BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANTS

    MDR report key: 6578261 · Received May 17, 2017

    Report

    Report Number
    MW5069896
    Event Type
    Injury
    Date Received
    May 17, 2017
    Date of Event
    January 1, 1987
    Report Date
    May 10, 2017
    Manufacturer
    BRISTOL-MYERS SQUIBB COMPANY
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MULTIPLE SETS OF BREAST IMPLANTS AFTER SUB Q MASTECTOMIES (BILATERAL) ONE SET OF TEXTURED IMPLANTS ON (B)(6) 1990 ALL SINCE REMOVED. I NOW HAVE A RARE NEOPLASMA IN PANCREAS. (SURGITEK IMPLANTS WERE REPORTED TO FDA BY DOCTOR IN (B)(6) 1989 - FDA FOUND "SERIOUS INJURIES. (B)(6). I BECAME VERY ILL AFTER IMPLANTS - THE ONLY MEDICATIONS I WAS TAKING DUE TO RECEIVING IMPLANTS WAS HORMONES REPLACEMENT AFTER THE RUPTURE. TRIGLYCERIDES ELEVATED TO ALMOST 700 - (PRIOR APPROX 100) - MY IMMUNE SYSTEM IS DAMAGED. SO MANY MULTIPLE DX OVER YEARS IS TOO HARD TO REMEMBER (SAME DX'S). IT WAS RECOMMENDED BY THE 3 OPINIONS AND RECEIVED TO HAVE MY PANCREAS AND GALL-BLADDER AND SPLEEN REMOVED - I WAS GIVEN A PROGNOSIS OF 2 TO 2.5 YEARS TO LIVE WITHOUT THE SURGERY AT (B)(6) - PROGNOSIS WAS VIA (B)(6). I DIDN'T FEEL WELL ENOUGH TO ENDURE THE SURGERY. HAVE BEEN ADVISED VIA (B)(6) TO HAVE PANCREAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355637 BREAST IMPLANTS BREAST IMPLANTS FTR BRISTOL-MYERS SQUIBB COMPANY
    355638 BREAST IMPLANTS BREAST IMPLANTS FTR BRISTOL-MYERS SQUIBB COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| O| R| S