BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE IMPLANTS

    MDR report key: 8288755 · Received January 30, 2019

    Report

    Report Number
    MW5083462
    Event Type
    Injury
    Date Received
    January 30, 2019
    Date of Event
    July 23, 2009
    Report Date
    January 28, 2019
    Manufacturer
    UNK
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SON WAS BORN WITH CONGENITAL LYMPHEDEMA WHICH I THINK WAS FORMED FROM MY 19 Y/O IMPLANTS (AT THAT TIME THEY WERE JUST OVER 10). I HAD A HORRIBLE PREGNANCY AND MY HEALTH CONTINUE TO SPIRAL DOWNWARD WITH NO EXPLANATION. HORRIBLE FATIGUE, BREAST PAIN, VERTIGO, MEMORY LOSS, SERIOUS IBS, MENOPAUSE AT (B)(6), LOSS OF LIBIDO, HIVES AND STAPH INFECTION UNDER MY BREASTS, INSOMNIA, SEVERE ANXIETY, HEART PALPITATION AND RACING, WEIGHT GAIN, EAR RINGING, HEADACHES AND MUCH MORE. I HAD A TOTAL CAPSULECTOMY AND REMOVED MY SALINE IMPLANTS 6 WEEKS AGO, AND AS SOON AS I DID HALF OF MY SYMPTOMS LEFT ME. I HONESTLY BELIEVE THEY NEED TO TAKE THESE IMPLANTS OFF THE MARKET AS THEY ARE A SILENT KILLER. I FELT AS I WAS A 90 Y/O WOMAN FOR THE LAST TEN YEARS. UNFORTUNATELY MY PS NEVER TOLD ME I WOULD HAVE TO REPLACE THEM AS THEY WERE CONSIDERED A LIFETIME DEVICE. I'M QUITE DISAPPOINTED AND DISGUSTED TO HEAR ON EVERY RADIO STATION SO MUCH PROMOTING OF THESE TOXIC "PROFANITY" BAGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81863 SALINE IMPLANTS SALINE IMPLANTS FWM UNK
    81864 SALINE IMPLANTS SALINE IMPLANTS FWM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Congenital Anomaly| S ALPRAZOLAM| NEFEDIPINE ER