MAUDE Adverse Event Report: ETHICON INC. GYNECARE UNKNOWN PRODUCT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Erosion (1750); Hematoma (1884); Pain (1994); Abnormal Vaginal Discharge (2123); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

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.Attempts are being made to clarify 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.Does the surgeon believe that ethicon products (gynemesh & gynemesh soft) 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 (gynemesh & gynesmesh soft) used in this procedure? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? the single complaint was reported with multiple events.There are no additional details regarding the additional events.Adverse events regarding gynemesh submitted.Adverse events regarding gynemesh soft submitted via 2210968-2020-03836.Citation: int urogynecol j (2007) 18: 73¿79; doi 10.1007/s0192-005-0041-2.(b)(4).

Event Description

Title: vaginal mesh erosion after transvaginal repair of cystocele using gynemesh or gynemesh-soft in 138 women: a comparative study.The main objective of this study is to compare the incidence of vaginal erosion after transvaginal repair of anterior vaginal wall prolapse using gynemesh and gynemesh-soft meshes.The second objective was to identify the risk factors associated with the occurrence of mesh erosion.Between oct1999 and oct2004, 138 female patients with cystocele underwent transvaginal repair using synthetic mesh.A total of 89 patients (64%) underwent the procedure with gynemesh mesh, and 49 patients (36%) with gynemesh-soft mesh.In the procedure, the mesh was then introduced, unsutured.A precut piece of polypropylene (gynemesh or gynemesh-soft, gynecare, ethicon, 1, rue camille desmoulins, 92787 issy-les-moulineaux cedex 9, france), measuring 6 cm in width by 15 cm in length.Within 6 months, three women (3%) in gynemesh group and four women (8%) in gynemesh-soft group developed recurrence of anterior prolapse.<12 weeks postoperatively, 16 patients had vaginal erosion (n=8 gynemesh group and n=8 gynemesh-soft group).Of the patients with vaginal erosion, associated symptoms included vaginal discharge (n=2), vaginal pain (n=1), vaginal discharge associated with vaginal pain (n=1), and postoperative vaginal hematoma (n=1; [1/16]) which necessitated immediate complete ablation of mesh.Moreover, 4 patients (4/16) with vaginal erosion underwent partial excision of mesh associated with a vaginal mucosal closure under general anesthesia of which 2 were successful with no recurrence, one with recurrent vaginal erosion and underwent additional excision procedure which was successful with no recurrence, and one with two recurrence of vaginal erosion and was further decided to perform a complete excision of the mesh.Furthermore, the remaining 11 patients (11/16) were treated with administration of intravaginal oestrogen and/or local antiseptic.One of these patients, presented complete reepithelization of the vagina; while 5 necessitated a partial excision of mesh associated with a vaginal mucosal closure and no recurrence in 4 patients and 1 vaginal erosion recurrence after 6 months, but now asymptomatic.>12 weeks postoperatively, 11 patients had vaginal erosion (n=7 gynemesh group and n=4 gynemesh-soft group).Of the patients with vaginal erosion, associated symptoms included dyspareunia (n=2) and dyspareunia with vaginal discharge (n=1).Four patients (4/11) with vaginal erosion necessitated a partial excision of mesh associated with a vaginal mucosal closure and no recurrence reported.The remaining patients (7/11) have been treated with administration of intravaginal oestrogen and/or local antiseptic.At the last follow-up, the size of the vaginal erosion decreased in two patients and was not modified in three patients.All of them are asymptomatic.Shrinkage of the mesh occurred in three patients from the gynemesh group.11% of the patients without vaginal erosion had de novo dyspareunia.Gynemesh-soft does not appear to decrease the incidence of vaginal erosion.We would recommend not to repair cystocele by placing synthetic mesh by vaginal route for patients presenting moderate cystocele.Furthermore, we recommend avoidance of vertical midline vaginal incision.In addition, vaginal sutures should not be directly adjacent to the mesh, as this may increase the possibility of vaginal erosion.However, management of vaginal erosion is relatively straightforward and is associated with a low rate of morbidity.

• Brand Name: GYNECARE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo ; *
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10044099
• MDR Text Key: 191120502
• Report Number: 2210968-2020-03835
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention