BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANTS

    MDR report key: 8671076 · Received June 4, 2019

    Report

    Report Number
    MW5087111
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    September 1, 2015
    Report Date
    May 30, 2019
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ORIGINALLY, I GOT BREAST IMPLANTS PLACED (B)(6) 2011. I DID NOT SEEM TO HAVE ANY ISSUES WITH MY IMPLANTS UNTIL I GAVE BIRTH TO MY DAUGHTER ((B)(6) 2015) AND I HAVE NOT RETURNED TO NORMAL. IT'S BEEN FOUR YEARS OF SUFFERING. I FEEL LIKE I'M DYING BECAUSE OF MY BREAST IMPLANTS. THE MAIN SYMPTOMS I FEEL EVERY DAY CONSTANTLY ARE BRAIN FOG (ESPECIALLY WORD RETRIEVAL), CHRONIC FATIGUE [IN BED MOST DAYS], DRY EYES, DEPRESSION, ANXIETY (PANIC ATTACKS), AND NUMBNESS / TINGLING IN MY ARMS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461528 BREAST IMPLANTS PROSTHESIS, BREAST, NON-INFLATABLE , INTERNAL, SILICONE GEL-FILLED FTR MENTOR WORLDWIDE LLC
    461536 BREAST IMPLANTS PROSTHESIS, BREAST, NON-INFLATABLE , INTERNAL, SILICONE GEL-FILLED FTR MENTOR WORLDWIDE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Disability