BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER SOFT PATCHLESS BREAST IMPLANT, 400 CC

    MDR report key: 12784 · Received March 31, 1994

    Report

    Report Number
    MW1001614
    Event Type
    Injury
    Date Received
    March 31, 1994
    Date of Event
    June 8, 1971
    Report Date
    March 31, 1994
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR RECEIVED IMPLANTS ON 6/8/71. IN 7/31/71 THEY WERE REMOVED BECAUSE THE SKIN WAS TOO THIN TO HOLD IT. ON 3/29/76 SHE HAD THE IMPLANTS PUT BACK IN. IN 4/78 SHE HAD SOME REPAIR WORK DONE FOR FIBROUS CAPSULAR CONTRACTURE. IN 8/83 THE LEFT IMPLANT WAS TAKEN OUT AND REPLACED BY ANOTHER MFR IMPLANT. THE RIGHT BREAST IMPLANT HAS BEEN RED, PAINFUL, EXTREMELY HARD FOR A FEW YRS. SHE IS TIRED ALL THE TIME, HURTS ALL OVER WITH ACHES, LEGS TINGLE ALL THE TIME, AND UNEXPLAINED SWELLING IN FEET. SHE HAS BEEN TO 2 DRS WHO DO BREAST SURGERY. THEY AGREE THE IMPLANTS NEED TO COME OUT DUE TO CAPSULAR CONTRACTURE, BUT THEY SAID THEY DO NOT BELIEVE IMPLANTS LEAK. THEY THINK THIS IS ALL A PUBLICITY THING. RPTR HAS NOT DONE ANYTHING WITH THEM UNTIL SHE CAN FIND A DR WHO AT LEAST BELIEVES THEY DO RUPTURE SO WHEN SHE HAS THEM TAKEN OUT, SHE CAN HAVE THEM CHECKED FOR LEAKAGE. (SEE ALSO 1001615.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER SOFT PATCHLESS BREAST IMPLANT, 400 CC Implant BREAST IMPLANT FTR DOW CORNING CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention