BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE SALINE FILLED MAMMARY PROSTHESIS

    MDR report key: 8009284 · Received October 25, 2018

    Report

    Report Number
    MW5080856
    Event Type
    Injury
    Date Received
    October 25, 2018
    Date of Event
    March 7, 2018
    Report Date
    October 25, 2018
    Manufacturer
    MENTOR TEXAS LP
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IMPLANTED WITH MENTOR TEXTURED IMPLANTS IN 1996. IN (B)(6) 2018 - ROUTINE ANNUAL MAMMO SHOWED THE LEFT BREAST WAS FOLDING OVER. THIS WAS AN ANATOMICAL CHANGE IN CONTRAST TO THE 2017 STUDY. THEREFORE, EXPLANTED IN (B)(6) 2018. LEFT IMPLANT HAD EVIDENCE OF BLACKISH FLUID WITHIN THE IMPLANT. LYMPHOMA WAS RULED OUT FORTUNATELY, PS DISCUSSED RECENT FINDINGS OF THIS TYPE OF IMPLANT AND STATED THAT HE DID NOT USE THEM. NOTE: ANOTHER SURGEON IN 1996 PERFORMED THE IMPLANTATION. ON MY OWN I CALLED MENTOR, ((B)(6) 2018) INQUIRED ABOUT THE TEXTURIZED IMPLANT FINDINGS. I WANTED TO KNOW HOW MANY WOMEN HAD BEEN DIAGNOSED WITH LYMPHOMA. THE RESEARCH PERSON ON THE PHONE WAS VERY DISMISSIVE AND SAID THAT SUCH RECORDS WERE NOT KEPT. AS A PT AND AN RN, I FELT THAT WAS NOT GIVEN ACCOUNTABILITY BY MENTOR DUE TO THE FINDINGS THAT CAME OUT AFTER MY INITIAL IMPLANTATION. WHEN THEY WERE IMPLANTED, THE SURGEON STRESSED THAT MY CASE AND THE IMPLANTS WOULD BE REGISTERED IN A REGISTRY WITH THE MFR WHICH WAS MENTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844313 SILICONE SALINE FILLED MAMMARY PROSTHESIS PROSTHESIS, BREAST, INFLATABLE, INTERNAL SALINE FWM MENTOR TEXAS LP STYLE: 2600 SILEX-R AND L 137052

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other