BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH SALINE

    MDR report key: 10032298 · Received May 6, 2020

    Report

    Report Number
    MW5094404
    Event Type
    Injury
    Date Received
    May 6, 2020
    Date of Event
    May 5, 2020
    Report Date
    May 5, 2020
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I ELECTED TO HAVE A BREAST AUGMENTATION WITH ALLERGAN SMOOTH SALINE IMPLANTS IN (B)(6) 2011. FOR THE LAST 6 MONTHS I'VE BEEN GETTING INCREASINGLY SICK. I HAVE TREMENDOUS BRAIN FOG AND MEMORY ISSUES. I HAD A SURGERY TO REMOVE MY GALLBLADDER DUE TO PAIN IN MY UPPER RIGHT QUADRANT AND CONSTANT DIARRHEA WHICH HAS NOT IMPROVED 6 MONTHS POST-OP. I HAVE ACQUIRED A RARE TUMOR IN MY PAROTID AREA, AND I HAVE BODY ACHES, BACK AND NECK PAIN, CHEST PAIN/RIB PAIN, EXTREME FATIGUE, ITCHING/RASHES, UNEXPLAINED NERVE SPASMS, NUMBNESS AND TINGLING IN MY HANDS AND FEET, AND CONSTANT TENSION HEADACHES THAT ARE ALL DEBILITATING. I HAVE BEEN TO 5 DIFFERENT SPECIALISTS INCLUDING NEUROLOGISTS, SURGEONS, ORTHO, GI, ENT AND ALL OF THEM HAVE STATED THAT THEY CAN'T FIND ANYTHING THAT COULD BE CAUSING MY SYMPTOMS. EVERY SINGLE ONE OF THEM IS BAFFLED AND HAS TOLD ME I'M CRAZY. AFTER BEING DIRECTED TO RESEARCH BREAST IMPLANT ILLNESS, I REALIZE ABOUT 90% OF MY HEALTH ISSUES COULD BE CAUSED BY MY IMPLANTS. I WANT TO LET MY VOICE BE HEARD AS AN ADVOCATE FOR OTHERS. THIS NEEDS TO BE RECOGNIZED AS AN ACTUAL MEDICAL CONDITION. THERE NEEDS TO BE SPECIFIC WARNINGS FOR THOSE GETTING IMPLANTS THAT THIS COULD POSSIBLY HAPPEN. WOMEN SHOULD NOT BE LEFT SEARCHING FOR ANSWERS AND HOPE WHILE DOCTORS ARE DISMISSIVE AND UNAWARE OF THE PROBLEMS ASSOCIATED WITH IMPLANTS. I BEG OF YOU TO PLEASE HEAR THE VOICES OF OTHERWISE HEALTHY WOMEN AND HELP CREATE AWARENESS OF THIS PROBLEM. CIGARETTES WERE ONCE CONSIDERED HARMLESS AND NOW SERIOUS WARNINGS ARE PLACED DIRECTLY ON BOXES. I JUST WISH I HAD KNOWN SURVIVING THE INITIAL SURGERY WOULDN'T HAVE BEEN MY ONLY POSSIBLE PROBLEM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494993 SMOOTH SALINE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN
    494994 SMOOTH SALINE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention| S SYNTHROID