BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR, SALINE BREAST IMPLANTS

    MDR report key: 1411965 · Received June 24, 2009

    Report

    Report Number
    MW5011815
    Event Type
    Injury
    Date Received
    June 24, 2009
    Report Date
    June 24, 2009
    Manufacturer
    MENTOR/HS, INC.
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    APPROX SEVEN YEARS FOLLOWING BREAST AUGMENTATION WITH MENTOR SALINE BREAST IMPLANTS, I EXPERIENCED THE ONSET OF SEVERE INFLAMMATION AND PAIN IN MY JOINTS AND MUSCLES, AND DEBILITATING FATIGUE. THIS PROBLEM CONTINUED, AND WAS GETTING WORSE, TO THE POINT WHERE I HAD DIFFICULTY EVEN GETTING UP OUT OF A CHAIR, AND WAS UNABLE TO PERFORM SIMPLE SELF CARE TASKS. IN 2008, I HAD SURGERY TO REMOVE THE IMPLANTS. FOLLOWING THIS SURGERY, THE FATIGUE IMPROVED DRAMATICALLY. WITH THE HELP OF A RHEUMATOLOGIST, THE JOINT PAIN ALSO IMPROVED, AND HAS IMPROVED TO THE POINT THAT I HAVE BEEN ABLE TO ELIMINATE SOME OF THE MEDICATIONS I WAS TAKING. I AM NOW ABLE TO DO MOST ACTIVITIES NORMALLY, INCLUDING 50 TO 60 MINUTES OF CARDIOVASCULAR EXERCISE, WORK IN THE YARD, ETC. MY RHEUMATOLOGIST STATED THAT MY ILLNESS APPEARS TO BE OF AUTOIMMUNE ORIGIN, HOWEVER, MY BLOOD WORK AND LAB TESTS HAVE BEEN NORMAL, WITH THE EXCEPTION OF C-REACTIVE PROTEIN LEVELS, WHICH WERE ELEVATED FOLLOWING SURGERY. THERE IS NO HISTORY OF AUTOIMMUNE DISEASE IN MY FAMILY, AND PREVIOUSLY, I WAS EXTREMELY HEALTHY. DATES OF USE: 1999 - 2008. DIAGNOSIS OR REASON FOR USE: COSMETIC. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR, SALINE BREAST IMPLANTS SALINE-FILLED MAMMARY PROSTHESIS, 300 CC FILLED TO MENTOR 325 FWM MENTOR/HS, INC. 1600 ROUND 194143

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention