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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL

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ETHICON INC. GYNECARE MESH UNKNOWN MESH, SURGICAL Back to Search Results
Device Problem Migration (4003)
Patient Problems Erosion (1750); Cyst(s) (1800); Pain (1994); Unspecified Tissue Injury (4559)
Event Date 01/01/2021
Event Type  Injury  
Event Description
It was reported in a journal article with title: early experience of transabdominal and novel transvaginal robot-assisted laparoscopic removal of transvaginal mesh. The prospective case series study aims to determine the feasibility and safety of using robot-assisted laparoscopic surgery in removal of pelvic mesh via the trans-abdominal and novel trans-vaginal approach. From may 2019 to march 2021, 30 patients across two centers, median age was 62 (iqr 50-72), who underwent robot-assisted laparoscopic removal of pelvic mesh, including mid-urethral slings, sacrocolpopexy mesh and trans-vaginal prolapse mesh kits were recruited. Reported complications included: a case of a (b)(6) (case no. (b)(6)) who underwent complete removal of the transobturator sling (tvt-o) in 2019, which was implanted in 2010, due to pelvic pain; bladder outlet obstruction; hispareunia; dyspareunia. Pelvic floor us findings: tape appears tight. Loosening of fascial sling. A case of a (b)(6) (case no. (b)(6)) who underwent complete removal of the retropubic sling (tvt exact) in 2019, which was implanted in 2014, due to pelvic pain; bladder outlet obstruction; overactive bladder; dyspareunia; lower limb pain; vaginal pain. A case of a (b)(6) (case no. (b)(6)) who underwent near complete removal of the vaginal prolapse mesh (anterior prolift) in 2020, which was implanted in 2012, due to pelvic pain; apareunia. Pelvic floor us findings - prolapse mesh: very folded mesh seen only at vaginal vault extending over 4cm with indentation into vaginal wall suspicious for vaginal erosion. After near complete removal of the vaginal prolapse mesh, patient had right groin site infection requiring excision and resuturing at 4 weeks. A case of a (b)(6) (case no (b)(6)) who underwent near complete removal of the vaginal prolapse mesh (self-fashioned gynemesh) in 2020, which was implanted in 2009, due to pelvic pain (right iliac fossa); dyspareunia. Anterior mesh with irregularity over upper vaginal wall abutting probe suspicious for erosion. After near complete removal of the mesh, the patient had left ureteric injury and cystostomy identified and repaired intra-operatively, nephrostomy post-operatively. A case of a (b)(6) (case no. (b)(6)) who underwent complete removal of the retropubic sling (tvt-exact) in 2020, which was implanted in 2014, due to groin pain (right); urethral mesh erosion; dyspareunia; persistent sui; difficult urinating. Sling passes through urethra from 6 to 1 o'clock position, passing into central echolucent complex (suggesting urethral erosion). A case of a (b)(6) (case no. (b)(6)) who underwent near complete removal of the vaginal prolapse mesh and retropubic sling (anterior prolift, tvt) in 2020, which was implanted in 2009, due to groin pain; vaginal pain; bladder outlet obstruction, overactive bladder. Sling folded into c shape with edges directed towards vaginal wall. Sling is embedded in posterior urethral wall (abutting echolucent complex). Sling appears tight. Inferior edge of prolapse mesh extends below tvt, cupping and compromising the anterior vaginal wall between the two. Mesh also folded back on itself. Mild thickening of right tvt arm with bowing of the urethra, mild bowing of vagina related to vaginal prolapse mesh. A case of a (b)(6) (case no. (b)(6)) who underwent complete removal of the sacrocolpopexy mesh (gynemesh) in 2020, which was implanted in 2005, due to pelvic pain; bladder outlet obstruction; dyspareunia. Skin thin over slings with concern for vaginal erosion. Tot and tvt not tight. Posterior mesh extends 4. 5cm down posterior wall with normal appearance. A case of a (b)(6) (case no. (b)(6)) who underwent partial complete removal of the retropubic sling (tvt) in 2020, which was implanted in 1999, due to bladder outlet obstruction, overactive bladder. Tight sling with 5mm gap with valsalva. Posterior tape embedded in outer urethral wall. A case of a (b)(6) (case no. (b)(6)) who underwent complete removal of the retropubic sling (tvt) in 2020, which was implanted in 2004, due to groin pain; bladder outlet obstruction, overactive bladder, uti. Folded configuration of tape. Suggesting tight sling with gap of 9mm. Embedded sling in posterior urethral wall. A case of a (b)(6) (case no. (b)(6)) who underwent complete removal of the retropubic sling (tvt-exact) in 2021, which was implanted in 2015, due to vaginal mesh erosion; vaginal pain; dyspareunia; difficulty urinating, sling embedded in right urethral wall. A case of a (b)(6) (case no. (b)(6)) who underwent complete removal of the retropubic sling (tvt-exact) in 2021, which was implanted in 2019, due to vaginal pain; bladder outlet obstruction; vaginal mesh erosion; dyspareunia. Tight sling that encroaches into urethra with a 5mm gap. After removal of the sling patient had hematoma (suprapubic area where right mesh exited abdominal wall). It was concluded, that this study presents the early experience of robotic-assisted removal of transvaginal mesh with a transvaginal or transabdominal approach and demonstrated feasibility of removal of both retropubic and transobturator muss as well as trans-vaginal prolapse meshes with transobturator and sacrospinous mesh arms. This is a highly subspecialized technique of mesh removal and should be performed by experienced robotic surgeons with an interest in female pelvic medicine and reconstructive surgery.
 
Manufacturer Narrative
(b)(4). This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.   the single complaint was reported with multiple events. There are no additional details regarding the additional events.   citation: journal of endourology © mary ann liebert, inc. Doi: 10. 1089/end. 2021. 0520 attempts are being made to obtain the following information.   to date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Additional information requested: were the cases discussed in this article previously reported to ethicon?  if yes, please provide a complaint reference number.   does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article?  does the surgeon believe there was any deficiency with the ethicon products involved? event related to (b)(6) patient with tvt exact device reported via mw # 2210968-2022-03089. Event related to (b)(6) patient with tvt exact device reported via mw # 2210968-2022-03090. Event related to (b)(6) patient with tvt device reported via mw # 2210968-2022-03091. Event related to (b)(6) patient with prolift device reported via mw # 2210968-2022-03092. Event related to (b)(6) patient with tvt device reported via mw # 2210968-2022-03093. Event related to (b)(6) patient with gynecare mesh device reported via this report. Event related to (b)(6) patient with gynecare mesh device reported via mw # 2210968-2022-03095. Event related to (b)(6) patient with prolift device reported via mw # 2210968-2022-03096. Event related to (b)(6) patient with tvt device reported via mw # 2210968-2022-03097. Event related to (b)(6) patient with tvt exact device reported via mw # 2210968-2022-03098. Event related to (b)(6) patient with tvt exact device reported via mw # 2210968-2022-03099. Event related to (b)(6) patient with tvt obturator device reported via mw # 2210968-2022-03100.
 
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Brand NameGYNECARE MESH UNKNOWN
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key14246283
MDR Text Key293559624
Report Number2210968-2022-03094
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeNZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/28/2022 Patient Sequence Number: 1
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