BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAST IMPLANTS

    MDR report key: 9769673 · Received February 27, 2020

    Report

    Report Number
    MW5093357
    Event Type
    Injury
    Date Received
    February 27, 2020
    Date of Event
    January 1, 2008
    Report Date
    February 25, 2020
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I GOT BREAST IMPLANTS ¿2007¿¿. STARTED GETTING SICK (B)(6) 2008. AFTER YEARS AND YEARS OF GOING TO THE ER, HOSPITALIZED, DOCTOR APPTS NO ONE COULD TELL ME WHAT WAS WRONG WITH ME. IN 2012 FINALLY DIAGNOSED WITH HASHIMOTO¿S DISEASE. WASN¿T UNTIL 2018 I GOT MY IMPLANTS REDONE THAT I GOT EVEN MORE SICK. LEGS GOING PARALYZED, HASHIMOTO¿S FLARE, CHRONIC FATIGUE, CHRONIC PAIN AND 50 + MORE SYMPTOMS AGAIN IN AND OUT OF HOSPITALS AND DOCTOR APPTS THAT I FINALLY CAME ACROSS BLL AND FIREWORKS WENT OFF!! I¿M 100% CONVINCED MY BREAST IMPLANTS ARE TO BLAME. I¿M SO SICK AND HAVE OVER 90% OF BLL SYMPTOMS! I DEMAND JUSTICE AND NECESSARY STEPS TO PROTECT WOMEN FROM THESE TOXIC BAGS. THIS IS NOT A COINCIDENCE THAT SO MANY WOMEN HAVE BEEN SICK! IF YOU DON¿T DO SOMETHING IT COULD BE YOUR MOTHER, YOUR SISTER OR YOUR DAUGHTER NEXT! THIS NEEDS TO BE TAKEN SERIOUSLY AND IMPLANTS NEED TO BE TAKEN OFF THE MARKET! I DON¿T KNOW MY EXACT TEST NAMES BUT IF YOU WANT THE HUNDREDS+ OF MEDICAL REPORTS AND DOCUMENTS OVER THE LAST 13 YEARS BE MY GUEST! 2007 IMPLANTS HEALTHY ATHLETE PRIOR AND 2008 TO 2020 MUST HAVE 500+ ER/DR. I¿D BE HAPPY TO GIVE YOU! FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229469 BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR MENTOR WORLDWIDE LLC
    229470 BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR MENTOR WORLDWIDE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| O| S