BEUDAMED
    FDA Adverse Event Summary report: N

    SURGITEK SILICONE IMPLANT

    MDR report key: 2334691 · Received November 8, 2011

    Report

    Report Number
    MW5023016
    Date Received
    November 8, 2011
    Date of Event
    September 8, 2011
    Report Date
    October 22, 2011
    Manufacturer
    MEDICAL ENGINEERING
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2011, DR. (B)(6) (RHEUMATOLOGIST) AFTER RECEIVING LAB REPORTS, CALL SCHEDULED AN APPOINTMENT WITH DR. (B)(6) (ONCOLOGIST) FOR THE NEXT DAY. SHE HAD NOTICED SEVERAL IRREGULARITIES IN MY LAB WORK AND WANTED A SECOND OPINION. DR. (B)(6) REVIEWED THE LAB WORK, HE DIAGNOSED WITH ME WITH WALDENSTROMS MACROGLOBULINAEMIA ALONG WITH MGUS. ON (B)(6), 1984, I HAD SURGITEK SILICONE IMPLANTS PLACED, BY DR. (B)(6). I WAS MARRIED AND MY NAME WAS (B)(6). THE PRODUCT# WAS (RIGHT) SIDE 15160000S0 SIZE 12.5 235 CC'S. THE MEDICAL ENGINEERING CORP # WAS (B)(4). THE (LEFT) WAS THE SAME IN EVERYTHING EXCEPT THE MEDICAL ENGINEERING CORP # WAS (B)(4). I BEGAN HAVING CHEST PAIN IN MY BREASTS, BURNING IN MY BREAST AND UNDER MY ARMS AND DID HAVE AN INFECTION IN MY LEFT BREAST ON (B)(6), 2004. I WENT TO SEE DR. (B)(6), FOR MY EVAL. MY SURGERY WAS SCHEDULED, FOR (B)(6), 2004. I UNDERWENT BILATERAL OPEN CAPSULECTOMIES WITH SALINE RE-IMPLANTATION USING MENTOR (RIGHT) (B)(4) AND THE LOT #266102 FILLED WITH 400 CC'S OF NORMAL SALINE. THE (LEFT) IS # (B)(4) AND LOT 252565 FILLED WITH 400 CC'S AND WERE SMOOTH SALINE IMPLANTS. MY LEFT AXILLARY LYMPH NODE WAS LARGE WITH SILICONE AND REMOVED FOR BIOPSY. AT SURGERY, BOTH IMPLANTS WERE FOUND TO BE RUPTURED. THE RIGHT HAD CAPSULAR CONTRACTURE, MASTODYNIA AND SILICONE IMMUNE DYSFUNCTION. I ALSO HAD BREAST PTOSIS. I NOW HAVE PAINFUL BREASTS THAT ARE ALSO SORE TO TOUCH AND BOTH SHOW A WHITE OBJECT ON THE INSIDE OF THEM. THEY DID A BIOPSY ON ONE AND COULD NOT IDENTIFY THE OBJECT. THEY STATED THAT IT WAS A BUBBLY SUBSTANCE. I AM GOING TO (B)(6) CENTER (B)(6), 2011 FOR TREATMENT OF LYMPHOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK SILICONE IMPLANT BREAST IMPLANTS FTR MEDICAL ENGINEERING
    2 SURGITEK SILICONE IMPLANT BREAST IMPLANTS FTR MEDICAL ENGINEERING

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| O| R| S