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

Device Problem Migration (4003)

Patient Problems Erosion (1750); Obstruction/Occlusion (2422); Not Applicable (3189)

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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.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? citation: int urogynecol j.2012; 23: 1387 1390.Doi: 10.1007/s00192-012-1741-z.(b)(4).

Event Description

Journal article title: long-term follow-up of persistent vaginal polypropylene mesh exposure for transvaginally placed mesh procedures.The surgical treatment of a cystocele via the vaginal route may require the placement of a synthetic mesh below the bladder.The placement of a mesh via the vaginal route is a surgical option among others.The use of such a mesh, at the time of anterior vaginal wall repair, reduces the risk of recurrent anterior wall prolapse.However, the placement of a synthetic mesh via the vaginal route can be associated with specific complications, such as vaginal mesh exposure or infection.A retrospective case series of 9 patients presenting with persistent vaginal mesh exposure following the placement of a macroporous type 1 gynemesh mesh (ethicon) via the vaginal route below the bladder for cystocele repair between 1999 and 2002.The exposures were located in the middle line area of the vagina in all cases.Reported complications included case 2, an (b)(6) female patient with vaginal mesh exposure treated with concomitant hysterectomy, case 3, an (b)(6) female patient with vaginal mesh exposure treated with concomitant hysterectomy, case 4, an (b)(6) female patient with vaginal mesh exposure treated with concomitant hysterectomy, case 5, a (b)(6) female patient with vaginal mesh exposure treated with concomitant hysterectomy, case 6, a (b)(6) female patient with vaginal mesh exposure treated with concomitant hysterectomy and partial surgical removal of an exposed mesh, case 7, an (b)(6) female patient with vaginal mesh exposure treated with concomitant hysterectomy and partial surgical removal of an exposed mesh, case 8, an (b)(6) female patient with vaginal mesh exposure treated with concomitant hysterectomy, and case 9, a (b)(6) female patient with vaginal mesh exposure treated with concomitant hysterectomy, and dyspareunia.Other reported complication included bladder outlet obstruction (n-1).It was reported that the vaginal mesh exposure is the main complication associated with synthetic placement via the vaginal route.It was concluded that persistent vaginal polypropylene mesh exposure is associated with few complications at long-term follow-up.The authors recommend that surgeons remain vigilant with respect to potential infections in their patients having chronic vaginal mesh exposure.

• Brand Name: GYNECARE UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7727570
• MDR Text Key: 115272825
• Report Number: 2210968-2018-74679
• 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: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• 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: 07/11/2018
• 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
• Patient Age: 78 YR