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BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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| Model Number M0068318170 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Bacterial Infection (1735); Erosion (1750); Hemorrhage/Bleeding (1888); Muscle Weakness (1967); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Discomfort (2330); Obstruction/Occlusion (2422); Prolapse (2475); Constipation (3274); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Insufficient Information (4580)
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| Event Date 10/08/2018 |
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Event Type
Injury
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Event Description
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This manufacturer report pertains to one of two devices used during the procedure.It was reported to boston scientific corporation that an uphold lite with capio slim device and an advantage system were used during a total vaginal hysterectomy, anterior/posterior repair, sacrospinous ligament fixation with advantage mid-urethral sling retropubic and cystoscopy procedure performed on (b)(6) 2015, for the treatment of menorrhagia, uterine prolapse, and stress urinary incontinence.Findings included cystocele, uterine prolapse with apical prolapse, and perineal relaxation.On (b)(6) 2018, the patient underwent vaginal mesh excision.She had vaginal pain and dyspareunia with complication of vaginal mesh.During the procedure, a transverse incision was made with a scalpel and metzenbaum used to undermine the vaginal epithelium.Blue colored mesh was encountered in the anterior vaginal wall with arms extending in the direction of the sacrospinous ligament.Sharp dissection was used to dissect free the vaginal side of the mesh.Next, an shnidt was passed underneath the medial portion of the mesh, and careful sharp dissection was used to dissect the medial portion of the mesh.The mesh was then transected and again, blunt and sharp dissection were used to dissect the mesh, including to the right arm, which extended to the sacrospinous ligament.Jorgenson scissors were used to cut the base of the mesh arm.Next, a copious amount of bleeding was encountered from the right pararectal, paravaginal area.Tamponade was held for 7 minutes and with improved bleeding, clamps were placed on the transected left portion of the mesh, and again, sharp dissection was used to dissect the medial and lateral surfaces of the mesh using peritoneal scissors to amputate the mesh as far laterally as possible.Gelfoam was applied to both portions of the surgical wound.The vaginal incision was then reapproximated in running fashion using 2-0 vicryl, and the vagina was then packed.The patient was then extubated and taken to the pacu in stable condition.On (b)(6) , 2019, the patient underwent laparoscopic sacrocolpopexy with restorelle y mesh, cystoscopy, and lynx midurethral sling with permanent mesh.She had post-hysterectomy vaginal vault prolapse, rectocele, and stress urinary incontinence.According to the findings from the procedure, cystoscopy was performed after the sacrocolpopexy and revealed bilateral ureteral efflux with no bladder injury.Cystoscopy was then repeated after sling and revealed no bladder injury, normal bladder mucosa, normal trigone and urethra.
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Manufacturer Narrative
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Date of event: date of event was approximated to (b)(6) 2018, the date of the vaginal mesh excision, as no event date was reported.This event was reported by the patient's legal representative.The implant surgeon is: (b)(6).The revision surgeon is: (b)(6).(b)(4).The complaint device 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 one of two devices used during the procedure.It was reported to boston scientific corporation that an uphold lite with capio slim device and an advantage system were used during a total vaginal hysterectomy, anterior/posterior repair, sacrospinous ligament fixation with advantage mid-urethral sling retropubic and cystoscopy procedure performed on (b)(6) 2015, for the treatment of menorrhagia, uterine prolapse, and stress urinary incontinence.Findings included cystocele, uterine prolapse with apical prolapse, and perineal relaxation.On (b)(6) 2018, the patient underwent vaginal mesh excision.She had vaginal pain and dyspareunia with complication of vaginal mesh.During the procedure, a transverse incision was made with a scalpel and metzenbaum used to undermine the vaginal epithelium.Blue colored mesh was encountered in the anterior vaginal wall with arms extending in the direction of the sacrospinous ligament.Sharp dissection was used to dissect free the vaginal side of the mesh.Next, an shnidt was passed underneath the medial portion of the mesh, and careful sharp dissection was used to dissect the medial portion of the mesh.The mesh was then transected and again, blunt and sharp dissection were used to dissect the mesh, including to the right arm, which extended to the sacrospinous ligament.Jorgenson scissors were used to cut the base of the mesh arm.Next, a copious amount of bleeding was encountered from the right pararectal, paravaginal area.Tamponade was held for 7 minutes and with improved bleeding, clamps were placed on the transected left portion of the mesh, and again, sharp dissection was used to dissect the medial and lateral surfaces of the mesh using peritoneal scissors to amputate the mesh as far laterally as possible.Gelfoam was applied to both portions of the surgical wound.The vaginal incision was then reapproximated in running fashion using 2-0 vicryl, and the vagina was then packed.The patient was then extubated and taken to the pacu in stable condition.On (b)(6) 2019, the patient underwent laparoscopic sacrocolpopexy with restorelle y mesh, cystoscopy, and lynx midurethral sling with permanent mesh.She had post-hysterectomy vaginal vault prolapse, rectocele, and stress urinary incontinence.According to the findings from the procedure, cystoscopy was performed after the sacrocolpopexy and revealed bilateral ureteral efflux with no bladder injury.Cystoscopy was then repeated after sling and revealed no bladder injury, normal bladder mucosa, normal trigone and urethra.Additional information received on november 16, 2022.On (b)(6) 2015, the patient was seen and examined due to vaginal sore and vulvar lump.The patient started having pain two days ago and noticed a painful lump on her left labia.The previous day, while having a bowel movement she felt a "pop" and the lump expressed bright red blood and clear fluid.The patient reported this was very painful.The patient denied history of stds and she had no new sexual partners.The patient continued to have brownish yellow vaginal discharge since her surgery in august 2015.In the physician's assessment the patient had vulvar abscess which was draining spontaneously.The physician reviewed the differential of vulvovaginal mass including bartholin cyst, inclusion cyst, perianal infection or folliculitis.Suspect bartholin abscess that has drained spontaneously, no palpable mass on exam today.Genital culture was obtained.The patient was prescribed with augmentin 875 mg bid for 7 days and clindamycin 300 mg old for 7 days.They discussed warm sitz bath to assist in further drainage.The physician instructed that the patient may use cold packs and tylenol for pain relief.The patient was instructed to return to the clinic if patient experiences worsening pain, fever or chills.The patient agreed with the plan.The patient's genital culture with gram results were abnormal.Gram stain revealed no polyps, altered flora consistent with bacterial vaginosis and no yeasts seen.On (b)(6) 2015, the patient was seen and examined for a post operation examination for a hysterectomy performed on (b)(6) 2015.The patient had intercourse at 7 weeks and 8 weeks post operation and bled both times.Otherwise, patient has no other issue.During intercourse the patient felt like it hurts, twinges of pain.Prior to the pain she had been riding in her car and has resolved the pelvic spasm associated with the prolapse.In the physician's assessment, the patient's vaginal cuff was not completely healed, and an estrogen cream was prescribed.The apex was well supported, the mesh was tight, and pressure induced some discomfort.The patient may need to be opened with small tension release, but the physician felt he would not do it at this time but may need to do it if this was not resolved in a month or two.The patient's urinary incontinence has also resolved.The patient needed to continue on pelvic rest for 2 more weeks.Okay to resume lifting, may return to work today.May resume normal activities, except intercourse.The patient was instructed for a follow up in two weeks and as needed.On (b)(6) 2018, the patient phoned and reported that something was sticking out of her vaginal area.There was no sling in place.An appointment was offered with the physician in september when the physician was first available, but she would like to be seen sooner or speak to someone who can give her medical advice.On (b)(6) 2018, the patient was seen and examined due to recurrent prolapse, stress urinary incontinence, pelvic pain and dyspareunia.The physician recommended mesh removal and pelvic floor pt.The patient's daily schedule wiould not allow her to do pelvic floor pt.They discussed d the risks, benefits, and alternatives of vaginal mesh excision including failure to improve pelvic pain, bladder or other visceral organ injury, bowel, bladder, blood vessels, ureters, urethra, prolonged catheterization, voiding dysfunction, need for subsequent procedures, pain, painful intercourse, recurrent prolapse or failure to treat the problem.They also discussed that a staged approach to treating her pelvic pain and then later, prolapse and sui would be most safe.She was interested in sacrocolpopexy with mesh for prolapse treatment in the future.They will discuss this further, as typical management of mesh-related pain would be to avoid mesh augmentation; would offer repair no sooner than 2-3 months postoperatively after mesh excision.On (b)(6) 2018, the patient had an ultrasound which revealed a simple left ovarian 3 cm cyst which was likely benign and did not need follow up.Tenderness was also noted in this region.The right ovary was not visualized, and the uterus was absent.On (b)(6) 2018, the patient was seen and examined status post vaginal mesh excision.The patient was doing well.The patient had a stage 2 rectocele, vaginal vault prolapse and shortened tvl.In the physician's assessment, the patient may return to sexual activity in a month if she desired.The patient underwent a procedure for mesh removal and pelvic reconstruction on (b)(6) 2019.The patient was diagnosed with pudendal neuralgia in (b)(6) 2022.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to october 08, 2018, the date of the vaginal mesh excision, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6).The revision surgeon is: dr.(b)(6).(b)(6).Block h6: the following imdrr patient codes capture the reportable events below: e2330 - pain.E1405 - dyspareunia.E0506 - heavy bleeding.E2401 - vaginal mesh complication.E0123 - pudendal neuralgia.E1901 - bacterial infection.E1401 - vaginal discharge.E0506 - hemorrhage.E2311 - discomfort.E1621 - muscle weakness.Imdrf impact code f1905: device revision of replacement has been used to capture vaginal mesh excision, laparoscopic sacrocolpopexy with restorelle y mesh, and midurethral sling with permanent mesh.Imdrf impact code f12 has been used in the light of the patient sought legal recourse for a personal injury related to the device.Block h11: blocks a4, b5, h6 and h10 have been updated based on the additional information received on november 16, 2022.
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Event Description
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Note: this manufacturer report pertains to one of two devices used during the procedure.It was reported to boston scientific corporation that an uphold lite with capio slim device and an advantage system were used during a total vaginal hysterectomy, anterior/posterior repair, sacrospinous ligament fixation with advantage mid-urethral sling retropubic and cystoscopy procedure performed on (b)(6) 2015, for the treatment of menorrhagia, uterine prolapse, and stress urinary incontinence.Findings included cystocele, uterine prolapse with apical prolapse, and perineal relaxation.On (b)(6) 2018, the patient underwent vaginal mesh excision.She had vaginal pain and dyspareunia with complication of vaginal mesh.During the procedure, a transverse incision was made with a scalpel and metzenbaum used to undermine the vaginal epithelium.Blue colored mesh was encountered in the anterior vaginal wall with arms extending in the direction of the sacrospinous ligament.Sharp dissection was used to dissect free the vaginal side of the mesh.Next, an shnidt was passed underneath the medial portion of the mesh, and careful sharp dissection was used to dissect the medial portion of the mesh.The mesh was then transected and again, blunt and sharp dissection were used to dissect the mesh, including to the right arm, which extended to the sacrospinous ligament.Jorgenson scissors were used to cut the base of the mesh arm.Next, a copious amount of bleeding was encountered from the right pararectal, paravaginal area.Tamponade was held for 7 minutes and with improved bleeding, clamps were placed on the transected left portion of the mesh, and again, sharp dissection was used to dissect the medial and lateral surfaces of the mesh using peritoneal scissors to amputate the mesh as far laterally as possible.Gelfoam was applied to both portions of the surgical wound.The vaginal incision was then reapproximated in running fashion using 2-0 vicryl, and the vagina was then packed.The patient was then extubated and taken to the pacu in stable condition.On (b)(6) 2019, the patient underwent laparoscopic sacrocolpopexy with restorelle y mesh, cystoscopy, and lynx midurethral sling with permanent mesh.She had post-hysterectomy vaginal vault prolapse, rectocele, and stress urinary incontinence.According to the findings from the procedure, cystoscopy was performed after the sacrocolpopexy and revealed bilateral ureteral efflux with no bladder injury.Cystoscopy was then repeated after sling and revealed no bladder injury, normal bladder mucosa, normal trigone and urethra.***additional information received on november 16, 2022*** on (b)(6) 2015, the patient was seen and examined due to vaginal sore and vulvar lump.The patient started having pain two days ago and noticed a painful lump on her left labia.The previous day, while having a bowel movement she felt a "pop" and the lump expressed bright red blood and clear fluid.The patient reported this was very painful.The patient denied history of stds and she had no new sexual partners.The patient continued to have brownish yellow vaginal discharge since her surgery in august 2015.In the physician's assessment the patient had vulvar abscess which was draining spontaneously.The physician reviewed the differential of vulvovaginal mass including bartholin cyst, inclusion cyst, perianal infection or folliculitis.Suspect bartholin abscess that has drained spontaneously, no palpable mass on exam today.Genital culture was obtained.The patient was prescribed with augmentin 875 mg bid for 7 days and clindamycin 300 mg old for 7 days.They discussed warm sitz bath to assist in further drainage.The physician instructed that the patient may use cold packs and tylenol for pain relief.The patient was instructed to return to the clinic if patient experiences worsening pain, fever or chills.The patient agreed with the plan.The patient's genital culture with gram results were abnormal.Gram stain revealed no polyps, altered flora consistent with bacterial vaginosis and no yeasts seen.On (b)(6) 2015, the patient was seen and examined for a post operation examination for a hysterectomy performed on (b)(6) 2015.The patient had intercourse at 7 weeks and 8 weeks post operation and bled both times.Otherwise, patient has no other issue.During intercourse the patient felt like it hurts, twinges of pain.Prior to the pain she had been riding in her car and has resolved the pelvic spasm associated with the prolapse.In the physician's assessment, the patient's vaginal cuff was not completely healed, and an estrogen cream was prescribed.The apex was well supported, the mesh was tight, and pressure induced some discomfort.The patient may need to be opened with small tension release, but the physician felt he would not do it at this time but may need to do it if this was not resolved in a month or two.The patient's urinary incontinence has also resolved.The patient needed to continue on pelvic rest for 2 more weeks.Okay to resume lifting, may return to work today.May resume normal activities, except intercourse.The patient was instructed for a follow up in two weeks and as needed.On august 1, 2018, the patient phoned and reported that something was sticking out of her vaginal area.There was no sling in place.An appointment was offered with the physician in september when the physician was first available, but she would like to be seen sooner or speak to someone who can give her medical advice.On (b)(6) 2018, the patient was seen and examined due to recurrent prolapse, stress urinary incontinence, pelvic pain and dyspareunia.The physician recommended mesh removal and pelvic floor pt.The patient's daily schedule wiould not allow her to do pelvic floor pt.They discussed d the risks, benefits, and alternatives of vaginal mesh excision including failure to improve pelvic pain, bladder or other visceral organ injury, bowel, bladder, blood vessels, ureters, urethra, prolonged catheterization, voiding dysfunction, need for subsequent procedures, pain, painful intercourse, recurrent prolapse or failure to treat the problem.They also discussed that a staged approach to treating her pelvic pain and then later, prolapse and sui would be most safe.She was interested in sacrocolpopexy with mesh for prolapse treatment in the future.They will discuss this further, as typical management of mesh-related pain would be to avoid mesh augmentation; would offer repair no sooner than 2-3 months postoperatively after mesh excision.On (b)(6) 2018, the patient had an ultrasound which revealed a simple left ovarian 3 cm cyst which was likely benign and did not need follow up.Tenderness was also noted in this region.The right ovary was not visualized, and the uterus was absent.On (b)(6) 2018, the patient was seen and examined status post vaginal mesh excision.The patient was doing well.The patient had a stage 2 rectocele, vaginal vault prolapse and shortened tvl.In the physician's assessment, the patient may return to sexual activity in a month if she desired.The patient underwent a procedure for mesh removal and pelvic reconstruction on (b)(6) 2019.The patient was diagnosed with pudendal neuralgia in june 2022.***additional information received on january 6, 2023*** additional information received clarifies that the mesh removal and pelvic reconstruction was performed on (b)(6) 2019 and not october 19, 2019 as previously indicated.On (b)(6) 2019, the patient underwent partial sling excision, urethral repair, cystoscopy, posterior colporrhaphy procedures.Preoperative diagnoses were rectocele, incomplete bladder emptying, voiding dysfunction, dyspareunia, and chronic pelvic pain.In the physician's assessment, the pelvic pain was likely related to 2 prior slings or prior uphold vaginal mesh.Following the procedure, the patient was diagnosed with a urethral injury from 2 tight slings.Procedure findings were as follows: 1.Prior lynx sling was located very distal near external meatus instead of the mid-urethra.The sling was on tension and "sawed through" the urethral meatus.2.Prior advantage sling also located near the external meatus, underneath the newer lynx sling.The sling was also on tension and "sawed through" the urethral meatus.A decision was made to remove this sling also as it was 2mm away from a mid-urethral erosion.3.Each sling was identified and incised.Each sling was dissected to remove approximately 2mm of mesh on each side.Cystoscopy confirmed no injury.4.Urethral muscle was injured from tight sling and needed reconstruction.Following excision of the slings, the urethral muscles were not present at the urethra and were instead attached to the vaginal incision and needed to be reconstructed.A paper-thin layer of urethral tissue could be palpated between the physician's finger and the foley.5.Blue mesh fragments consistent with prior uphold mesh.6.Short transvaginal length, 5-6cm, likely related to multiple surgeries.The procedure was completed with no complications.
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Manufacturer Narrative
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Block b3 date of event: date of event was approximated to (b)(6) 2018, the date of the vaginal mesh excision, as no event date was reported.Block e1: this event was reported by the patient's legal representative.The implant surgeon is: dr.(b)(6) the revision surgeon is: dr.(b)(6) (b)(6) block h6: the following imdrr patient codes capture the reportable events below: e2330 - pain e1405 - dyspareunia e0506 - heavy bleeding e2401 - vaginal mesh complication e0123 - pudendal neuralgia e1901 - bacterial infection e1401 - vaginal discharge.E0506 - hemorrhage.E2311 - discomfort.E1621 - muscle weakness.Imdrf impact code f1905: device revision of replacement has been used to capture vaginal mesh excision, laparoscopic sacrocolpopexy with restorelle y mesh, and midurethral sling with permanent mesh.Imdrf impact code f12 has been used in the light of the patient sought legal recourse for a personal injury related to the device.Block h11: blocks a4, b5, h6 and h10 have been updated based on the additional information received on november 16, 2022.Block h11: blocks b5, h6 and h10 have been updated based on the additional information received on january 6, 2023.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6) (b)(6) center usa the revision procedure was performed by: (b)(6) md (b)(6) hospital (b)(6) block h6: the following imdrr patient codes capture the reportable events below: e2330 - pain e1405 - dyspareunia e0506 - heavy bleeding e2401 - vaginal mesh complication e0123 - pudendal neuralgia e1901 - bacterial infection e1401 - vaginal discharge.E0506 - hemorrhage.E2311 - discomfort.E1621 - muscle weakness.E2006 - erosion e1715 - scar tissue imdrf impact code f1905: device revision of replacement has been used to capture vaginal mesh excision, laparoscopic sacrocolpopexy with restorelle y mesh, and midurethral sling with permanent mesh.Imdrf impact code f12 has been used in the light of the patient sought legal recourse for a personal injury related to the device.
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Manufacturer Narrative
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Block h2: additional information blocks h5 (event description) and h6 (patient codes and impact codes) has been updated based on the additional information received on july 19, 2023.Correction: block e1 (initial reporter) has been updated.Block b3 date of event: date of event was approximated to october 08, 2018, the date of the vaginal mesh excision, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The revision procedure was performed by: (b)(6).Block h6: the following imdrf patient codes capture the reportable events below: e2330 - pain.E1405 - dyspareunia.E0506 - heavy bleeding.E2401 - vaginal mesh complication.E0123 - pudendal neuralgia.E1901 - bacterial infection.E1401 - vaginal discharge.E0506 - hemorrhage.E2311 - discomfort.E1621 - muscle weakness.E2006 - erosion.E1715 - scar tissue.E2328 - incomplete bowel movement and bowel movement straining.The following imdrf patient codes capture the reportable events below: f1905: device revision of replacement has been used to capture vaginal mesh excision, laparoscopic sacrocolpopexy with restorelle y mesh, and midurethral sling with permanent mesh.F12 has been used in the light of the patient sought legal recourse for a personal injury related to the device.F2303 has been used to capture the event of patient was prescribed with vaginal estrogen and motrin.
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Event Description
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Note: this manufacturer report pertains to one of two devices used during the procedure.It was reported to boston scientific corporation that an uphold lite with capio slim device and an advantage system were used during a total vaginal hysterectomy, anterior/posterior repair, sacrospinous ligament fixation with advantage mid-urethral sling retropubic and cystoscopy procedure performed on august 28, 2015, for the treatment of menorrhagia, uterine prolapse, and stress urinary incontinence.Findings included cystocele, uterine prolapse with apical prolapse, and perineal relaxation.On october 08, 2018, the patient underwent vaginal mesh excision.She had vaginal pain and dyspareunia with complication of vaginal mesh.During the procedure, a transverse incision was made with a scalpel and metzenbaum used to undermine the vaginal epithelium.Blue colored mesh was encountered in the anterior vaginal wall with arms extending in the direction of the sacrospinous ligament.Sharp dissection was used to dissect free the vaginal side of the mesh.Next, an shnidt was passed underneath the medial portion of the mesh, and careful sharp dissection was used to dissect the medial portion of the mesh.The mesh was then transected and again, blunt and sharp dissection were used to dissect the mesh, including to the right arm, which extended to the sacrospinous ligament.Jorgenson scissors were used to cut the base of the mesh arm.Next, a copious amount of bleeding was encountered from the right pararectal, paravaginal area.Tamponade was held for 7 minutes and with improved bleeding, clamps were placed on the transected left portion of the mesh, and again, sharp dissection was used to dissect the medial and lateral surfaces of the mesh using peritoneal scissors to amputate the mesh as far laterally as possible.Gelfoam was applied to both portions of the surgical wound.The vaginal incision was then reapproximated in running fashion using 2-0 vicryl, and the vagina was then packed.The patient was then extubated and taken to the pacu in stable condition.On (b)(6), 2019, the patient underwent laparoscopic sacrocolpopexy with restorelle y mesh, cystoscopy, and lynx midurethral sling with permanent mesh.She had post-hysterectomy vaginal vault prolapse, rectocele, and stress urinary incontinence.According to the findings from the procedure, cystoscopy was performed after the sacrocolpopexy and revealed bilateral ureteral efflux with no bladder injury.Cystoscopy was then repeated after sling and revealed no bladder injury, normal bladder mucosa, normal trigone and urethra.***additional information received on november 16, 2022*** on october 16, 2015, the patient was seen and examined due to vaginal sore and vulvar lump.The patient started having pain two days ago and noticed a painful lump on her left labia.The previous day, while having a bowel movement she felt a "pop" and the lump expressed bright red blood and clear fluid.The patient reported this was very painful.The patient denied history of stds and she had no new sexual partners.The patient continued to have brownish yellow vaginal discharge since her surgery in august 2015.In the physician's assessment the patient had vulvar abscess which was draining spontaneously.The physician reviewed the differential of vulvovaginal mass including bartholin cyst, inclusion cyst, perianal infection or folliculitis.Suspect bartholin abscess that has drained spontaneously, no palpable mass on exam today.Genital culture was obtained.The patient was prescribed with augmentin 875 mg bid for 7 days and clindamycin 300 mg old for 7 days.They discussed warm sitz bath to assist in further drainage.The physician instructed that the patient may use cold packs and tylenol for pain relief.The patient was instructed to return to the clinic if patient experiences worsening pain, fever or chills.The patient agreed with the plan.The patient's genital culture with gram results were abnormal.Gram stain revealed no polyps, altered flora consistent with bacterial vaginosis and no yeasts seen.On october 26, 2015, the patient was seen and examined for a post operation examination for a hysterectomy performed on september 22, 2015.The patient had intercourse at 7 weeks and 8 weeks post operation and bled both times.Otherwise, patient has no other issue.During intercourse the patient felt like it hurts, twinges of pain.Prior to the pain she had been riding in her car and has resolved the pelvic spasm associated with the prolapse.In the physician's assessment, the patient's vaginal cuff was not completely healed, and an estrogen cream was prescribed.The apex was well supported, the mesh was tight, and pressure induced some discomfort.The patient may need to be opened with small tension release, but the physician felt he would not do it at this time but may need to do it if this was not resolved in a month or two.The patient's urinary incontinence has also resolved.The patient needed to continue on pelvic rest for 2 more weeks.Okay to resume lifting, may return to work today.May resume normal activities, except intercourse.The patient was instructed for a follow up in two weeks and as needed.On august 1, 2018, the patient phoned and reported that something was sticking out of her vaginal area.There was no sling in place.An appointment was offered with the physician in september when the physician was first available, but she would like to be seen sooner or speak to someone who can give her medical advice.On september 27, 2018, the patient was seen and examined due to recurrent prolapse, stress urinary incontinence, pelvic pain and dyspareunia.The physician recommended mesh removal and pelvic floor pt.The patient's daily schedule wiould not allow her to do pelvic floor pt.They discussed d the risks, benefits, and alternatives of vaginal mesh excision including failure to improve pelvic pain, bladder or other visceral organ injury, bowel, bladder, blood vessels, ureters, urethra, prolonged catheterization, voiding dysfunction, need for subsequent procedures, pain, painful intercourse, recurrent prolapse or failure to treat the problem.They also discussed that a staged approach to treating her pelvic pain and then later, prolapse and sui would be most safe.She was interested in sacrocolpopexy with mesh for prolapse treatment in the future.They will discuss this further, as typical management of mesh-related pain would be to avoid mesh augmentation; would offer repair no sooner than 2-3 months postoperatively after mesh excision.On october 2, 2018, the patient had an ultrasound which revealed a simple left ovarian 3 cm cyst which was likely benign and did not need follow up.Tenderness was also noted in this region.The right ovary was not visualized, and the uterus was absent.On november 12, 2018, the patient was seen and examined status post vaginal mesh excision.The patient was doing well.The patient had a stage 2 rectocele, vaginal vault prolapse and shortened tvl.In the physician's assessment, the patient may return to sexual activity in a month if she desired.The patient underwent a procedure for mesh removal and pelvic reconstruction on october 19, 2019.The patient was diagnosed with pudendal neuralgia in june 2022.***additional information received on january 6, 2023*** additional information received clarifies that the mesh removal and pelvic reconstruction was performed on october 7, 2019 and not october 19, 2019 as previously indicated.On october 7, 2019, the patient underwent partial sling excision, urethral repair, cystoscopy, posterior colporrhaphy procedures.Preoperative diagnoses were rectocele, incomplete bladder emptying, voiding dysfunction, dyspareunia, and chronic pelvic pain.In the physician's assessment, the pelvic pain was likely related to 2 prior slings or prior uphold vaginal mesh.Following the procedure, the patient was diagnosed with a urethral injury from 2 tight slings.Procedure findings were as follows: 1.Prior lynx sling was located very distal near external meatus instead of the mid-urethra.The sling was on tension and "sawed through" the urethral meatus.2.Prior advantage sling also located near the external meatus, underneath the newer lynx sling.The sling was also on tension and "sawed through" the urethral meatus.A decision was made to remove this sling also as it was 2mm away from a mid-urethral erosion.3.Each sling was identified and incised.Each sling was dissected to remove approximately 2mm of mesh on each side.Cystoscopy confirmed no injury.4.Urethral muscle was injured from tight sling and needed reconstruction.Following excision of the slings, the urethral muscles were not present at the urethra and were instead attached to the vaginal incision and needed to be reconstructed.A paper-thin layer of urethral tissue could be palpated between the physician's finger and the foley.5.Blue mesh fragments consistent with prior uphold mesh.6.Short transvaginal length, 5-6cm, likely related to multiple surgeries.The procedure was completed with no complications.***additional information received on july 19, 2023*** on september 27, 2018, the patient was seen and examined due to recurrent prolapse, stress urinary incontinence, pelvic pain, and dyspareunia.The patient reports stress urinary incontinence with walking most of the time.She reports spraying urine with voiding.She reports pain with intercourse and at rest, intermittent throughout the day, depending on if she sits on a hard surface or if she is walking a lot.She claims that vaginal pain is not severe.Since the prolapse returned, she has been experiencing pain during intercourse, as if her partner is striking something.On november 12, 2018, the patient was seen and checked for status following vaginal mesh removal on october 8, 2018.The patient denies experiencing vaginal bleeding.Her pain is well tolerated.She denies difficulty voiding or urinary incontinence.She denies having problems voiding or having urine incontinence.Her bowel movements are soft daily.She desires surgery for prolapse.She wishes to have surgery for prolapse.She no longer gets vaginal pain while resting and was very happy about this.She reports she is sexually active but that sometimes, due to her husband's medical condition, he is often unable to maintain an erection.On (b)(6) 2019, the patient underwent a laparoscopic sacrocolpopexy, cystoscopy, and mid-urethral sling with permanent mesh placement.On (b)(6) 2019, the patient reported incomplete bladder emptying occasionally, but empties after a second attempt.She reports abdominal soreness with prolonged standing or sitting.As of april 4, 2019, the patient has reported tolerating her pain well and has experienced no difficulty with voiding or urinary incontinence.Bowel movements are soft daily.She had minimal cramping with initial penetration and no vaginal pain at rest.She was noted to have decreased stream and stress urinary incontinence with a full bladder.She was happy with the outcome so far.On april 15, 2019, the patient returned to work and experienced vaginal pain inside and near the opening when walking.She was also in pain throughout intercourse.There was no dysuria.She denies having stress incontinence of urine.Bowel movement feels incomplete, and she notices a vaginal bulge again.The doctor prescribed vaginal estrogen to the patient, and they also discussed surgically reducing the tension on the y-mesh.This will be done if her pain persists for more than two months.On may 2, 2019, the patient visited the clinic for a follow-up on prolapse and pelvic pain.Since her last visit, she has tried vaginal estrogen, which did not help.She also had constant lower back and lower abdominal pain, going from a 7 out of 10 pain score to a 3 out of 10 with motrin, which she takes daily at work.Reportedly, she was unable to have sex.She has pain with valsalva for voiding.Valsalva voiding is not new, but the pain associated with it is.She denies stress urinary incontinence with coughing, as she did before the sling procedure, but notes that her underwear always feels damp.On june 19, 2019, the patient presented for evaluation of urinary incontinence, pelvic pain, and pelvic organ prolapse.Assessment and plan: *urinary incontinence/overactive bladder - since the surgery in 2019, the urinary incontinence leaking is worse, and no obvious sui trigger - voids every hour of a day; she also has urge urinary incontinence and leaking seems random to her.- main ui triggers are walking, no leaking felt, knows it is wet when she goes to void - uses 3-4 medium pads during the day, and at night.- they will do a trial of ditropan.*pelvic pain - since the vaginal uphold mesh removal surgery in 2018, the pelvic pain went from a 7 to a 3 out of 10.- since the mesh insertion and pop repair, she has had pain daily, constant.- pain is described as a dull ache in the lower abdomen, pelvis, and low back, not burning or sharp.- she points to the lower back/buttock, bilateral, not at the top of the sacrum where the mesh was.- she uses motrin 800 mg twice at work, which helps with pain.- she has not used tylenol or gabapentin, or elavil; the physician has recommended trying these before repeat surgery.*pelvic organ prolapse - she has a vaginal bulge, desires repair, pelvic organ prolapse signs of bulge, pressure, heaviness, bowel movement strain, and incomplete bladder emptying.The patient presented to the clinic on august 15, 2019, for evaluation of pelvic organ prolapse, urinary incontinence, and pain.The patient complains of a bothersome recurring vaginal bulge.She experiences a "baby crowning" sensation, her urinary stream is sprayed, she has to strain for bowel movement, and she denies splinting for voiding or bowel movement.She claims that sex is painful.She also feels pain in her groin, lower belly, and back merely sitting and walking.She claimed that the pain is a 3 out of 10, with a maximum of a 6 out of 10.She claims it frequently reaches 6 out of 10 because she walks a lot for work.Assessment: *likely due to too much tension on sacrocolpopexy mesh *rectocele plan: *magnetic resonance imaging (mri) lumbar spine to evaluate for discitis or osteitis.*if magnetic resonance imaging (mri) is normal, the physician will plan for laparoscopic mesh revision, cystoscopy, and posterior colporrhaphy.Review of systems: abdomen: soft, no mass, non-distended, no hernia, bmi 44 non-tender, except for right lower quadrant tenderness, possibly over the lapsc mesh implant.Vagina: no lesions, no discharge, no atrophy, non-tender.There was some tender scarring near the apex and a tender nodule, about 5 mm.No mesh erosion.There is no obvious tender location from the prior uphold mesh (per her report, there is still some mesh on the left apex).The lapsc/non-boston scientific mesh does not appear too tight, has some mild tenderness but "sags" mildly, and does not appear to be tight at all.On november 19, 2019, the patient reported that she voids better.She hadn't had sex yet, but there was no pelvic pain at rest, and on the exam, only mid discomfort was felt, so likely the dyspareunia improved significantly.She no longer has symptoms of urinary incontinence.The patient presented to the clinic on november 19, 2019, for a postoperative visit.She reported voiding more frequently.She hadn't had sex yet, but there was no pelvic pain at rest or mild discomfort on the exam, indicating that the dyspareunia had likely improved significantly.She no longer has urine incontinence symptoms.On september 8, 2020, the patient visited the clinic and believed she had prolapsed again.Below are patient's diagnosis during her visit: *overactive bladder *dyspareunia *vaginal vault prolapse *cystocele.
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Manufacturer Narrative
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Block h2: correction block h6 (patient code): the imdrf patient code e2328 was removed, and imdrf patient code e1007 was added to capture the reported event of incomplete bowel movement and bowel movement straining.Block b3 date of event: date of event was approximated to (b)(6) 2018, the date of the vaginal mesh excision, as no event date was reported.Block e1: this event was reported by the patient's legal representation.The implant surgeon is: (b)(6).The revision procedure was performed by: (b)(6).Block h6: the following imdrf patient codes capture the reportable events below: e2330 - pain e1405 - dyspareunia e0506 - heavy bleeding e2401 - vaginal mesh complication e0123 - pudendal neuralgia e1901 - bacterial infection e1401 - vaginal discharge.E0506 - hemorrhage.E2311 - discomfort.E1621 - muscle weakness.E2006 - erosion e1715 - scar tissue.The following imdrf patient codes capture the reportable events below: f1905: device revision of replacement has been used to capture vaginal mesh excision, laparoscopic sacrocolpopexy with restorelle y mesh, and midurethral sling with permanent mesh.F12 has been used in the light of the patient sought legal recourse for a personal injury related to the device.F2303 has been used to capture the event of patient was prescribed with vaginal estrogen and motrin.
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Event Description
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Note: this manufacturer report pertains to one of two devices used during the procedure.It was reported to boston scientific corporation that an uphold lite with capio slim device and an advantage system were used during a total vaginal hysterectomy, anterior/posterior repair, sacrospinous ligament fixation with advantage mid-urethral sling retropubic and cystoscopy procedure performed on (b)(6) 2015, for the treatment of menorrhagia, uterine prolapse, and stress urinary incontinence.Findings included cystocele, uterine prolapse with apical prolapse, and perineal relaxation.On (b)(6) 2018, the patient underwent vaginal mesh excision.She had vaginal pain and dyspareunia with complication of vaginal mesh.During the procedure, a transverse incision was made with a scalpel and metzenbaum used to undermine the vaginal epithelium.Blue colored mesh was encountered in the anterior vaginal wall with arms extending in the direction of the sacrospinous ligament.Sharp dissection was used to dissect free the vaginal side of the mesh.Next, an shnidt was passed underneath the medial portion of the mesh, and careful sharp dissection was used to dissect the medial portion of the mesh.The mesh was then transected and again, blunt and sharp dissection were used to dissect the mesh, including to the right arm, which extended to the sacrospinous ligament.Jorgenson scissors were used to cut the base of the mesh arm.Next, a copious amount of bleeding was encountered from the right pararectal, paravaginal area.Tamponade was held for 7 minutes and with improved bleeding, clamps were placed on the transected left portion of the mesh, and again, sharp dissection was used to dissect the medial and lateral surfaces of the mesh using peritoneal scissors to amputate the mesh as far laterally as possible.Gelfoam was applied to both portions of the surgical wound.The vaginal incision was then reapproximated in running fashion using 2-0 vicryl, and the vagina was then packed.The patient was then extubated and taken to the pacu in stable condition.On (b)(6) 2019, the patient underwent laparoscopic sacrocolpopexy with restorelle y mesh, cystoscopy, and lynx midurethral sling with permanent mesh.She had post-hysterectomy vaginal vault prolapse, rectocele, and stress urinary incontinence.According to the findings from the procedure, cystoscopy was performed after the sacrocolpopexy and revealed bilateral ureteral efflux with no bladder injury.Cystoscopy was then repeated after sling and revealed no bladder injury, normal bladder mucosa, normal trigone and urethra.***additional information received on november 16, 2022*** on (b)(6) 2015, the patient was seen and examined due to vaginal sore and vulvar lump.The patient started having pain two days ago and noticed a painful lump on her left labia.The previous day, while having a bowel movement she felt a "pop" and the lump expressed bright red blood and clear fluid.The patient reported this was very painful.The patient denied history of stds and she had no new sexual partners.The patient continued to have brownish yellow vaginal discharge since her surgery in (b)(6) 2015.In the physician's assessment the patient had vulvar abscess which was draining spontaneously.The physician reviewed the differential of vulvovaginal mass including bartholin cyst, inclusion cyst, perianal infection or folliculitis.Suspect bartholin abscess that has drained spontaneously, no palpable mass on exam today.Genital culture was obtained.The patient was prescribed with augmentin 875 mg bid for 7 days and clindamycin 300 mg old for 7 days.They discussed warm sitz bath to assist in further drainage.The physician instructed that the patient may use cold packs and tylenol for pain relief.The patient was instructed to return to the clinic if patient experiences worsening pain, fever or chills.The patient agreed with the plan.The patient's genital culture with gram results were abnormal.Gram stain revealed no polyps, altered flora consistent with bacterial vaginosis and no yeasts seen.On (b)(6) 2015, the patient was seen and examined for a post operation examination for a hysterectomy performed on (b)(6) 2015.The patient had intercourse at 7 weeks and 8 weeks post operation and bled both times.Otherwise, patient has no other issue.During intercourse the patient felt like it hurts, twinges of pain.Prior to the pain she had been riding in her car and has resolved the pelvic spasm associated with the prolapse.In the physician's assessment, the patient's vaginal cuff was not completely healed, and an estrogen cream was prescribed.The apex was well supported, the mesh was tight, and pressure induced some discomfort.The patient may need to be opened with small tension release, but the physician felt he would not do it at this time but may need to do it if this was not resolved in a month or two.The patient's urinary incontinence has also resolved.The patient needed to continue on pelvic rest for 2 more weeks.Okay to resume lifting, may return to work today.May resume normal activities, except intercourse.The patient was instructed for a follow up in two weeks and as needed.On (b)(6) 2018, the patient phoned and reported that something was sticking out of her vaginal area.There was no sling in place.An appointment was offered with the physician in september when the physician was first available, but she would like to be seen sooner or speak to someone who can give her medical advice.On (b)(6) 2018, the patient was seen and examined due to recurrent prolapse, stress urinary incontinence, pelvic pain and dyspareunia.The physician recommended mesh removal and pelvic floor pt.The patient's daily schedule wiould not allow her to do pelvic floor pt.They discussed d the risks, benefits, and alternatives of vaginal mesh excision including failure to improve pelvic pain, bladder or other visceral organ injury, bowel, bladder, blood vessels, ureters, urethra, prolonged catheterization, voiding dysfunction, need for subsequent procedures, pain, painful intercourse, recurrent prolapse or failure to treat the problem.They also discussed that a staged approach to treating her pelvic pain and then later, prolapse and sui would be most safe.She was interested in sacrocolpopexy with mesh for prolapse treatment in the future.They will discuss this further, as typical management of mesh-related pain would be to avoid mesh augmentation; would offer repair no sooner than 2-3 months postoperatively after mesh excision.On (b)(6) 2018, the patient had an ultrasound which revealed a simple left ovarian 3 cm cyst which was likely benign and did not need follow up.Tenderness was also noted in this region.The right ovary was not visualized, and the uterus was absent.On (b)(6) 2018, the patient was seen and examined status post vaginal mesh excision.The patient was doing well.The patient had a stage 2 rectocele, vaginal vault prolapse and shortened tvl.In the physician's assessment, the patient may return to sexual activity in a month if she desired.The patient underwent a procedure for mesh removal and pelvic reconstruction on (b)(6) 2019.The patient was diagnosed with pudendal neuralgia in (b)(6) 2022.***additional information received on january 6, 2023*** additional information received clarifies that the mesh removal and pelvic reconstruction was performed on (b)(6) 2019 and not (b)(6) 2019 as previously indicated.On (b)(6) 2019, the patient underwent partial sling excision, urethral repair, cystoscopy, posterior colporrhaphy procedures.Preoperative diagnoses were rectocele, incomplete bladder emptying, voiding dysfunction, dyspareunia, and chronic pelvic pain.In the physician's assessment, the pelvic pain was likely related to 2 prior slings or prior uphold vaginal mesh.Following the procedure, the patient was diagnosed with a urethral injury from 2 tight slings.Procedure findings were as follows: 1.Prior lynx sling was located very distal near external meatus instead of the mid-urethra.The sling was on tension and "sawed through" the urethral meatus.2.Prior advantage sling also located near the external meatus, underneath the newer lynx sling.The sling was also on tension and "sawed through" the urethral meatus.A decision was made to remove this sling also as it was 2mm away from a mid-urethral erosion.3.Each sling was identified and incised.Each sling was dissected to remove approximately 2mm of mesh on each side.Cystoscopy confirmed no injury.4.Urethral muscle was injured from tight sling and needed reconstruction.Following excision of the slings, the urethral muscles were not present at the urethra and were instead attached to the vaginal incision and needed to be reconstructed.A paper-thin layer of urethral tissue could be palpated between the physician's finger and the foley.5.Blue mesh fragments consistent with prior uphold mesh.6.Short transvaginal length, 5-6cm, likely related to multiple surgeries.The procedure was completed with no complications.***additional information received on july 19, 2023*** on (b)(6) 2018, the patient was seen and examined due to recurrent prolapse, stress urinary incontinence, pelvic pain, and dyspareunia.The patient reports stress urinary incontinence with walking most of the time.She reports spraying urine with voiding.She reports pain with intercourse and at rest, intermittent throughout the day, depending on if she sits on a hard surface or if she is walking a lot.She claims that vaginal pain is not severe.Since the prolapse returned, she has been experiencing pain during intercourse, as if her partner is striking something.On (b)(6) 2018, the patient was seen and checked for status following vaginal mesh removal on (b)(6) 2018.The patient denies experiencing vaginal bleeding.Her pain is well tolerated.She denies difficulty voiding or urinary incontinence.She denies having problems voiding or having urine incontinence.Her bowel movements are soft daily.She desires surgery for prolapse.She wishes to have surgery for prolapse.She no longer gets vaginal pain while resting and was very happy about this.She reports she is sexually active but that sometimes, due to her husband's medical condition, he is often unable to maintain an erection.On (b)(6) 2019, the patient underwent a laparoscopic sacrocolpopexy, cystoscopy, and mid-urethral sling with permanent mesh placement.On (b)(6) 2019, the patient reported incomplete bladder emptying occasionally, but empties after a second attempt.She reports abdominal soreness with prolonged standing or sitting.As of (b)(6) 2019, the patient has reported tolerating her pain well and has experienced no difficulty with voiding or urinary incontinence.Bowel movements are soft daily.She had minimal cramping with initial penetration and no vaginal pain at rest.She was noted to have decreased stream and stress urinary incontinence with a full bladder.She was happy with the outcome so far.On (b)(6) 2019, the patient returned to work and experienced vaginal pain inside and near the opening when walking.She was also in pain throughout intercourse.There was no dysuria.She denies having stress incontinence of urine.Bowel movement feels incomplete, and she notices a vaginal bulge again.The doctor prescribed vaginal estrogen to the patient, and they also discussed surgically reducing the tension on the y-mesh.This will be done if her pain persists for more than two months.On (b)(6) 2019, the patient visited the clinic for a follow-up on prolapse and pelvic pain.Since her last visit, she has tried vaginal estrogen, which did not help.She also had constant lower back and lower abdominal pain, going from a 7 out of 10 pain score to a 3 out of 10 with motrin, which she takes daily at work.Reportedly, she was unable to have sex.She has pain with valsalva for voiding.Valsalva voiding is not new, but the pain associated with it is.She denies stress urinary incontinence with coughing, as she did before the sling procedure, but notes that her underwear always feels damp.On (b)(6) 2019, the patient presented for evaluation of urinary incontinence, pelvic pain, and pelvic organ prolapse.Assessment and plan: *urinary incontinence/overactive bladder - since the surgery in 2019, the urinary incontinence leaking is worse, and no obvious sui trigger - voids every hour of a day; she also has urge urinary incontinence and leaking seems random to her.- main ui triggers are walking, no leaking felt, knows it is wet when she goes to void - uses 3-4 medium pads during the day, and at night.- they will do a trial of ditropan.*pelvic pain - since the vaginal uphold mesh removal surgery in 2018, the pelvic pain went from a 7 to a 3 out of 10.- since the mesh insertion and pop repair, she has had pain daily, constant.- pain is described as a dull ache in the lower abdomen, pelvis, and low back, not burning or sharp.- she points to the lower back/buttock, bilateral, not at the top of the sacrum where the mesh was.- she uses motrin 800 mg twice at work, which helps with pain.- she has not used tylenol or gabapentin, or elavil; the physician has recommended trying these before repeat surgery.*pelvic organ prolapse: - she has a vaginal bulge, desires repair, pelvic organ prolapse signs of bulge, pressure, heaviness, bowel movement strain, and incomplete bladder emptying.The patient presented to the clinic on august 15, 2019, for evaluation of pelvic organ prolapse, urinary incontinence, and pain.The patient complains of a bothersome recurring vaginal bulge.She experiences a "baby crowning" sensation, her urinary stream is sprayed, she has to strain for bowel movement, and she denies splinting for voiding or bowel movement.She claims that sex is painful.She also feels pain in her groin, lower belly, and back merely sitting and walking.She claimed that the pain is a 3 out of 10, with a maximum of a 6 out of 10.She claims it frequently reaches 6 out of 10 because she walks a lot for work.Assessment: *likely due to too much tension on sacrocolpopexy mesh.*rectocele.Plan: *magnetic resonance imaging (mri) lumbar spine to evaluate for discitis or osteitis.*if magnetic resonance imaging (mri) is normal, the physician will plan for laparoscopic mesh revision, cystoscopy, and posterior colporrhaphy.Review of systems: abdomen: soft, no mass, non-distended, no hernia, bmi 44 non-tender, except for right lower quadrant tenderness, possibly over the lapsc mesh implant.Vagina: no lesions, no discharge, no atrophy, non-tender.There was some tender scarring near the apex and a tender nodule, about 5 mm.No mesh erosion.There is no obvious tender location from the prior uphold mesh (per her report, there is still some mesh on the left apex).The lapsc/non-boston scientific mesh does not appear too tight, has some mild tenderness but "sags" mildly, and does not appear to be tight at all.On (b)(6) 2019, the patient reported that she voids better.She hadn't had sex yet, but there was no pelvic pain at rest, and on the exam, only mid discomfort was felt, so likely the dyspareunia improved significantly.She no longer has symptoms of urinary incontinence.The patient presented to the clinic on (b)(6) 2019, for a postoperative visit.She reported voiding more frequently.She hadn't had sex yet, but there was no pelvic pain at rest or mild discomfort on the exam, indicating that the dyspareunia had likely improved significantly.She no longer has urine incontinence symptoms.On (b)(6) 2020, the patient visited the clinic and believed she had prolapsed again.Below are patient's diagnosis during her visit: *overactive bladder.*dyspareunia.*vaginal vault prolapse.*cystocele.
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Search Alerts/Recalls
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