BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOAM COVERED BREAST IMPLANT

    MDR report key: 1000357 · Received January 17, 2008

    Report

    Report Number
    MW5005574
    Event Type
    Injury
    Date Received
    January 17, 2008
    Date of Event
    February 15, 2003
    Report Date
    February 17, 2008
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 1990, I HAD FOAM COVERED BREAST IMPLANTS PUT IN. IN 2003 I BECAME VERY ILL. NO DOCTOR, INTERNIST, OR G.I. DOCTOR COULD FIND ANYTHING WRONG WITH ME. I'VE HAD 6 CAT SCANS, MRA OF ABDOMEN, PELVIC EXAMS, MANY BLOOD TESTS, IN THE FIRST 2 YEARS I WAS SICK AND ALL THEY COULD FIND WAS HIGH WHITE CELL COUNT FROM TIME TO TIME, THEY DID A NUCLEAR TEST TO FIND THE INFECTION, NONE THERE AT THAT TIME. ALL TOGETHER I HAVE BEEN IN SEVERE WIDE SPREAD BURNING PAIN EVERYDAY FOR THE LAST FIVE YEARS, NAUSEA, WEIGHT LOSS, HAIR FALLING OUT, I'VE BEEN SO ILL THAT I LOST A JOB AND FELT LIKE I WAS GOING TO DIE BEFORE THEY FIND OUT WHAT'S WRONG WITH ME. IN 2007, I NOTICED MY RIGHT IMPLANT FELT A LITTLE TIGHTER THAN THE LEFT. AND AS TIME WENT ON IT CONTINUED TO GET HARDER AND BECAME VERY PAINFUL AND ROUND AND HARD. IN 2008 I SAW A PLASTIC SURGEON, AND HE SAID THEY HAD TO COME OUT. HE SAID HE THOUGHT THEY PROBABLY HAD BEEN LEAKING, BUT HE SAID THERE WASN'T ENOUGH RESEARCH ON THE SUBJECT TO KNOW IF I WOULD EVER GET BETTER EVEN THOUGH WE ARE REMOVING THEM. I'M NOT TOO SURE HOW MUCH LONGER I CAN TOLERATE THIS PAIN. I AM IN VERY POOR HEALTH AND I WILL NOT LIVE LIKE THIS FOR THE REST OF MY LIFE. I'D JUST AS SOON KILL MYSELF, ACCORDING TO ALL THE TESTS I AM IN GOOD HEALTH, HOWEVER IF YOU SAW ME YOU WOULD KNOW I AM VERY SICK. LAST YEAR I LOST DOWN TO 95 LBS. MY USUAL WEIGHT IS 150LBS. I'VE BEEN HOSPITALIZED 2 TIMES, THE FIRST TWO YEARS I WAS SICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOAM COVERED BREAST IMPLANT FTR

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| S