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

Catalog Number MESHUNK

Device Problem Migration (4003)

Patient Problems Erosion (1750); Pain (1994); Not Applicable (3189)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.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.The patient demographic info: weight, bmi at the time of index procedure name of initial surgical procedure in 2004? the diagnosis/indication and initial approach for the initial surgical procedure? any concurrent procedure/device implantation? other relevant patient history/concomitant medications when was the mesh exposure first noted by a physician? was the device removed on (b)(6) 2018? if so, please provide details of the re-operation.What is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status?.

Event Description

It was reported that the patient underwent an unknown surgical procedure on (b)(6) 2004 and the mesh was implanted.The patient experienced vaginal mesh exposure with dyspareunia.Event occurred on (b)(6) 2018.The patient underwent explantation procedure on (b)(6) 2018.Additional information has been requested.

Manufacturer Narrative

Additional information was requested, and the following was obtained: name of initial surgical procedure in 2004? the diagnosis/indication and initial approach for the initial surgical procedure? any concurrent procedure/device implantation? other relevant patient history/concomitant medications.Prolapsus cure (rectocele) by vaginal route with interposition gynemesh (in intra-rectal-vaginal).Concomitant procedure: cystocele cure with gynemesh in intra-vesical-vaginal.When was the mesh exposure first noted by a physician? on (b)(6) 2018.Was the device removed on (b)(6) 2018? if so, please provide details of the re-operation.Yes, partially (partial exeresis of the portion exposed into the vagina).What is physician¿s opinion as to the etiology of or contributing factors to this event ? the vaginal surgery with prosthetic interposition exposes to this risk.Gynemesh was a prothesis which, a posteriori, turns out to be "heavy" (high grammage), so potentially a higher risk of prosthetic exposure.What is the patient's current status? asymptomatic, she is well.

• Brand Name: GYNECARE MESH UNKNOWN
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8259623
• MDR Text Key: 133461170
• Report Number: 2210968-2019-78481
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MESHUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 65