BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLICON

    MDR report key: 25256 · Received August 9, 1995

    Report

    Report Number
    25256
    Event Type
    Injury
    Date Received
    August 9, 1995
    Date of Event
    April 1, 1989
    Report Date
    December 27, 1994
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT IS A 49 YEAR-OLD WHITE FEMALE WHO HAD INITIAL BILATERAL BREAST AUGMENTATION 22 YEARS AGO. IN 1984, AS A RESULT OF CAPSULAR CONTRACTURE THE RIGHT BREAST UNDERWENT AN OPEN CAPSULOTOMY. IN 6/84, SHE UNDERWENT A LEFT BREAST OPEN CAPSULOTOMY WITH IMPLANT EXCHANGE. IN 6/84 AFTER THAT SURGERY, THE LEFT BREAST DEVELOPED HEMATOMA WHICH REQUIRED EVACUACION. IN 4/89 DUE TO CONTINUED HARDNESS AND CAPSULAR CONTRACTURE SHE UNDERWENT NUMEROUS CLOSED CAPSULOTOMIES. SHE ALSO UNDERWENT EXCHANGE IN 4/89. SHE WAS THEN REPLACED WITH POLYURETHANE-COVERED SILICONE GEL IMPLANTS. THE RIGHT WAS 255 GRAMS LOT #9070575. IN THE LEFT SIDE 235 GRAMS, LOT # 9060726. SHE DEVELOPED NUMBNESS AND TINGLING IN THE ARMS AND LEGS WITH HAIR LOSS AND FATIGUE AND PERIODIC LYMPHADENOPATHY, MUSCLE CRAMPS, IRRITABLE BOWEL SYNDROM, MEMORY LOSS CHEST PAIN, CHILLS AND SWEATS,DRY EYES. ON EXAMINATION SHE HAS A CLASS III CONTRACTURE ON BOTH SIDES. ULTRASOUND EXAMINATION SHOWS EXTENSIVE SILICONE GRANULOMA IN THE RETROPECTORAL SPACE ALTHOUGH THE IMPLANTS ARE IN THE RETROGLANDULAR SPACE. ON THE RIGHT SIDE, THERE WAS A LARGE SILICONE COLLECTION IN THE RETROPECTORAL SPACE WHICH EXTENDS THROUGH THE SIDE, SILICONE GRANULOMA WAS ALSO RETROPECTORAL AROUND MAJOR VESSELS, SUBCLAVIAN ARTERY AND VEIN AND BRACHIAL PLEXUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLICON Implant BREAST IMPLANT FTR MEDICAL ENGINEERING CORP. UNKNOWN RT.9070575 LT. 9060762

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention