FDA Adverse Event Injury Summary report: N

DOW CORNING GEL BREAST IMPLANTS

MDR report key: 5633639 · Received May 2, 2016

Report

Report Number
MW5062080
Event Type
Injury
Date Received
May 2, 2016
Report Date
May 2, 2016
Manufacturer
COX UPHOFF DOW CORNING GEL
Product Code
FTR
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WAS IMPLANTED WITH COX UPHOFF (DOW CORNING GEL) IMPLANTS 1982. I BEGAN HAVING SERIOUS HEALTH PROBLEMS BEGINNING AROUND 1988. I NEVER ONCE CONTRIBUTED MY HEALTH SITUATION/PROBLEMS TO THE IMPLANTS AND CONTINUED ON FOR SEVERAL YEARS GOING TO DR. AFTER DR. NO ONE COULD HELP ME AND SAID IT WAS ALL IN MY HEAD. THEN I STARTED SEEING STORIES ON TELEVISION CONCERNING BREAST IMPLANTS AND A LIGHT WENT OFF AND I STILL DIDN'T WANT TO BELIEVE IT. I FINALLY FOUND DR. (B)(6) FROM (B)(6) IN 1994, WHO DID AN ULTRASOUND AND FOUND RUPTURE AND LEAKING. THEY WERE EXPLANTED RIGHT AWAY. I FELT IMMEDIATE RELIEF FOR A WHILE. THEN BECAUSE THE SILICONE POISON WAS STILL IN MY BLOOD STREAM/SYSTEM, I BEGAN HAVING HEALTH PROBLEMS AGAIN. DOCTORS ARE MYSTIFIED TO THIS DAY. I BECAME PERMANENTLY DISABLED AND PUT ON (B)(6) DISABILITY AFTER HAVING WORKED MY WHOLE LIFE. I WAS A VERY ATHLETIC, HEALTHY PERSON AND WHEN THOSE TOXIC BAGS WERE PUT IN MY BODY, THEY RUPTURED AND BROUGHT ME TO MY KNEES. I HAVE BEEN SICK SINCE 1982 AND LIVING IN POVERTY BECAUSE I AM DISABLED, ALL BECAUSE OF FAULTY IMPLANTS. NONE OF THEM ARE SAFE AND THOUSANDS OF WOMEN HAVE DIED INCLUDING 3 OF MY CLOSE FRIENDS. THEY NEED TO BE TAKEN OFF THE MARKET AS THEY WERE ONCE BEFORE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
279499 DOW CORNING GEL BREAST IMPLANTS BREAST IMPLANTS FTR COX UPHOFF DOW CORNING GEL
279500 DOW CORNING GEL BREAST IMPLANTS BREAST IMPLANTS FTR COX UPHOFF DOW CORNING GEL

Patients

Seq Age Sex Outcome Treatment
1 68 YR Hospitalization| L| R| S