BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE FILLED BREAST IMPLANTS

    MDR report key: 8612802 · Received May 14, 2019

    Report

    Report Number
    MW5086660
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    April 1, 2014
    Report Date
    May 11, 2019
    Manufacturer
    INAMED / ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A BREAST AUGMENTATION DONE IN (B)(6) 2007, THE DR PUSHED ME TO GET SILICONE OVER SALINE. TWO WEEKS POST OP AT MY F/U APPT, THE NURSE ADVISED ME SHE HAD CHANGED MY BIRTHDATE BECAUSE I WAS ONLY 21 AND SILICONE REQUIRED YOU TO BE 22. AROUND 7 YEARS LATER, I STARTED HAVING A LOT OF PAIN IN MY BREASTS, AND TINGLING IN MY HANDS AND ARMS, HAIR LOSS ON HEAD, HAIR GROWTH ON FACE AND ARMS, SHORTNESS OF BREATH, MISCARRIAGES THAT REQUIRED FERTILITY TREATMENT, IRREGULAR PERIODS, JOINT AND MUSCLE PAIN, AND MUCH MORE. ALL DIAGNOSTIC TESTS ARE NEGATIVE, NO REASON EXCEPT THESE IMPLANTS. I REQUESTED A COPY OF MY MEDICAL RECORDS, THERE'S ONLY 3 PAGES, ALL THE REST ARE MISSING. ON THE DEVICE REGISTER PAGE MY BIRTHDATE IS LISTED INCORRECTLY. ON MY SURGERY REPORT IT STATES I HAVE 40 GRAM MENTOR IMPLANTS, BUT ON MY ID IT SAYS 500CC INAMED IMPLANTS. I WASN'T TOLD YOU NEED MRIS EVERY TWO YEARS. THE DR TOLD ME MY IMPLANTS WOULD LAST MY LIFETIME. I WAS ALSO TOLD IT WOULDN'T INTERFERE WITH BREASTFEEDING. THIS DR LIED TO ME AND NOW MY LIFE IS "MISSING" COINCIDENTALLY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403476 SILICONE FILLED BREAST IMPLANTS PROSTHESIS, BREAST, NON-INFLATABLE , INTERNAL, SILICONE GEL-FILLED FTR INAMED / ALLERGAN STYLE 120
    403477 SILICONE FILLED BREAST IMPLANTS PROSTHESIS, BREAST, NON-INFLATABLE , INTERNAL, SILICONE GEL-FILLED FTR INAMED / ALLERGAN STYLE 120

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR