BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE LUMEN BREAST IMPLANT, 400 CC

    MDR report key: 13286 · Received May 17, 1994

    Report

    Report Number
    MW1002015
    Event Type
    Injury
    Date Received
    May 17, 1994
    Date of Event
    February 1, 1986
    Report Date
    May 5, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AS PART OF POST-CANCER BREAST RECONSTRUCTION, A DOUBLE LUMEN IMPLANT WAS INSERTED IN 1985. AFTER 6 YRS OF REPEATED PAIN, LOCALIZED ERYTHEMA, WEAKENED IMMUNE SYSTEM, ARTHRITIS BOUTS, INFECTIONS, AND SEVERE CAPSULAR CONTRACTURE, THE IMPLANT WAS EXCISED ON 7/91 AND REPLACED BY ANOTHER IMPLANT. REPEATED SURGERIES SUCH AS PLACEMENT OF TISSUE EXPANDER, INSERTION OF THE IMPLANT, EXPLANTATION AND INSERTION OF YET ANOTHER IMPLANT, AND THEN FINAL EXPLANTATION, CONSTANT MEDICAL CARE, LAB AND RADIOLOGY TESTS, ANXIETY AND DEPRESSION, RECURRENT USE OF ANTIBIOTICS AND SEVERE ALLERGIC REACTIONS TO SEVERAL OF THEM, ALONG WITH EXCESSIVE USE OF SICK LEAVE, HAVE DEEPLY AFFECTED RPTR'S PROFESSIONAL CAREER, FAMILY RELATIONSHIPS, HER QUALITY OF LIFE AND SELF-CONFIDENCE. SINCE EXPLANTATION IN 11/91, THE FREQUENCY AND NUMBER OF IMMUNE-SYSTEM RELATED INFECTIONS HAVE DRAMATICALLY DECREASED. RPTR IS NOW EXPERIENCING PROBLEMS FOUND ON AN EMG WITH WHAT SEEMS TO BE BRACHIAL-PLEXOPATHY IN THE MULTIPLE SURGICAL AREAS. RPTR EXPERIENCED REPEATED INFECTIONS (AUTOIMMUNE RELATED), CHRONIC AND ACUTE FATIGUE, ARTHRITIS, JOINT PAIN, SKIN BURNING (BODY-WIDE) "DERMOGRAPHIA," BREAST PAIN, DEFORMITY, AND CONTRACTURE. (SAME RPTR REFERRED TO IN 1002016.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE LUMEN BREAST IMPLANT, 400 CC Implant BREAST IMPLANT FTR MCGHAN MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R| S