BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANTS

    MDR report key: 5996172 · Received October 1, 2016

    Report

    Report Number
    MW5065143
    Event Type
    Injury
    Date Received
    October 1, 2016
    Date of Event
    September 28, 2016
    Report Date
    October 1, 2016
    Manufacturer
    SILLMED
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE DATE ABOVE IS ACTUALLY THE DATE I HAD MY SILLMED COHESIVE GEL BREAST IMPLANTS REMOVED, AFTER YEARS OF UNEXPLAINED SYMPTOMS OF DEBILITATING JOINT AND MUSCLE PAINS, INSOMNIA, ANXIETY, URINARY RETENTION, FATIGUE, HEAT INTOLERANCE AND NIGHT SWEATS EVERY 15 MINUTES ALL NIGHT LONG. SYMPTOMS MOST SEVERE PAST 3 YEARS WITH TENS OF THOUSANDS OF DOLLARS SPENT ON DRS, LABS, X-RAYS, PROCEDURES AND UNNECESSARY SURGERIES WITH NO ANSWERS OR RELIEF. I WAS CONSIDERING SUICIDE UNTIL SOMEONE, NOT A DR. SUGGESTED IT WAS MY IMPLANTS. I HAD THEM REMOVED ON (B)(6) 2016. THE RIGHT IMPLANT WAS RUPTURED AND SWEATING INTO MY BODY. I HAVE HAD IMMEDIATE RELIEF FROM ALL MY SYMPTOMS. I WAS BEING SLOWLY POISONED BY THE LEAKING CHEMICALS AND HEAVY METALS THAT I WAS NEVER TOLD WERE EVEN IN THE IMPLANTS WHEN I GOT THEM IN 2006!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643729 BREAST IMPLANTS GEL BREAST IMPLANTS FTR SILLMED
    643730 BREAST IMPLANTS GEL BREAST IMPLANTS FTR SILLMED

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention