BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATRELLE SILICONE SEM IMPLANT

    MDR report key: 7714113 · Received July 23, 2018

    Report

    Report Number
    MW5078536
    Event Type
    Injury
    Date Received
    July 23, 2018
    Date of Event
    August 1, 2016
    Report Date
    July 20, 2018
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I GOT BREAST IMPLANTS IN (B)(6) 2016. BY (B)(6) ALL OF MY THYROID LEVELS (T3,T4 TSH) DROPPED BELOW NORMAL. THE DRS DIDN'T KNOW WHY. I DEVELOPED PITTING EDEMA IN MY LEGS. EXTREME FATIGUE. STARTED GAINING WEIGHT QUICKLY DESPITE EATING HEALTHY AND EXERCISING TO NOT GAIN WEIGHT. I STARTED ON 2 THYROID MEDICATIONS TAKING ONE OF THEM 3 TIMES A DAY. I NEVER FELT BETTER THINGS CONTINUED TO GET WORSE OVER THE YEARS. I NOW HAVE INSUFFICIENT ADRENAL GLAND FUNCTION. MY ENDOCRINOLOGIST WANTS TO PUT ME ON STEROIDS BUT I DON'T WANT TO BECAUSE I'M ALREADY SO SWOLLEN. I HAVE FLUID RETENTION ALL OVER MY BODY. TO THE POINT IT HURTS TO BEND MY EXTREMITIES. I HAVE SEVERE JOINT PAIN AND STIFFNESS IN EVERY JOINT. BURNING PAIN IN THE BOTTOMS OF MY FEET, ACROSS THE MIDDLE OF MY BACK WHERE MY IMPLANTS SIT AND THE TOP OF MY SKULL. I HAVE RANDOM STABBING PAINS ALL OVER MY BODY THAT HURTS SO BAD I HAVE TO STOP WHAT I'M DOING UNTIL IT PASSES. MY BREASTS HURT ALL THE TIME AND I GET STABBING PAINS IN THEM AS WELL. I HAVE SHORTNESS OF BREATH WITH LITTLE ACTIVITY. I'VE GAINED 70 LBS IN THE PAST YEAR. I HAVE NO ENERGY. IT TAKES DAYS FOR ME TO RECOVER FORM DOING ANY KIND OF PHYSICAL ACTIVITY. MY EYES ARE ALWAYS RED AND BLOOD SHOT. AFTER I GOT A MAMMOGRAM IN (B)(6) 2018, MY EYES WERE REALLY RED AND I WAS SO SICK FOR ABOUT A WEEK TO WHERE I COULD BARELY GET OUT OF BED. I HAVE CELLULITE ALL OVER MY BODY FROM THE TOXINS IN THESE IMPLANTS. I HAVE BRAIN FOG, BAD HEADACHES DAILY. I FEEL IRRITABLE, ANGRY AND DEPRESSED - NEVER FELT THAT WAY UNTIL AFTER GETTING IMPLANTS. I HAD AN ECHO DONE AND IT SHOWED MILD REGURGITATION IN 3 OF MY VALVES. I'VE HAD PREVIOUS ECHO'S AND DID NOT SHOW REGURGITATION. I ALSO HAD A VENOUS DOPPLER STUDY OF MY LEGS BECAUSE OF THE EDEMA AND MY PRESSURES RANGED IN THE 1000'S UP TO 4000 (SHOULD BE LESS THAN 500). I HAVE A VENOUS DOPPLER STUDY BEFORE IMPLANTS AND IT WAS NORMAL. SO IT APPEARS SOMETHING IS WEAKENING MY VALVES. MUSCLE TWITCHING, PALPITATIONS. BLOATING LOOK 6 MONTHS PREGNANT. EXPLANTING (B)(6) 2018 IN RESPONSE TO THE QUESTION BELOW - I WILL NOT HAVE THE IMPLANTS AFTER (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555062 NATRELLE SILICONE SEM IMPLANT PROSTHESIS BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN
    555063 NATRELLE SILICONE SEM IMPLANT PROSTHESIS BREAST, NONINFLATABLE, INTERNAL SILICONE GEL-FILLED FTR ALLERGAN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Disability