BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANT

    MDR report key: 8289639 · Received January 29, 2019

    Report

    Report Number
    MW5083470
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    May 11, 2005
    Report Date
    January 27, 2019
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WITHIN MONTHS OF GETTING BREAST IMPLANTS, I STARTED HAVING SIDE EFFECTS OF SEVERE FATIGUE THAT WERE NOT PRESENT PRIOR TO IMPLANTS. I DEVELOPED SEVERE ALCOHOL INTOLERANCE AND MULTIPLE FOOD INTOLERANCES. THEN, I GOT A RASH ON MY JAW THAT WOULD NOT GO AWAY WITH TOPICAL MEDICATIONS. I CONTINUED TO HAVE MILD PAIN IN MY BREAST THAT NEVER FULLY RESOLVED. I DEVELOPED CHRONIC PAIN IN MY NECK AND SHOULDERS FROM THE WEIGHT OF THE IMPLANTS. THE SURGEON USED IMPLANTS LARGER THAN WE DISCUSSED, EACH WEIGHED 16 OZ. I DEVELOPED HYPOTHYROID ISSUES THEN SEVERE IBS. I FOUND OUT I HAD H PYLORI, MICROSPORIDIUM, CYCLOSPORA AND OTHER GUT INFECTIONS THAT WERE RESISTANT TO TREATMENTS. I DEVELOPED LIGHT AND SOUND SENSITIVITY. SEVERE NAUSEA AND WEIGHT LOSS. THE FATIGUE WORSENED AND I SPENT DAYS IN BED . I HAD TACHYCARDIA SEVERE ENOUGH TO HAVE A 24 HOUR HEART MONITOR. UPON EXPLANT I TREATED THE GUT INFECTIONS AND WAS ABLE TO FINALLY GET RID OF THE CHRONIC INFECTIONS. MY FATIGUE HAS IMPROVED. I NO LONGER HAVE CHRONICALLY COLD HANDS AND FEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78977 BREAST IMPLANT PROSTHESIS, BREAST FWM MENTOR 350-1670 5589472
    78978 BREAST IMPLANT PROSTHESIS, BREAST FWM MENTOR 350-1670 5590286

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Disability