BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE BREAST IMPLANTS

    MDR report key: 8325513 · Received February 8, 2019

    Report

    Report Number
    MW5083877
    Event Type
    Injury
    Date Received
    February 8, 2019
    Date of Event
    January 1, 1996
    Report Date
    February 6, 2019
    Manufacturer
    DOW CORNING / MENTOR WORLDWIDE LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BREAST IMPLANTS BY DOW CORNING IMPLANTED 1991. BY 1993 SEVERE BREAST PAIN. THROUGH THE YEARS FATIGUE LEADING TO SEVERE FATIGUE BY 2000. ALONG WITH EXHAUSTION THERE ARE BRAIN FOGS, CONCENTRATION AND SEVERE MEMORY PROBLEMS. AGING AT AN ACCELERATED PACE. EYES DETERIORATING AT A RAPID RATE. MY LIFE HAS BECOME MEANINGLESS BECAUSE I CAN'T WORK OR FUNCTION. I'M NOT MYSELF AND HAVE DEPRESSION. I MERELY EXIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112162 SILICONE BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE, GEL-FILLED FTR DOW CORNING / MENTOR WORLDWIDE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability