MAUDE Adverse Event Report: JOHNSON & JOHNSON / GMED HEALTHCARE BVBA ( A JOHNSON & JOHNSON COMPANY) GYNECARE TVT ABBREVO TVTOML; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number 016 LAB0013088.1

Device Problems Material Erosion (1214); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Pain (1994); Urinary Tract Infection (2120)

Event Date 06/01/2016

Event Type  Injury  

Event Description

In 2015 i had a johnson & johnson tvt-o mesh sling inserted to fix my stage 1 cystocele.Within 6 months i knew there was a problem with it, but my implanting surgeon assured me all was well.In fact, the mesh had eroded into my vaginal wall and was causing constant pain and chronic utis.I had to save up the (b)(6) to pay for full removal of the mesh in (b)(6) 2021.Photos show the erosion, and also the partially disintegrated plastic sling that should never be implanted in a human body, it is not fit for purpose.And it didn't even fix the incontinence issue in the first place.Please remove this product from the market, it is dangerous.Fda safety report id# (b)(4).

• Brand Name: GYNECARE TVT ABBREVO TVTOML
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): JOHNSON & JOHNSON / GMED HEALTHCARE BVBA ( A JOHNSON & JOHNSON COMPANY)
• MDR Report Key: 12513015
• MDR Text Key: 272943187
• Report Number: MW5104128
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: TC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 016 LAB0013088.1
• Device Lot Number: 3833380
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 56