BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4101982 · Received September 19, 2014

    Report

    Report Number
    MW5038235
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    February 6, 2008
    Report Date
    March 24, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). AFTER THE BIRTH OF MY 4TH CHILD, I DECIDED IT TO GET A PERMANENT BIRTH CONTROL, AND MY DOCTOR RECOMMENDED ESSURE, IN 2007 ESSURE WAS PLACED, COUPLE MONTHS PAST AND I STARTED TO EXPERIENCE HEAVIER PERIODS THAT LASTED A WEEK AND MORE CRAMPS. SLOWLY A WEIGH GAIN AND LOWER BACK PAINS. A YEAR PASS, AND MORE SYMPTOMS STARTED TO APPEAR HEAD ACHES AND BODY ACHES MORE WEIGH GAIN. AS THE YEARS "WHEN" BY, MORE SYMPTOMS STARTED TO APPEAR BRAIN FOGS, FATIGUE, ACNE, FLAKY SKIN IN MY ELBOWS AND KNEES, MOOD SWINGS, DEPRESSION, JOINT AND MUSCLE PAIN, DIZZY SPELLS, STOMACH ISSUES, TENDER BREAST, PAINFUL INTERCOURSE, TOOTH DECAY, METAL TASTE IN MY MOUTH, DIABETES TYPE 2, HIGH BLOOD PRESSURE, PAIN IN MY ANKLES, SWELLING OF MY ANKLES, PAIN ON THE BOTTOM OF MY HEALS LIKE NEEDLES, TROUBLE FALLING ASLEEP, ALWAYS FEELING DRAINED DURING THE DAY, TIRED ALL THE TIME, AFTER DIFFERENT VISIT TO THE DOCTORS AND COULDN'T FIND THE ROOT OF MY POOR HEALTH AND COMPLAINTS, I STARTED TO DO SOME RESEARCH AND IN THE BEGINNING OF 2014, I CAME ACROSS A GROUP OF LADIES THAT SIMILAR HEALTH ISSUES, THOUSANDS OF LADIES AND THE ONLY THING WE HAD IN COMMON ITS THE ESSURE DEVICE CAME IN CONTACT WITH DOCTORS THAT LISTENED TO ME AND THEY WERE WILLING TO HELP ME FEEL BETTER IN (B)(6) 2014; THE DECISION WAS MADE THAT THE BEST OPTION FOR ME WAS HAVING A HYSTERECTOMY AND SAFELY REMOVE THE DEVICE ESSURE; THIS PROCEDURE WAS DONE IN (B)(6) 2014 DURING THE SURGERY, THE DOCTOR FOUND THAT MY FALLOPIAN TUBES HAD CYSTS IN THEM AND MY UTERUS WAS WEIGHTING 200 GRAMS WHEN A HEALTHY NORMAL UTERUS WEIGHTS 70 GRAMS. RIGHT AFTER I GOT OUT OF SURGERY THE PAIN ON MY ANKLES AND THE SWELLING INSTANTLY DISAPPEARED MY HIGH BLOOD PRESSURE STARTED TO BE IN THE NORMAL SIDE NOW THAT IT HAS BEEN A MONTH I FEEL MUCH BETTER AS MY SYMPTOMS KEEP DISAPPEARING, THE JOINT PAIN ITS GONE, THE CRAMPS ARE GONE AND I DON'T FEEL TIRED ALL THE TIME, I AM SLEEPING BETTER AND I CAN CONCENTRATE BETTER. ESSURE WAS A TOXIN IN MY BODY DEFINITELY, I AM SO HAPPY THAT THIS IS OUT OF MY BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582764 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 30.000 YR Other ESSURE