BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE SALINE FILLED BREAST IMPLANT

    MDR report key: 8336968 · Received February 12, 2019

    Report

    Report Number
    MW5084014
    Event Type
    Injury
    Date Received
    February 12, 2019
    Date of Event
    November 27, 2012
    Report Date
    February 11, 2019
    Manufacturer
    ALLERGAN, INC
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NATRELLE SALINE BREAST IMPLANTS. I HAVE BECOME INCREASINGLY ILL OVER THE PAST 6 YEARS. I¿M CONSTANTLY FATIGUED. I CAN¿T THINK CLEARLY, HAVE HEART PALPITATIONS, HOT ALL THE TIME, BUT ALSO MORE SENSITIVE TO COLD, MY HANDS SHAKE, MY VISION HAS DECLINED RAPIDLY, I CAN¿T REMEMBER THE MOST SIMPLE WORDS OR THE NAMES OF PEOPLE I¿VE KNOWN FOREVER. I CAN¿T FOCUS AND I OWN A CONSULTING FIRM. I HAVE TO FOCUS. I¿VE LOST BUSINESS BECAUSE OF ALL OF THIS. I HAVEN¿T HAD JOY IN LIFE IN YEARS. MY HAIR IS THINNING, I HAVE MORE DIFFICULTY TAKING DEEP BREATHS. I HAVE LUMPS IN MY LEFT BREAST, HURTS CONSTANTLY. MY RIGHT BREATH HAS SHOOTING PAIN. THE LEFT UNDER ARM ACHES AND STINGS. I HAVE LOW THYROID. I DON¿T SLEEP WELL AT ALL. I¿M ANXIOUS ALL OF THE TIME . I HAVE HORRIBLE UNDER EYE DARK CIRCLES AND PUFFINESS. I HAVE NO LIBIDO. I FEEL LIKE I SPEND EACH DAY GOING THROUGH THE MOTIONS OF BEING ALIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127297 NATRELLE SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN, INC 68LP-300
    127298 NATRELLE SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN, INC 60LP-300

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability