BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR CORP

    MDR report key: 409069 · Received August 2, 2002

    Report

    Report Number
    MW1025757
    Event Type
    Malfunction
    Date Received
    August 2, 2002
    Date of Event
    November 4, 1993
    Report Date
    July 26, 2002
    Manufacturer
    MENTOR
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IMPLANTS WERE PUT IN PLACE IN 1993. SURGERY WENT WELL AND PT WAS PLEASED WITH THE RESULTS. AFTER 3 MOS CHECK-UP WITH THE DR, HE SAID THE LEFT IMPLANT WAS NOT STAYING IN PLACE; IT WAS DROPPING AND MOVING TO THE LEFT. PT MOVED TO ANOTHER CITY ABOUT 6-8 MOS AGO. PT NOTICED THAT THEIR LEFT BREAST WAS GETTING SMALLER. 3 WEEKS LATER IT WAS SAGGING. PT WENT TO A DR IN THE NEW CITY AND HE SAID IT HAD DEFLATED AND DOUBLED OVER. IT IS UNCOMFORTABLE AND BOTHERS PT. IT NEEDS TO BE REPLACED BUT PT DOESN'T HAVE $2400.00. WITHIN THE LAST 6 YEARS PT REPORTS THAT 6 OTHERS HAD THE SAME SURGERY DONE. EVERY ONE OF THEM HAS HAD ONE TO BUST EXCEPT ONE AND THEY HAD THEIRS A LITTLE OVER 1 YEAR. AT THE TIME OF SURGERY, PT SIGNED A PAPER ALLOWING MENTOR TO SEND THEM NEWS AND INFO ABOUT IMPLANTS AND IN 9 YEARS NEVER ONCE DID THEY GET ANY NEWS. PT KNOWS NOTHING LASTS FOREVER, BUT FEELS THAT IS A LOT OF MONEY TO SPEND AND THEN FIND OUT DOWN THE ROAD THAT SOMETHING OR ANOTHER HAS GONE WRONG WITH THE IMPLANTS OF JUST FAMILY AND FRIENDS. PT FEELS THEY LOOK SO STUPID. THEY CAN'T EVEN WEAR A BATHING SUIT AND HAS TO WEAR XX LARGE SHIRTS SO THAT NO ONE WILL NOTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR CORP TEXTURED SALINE FILLED BREAST IMPLANTS FWM MENTOR STYLE# 2600 84238

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other