery and the top portion of the sacrum, with obliteration of the usual avascular planes.These planes were regained further afield.The doctor could palpate the mesh within the bowel and between the bowel and the vagina since the rectum and vagina were totally connected.They soon found a few sutures connecting the mesh to the vagina.There was no evidence of hydronephrosis.There was no evidence of cancer.There was no evidence of an obstruction.There was sigmoid colon diverticulosis present, but no pus or fecal contamination outside the bowel lumen.The left side of the liver was normal and easily palpable.Adhesions to the diaphragm hid the right side of the liver.The esophageal hiatus fit perfectly.There was a distal ileum loop that was highly adherent to the base of the sigmoid colon mesentery, which appeared to be related to her previous pelvic operation.There was no fistula present.Following exploration, the incision was taken down to the neo-cul-de-sac.On the right side, the planes were less distinct due to scarring from previous surgery; however, the plane of the fascia propria was able to be entered in the presacral space and was extended down to the cul-de-sac as well.Dissection continued until the only area of adherence was the anterior mid which was where the problem with the mesh appeared to be.The vagina was dissected away from the bladder without any injury to the bladder but the vagina and rectum were fused in the area of the mesh.A small portion of the vaginal cuff was removed so the mesh could be completely excised and also included a small portion of the posterior vaginal wall.After this, dissection continued well beyond the fibrotic changes in the rectovaginal septum.The vagina was reconstructed with running locking 2-0 vicryl suture.The rectal mesentery was cleared about 6-7 cm above the anal verge and the bowel was transected with the green contour stapler.The entire fibrotic portion of the rectum was elevated out of the pelvis, and a low ligation of the inferior mesenteric vascular pedicle was performed.The sigmoid colon was then transected at the junction of the proximal and middle thirds between the automatic pursestring device and an isolation clamp.The specimen was handed off the table and opened to confirm the entire mesh was removed before submitting to the pathology department.An end-to-end anastomosis was performed using the double staple technique and was airtight.An omental pedicle flap was constructed based on the left gastroepiploic arcade and was run down the left colonic gutter into the pelvis interposed between the rectal anastomosis and the suture in the vagina.A drain was also placed through the lower left quadrant stab wound and sewn to the skin.Because of the distal level of the anastomosis and the presence of another hollow viscus repair in the immediate vicinity, a temporary transverse loop colostomy was performed as a form of fecal diversion to allow the anastomosis to heal without any intraluminal pressure.The abdomen was trephinated at a previously designated site though the right belly of the rectus muscle and the proximal transverse colon was delivered through the aperture supported on a bar.The site was closed over a large sheet of seprafilm with running looped pds suture.The skin was irrigated and closed with staples, the main incision was quarantined, and the colostomy was sutured with interrupted 3-0 chromic suture, and the appliance was pasted to the skin.The patient tolerated the procedure well.***additional information received on 03nov2022*** on (b)(6) 2021, the patient underwent a colonoscopy with biopsy and cold biopsy forceps polypectomy.During the procedure, the patient was placed in the left lateral decubitus position, and a pediatric flexible colonoscope was inserted through the anus and advanced to the cecum without difficulty.The cecum was identified by the location of the appendiceal orifice and ileocecal valve.A retroflexed exam of the rectum was performed.At approximately 10--12 centimeters from the anus, a large amount of retained stool was present, caught up in retained mesh.The surrounding area was inflamed.The remaining colonic mucosa was normal.Biopsies were obtained from the ascending and descending colons.Within the distal transverse colon, a 4-millimeter flat polyp was present and was excised by cold biopsy forceps polypectomy.Mild-to-moderate diverticular disease was noted throughout the colon.On retroflexed exam, grade 1 internal hemorrhoids were present.Moreover, the estimated blood loss was minimal.The time to cecum was 8 minutes, and the scope withdrawal time was 8 minutes.***additional information received on 25jan2023*** the patient contacted on (b)(6) 2020, to report an ongoing issue.She claims she went to she went to her primary care physician, who believed she may still have product left from her surgery coming from her rectum.However, according to the doctor, it is possible that the patient had something eroded in her vagina, such as mesh from her initial surgery, but there is little to no likelihood that something is coming from her rectum as a result of her earlier urologic procedures.
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Search Alerts/Recalls
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