BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMORY SHAPE GEL TEXTURED

    MDR report key: 6584865 · Received May 19, 2017

    Report

    Report Number
    MW5069938
    Event Type
    Injury
    Date Received
    May 19, 2017
    Date of Event
    October 14, 2015
    Report Date
    May 19, 2017
    Manufacturer
    MENTOR
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    STARTED HAVING A CAPSULE AROUND THIS DATE. I STILL HAVE THE TEXTURED IMPLANT IN MY BODY. I FIT SEVERAL SYMPTOMS OF THE RARE CANCER SYMPTOMS. I HAVE CONTACTED MENTOR AND THEY HAVE INFORMED ME A FEW CASES DOESN'T MAKE THEM HAVE TO STAND BEHIND REMOVING THEM ALTHOUGH I AM ONE CLEARLY HAVING MANY SYMPTOMS. THEY SAID FDA HAD DONE NO RECALLS THERE FOR IT WAS MY PROBLEM AND I COULD TAKE OUT A LOAN AND PAY TO HAVE THEM REMOVED IF I WAS THAT CONCERNED OR WORRIED. THEY ALSO DECIDED ASSISTING WITH ANY COST TO MY PS OFFICE AS WELL. HAVE BEEN ON A MEDICATION TO HELP THE CAPSULE OR BLOOD VESSELS AND IT NO LONGER WORKS. MY LEFT BREAST IS DISTORTED AND DOUBLE THE SIZE OF RIGHT ONE FROM CAPSULE AND HARDENED TISSUES. I ALSO HAVE PICTURES OF ALL THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361292 MEMORY SHAPE GEL TEXTURED BREAST IMPLANTS FTR MENTOR 334-1305
    361293 MEMORY SHAPE GEL TEXTURED BREAST IMPLANTS FTR MENTOR 334-1305

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other