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BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Back to Search Results |
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| Model Number M0068502111 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Erosion (1750); Fistula (1862); Inflammation (1932); Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Seroma (2069); Urinary Retention (2119); Urinary Tract Infection (2120); Hernia (2240); Discomfort (2330); Numbness (2415); Obstruction/Occlusion (2422); Prolapse (2475); Dysuria (2684); Fluid Discharge (2686); Fibrosis (3167); Constipation (3274); Vesicovaginal Fistula (4512); Insufficient Information (4580)
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| Event Date 05/26/2015 |
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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) 2015 was chosen as a best estimate based on the date of the mesh was implanted.This event was reported by the patient's legal representation.The surgeon is: (b)(6).(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2015.As reported by the patient's attorney, the patient has experienced an unspecified injury.
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Manufacturer Narrative
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Additional information received as of (b)(6) 2022: a2, b5, b7, h6 patient & impact codes.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2015 was chosen based on when the patient first presented with symptoms.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).For repair of fistula: dr.(b)(6).Block h6: patient codes e1416, e1301, e2328, e2002 capture the reportable events of vesicovaginal fistula, dysuria, obstruction of ureter, and abdominal pain impact codes f2203, f19, f2303, f1905 capture the reportable events imaging required, surgical intervention, medication required, device revision or replacement conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2015.As reported by the patient's attorney, the patient has experienced an unspecified injury.Additional information was received by boston scientific corporation on (b)(6) 2022 as follows: on (b)(6) 2015, the patient presented for evaluation of a vesical vaginal fistula.She had previously underwent a total laparoscopic hysterectomy, posterior vaginal vault repair, mid urethral sling placement for treatment of posterior prolapse and urinary incontinence.At the time, she had very dense adhesions and a somewhat hostile abdomen.Post operatively, she had difficulty urinating and urinary discharge from her vagina.Prior to sling placement, the patient reported no difficulty urinating.She had difficulty tolerating the foley catheter and the discharge resolved after it was removed.On (b)(6) 2015, the patient underwent cystoscopy, bilateral retrograde pyelogram, and bilateral ureteral stent placement with 22 modifier for treatment of vesicovaginal fistula and kinked left ureter.A cystoscope was placed with an obturator into the bladder and two moderate sized fistula were observed at the posterior wall that were supra-trigonal.These were very close to the left ureteral orifice.The rest of the bladder was surveyed and no additional stones were seen.The retrograde pyelogram was performed on the right side and there was no obstruction and no extravasation.A 6-french x 24-cm stent was then placed.The physician then began the pyelogram on the left side and observed a kinked distal ureter with narrowing.It was difficult to uncoil but it was accomplished using a guidewire and the pyelogram was able to be completed.Mild hydronephrosis was observed on the left side and there was no extravasation seen.A 6-french x 24-cm stent was then placed.The urethra was surveyed and no damage was seen.The physician did not observe extrusion of mesh.Another surgeon continued to the case for examination of the fistula.It appeared to be a supra-trigonal fistula that was high in the vaginal vault.The physicians felt that fistula repair would require caution due to the left ureter's proximity to the fistula.The patient was seen on (b)(6) 2016 for abdominal pain.It was reported that she had previously undergone abdominal vesicovaginal fistula repair and right ureteral reimplantation, along with mesh sling removal.The patient reported that her abdominal pain continued after her original surgery and has worsened.The pain is mostly in the right lower quadrant radiating to the right area, where the ureteral implantation took place.The patient reports progressive difficulty urinating some constipation.No gross hematuria was noted.A ct showed no ureteral obstruction.Bilateral peripelvic renal cysts were observed and the patient's right ureteral flowed well without hydronephrosis.The patient's bladder was somewhat distended and she was constipated.Given that there was no hydronephrosis, the physician felt it was unlikely related to her right ureteral reimplantation.Per physician's notes, the plan was a trial of a ureteral stent, placement of a foley catheter, and magnesium citrate for constipation as well as continuation of dilaudid for pain along with zofran for nausea.On (b)(6) 2017, the patient was seen for flank pain.The physician recommended physical therapy, heat packs, and a three day voiding diary including fluid intake and output.
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Manufacturer Narrative
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Block h2: additional information blocks b5, b7, h6 (patient codes and impact codes) has been updated based on the additional information received on october 24, 2022.Correction: blocks b2, b3, e1 (initial reporter facility name and initial reporter address 1) and h6 (evaluation conclusion codes).Block b3 date of event: the exact event onset date is unknown.The provided event date of may 26, 2015 , implant procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).For repair of fistula: (b)(6).Block h6: patient codes e1416, e1301, e2328, e1002, e0307, e2330, e1310 capture the reportable events of vesicovaginal fistula, dysuria, obstruction of ureter, abdominal pain, seroma, pain and urinary tract infection.Impact codes f2203, f19, f2303, f1905, f23 capture the reportable events imaging required, surgical intervention, medication required, device revision or replacement and botox injection.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2015.As reported by the patient's attorney, the patient has experienced an unspecified injury.Additional information was received by boston scientific corporation on july 22, 2022 as follows: on (b)(6) 2015, the patient presented for evaluation of a vesical vaginal fistula.She had previously underwent a total laparoscopic hysterectomy, posterior vaginal vault repair, mid urethral sling placement for treatment of posterior prolapse and urinary incontinence.At the time, she had very dense adhesions and a somewhat hostile abdomen.Post operatively, she had difficulty urinating and urinary discharge from her vagina.Prior to sling placement, the patient reported no difficulty urinating.She had difficulty tolerating the foley catheter and the discharge resolved after it was removed.On (b)(6) 2015, the patient underwent cystoscopy, bilateral retrograde pyelogram, and bilateral ureteral stent placement with 22 modifier for treatment of vesicovaginal fistula and kinked left ureter.A cystoscope was placed with an obturator into the bladder and two moderate sized fistula were observed at the posterior wall that were supra-trigonal.These were very close to the left ureteral orifice.The rest of the bladder was surveyed and no additional stones were seen.The retrograde pyelogram was performed on the right side and there was no obstruction and no extravasation.A 6-french x 24-cm stent was then placed.The physician then began the pyelogram on the left side and observed a kinked distal ureter with narrowing.It was difficult to uncoil but it was accomplished using a guidewire and the pyelogram was able to be completed.Mild hydronephrosis was observed on the left side and there was no extravasation seen.A 6-french x 24-cm stent was then placed.The urethra was surveyed and no damage was seen.The physician did not observe extrusion of mesh.Another surgeon continued to the case for examination of the fistula.It appeared to be a supra-trigonal fistula that was high in the vaginal vault.The physicians felt that fistula repair would require caution due to the left ureter's proximity to the fistula.The patient was seen on (b)(6) 2016 for abdominal pain.It was reported that she had previously undergone abdominal vesicovaginal fistula repair and right ureteral reimplantation, along with mesh sling removal.The patient reported that her abdominal pain continued after her original surgery and has worsened.The pain is mostly in the right lower quadrant radiating to the right area, where the ureteral implantation took place.The patient reports progressive difficulty urinating some constipation.No gross hematuria was noted.A ct showed no ureteral obstruction.Bilateral peripelvic renal cysts were observed and the patient's right ureteral flowed well without hydronephrosis.The patient's bladder was somewhat distended and she was constipated.Given that there was no hydronephrosis, the physician felt it was unlikely related to her right ureteral reimplantation.Per physician's notes, the plan was a trial of a ureteral stent, placement of a foley catheter, and magnesium citrate for constipation as well as continuation of dilaudid for pain along with zofran for nausea.On (b)(6) 2017, the patient was seen for flank pain.The physician recommended physical therapy, heat packs, and a three day voiding diary including fluid intake and output.Additional information was received by boston scientific corporation on october 24, 2022, as follows: on (b)(6) 2015, an advantage fit system device was implanted into the patient during a total laparoscopic hysterectomy, resection of the bladder from the uterus with cystoscopy, left ovarian cyst incision and drainage, bladder sling, and vaginal packing for the treatment of menopausal bleeding, pelvic pain, urinary incontinence, and prior three pelvic surgeries, plus severe adhesions of the bladder through the uterus and a left hemorrhagic cyst.Operative findings revealed that the patient had a globular uterus measuring about 10 to 12 cm.She had multiple dense bladder adhesions that began at the midpoint of the uterus and extended along the entire cervix and nearby structures.The patient has a left simple ovarian cyst measuring about 3 cm.On the cystoscopy, her bladder mucosa appeared slightly hemorrhagic, but without injury.The ostia appeared to be intact and functioning well.The patient had a hypermobile urethra.Reportedly, the patient's condition is stable.On march 9, 2018, the patient reported surgery pain and a possible infection.The patient is recovering from surgery and is taking 10 tramadol per day.The patient had no fever, chills, dysuria, frequency, urgency, diarrhea, abdominal pain, back pain, or joint pain.According to the report, the patient also had other specified nutritional anemias, hyperlipidemia, mild protein-calorie malnutrition, and a urinary tract infection.Additionally, the patient was given a cipro 500 mg prescription twice daily for 10 days to treat a urinary tract infection.On (b)(6) 2018, the underwent a transcutaneous injection of trigger points (botox 100 units).The patient has complications from retropubic mesh.She had the mesh removed.The surgeon has done a retropubic exploration and removed residual mesh that was not removed on her first operation.She developed a hernia in the suprapubic area that was repaired using mesh.The patient developed a seroma in the suprapubic area.Also, the surgeon has done a right ureteric reimplantation using a boari flap.She has significant suprapubic pain localized to the suprapubic area on the bone itself in the area of the prior mesh removal.Because the pain is not responding to anything else, they are going to do a local botox injection.During the surgery, the patient was placed in the supine position.They marked the areas of exquisite point just above the pubic bone after preparing the suprapubic area.The surgeon injected a total of 100 units of botox in the suprapubic area, in the area over the localized pain.Also, they injected 1% xylocaine to improve the immediate postoperative result.There was no complication, bleeding, or specimen.The patient was discharged to go home and will contact the medical team if there are any problems.On (b)(6) 2018, the patient had an evaluation after the repair of her hernia.During the evaluation, it was revealed that the hernia repair had not held sufficiently, resulting in recurrent/persistent hernia.Moreover, the patient reported having a pain scale of 10, but seems to be pain-free at times.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2015.As reported by the patient's attorney, the patient has experienced an unspecified injury.Additional information was received by boston scientific corporation on (b)(6) 2022 as follows: on (b)(6) 2015, the patient presented for evaluation of a vesical vaginal fistula.She had previously underwent a total laparoscopic hysterectomy, posterior vaginal vault repair, mid urethral sling placement for treatment of posterior prolapse and urinary incontinence.At the time, she had very dense adhesions and a somewhat hostile abdomen.Post operatively, she had difficulty urinating and urinary discharge from her vagina.Prior to sling placement, the patient reported no difficulty urinating.She had difficulty tolerating the foley catheter and the discharge resolved after it was removed.On (b)(6) 2015, the patient underwent cystoscopy, bilateral retrograde pyelogram, and bilateral ureteral stent placement with 22 modifier for treatment of vesicovaginal fistula and kinked left ureter.A cystoscope was placed with an obturator into the bladder and two moderate sized fistula were observed at the posterior wall that were supra-trigonal.These were very close to the left ureteral orifice.The rest of the bladder was surveyed and no additional stones were seen.The retrograde pyelogram was performed on the right side and there was no obstruction and no extravasation.A 6-french x 24-cm stent was then placed.The physician then began the pyelogram on the left side and observed a kinked distal ureter with narrowing.It was difficult to uncoil but it was accomplished using a guidewire and the pyelogram was able to be completed.Mild hydronephrosis was observed on the left side and there was no extravasation seen.A 6-french x 24-cm stent was then placed.The urethra was surveyed and no damage was seen.The physician did not observe extrusion of mesh.Another surgeon continued to the case for examination of the fistula.It appeared to be a supra-trigonal fistula that was high in the vaginal vault.The physicians felt that fistula repair would require caution due to the left ureter's proximity to the fistula.The patient was seen on (b)(6) 2016 for abdominal pain.It was reported that she had previously undergone abdominal vesicovaginal fistula repair and right ureteral reimplantation, along with mesh sling removal.The patient reported that her abdominal pain continued after her original surgery and has worsened.The pain is mostly in the right lower quadrant radiating to the right area, where the ureteral implantation took place.The patient reports progressive difficulty urinating some constipation.No gross hematuria was noted.A ct showed no ureteral obstruction.Bilateral peripelvic renal cysts were observed and the patient's right ureteral flowed well without hydronephrosis.The patient's bladder was somewhat distended and she was constipated.Given that there was no hydronephrosis, the physician felt it was unlikely related to her right ureteral reimplantation.Per physician's notes, the plan was a trial of a ureteral stent, placement of a foley catheter, and magnesium citrate for constipation as well as continuation of dilaudid for pain along with zofran for nausea.On (b)(6) 2017, the patient was seen for flank pain.The physician recommended physical therapy, heat packs, and a three day voiding diary including fluid intake and output.Additional information was received by boston scientific corporation on (b)(6) 2022, as follows: on (b)(6) 2015, an advantage fit system device was implanted into the patient during a total laparoscopic hysterectomy, resection of the bladder from the uterus with cystoscopy, left ovarian cyst incision and drainage, bladder sling, and vaginal packing for the treatment of menopausal bleeding, pelvic pain, urinary incontinence, and prior three pelvic surgeries, plus severe adhesions of the bladder through the uterus and a left hemorrhagic cyst.Operative findings revealed that the patient had a globular uterus measuring about 10 to 12 cm.She had multiple dense bladder adhesions that began at the midpoint of the uterus and extended along the entire cervix and nearby structures.The patient has a left simple ovarian cyst measuring about 3 cm.On the cystoscopy, her bladder mucosa appeared slightly hemorrhagic, but without injury.The ostia appeared to be intact and functioning well.The patient had a hypermobile urethra.Reportedly, the patient's condition is stable.On (b)(6) 2018, the patient reported surgery pain and a possible infection.The patient is recovering from surgery and is taking 10 tramadol per day.The patient had no fever, chills, dysuria, frequency, urgency, diarrhea, abdominal pain, back pain, or joint pain.According to the report, the patient also had other specified nutritional anemias, hyperlipidemia, mild protein-calorie malnutrition, and a urinary tract infection.Additionally, the patient was given a cipro 500 mg prescription twice daily for 10 days to treat a urinary tract infection.On (b)(6) 2018, the underwent a transcutaneous injection of trigger points (botox 100 units).The patient has complications from retropubic mesh.She had the mesh removed.The surgeon has done a retropubic exploration and removed residual mesh that was not removed on her first operation.She developed a hernia in the suprapubic area that was repaired using mesh.The patient developed a seroma in the suprapubic area.Also, the surgeon has done a right ureteric reimplantation using a boari flap.She has significant suprapubic pain localized to the suprapubic area on the bone itself in the area of the prior mesh removal.Because the pain is not responding to anything else, they are going to do a local botox injection.During the surgery, the patient was placed in the supine position.They marked the areas of exquisite point just above the pubic bone after preparing the suprapubic area.The surgeon injected a total of 100 units of botox in the suprapubic area, in the area over the localized pain.Also, they injected 1% xylocaine to improve the immediate postoperative result.There was no complication, bleeding, or specimen.The patient was discharged to go home and will contact the medical team if there are any problems.On (b)(6) 2018, the patient had an evaluation after the repair of her hernia.During the evaluation, it was revealed that the hernia repair had not held sufficiently, resulting in recurrent/persistent hernia.Moreover, the patient reported having a pain scale of 10, but seems to be pain-free at times.Additional information was received by boston scientific corporation on (b)(6) 2023, as follows: according to the report, the patient suffered complications following a hysterectomy and sling procedure.The patient was said to have suffered a right ureter injury as well as a vesicovaginal fistula as a result of the hysterectomy.The patient's vesicovaginal fistula healed on its own, but she is still on self-catheterization for retention.She did not experience any lumbar discomfort immediately after the surgery while she had a foley catheter, but since the catheter was removed and she began self-catheterization, the pain in the right lumbar area has increased dramatically.Bilateral ultrasonography revealed no evidence of caliceal system dilatation or the presence of parapelvic cysts.Moreover, there appears to be no ureteric dilation.Subsequently, the patient underwent a urethrolysis and the removal of retropubic and periurethral mesh on (b)(6) 2016, to address the following complications: 1.Urinary obstruction.2.Vaginal wall erosion in the right distal vagina.3.Post-ureteric injury at the time of hysterectomy.4.Right ureteric reimplantation.5.Urinary retention after self-catheterization.6.Significant right lumbar pain.The procedure findings are as follows: 1.There was a small area of erosion on the right side, around 0.5 cm in the right periurethral distal area.2.The retropubic space was entered, and the mesh was isolated from the wall of the urethra after a very delicate and difficult dissection.3.The vaginal segment included in the erosion was removed together with a segment of 1 to 1.5 cm from the anterior vaginal wall.4.The superior and inferior flaps on the vaginal wall were created.5.The mesh was dissected free from the urethral wall on each side up to the pubic bone and transected high.6.As mentioned, the mesh was transected 1 or 2 cm from the pubic bone.7.The patient was transferred to the recovery room in good condition.Moreover, since the right ureteric reimplantation, the patient has had debilitating right lumbar pain.The patient also has multiple insertion of stents that improved minimally, or the pain is worsened.Reportedly, the patient is not responding to any therapy.In the ct scan, the patient was noted to have a kinking of the distal ureter.Additionally, on (b)(6) 2016, the patient underwent a right ureteric reimplantation and the creation of a boari flap to address the following issues: right ureteric obstruction, complications of mesh surgery, and post-removal of vaginal mesh.The procedure findings are as follows: 1.A small window of about 2 cm was made in the peritoneum that is not affecting the exposure.2.A severe inflammatory ureter was attached to the bladder dome.3.The ureter is fixed and requires extensive ureterolysis to free up the ureter.It looks likely that extravasation or kinking has created chronic obstruction.4.It is possible that the manipulation of the stent also created inflammatory changes.5.There is significant fibrosis in the anastomosis.6.The ureter is thickened.7.The thick segment of the ureter and the anastomosis were excised until good circulation in the distal ureter was found.8.The patient is transferred to the recovery room in good condition.There was no complication.On (b)(6) 2018, the patient underwent an abdominal exploration, the removal of residual retropubic mesh, and an anterior vaginal wall reconstruction to address the following: complications of retropubic mesh, suprapubic pelvic pain, and a post-boari flap for right ureteric obstruction.The procedure findings are as follows: 1.A transverse semicircular incision was made just above the pubic bone to expose the skin and the musculature and enter the retropubic space.2.The bladder is completely free from the pubic bone on both sides.On each side of the bladder, they can find the residual mesh.3.The mesh is fixed to the pubic bone and to the ridge in the obturator fossa on each side.4.The surgeon was able to detach it after a difficult dissection from the right periosteum of the pubic bone posteriorly and from the obturator internus, follow it to the subcutaneous tissue, and remove it entirely.5.There was no extravasation of urine.6.The abdominal wall is closed with multiple interrupted sutures of #1 vicryl, including the fascial superior aspect.7.The periosteum of the pubic bone and inferior segment of the fascia subcutaneous tissue was approximated with 2-0 vicryl and the skin with monocryl.8.The patient is transferred to the recovery room in good condition.9.There were no complications or bleeding.
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Manufacturer Narrative
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Block h2: additional information blocks b5 (narrative) and h6 (patient codes) has been updated based on the additional information received on february 20, 2023.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2015, implant procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: dr.(b)(6).For repair of fistula: dr (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2006 - vaginal wall erosion.E2328 - urethral obstruction.E2330 - pain.E2323 - fibrosis.E2319 - hernia.E2314 - vesicovaginal fistula.E1301 - dysuria.E1309 - urinary retention.E1310 - urinary tract infection.E2326 - inflammation.E2401 - unspecified personal injury.The following imdrf impact code capture the reportable event of: f2303 - medication required.F1905 - device revisions.F19 - surgical intervention.F23 - unexpected medical intervention.
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Manufacturer Narrative
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Block h2: additional information blocks b5 (narrative) and h6 (patient codes and impact codes) has been updated based on the additional information received on april 12, 2023.Correction: block b3 (date of event) has been corrected.Block d7a (sud reprocessed and reused) has been corrected.Block b3 date of event: the exact event onset date is unknown.The provided event date of (b)(6) 2015, implant procedure date, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).Block h6: the following imdrf patient code capture the reportable event of: e2006 - vaginal wall erosion.E2328 - urethral obstruction.E2330 - pain.E2323 - fibrosis.E2319 - hernia.E2314 - vesicovaginal fistula.E1301 - dysuria.E1309 - urinary retention.E1310 - urinary tract infection.E2326 - inflammation.E2401 - unspecified personal injury.E2311 - tenderness in the lower left quadrant.E1621 - rle weakness.E0123 - nerve damage from the patient's prior mesh surgeries.The following imdrf impact code capture the reportable event of: f2303 - medication required.F1905 - device revisions.F19 - surgical intervention.F23 - unexpected medical intervention.F1202 - inability to walk post procedure.
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Event Description
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It was reported to boston scientific corporation that an advantage fit system device was implanted into the patient during a procedure performed on (b)(6) 2015.As reported by the patient's attorney, the patient has experienced an unspecified injury.Additional information was received by boston scientific corporation on july 22, 2022 as follows: on (b)(6) 2015, the patient presented for evaluation of a vesical vaginal fistula.She had previously underwent a total laparoscopic hysterectomy, posterior vaginal vault repair, mid urethral sling placement for treatment of posterior prolapse and urinary incontinence.At the time, she had very dense adhesions and a somewhat hostile abdomen.Post operatively, she had difficulty urinating and urinary discharge from her vagina.Prior to sling placement, the patient reported no difficulty urinating.She had difficulty tolerating the foley catheter and the discharge resolved after it was removed.On (b)(6) 2015, the patient underwent cystoscopy, bilateral retrograde pyelogram, and bilateral ureteral stent placement with 22 modifier for treatment of vesicovaginal fistula and kinked left ureter.A cystoscope was placed with an obturator into the bladder and two moderate sized fistula were observed at the posterior wall that were supra-trigonal.These were very close to the left ureteral orifice.The rest of the bladder was surveyed and no additional stones were seen.The retrograde pyelogram was performed on the right side and there was no obstruction and no extravasation.A 6-french x 24-cm stent was then placed.The physician then began the pyelogram on the left side and observed a kinked distal ureter with narrowing.It was difficult to uncoil but it was accomplished using a guidewire and the pyelogram was able to be completed.Mild hydronephrosis was observed on the left side and there was no extravasation seen.A 6-french x 24-cm stent was then placed.The urethra was surveyed and no damage was seen.The physician did not observe extrusion of mesh.Another surgeon continued to the case for examination of the fistula.It appeared to be a supra-trigonal fistula that was high in the vaginal vault.The physicians felt that fistula repair would require caution due to the left ureter's proximity to the fistula.The patient was seen on (b)(6) 2016 for abdominal pain.It was reported that she had previously undergone abdominal vesicovaginal fistula repair and right ureteral reimplantation, along with mesh sling removal.The patient reported that her abdominal pain continued after her original surgery and has worsened.The pain is mostly in the right lower quadrant radiating to the right area, where the ureteral implantation took place.The patient reports progressive difficulty urinating some constipation.No gross hematuria was noted.A ct showed no ureteral obstruction.Bilateral peripelvic renal cysts were observed and the patient's right ureteral flowed well without hydronephrosis.The patient's bladder was somewhat distended and she was constipated.Given that there was no hydronephrosis, the physician felt it was unlikely related to her right ureteral reimplantation.Per physician's notes, the plan was a trial of a ureteral stent, placement of a foley catheter, and magnesium citrate for constipation as well as continuation of dilaudid for pain along with zofran for nausea.On (b)(6) 2017, the patient was seen for flank pain.The physician recommended physical therapy, heat packs, and a three day voiding diary including fluid intake and output.Additional information was received by boston scientific corporation on october 24, 2022, as follows: on (b)(6) 2015, an advantage fit system device was implanted into the patient during a total laparoscopic hysterectomy, resection of the bladder from the uterus with cystoscopy, left ovarian cyst incision and drainage, bladder sling, and vaginal packing for the treatment of menopausal bleeding, pelvic pain, urinary incontinence, and prior three pelvic surgeries, plus severe adhesions of the bladder through the uterus and a left hemorrhagic cyst.Operative findings revealed that the patient had a globular uterus measuring about 10 to 12 cm.She had multiple dense bladder adhesions that began at the midpoint of the uterus and extended along the entire cervix and nearby structures.The patient has a left simple ovarian cyst measuring about 3 cm.On the cystoscopy, her bladder mucosa appeared slightly hemorrhagic, but without injury.The ostia appeared to be intact and functioning well.The patient had a hypermobile urethra.Reportedly, the patient's condition is stable.On (b)(6) 2018, the patient reported surgery pain and a possible infection.The patient is recovering from surgery and is taking 10 tramadol per day.The patient had no fever, chills, dysuria, frequency, urgency, diarrhea, abdominal pain, back pain, or joint pain.According to the report, the patient also had other specified nutritional anemias, hyperlipidemia, mild protein-calorie malnutrition, and a urinary tract infection.Additionally, the patient was given a cipro 500 mg prescription twice daily for 10 days to treat a urinary tract infection.On (b)(6) 2018, the underwent a transcutaneous injection of trigger points (botox 100 units).The patient has complications from retropubic mesh.She had the mesh removed.The surgeon has done a retropubic exploration and removed residual mesh that was not removed on her first operation.She developed a hernia in the suprapubic area that was repaired using mesh.The patient developed a seroma in the suprapubic area.Also, the surgeon has done a right ureteric reimplantation using a boari flap.She has significant suprapubic pain localized to the suprapubic area on the bone itself in the area of the prior mesh removal.Because the pain is not responding to anything else, they are going to do a local botox injection.During the surgery, the patient was placed in the supine position.They marked the areas of exquisite point just above the pubic bone after preparing the suprapubic area.The surgeon injected a total of 100 units of botox in the suprapubic area, in the area over the localized pain.Also, they injected 1% xylocaine to improve the immediate postoperative result.There was no complication, bleeding, or specimen.The patient was discharged to go home and will contact the medical team if there are any problems.On (b)(6) 2018, the patient had an evaluation after the repair of her hernia.During the evaluation, it was revealed that the hernia repair had not held sufficiently, resulting in recurrent/persistent hernia.Moreover, the patient reported having a pain scale of 10, but seems to be pain-free at times.Additional information was received by boston scientific corporation on february 20, 2023, as follows: according to the report, the patient suffered complications following a hysterectomy and sling procedure.The patient was said to have suffered a right ureter injury as well as a vesicovaginal fistula as a result of the hysterectomy.The patient's vesicovaginal fistula healed on its own, but she is still on self-catheterization for retention.She did not experience any lumbar discomfort immediately after the surgery while she had a foley catheter, but since the catheter was removed and she began self-catheterization, the pain in the right lumbar area has increased dramatically.Bilateral ultrasonography revealed no evidence of caliceal system dilatation or the presence of parapelvic cysts.Moreover, there appears to be no ureteric dilation.Subsequently, the patient underwent a urethrolysis and the removal of retropubic and periurethral mesh on (b)(6) 2016, to address the following complications: 1.Urinary obstruction.2.Vaginal wall erosion in the right distal vagina.3.Post-ureteric injury at the time of hysterectomy.4.Right ureteric reimplantation.5.Urinary retention after self-catheterization.6.Significant right lumbar pain.The procedure findings are as follows: 1.There was a small area of erosion on the right side, around 0.5 cm in the right periurethral distal area.2.The retropubic space was entered, and the mesh was isolated from the wall of the urethra after a very delicate and difficult dissection.3.The vaginal segment included in the erosion was removed together with a segment of 1 to 1.5 cm from the anterior vaginal wall.4.The superior and inferior flaps on the vaginal wall were created.5.The mesh was dissected free from the urethral wall on each side up to the pubic bone and transected high.6.As mentioned, the mesh was transected 1 or 2 cm from the pubic bone.7.The patient was transferred to the recovery room in good condition.Moreover, since the right ureteric reimplantation, the patient has had debilitating right lumbar pain.The patient also has multiple insertion of stents that improved minimally, or the pain is worsened.Reportedly, the patient is not responding to any therapy.In the ct scan, the patient was noted to have a kinking of the distal ureter.Additionally, on (b)(6)2016, the patient underwent a right ureteric reimplantation and the creation of a boari flap to address the following issues: right ureteric obstruction, complications of mesh surgery, and post-removal of vaginal mesh.The procedure findings are as follows: 1.A small window of about 2 cm was made in the peritoneum that is not affecting the exposure.2.A severe inflammatory ureter was attached to the bladder dome.3.The ureter is fixed and requires extensive ureterolysis to free up the ureter.It looks likely that extravasation or kinking has created chronic obstruction.4.It is possible that the manipulation of the stent also created inflammatory changes.5.There is significant fibrosis in the anastomosis.6.The ureter is thickened.7.The thick segment of the ureter and the anastomosis were excised until good circulation in the distal ureter was found.8.The patient is transferred to the recovery room in good condition.There was no complication.On (b)(6) 2018, the patient underwent an abdominal exploration, the removal of residual retropubic mesh, and an anterior vaginal wall reconstruction to address the following: complications of retropubic mesh, suprapubic pelvic pain, and a post-boari flap for right ureteric obstruction.The procedure findings are as follows: 1.A transverse semicircular incision was made just above the pubic bone to expose the skin and the musculature and enter the retropubic space.2.The bladder is completely free from the pubic bone on both sides.On each side of the bladder, they can find the residual mesh.3.The mesh is fixed to the pubic bone and to the ridge in the obturator fossa on each side.4.The surgeon was able to detach it after a difficult dissection from the right periosteum of the pubic bone posteriorly and from the obturator internus, follow it to the subcutaneous tissue, and remove it entirely.5.There was no extravasation of urine.6.The abdominal wall is closed with multiple interrupted sutures of #1 vicryl, including the fascial superior aspect.7.The periosteum of the pubic bone and inferior segment of the fascia subcutaneous tissue was approximated with 2-0 vicryl and the skin with monocryl.8.The patient is transferred to the recovery room in good condition.9.There were no complications or bleeding.Additional information was received by boston scientific corporation on april 12, 2023 as follows: on (b)(6) 2015, the patient underwent an ultrasound procedure.Mesh segments were noted posterior to the mid urethra according to the ultrasound findings.The patient presented at the clinic on (b)(6) 2016, reporting obstructive symptoms and pelvic pain.A vaginal examination revealed tenderness in the periurethral region.The mesh was said to be infiltrating the vaginal epithelium without frank exposure.Hence, surgical procedures such as transvaginal mesh removal, retropubic mesh removal, and transvaginal urethrolysis were planned due to these symptoms.Translabial ultrasonography (tlus) and videourodynamics (vuds) were also performed on the patient in preparation for sling removal.During the urodynamic tests, the patient had modest detrusor overactivity but no incontinence with stress maneuvers.The voiding phase revealed no signs of obstruction.The patient is experiencing some vague flank discomfort, although there is no evidence of reflux.A renal ultrasound revealed no signs of hydronephrosis.On (b)(6) 2016, pathology results showed that the patient experienced mild chronic inflammation and a reaction to a foreign body as a result of the vaginal mesh implant.On (b)(6) 2016, the patient presented to the clinic with persistent right flank pain that she described as coming and going.She further stated that the pain is so bad that it radiates to the opposite side.She felt like the pain had not improved since the reimplantation, and applying pressure to the flank made it worse.She also said that urinating does not alleviate the pain.She also experienced pain while wearing a catheter for a week following the urethrolysis.During her visit, a computerized tomography (ct) was performed, which revealed kinking in the distal ureter on the right, which is implanted in the dome of the bladder.Furthermore, the physician's assessment revealed that the patient's urination has improved; while she is still not completely emptying, this is not bothering her.The doctor suspected that the kinking of the distal ureter had contributed to her pain.The physician also had an extensive discussion with the patient regarding the next steps in management.According to reports, the patient wishes to proceed with the boari flap and reimplantation of the right ureter.A pathology was performed on (b)(6) 2018, and the results showed fibroconnective tissue with a change in the procedure site and lymphocytic inflammation.On (b)(6) 2018, the patient had an abdominal exploration, residual retropubic mesh removal, and anterior vaginal wall reconstruction.According to the doctor, the patient is doing really well in terms of kidney function.Normal ultrasonography, drainage, and renal function are all retained (42% vs.57% previously).The patient is experiencing retropubic and suprapubic pain.Because of the obstruction and a small area of erosion, the patient had a tvt, and only the suburethral and periurethral segments of the mesh were removed to relieve the obstruction.The patient had no suprapubic area discomfort at the time of the surgery in april 2016, only obstruction, thus the retropubic piece of the mesh was not removed.She gradually began to experience substantial suprapubic pain over the course of the previous year or so, and she has not responded to any medication related to activity.The patient had rare urinary incontinence.Since the mesh is in the retropubic space, it was expected that the translabial ultrasound would not reveal any mesh.A ct scan reveals that both kidneys are operating normally.A cystogram reveals minimal reflux on the left side and none on the right, and an mri reveals no indication of osteomyelitis or other inflammatory changes in the bones.On (b)(6) 2018, the patient had persistent suprapubic pain and on-and-off right flank pain with a suprapubic ventral incisional hernia.The patient was seen by a doctor, who scheduled a hernia repair.Her suprapubic pain likely represents nerve damage from her prior mesh surgeries.They also discussed options for intervention, including botox trigger point injections, for which the patient is amendable.Furthermore, physical examination revealed a bulge over the low transverse incision site that increased with standing.Soft and reducible.When lying supine, the doctor palpated the edges of the fascial defect, which was 5cm long and 2cm wide.On (b)(6) 2018, the patient underwent a botox trigger point injection.However, the pain comes on in flares and generally responds to tramadol.The patient reportedly took about six tablets daily.According to the discharge summary on (b)(6) 2018, the patient had a stable exam, was breathing easily on room air, had return of bowel function, was tolerating a diet, and had adequate pain control with oral medication.The patient was deemed stable for discharge.On (b)(6) 2018, the patient reported that she continues to have pubic pain.She was taking narcotics for this; however, she had significant constipation issues.Her pain has not improved since her last surgery for mesh removal.On (b)(6) 2018, underwent an ultrasound procedure.On (b)(6) 2018, the patient was scheduled for a botox trigger point; however, it was noted that she still had a persistent suprapubic fluid collection.She has since followed up with her doctor, and her fluid collection is noted to be improving, but she is still having significant suprapubic pain.Targeted sonography of the lower abdominal wall in the area of the patient's concern demonstrates a fairly extensive subcutaneous fluid collection measuring approximately 10 cm x 2 cm x 2 cm, confined to the anterior aspect of the underlying mesh.The fluid contains debris.A mostly simple appearing subcutaneous fluid containing scattered debris is seen in the midline of the lower abdominal wall corresponding to the region of interest, most likely representing seroma versus hematoma.A superimposed infection is not excluded.A mesh appears to form the floor of this fluid collection.On (b)(6) 2019, the patient had a trigger point injection with botox.The patient was placed in the supine position.After preparation and draping, they marked the trigger points that reproduced the places of pain.Four areas were found.They injected diluted botox (100 units of botox in 20 cc of saline) 5 cc in each area of the trigger points in the subcutaneous tissue down to the area of the suprapubic bone.Marcaine was injected in the same place, a total of 20 cc 0.5%.There were no complications noted and the patient was discharged home.On (b)(6) 2019, the patient stated that the most recent set of injections had been the most beneficial, but that they had worn off.Tramadol is also prescribed for the patient's pain.On (b)(6) 2019, the patient had a trigger point injection with botox (100 units).The patient was discharged home on pain medicine.No complications bleeding or specimen.On (b)(6) 2019, the patient presented at the clinic with chronic pelvic rim and lower abdominal pain following multiple prior urology gynecologic surgeries.She developed incisional hernia requiring bridging repair with mesh.She presents in the clinic due to persistent pain and bulging in the llq area.On (b)(6) 2019, the patient had a botox injection for trigger point in the suprapubic and labial area bilaterally.The patient was placed in the supine position.After preparation and draping and marking the area of the pain bilaterally, we performed injection of 100 units of botox diluted in 20 cc of normal saline.Also, after the injection of botox, we injected marcaine, a total of 20 cc of 0.5% bilaterally.She tolerated the procedure well.There was no complication, bleeding or specimen.She was discharged home on oral antibiotics and return to the office in a few weeks.On (b)(6) 2019, the patient had a botox trigger point injection.According to reports, they prepared 100 units of botox diluted in 20 cc of saline and 20 cc of 1% marcaine for the trigger points on each side of the superior inguinal area after marking the trigger points in the suprapubic area, including pubic tubercles and slightly above the clitoral area.The doctor injected 3 cc of the diluted botox and marcaine into each designated location.Additionally, some suprapubic areas are marked and injected.The procedure was well tolerated by the patient.During physical examination, a lower abdominal wall bulge upon straining or standing up, especially pronounced on the left side just above the superior pubic ramus, was observed.On palpation, a small defect about 3x3 cm could be appreciated at the llq area but not the rest of the lower abdomen.There is some tenderness, specifically in the llq.There is no incarcerated content.In addition, a small area of fascial unevenness, possibly representing wrinkled mesh or scar tissue, could be felt in the rlq.There is a low midline incision and two separate low abdominal transverse incisions, all of which are well healed.According to reports, it was not clear whether patient has a recurrent hernia in the llq due to displaced/migrated ventral hernia repair mesh, or whether there is recurrence of the whole lower abdominal area underlying prior low midline incision.If the doctors were to offer surgical intervention, it would either involve a limited hernia repair in the llq or extensive dissection and removal of the prior mesh repair mesh and repeat repair with mesh and bone anchors.In addition, the multiple prior criss crossing incisions on her skin at this area may mean that additional dissection may devascularize the skin and require additional flaps for skin coverage.Furthermore, it is unclear whether the additional dissection and bone anchors would provide resolution to patient's current pain complaints.In view of the increased risks and questionable benefits associated with surgery, they are currently recommending withholding surgical intervention.The above considerations were discussed with the patient in length and the patient voiced understanding and agrees to be followed up at their clinic in approximately 6 months.Patient discussed with attending surgeon, who agree with above assessment and plan.On (b)(6) 2020 and (b)(6) 2021, the patient underwent a botox trigger point injection.After marking the trigger points in the suprapubic area, including pubic tubercles and just above the clitoral area, they prepared 5 cc of 1 % lidocaine, 100 units of botox diluted in 20 cc of saline, and 20 cc of 0.25 % marcaine in the trigger points in each side of the superior inguinal area.They injected 3cc of the diluted botox in each marked spot and marcaine in the same spots.Some suprapubic area also marked was also injected.The patient tolerated the procedure of without any complication.On (b)(6) 2021, the patient reported that she had numbness in the right groin area radiating down medially to her ankle after a procedure.She also had weakness in the right leg, but was able to move her foot/toes without any issues.The surgeon waited for 3 hours, but she had persistent numbness/weakness which did not correlate to the areas they injected.The patient was sent to emergency room for urgent evaluation.Also, she is having persistent left flank pain.U/s was normal except for extrarenal pelvis.They will obtain mag 3(mercaptoacetyltriglycine) renal scan to rule out functional obstruction.The patient was admitted given acute onset rle weakness, decreased sensation and inability to walk post procedure.On (b)(6) 2021, the patient reported that she feels much better but still using the crutch, in case she might be having a some right knee swelling, although on exam the knees are symmetric.She says that without the trigger point injections, she will "die" and that she is desperate to have another injection during her visit.Furthermore, the patient was last seen by the physician on (b)(6) 2021, and she reported that she had multiple botox trigger point injections, most recently on (b)(6) 2021, which have been very helpful in alleviating her chronic pain, which is localized to the right pubic bone and radiates down to the labia.
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