BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE 410

    MDR report key: 6839050 · Received September 1, 2017

    Report

    Report Number
    MW5071909
    Event Type
    Injury
    Date Received
    September 1, 2017
    Date of Event
    May 19, 2017
    Report Date
    August 30, 2017
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVE FROM REPORTER FOR MW5071909 ON (B)(6) 2018: COHESIVE TEXTURED GUMMY BEAR IMPLANTS ROBBED ME OF MY HEALTH AND HAPPINESS. THESE ARE DANGEROUS. I USED TO BE ACTIVE, NOW I AM BARELY ABLE TO GET OUT OF BED. THESE NEED TO COME OFF THE MARKET, ALL IMPLANTS SHOULD.

    Description of Event or Problem · 1

    I GOT ALLERGAN NATRELLE 410 COHESIVE TEXTURED GEL BREAST IMPLANTS IN (B)(6) 2016 AND FROM THE ONSET OF GETTING THE IMPLANTS, I HAD A HOST OF AUTOIMMUNE SYMPTOMS ARISE. ALL TESTS CAME BACK NEGATIVE YET I FELT LIKE I WAS DYING AND GETTING SICKER AS THE YEARS PROGRESSED. I WAS EXTREMELY HEALTHY BEFORE GETTING IMPLANTS, YET WAS SEEING ALL SORTS OF DOCTORS AND HAD 7 ER VISITS IN ONE YEAR!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618670 NATRELLE 410 NATRELLE 410 FTR ALLERGAN
    618671 NATRELLE 410 NATRELLE 410 FTR ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| S