BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SALINE BREAST IMPLANTS

    MDR report key: 7209059 · Received January 19, 2018

    Report

    Report Number
    MW5074696
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    March 17, 2004
    Report Date
    January 17, 2018
    Manufacturer
    MENTOR
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN FEELING TERRIBLE FOR AT LEAST THE LAST TEN YEARS OR MORE. I'VE SEEN DRS, HAD TESTS, MULTIPLE LYME AND BLOOD TESTS, XRAYS, BEEN TO PHYSICAL THERAPY BUT NOTHING. I HAVE CHRONIC SYMPTOMS SUCH AS BONE PAIN, NECK AND BACK PAIN, BRAIN FOG, SEVERE FATIGUE THAT AFFECTS MY CONCENTRATION AND DRIVING, STOMACH AND DIGESTIVE ISSUES, AND EYE PROBLEMS, ETC. AMONG MANY SYMPTOMS THAT MAKE ME FEEL LIKE I'M DYING A SLOW DEATH. I HAVE COME TO LEARN THAT THESE SYMPTOMS ARE ALL FROM THE MENTOR SALINE IMPLANTS DONE BACK IN (B)(6) 2004, WHICH I CANNOT AFFORD TO HAVE REMOVED. FUNCTIONING IN LIFE IS DIFFICULT AND PAINFUL. MY QUALITY OF LIFE IS VERY POOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48527 MENTOR SALINE BREAST IMPLANTS MENTOR SALINE BREAST IMPLANTS FWM MENTOR REF 350-1650 271355
    48528 MENTOR SALINE BREAST IMPLANTS MENTOR SALINE BREAST IMPLANTS FWM MENTOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability