BEUDAMED
    FDA Adverse Event Injury Summary report: N

    410 COHESIVE GEL BREAST IMPLANTS

    MDR report key: 8231797 · Received January 8, 2019

    Report

    Report Number
    MW5083006
    Event Type
    Injury
    Date Received
    January 8, 2019
    Date of Event
    February 11, 2009
    Report Date
    January 5, 2019
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD BREAST AUGMENTATION IN (B)(6) 2009. THEY ARE ALLERGAN COHESIVE GEL 410 IMPLANTS. I STARTED HAVING HEALTH PROBLEMS ALMOST IMMEDIATELY AND HAVE CONTINUED TO HAVE THEM FOR ALMOST TEN YEARS NOW. I AM HAVING SURGERY TO GET THEM REMOVED ON (B)(6). MY HEALTH PROBLEMS STARTED WITH CONSTANT FATIGUE, THYROID ISSUES, ASTHMA, AND ACID REFLUX IN THE FIRST YEAR. IN THE PAST THREE YEARS, MY HEALTH HAS DECLINED AND I HAVE BEEN TESTED FOR RHEUMATOID ARTHRITIS AND HASHIMOTOS. I HAVE HAD NUMEROUS SYMPTOMS OF AN AUTOIMMUNE DISORDER, BUT DRS HAVE BEEN PUZZLED WITH NO OFFICIAL DIAGNOSIS, JUST THAT I HAVE BEEN ON THE AUTOIMMUNE "SPECTRUM". I HAVE JOINT AND TISSUE PAIN, BACK PAIN, BLURRY VISION, WEIGHT GAIN, INFLAMMATION, NO LIBIDOS, SIBO, CANDIDA AND OTHER GUT INFECTIONS, FATIGUE, DEPRESSION, ANXIETY AND A NUMBER OF OTHER SYMPTOMS. PRIOR TO IMPLANTS, I WAS EXTREMELY HEALTHY. AT FIRST, I DIDN'T THINK TO CONNECT MY HEALTH ISSUES TO MY IMPLANTS, BUT IT HAS BECOME INCREASINGLY CLEAR TO ME THAT MY BODY IS FIGHT THESE FOREIGN OBJECTS. MY LAB TESTS SHOW AN ELEVATED CRP AND TROUBLE DETOXING. KNOWING ALL OF THE TOXINS THAT THE IMPLANTS ARE MADE OF I'M NOT SURPRISED NOW. THIS HAS BEEN VERY EMOTIONAL FOR ME TO HAVE TRUSTED IN THE SAFETY REGULATIONS OF THE FDA. I WAS IN THE ALLERGAN STUDY TO GET THESE "GUMMY BEAR" IMPLANTS APPROVED AND AFTER FIVE YEARS, WAS TOLD I NO LONGER NEEDED TO CONTINUE MY F/U APPTS BECAUSE THEY HAD BEEN APPROVED. IF I HAD CONTINUED WITH THE TEN YEARS I WAS SUPPOSED TO BE IN THE STUDY, THE CONNECTION TO AUTOIMMUNE DISEASE AND OTHER SYMPTOMS WOULD HAVE BEEN MUCH CLEARER. HAVING EXPERIENCED THE PROCESS OF APPROVAL, I DO NOT BELIEVE AT ALL THAT IT IS A VALID METHOD FOR COLLECTING THE APPROPRIATE DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17942 410 COHESIVE GEL BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN
    17943 410 COHESIVE GEL BREAST IMPLANTS PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Disability