BEUDAMED
    FDA Adverse Event Summary report: N

    SALINE MAMMARY IMPLANT, 370 CC

    MDR report key: 17131 · Received October 24, 1994

    Report

    Report Number
    MW1003787
    Date Received
    October 24, 1994
    Report Date
    February 11, 1994
    Manufacturer
    MENTOR CORP.
    Product Code
    FWM
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD THESE IMPLANTS IMPLANTED TO REPLACE ANOTHER CO'S IMPLANTS WHICH WERE REMOVED DUE TO CAPSULECTOMY AND RUPTURE. SHE COMPLAINS OF THE FOLLOWING: FIBROCYSTIC BREASTS, CHRONIC INFLAMMATION/FOREIGN GIANT CELL GRANULOMA, LIPOMA, BREAST: DEFORMITIES, DISCOMFORT, PAIN, MULTIPLE OPERATIONS, CAPSULAR CONTRACTURES, HEMATOMAS, BRUISING, DISCOLORATION, SEVERE PAIN, ADHESIONS, SWELLING, ASYMMETRY, IMPLANT FOLDS, EXCESSIVE BLEEDING, IMPLANT WRINKLES, INCORRECT SIZE OF IMPLANTS, ASYMMETRY, MALPOSITION OF IMPLANTS, VISIBLE WRINKLES OF IMPLANTS, SLOSHING NOISES FROM IMPLANTS, CLOSED CAPSULOTOMIES 3/16/81, 3/30/81, 1/29/82 - UNSUCCESSFUL, 3/2/82 - UNSUCCESSFUL, ARM AND SHOULDER DISCOMFORT, CHEST PAIN (PROBABLY GI OR MUSCULOSKELETAL, TMJ, APICAL SYSTOLIC MURMUR, BREAST MASSES, BACK PAIN AND HEMATURIA, CHRONIC ARTHRITIC SYMPTOMS IN NECK, BACK, CHEST, ARMS, SWOLLEN LYMPH NODES IN NECK, SINUSITIS, RIGHT LUNG PAIN, IMPLANT RUPTURES, NEUROFIBROMAS, JOINT SWELLING, PAIN AND STIFFNESS, MUSCLE FATIGUE, HARDENING OF SKIN AROUND IMPLANT, SWELLING OF FINGERS AND HANDS, UNEXPLAINED RASHES, BREAST TENDERNESS, FATIGUE, GENERAL ACHING AND STIFFNESS, HAIR LOSS, AND COLDNESS AND PAIN OF EXTREMITIES, RAYNAUDS, FIBROMYALGIA AND NON-SPECIFIC AUTO-IMMUNE CONDITION. (ALSO SEE 1003784-1003787.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE MAMMARY IMPLANT, 370 CC Implant BREAST IMPLANT FWM MENTOR CORP. 73532

    Patients

    Seq Age Sex Outcome Treatment
    1 *