FDA Adverse Event Injury Summary report: N

GYNECARE TVT ABBREVO TRADEMARK BY JOHNSON & JOHNSON

MDR report key: 2544753 · Received April 17, 2012

Report

Report Number
MW5025120
Event Type
Injury
Date Received
April 17, 2012
Date of Event
January 7, 2011
Report Date
April 17, 2012
Manufacturer
JOHNSON & JOHNSON
Product Code
FTL
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

I HAD A MESH SLING PUT IN AND WITHIN A YEAR THE MESH STARTED BREAKING THROUGH MY VAGINAL WALL. I WAS STILL RECOVERING FROM THE SURGERY, AS FAR AS NOT BEING ABLE TO HAVE SEXUAL INTERCOURSE WITH MY HUSBAND AND THEN THIS HAPPENED. I THEN HAD TO GO FOR A SECOND SURGERY TO TRY TO REMOVE AS MUCH OF THE MESH THAT THEY WERE ABLE TO ON (B)(6) 2012. NOW THERE IS MORE MESH COMING THROUGH AND I HAVE TO GO HAVE ANOTHER OPERATION, THEN HEAL FROM THAT, AND PRAY MORE DOESN'T COME THROUGH SO THAT I MAY HAVE MY BLADDER FIXED AGAIN AND THAT'S ANOTHER SURGERY. MEANWHILE I'M WORSE THAN WHEN I STARTED OUT. I HAVE TO WEAR AN ADULT DIAPER DAY AND NIGHT AT (B)(6). I'M IN CONSTANT PAIN AND HAVE THIS RAW FEELING INSIDE. I WAS NEVER EVER TOLD ABOUT ANY OF THE COMPLICATIONS THIS DEVICE WOULD HAVE OR ELSE I NEVER EVER WOULD HAVE HAD THIS DONE. I FEEL, AND IT HAPPENS TO BE TRUE, THAT MY SEX LIFE IS OVER AND MY MARRIAGE IS DONE AND I HAVE NO HOPE OF EVER BEING WITH A MAN. MY WOMANHOOD HAS BEEN TAKEN FROM ME AND MY VAGINA LOOKS DISTORTED, AND THE SECOND DOCTOR I HAD DO MY SECOND SURGERY, REALLY TRIED TO FIX THE DISTORTION THE BEST HE COULD. I'M SO BROKEN AND DO NOT WANT THIS EVER, EVER HAPPEN TO ANOTHER WOMAN. THIS IS VERY SERIOUS AND THE EMOTIONAL SIDE OF IT IS DEFINITELY HORRIBLE. THIS SLING SHOULD BE TAKEN OFF THE MARKET IMMEDIATELY. I AM BEGGING YOU. PLEASE DON'T LET THIS HAPPEN TO ANYONE ELSE. IT TEARS YOUR LIFE IN HALF. I JUST CANNOT EVEN TELL YOU IN WORDS WHAT IT DOES TO A WOMAN, A MARRIAGE, A RELATIONSHIP, AND THE HOPE OF ONE EVER IN A WOMAN'S FUTURE. PLEASE TAKE IT OFF THE MARKET.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 GYNECARE TVT ABBREVO TRADEMARK BY JOHNSON & JOHNSON TRANSVAGINAL MESH SLING FTL JOHNSON & JOHNSON

Patients

Seq Age Sex Outcome Treatment
1 42 YR