BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE GEL BREAST IMPLANTS

    MDR report key: 26635 · Received October 6, 1995

    Report

    Report Number
    MW1007241
    Event Type
    Injury
    Date Received
    October 6, 1995
    Date of Event
    December 14, 1978
    Report Date
    September 22, 1995
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR WAS IMPLANTED WITH SILICONE-GEL BREAST IMPLANTS 12/14/78. SYMPTOMS BEGAN 5 MONTHS LATER, PROBABLY BEFORE IN RETROSPECT. SHE C/O FATIGUE, NUMBNESS AND TINGLING IN ARMS AND LEGS, NUMBNESS IN LEFT SIDE OF FACE, RASHES, HAS DEVELOPED ACUTE SENSITIVITY TO CHEMICALS, HEADACHES ACUTE CRAMPING AND BLOATING WITH MENSES. VISION PROBLEMS, SJOGREN'S SYNDROME, PROGRESSIVE NEUROLOGICAL DETERIORATION, MULTIPLE AUTOANTIBODIES, SMOOTH MUSCLE ANTIBODY, MYELIN BASIC PROTEIN ANTIBODY, ANTINUCLEAR ANTIBODY. VISION AND VESTIBULAR DYSFUNCTION, REACTIVE AIRWAY DISEASE, NEUROMUSCULAR DISEASE OF THE G.I. TRACT. TYPE II MUSCLE ATROPHY, MICROVASCULAR DISEASE, SEIZURES, MEMORY LOSS, VERTIGO, SEVERE MUSCLE WEAKNESS, JOINT PAIN, HEART MUSCLE, DAMAGE, BRAIN STEM DAMAGE. PERIPHERAL NERVE DAMAGE IN EARS. AND MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE GEL BREAST IMPLANTS Implant SILICONE GEL BREAST IMPLANTS FTR DOW CORNING CORP. SMOOTH SHELL HH4264

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening| R| S