BEUDAMED
    FDA Adverse Event Summary report: N

    SILICONE GEL MAMMARY IMPLANT

    MDR report key: 16567 · Received August 12, 1994

    Report

    Report Number
    MW4000493
    Date Received
    August 12, 1994
    Date of Event
    October 28, 1993
    Report Date
    August 12, 1994
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MASTECTOMY WAS ON 3/21/85. RPTR HAD FIBROCYSTIC DISEASE. ABOUT 6 MONTHS AFTER RPTR'S IMPLANT WAS INSERTED SHE STARTED HAVING WEAKNESS IN HER ARMS AND LEGS. SHE THOUGHT IT WAS FROM HAVING THE SURGERY. THEN HER UTERUS STARTED SWELLING. DR TOLD HER SHE WAS PREGNANT. RPTR HAD HER TUBES CUT AND TIED IN 10/73. SHE WENT TO GYB. GYNECOLOGIST SAID RPTR'S UTERUS WAS THE SIZE OF A 12 WEEK OLD FETUS. RPTR HAD A D&C IN 1986. IT GOT WORSE AND THIS RESULTED IN COMPLETE HYSTERECTOMY IN 1/89. RPTR HAS BEEN ON HORMONES EVER SINCE AND THEN OTHER PROBLEMS BEGAN. RPTR HAS FIBROMYALGIA AND DJD OF THE SPINE IN HER NECK AND TAILBONE. RPTR HAS ALWAYS BEEN A VERY ACTIVE PERSON. NOW SHE CAN BARELY PUT A MEAL TOGETHER. SHE IS IN PAIN 24 HOURS A DAY. RPTR ALSO COMPLAINS OF CHRONIC FATIGUE, SWOLLEN JOINTS HANDS AND FEET, MEMORY LOSS, SWOLLEN LYMPH NODES, MUSCLE SPASMS AND WEAKNESS, DRY MOUTH AND EYES, RASHES, NUMBNESS AND TINGLING OF HANDS AND FEET, DIFFICULTY SWALLOWING, IRRITABLE BOWEL, BLURRED VISION AND BALANCE PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE GEL MAMMARY IMPLANT Implant FTR DOW CORNING CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 *