GYNECARE TVT ABBREVO TVTOML
Received Sep 21, 2021 · Event occurred Jun 1, 2016
Report MW5104128 · MDR key 12513015
Device
Generic name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retr
Model number
016 LAB0013088.1Lot number
3833380
Product problems
- Material Erosion
- Appropriate Device Problem Term/Code Not Available
Patient
36 YR
- Failure of Implant
- Pain
- Urinary Tract Infection
- Failure of Implant
- Pain
- Urinary Tract Infection
Narrative
Description of Event or Problem
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).