BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORY SHAPE TEXTURED BREAST IMPLANTS

    MDR report key: 8692715 · Received June 11, 2019

    Report

    Report Number
    MW5087298
    Event Type
    Injury
    Date Received
    June 11, 2019
    Date of Event
    June 6, 2016
    Report Date
    June 9, 2019
    Manufacturer
    MENTOR WORLDWIDE LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD DOUBLE MASTECTOMY FOLLOWED BY IMMEDIATE RECONSTRUCTION THE DATE LISTED ABOVE. IT WAS A GREAT CANDIDATE FOR A LUMPECTOMY BY HAVING JUST WITNESSED SEVERAL PEOPLE AROUND ME DIE OF CANCER. I CHOSE THIS RADICAL ROUTE. I DID NOT HAVE TO DO CHEMO OR RADIATION SINCE MY APPROACH WAS SO RADICAL. OTHER THAN THE BREAST CANCER DIAGNOSIS, I WAS A VERY HEALTHY PERSON. I ATE ORGANIC FOODS AND AVOIDED GLUTEN, GMO'S ETC. I WORKED OUT A LOT. I WEIGHTED (B)(6) LBS ((B)(6) NOW). AFTER THE MASTECTOMY AND RECONSTRUCTION WITH MENTOR MEMORY SHAPE TEXTURED BREAST IMPLANTS, MY HEALTH SLOWLY STARTING SLIPPING FOR ME. IT WAS A BUNCH OF RANDOM SYMPTOMS THAT DID NOT FIT INTO 1 NICE LITTLE DIAGNOSIS. OVER THE LAST 3 YEARS I HAVE HAD THE FOLLOWING SYMPTOMS. FATIGUE, BRAIN FOG (HAND OVER), TROUBLE SPELLING, TROUBLE REMEMBERING THINGS, TROUBLE DRIVING THE CAR, RIGHT ARM AND SHOULDER MOBILITY AND PAIN PROBLEMS ALONG WITH WEAKNESS, SWELLING UNDER EYES, DRY MOUTH AND LIPS, NO APPETITE, COULD NOT FORCE MYSELF TO EAT MUCH, TASTES CHANGED, INSOMNIA, POOR SLEEP, RACING HEART WHILE LYING DOWN, SHALLOW BREATHING, DRY AND YELLOW EYES, VISION CHANGES, SWOLLEN NECK (HAD ULTRA SOUND DONE ON MY THYROID AND THEY FOUND A MODULE), HARD TO SWALLOW, CHOKED EASILY, FELT MY BITE WAS OFF, LACK OF MOTIVATION, ANXIETY (ALMOST TO THE POINT OF PANIC), EASILY BRUISED, NIGHT SWEATS OR HOT THEN COLD, INTOLERANCE TO WINTER COLD ON MY GLOVED HANDS, DEPRESSION, IRRITABLE / MOOD SWINGS/RAGING ANGER (CHEST AT INAPPROPRIATE TIMES), EAR RINGING, HEADACHES, FEELING WEIRD BUT TIRED, CHEMICAL SENSITIVITIES BEGAN TO DEVELOP (NAIL POLISH AND PROPYLENE GLYCOL), CONSTANTLY HUMMING, SHAKY HANDS, DIFFICULTY WRITING, MY MOUTH FELT AWKWARD WHEN SPEAKING, EXTREME SWINGS IN MY CHOLESTEROL AND BLOOD PRESSURE READINGS, ETC. MY NEW CHEMICAL SENSITIVITY TO PROPYLENE GLYCOL (WHICH IS ALMOST EVERYTHING) CAUSED MY FINGERTIPS TO PEEL TO THE POINT THAT THEY WERE RAW. THIS ALLERGY WAS CONFIRMED BY AN ALLERGIST. MOST RECENTLY, I SOUGHT HELP FOR WHAT I THOUGHT WAS THYROID ISSUES. THE DR I SAW FELT I HAD THE CLASSIC HASHIMOTO'S THYROID ISSUES. A FULL THYROID PANEL WAS DONE. I DO NOT HAVE THOSE RESULTS BACK YET. BUT, I DID HAVE THE ULTRASOUND ON MY THYROID WHICH INDICATED A NODULE THAT THEY WANT TO DO A NEEDLE BIOPSY ON. I FELT THINGS WERE ESCALATING, AS IF I WAS BEING POISONED. I HAD TO DETOX IN THE SAUNA EVERY NIGHT JUST TO BE ABLE TO THINK AND FUNCTION. I WAS ALSO DOING CLAY BATHS TO DETOX MYSELF. I EVEN TOOK ACTIVATED CHARCOAL (WHAT THEY GIVE TO YOU IF YOU HAVE BEEN POISONED) TO PULL THE TOXINS OUT OF ME. IT WAS DURING THIS TIME THAT I BECAME AWARE OF SOMETHING CALLED BREAST IMPLANT ILLNESS. THERE WAS NO WAY TO PROVE THAT TAKING THE IMPLANTS OUT WOULD MAKE MY SYMPTOMS DISAPPEAR. BUT, I ALSO HAD A LARGER CONCERN; MY IMMUNE SYSTEM. I HAD TRIED TO TAKE EVERY TOXIN OUT OF MY LIFE THAT I COULD CONTROL SO AS NOT TO GET CANCER AGAIN. GETTING BREAST IMPLANTS IS SO COMMON PLACE THAT I DID NOT EVEN THINK OF THEM AS WHAT THEY ARE: HUGE FOREIGN OBJECTS COMPRISED OF A LUNCH OF TOXIC CHEMICALS, PLACED ON MY CHEST AROUND A TON OF VITAL ORGANS. HOW STUPID I FELT. I ACTUALLY INVITED A TOXIN INTO MY BODY AND NOW MY POOR IMMUNE SYSTEM HAD TO FIGHT IT EVERY DAY. FOR NO OTHER REASON THAN THAT, I WANTED THEM OUT. I WAS FORTUNATE TO FIND AN EXPLANT EXPERT NEAR MY HOME. I WAS ALSO FORTUNATE ENOUGH TO GET MYSELF IN AND NOT BE ON A MONTHS LONG WAIT LIST. I HAD MY EXPLANT SURGERY ON (B)(6) 2019. THE SURGERY WAS IN THE EARLY MORNING. BY THE AFTERNOON, I REALIZED THAT A TON OF MY SYMPTOMS WERE GONE; MY MOOD WAS MUCH HAPPIER AND STABLE, AND MY RIGHT ARM HAD NO PAIN ANYMORE. I AM HOPING IN TIME I WILL RETAKE THYROID PANEL AND SEE IF IT IS SETTING DOWN AS WELL. MINE IS NOT THE ONLY STORY LIKE THIS. THERE IS A (B)(6) PAGE WITH ABOUT 80,000 WOMEN WHO HAVE SIMILAR STORIES. THERE SHOULD BE MUCH STRONGER WARNINGS REGARDING IMPLANTS AND THEIR EFFECTS ON YOUR IMMUNE SYSTEM AND DEVELOPMENT OF AUTO IMMUNE DISORDERS. THE CAPSULE OF THE IMPLANTS HAS BEEN SENT TO THE LAB FOR TESTING. FDA SAFETY REPORT ID# (B)(4).

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM REPORTER ON 02/04/2020 FOR REPORT MW5087298. I HAVE ALREADY FILED A COMPLAINT BACK IN JULY OF 2019. MY ACCESS NUMBER IS MW5087298. I DO HAVE ADD'L INFO REGARDING MY CASE. SINCE SUFFERING FROM BREAST IMPLANT ILLNESS, I CAME TO LEARN THAT THE IMPLANTS ARE MADE OF A LOT HEAVY METALS. I REMEMBERED THAT I HAD DONE A HAIR ANALYSIS TESTING FOR HEAVY METAL AFTER THE IMPLANTS WERE IN MY BODY FOR ABOUT 14 MONTHS. I LOOKED AT THE RESULTS AGAIN AND FOUND THAT I WAS "HIGH" OR "CRITICALLY HIGH" FOR A LOT OF THE HEAVY METALS THAT ARE IN THE IMPLANTS. I THEN REPEATED THE TEST AFTER THE IMPLANTS HAD BEEN REMOVED. THE LEVELS DROPPED AND IN SOME CASES COMPLETELY DISAPPEARED. THIS SHOULD SHOW THE LINK BETWEEN IMPLANTS HEAVY METALS. HAVING HEAVY METALS IN YOUR BODY IS OBVIOUSLY TOXIC. I HAD MY EXPLANT SURGERY ALMOST 8 MONTHS AGO AND AM STILL RECOVERING FROM ALL THE DISRUPTIONS THAT HAPPENED TO MY BODY (ADRENAL FAILURE, DISRUPTION AT THE CELLULAR LEVEL, AND WATCHING A THYROID NODULE TO MAKE SURE IT DOES NOT BECOME CANCER). THERE IS A (B)(6) PAGE FOR BII WITH OVER 100,000 WOMEN ON IT. PLEASE INVESTIGATE THE IMPLANTS. DO NOT RELY ON THE COMPANIES TO GIVE YOU ACCURATE INFO. IF EVERY WOMAN KNEW ABOUT THE TOXIC HEAVY METALS IN IMPLANTS; VERY FEW WOULD WANT THESE DEVICES PUT IN THEM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483088 MENTOR MEMORY SHAPE TEXTURED BREAST IMPLANTS PROSTHESIS, BREAST, NON-INFLATABLE , INTERNAL, SILICONE GEL-FILLED FTR MENTOR WORLDWIDE LLC 7279913
    483089 MENTOR MEMORY SHAPE TEXTURED BREAST IMPLANTS PROSTHESIS, BREAST, NON-INFLATABLE , INTERNAL, SILICONE GEL-FILLED FTR MENTOR WORLDWIDE LLC 729967

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| S