BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIPLE LUMEN SILICONE BREAST IMPLANT

    MDR report key: 11006 · Received January 21, 1994

    Report

    Report Number
    MW1000438
    Event Type
    Injury
    Date Received
    January 21, 1994
    Date of Event
    September 29, 1993
    Report Date
    January 7, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SILICONE BREAST IMPLANTS WERE EXPLANTED. BOTH IMPLANTS HAD RUPTURED AND SILICONE MATERIAL HAD EXUDED OUT. BOTH SPECIMENS SHOWED CAPSULAR DISRUPTION WITH SILICONE MATERIAL EXUDING OUT. STICKY SILICONE MATERIAL IS ADHERENT TO THE CAPSULAR TISSUE. ADHERENT FIBROUS MATERIAL SHOWS SHEETS OF FOAMY HISTIOCYTIC CELLS AS WELL AS SHEETS OF LYMPHOHISTIOCYTIC CELLS AND CONGESTION. SECTIONS TAKEN AT MULTIPLE LEVELS SHOW HYALINIZING FIBROUS SCARRING AS WELL AS CALCIFICATION AND DIFFUSE CHRONIC INFLAMMATION OF THE CAPSULAR TISSUES. (SAME RPTR AS MEDWATCH 1000430.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIPLE LUMEN SILICONE BREAST IMPLANT Implant FTR MCGHAN MEDICAL CORP. STYLE 57 DD0876(R) DD0877 (L)

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention