BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMORYGEL BREAST SMOOTH ROUND ULTRA HIGH PROFILE

    MDR report key: 8374717 · Received February 26, 2019

    Report

    Report Number
    MW5084437
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    November 8, 2017
    Report Date
    February 22, 2019
    Manufacturer
    MENTOR WORLDWIDE, LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BREAST IMPLANTS RAVAGED MY BODY VERY QUICKLY. FROM DAY ONE MY MUSCULAR SYSTEM STARTED TO DECLINE. NERVE DAMAGE IN CHEST/BACK, TRAVELING PAIN UNDER THE MUSCLE CAUSED SEVERE AND PAINFUL MUSCLE DISTORTION. MY IMMUNE SYSTEM STARTED TO FAIL ME, FATIGUE BRAIN FOG, MEMORY LOSS, MUSCLE AND JOINT PAIN, HAIR LOSS, DRY SKIN AND HAIR, PREMATURE AGAIN, LOW LIBIDO, SLOW HEALING, EASY BRUISING, THROAT CLEARING, COUGH, DIFFICULTY SWALLOWING, CHOKING, REFLUX, METALLIC, TASTES, ACID REFLUX, IBS, FEVERS, NIGHT SWEATS, INTOLERANT TO HEAT/COLD, ARMPIT RASHES, EAR RINGING, FOOD/ALCOHOL INTOLERANCE, HEADACHES, SLOW MUSCLE RECOVERY AFTER ACTIVITY, HEART PALPITATIONS, SORE AND ACHING JOINTS OF SHOULDERS, HIPS, BACKBONE, HANDS AND FEET PAIN AND OR BURNING SENSATION AROUND IMPLANT, ANXIETY, DEPRESSION AND PANIC ATTACKS, FEELING LIKE I¿M DYING. SYMPTOMS OF FIBROMYALGIA- NERVES FEEL LIKE THEY ARE FIRING OFF EVERYWHERE SOMETIMES. (B)(6) 2017- WENT TO URGENT CARE ¿ ANTIBIOTICS FOR PNEUMONIA. (B)(6) 2018 ¿ EXTREME FATIGUE, LOW MUSCLE EFFICIENCY, HEALTH DECLINE, STARTED HAVING OUT OF THE BLUE PANIC ATTACKS. (B)(6) 2018 ¿ STRAIN/SPRAINED/HURT BACK MUSCLE. (B)(6) 2018 ¿ SICK WITH VERY LITTLE MOBILITY. (B)(6) 2018 ¿ STARTED SEEING FIRST CHIROPRACTOR WITH NO RELIEF. (B)(6) 2018 ¿ STARTED SEEING 2ND CHIROPRACTOR (3X) WHO REFERRED ME TO ORTHOPEDIC SPECIALIST. (B)(6) 2018 PA PRESCRIBED PT AND WE DISCUSSED BREAST IMPLANTS BEING THE ¿SOURCE¿ ¿ PA WAS IN 'AGREEANCE.'(B)(6) 2018 ¿ PT WAS STARTED AND DISCUSSED LIMITATIONS IMPLANTS WERE GIVING TO SUCCESSFUL PT SESSIONS. (B)(6) 2018 ¿ MRI COMPLETED. (B)(6) - CURRENT ¿ CONTINUE SEEING PT, ORTHO, GENERAL DOCTOR, MASSAGE THERAPIST AND SCHEDULING EXPLANT WITH HIGHLY RECOMMENDED MICROSURGEON. I DO NOT WISH TO BE TAKING ANYTHING FOR SUCH A RIDICULOUS REASON AS BREAST IMPLANTS. CURRENTLY PRESCRIBED MUSCLE RELAXER FOR BREAST AND BACK PAIN. DOCTOR PRESCRIBED GABAPENTIN FOR NERVE PAIN/DAMAGE, BUT DO NOT TAKE BECAUSE OF RISKS AND SIDE EFFECT. TAKING PROBIOTIC AND VITAMINS TO STAY SOMEWHAT HEALTHY AND NOT CONSTANTLY SICK. MANY, MANY MORE INSTANCES AND DATES THAT WERE UNACCOUNTED FOR WITH PRIMARY PHYSICIAN AND OTHER WHERE TREATMENTS AND PLANS DISCUSSED, BUT ALL LEAD BACK TO BREAST IMPLANTS BEING SOURCE OF HEALTH DECLINE. SO MANY OTHER UNIDENTIFIED ISSUES THAT ARE LINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165623 MEMORYGEL BREAST SMOOTH ROUND ULTRA HIGH PROFILE PROSTHESIS, BREAST, NON INFLATABLE, INTERNAL SILICONE GEL-FILLED FTR MENTOR WORLDWIDE, LLC REF 350-5650BC
    165624 MEMORYGEL BREAST IMPLANT SMOOTH ROUND ULTRA HIGH PROFILE PROSTHESIS, BREAST, NON INFLATABLE, INTERNAL SILICONE GEL-FILLED FTR MENTOR WORLDWIDE, LLC REF 350-5650BC

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention