BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESSURE

    MDR report key: 5213531 · Received November 10, 2015

    Report

    Report Number
    MW5057766
    Event Type
    Death
    Date Received
    November 10, 2015
    Date of Event
    June 14, 2013
    Report Date
    January 5, 2016
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). I HAD A COMPLETE HYSTERECTOMY ON (B)(6) 2015 DUE TO PAIN AND ABNORMAL BLEEDING. THE LEFT ESSURE COIL WAS FOUND EMBEDDED IN THE MYOMETRIUM (MIDDLE MUSCLE LAYER OF UTERUS). MY UTERUS HAD BECOME BOGGY AND SPONGE-LIKE AND DID NOT STOP BLEEDING WITH CAUTERIZATION DURING SURGERY (NEARLY REQUIRING A BLOOD TRANSFUSION). I AM THREE WEEKS POST-HYSTERECTOMY, AND THE PAIN IN MY ABDOMEN/HIP IS GONE. THE ESSURE COILS WERE PROPERLY PLACED IN MY FALLOPIAN TUBES IN (B)(6) 2011 AND THEY WERE STILL IN PLACE AND THE TUBES CONFIRMED OCCLUDED BY HSG IN (B)(6) 2011. SO HOW DID ONE COIL END UP EMBEDDED IN MY UTERINE MUSCLE? THE DOCTOR DID LAVH FOR REMOVAL. HE REMOVED THE CERVIX, UTERUS, AND TUBES (WITH COILS INTACT) LEAVING OVARIES. THIS COMPLEX SURGERY WOULD NOT HAVE BEEN REQUIRED, IF I HAD OPTED FOR A TUBAL LIGATION INSTEAD OF THE ESSURE COILS BACK IN (B)(6) 2011!!! I TRULY HOPE THAT BAYER CORP IS DOING SOME INTENSE RESEARCH AS TO THE DEGRADATION OF ORGANS SUCH AS MINE ALONG WITH HOW THESE DEVICES ARE MIGRATING MONTHS OR YEARS AFTER PLACEMENT. GLAD TO HAVE THE ESSURE COILS WITH THEIR PET FIBERS AND NICKEL OUT OF MY BODY!!!

    Description of Event or Problem · 1

    (B)(4). I HAD ESSURE IMPLANTED IN (B)(6) 2011 BY MY OB/GYN WHO DELIVERED MY BABIES. AFTER HAVING 5 HEALTHY/NORMAL PREGNANCIES, I WANTED TO FOCUS ON RAISING THESE 5 YOUNG CHILDREN AND WANTED THE MOST RELIABLE FORM OF PERMANENT BIRTH CONTROL. THREE MONTHS LATER, I HAD A POSITIVE HSG CONFIRMATION TEST AND WAS GIVEN THE ALL-CLEAR TO BEGIN RELYING ON ESSURE AS MY SOLE MEANS OF BIRTH CONTROL. HOWEVER, IN (B)(6) 2013, I BEGAN TO HEMORRHAGE AND WENT TO THE ER. AT THE ER, IT WAS DETERMINED THAT I WAS SEVERAL WEEKS PREGNANT AND WAS MISCARRYING. THIS WAS A DEVASTATINGLY EMOTIONAL TIME FOR ME. THIS BABY WAS CONCEIVED AFTER IT WAS CONFIRMED THAT I WAS STERILE AND THEN BECAUSE OF ESSURE, I SUBSEQUENTLY MISCARRIED. FOLLOWING THE REMOVAL OF THE FETUS, I BLED FOR TWO MONTHS STRAIGHT. THROUGH SALINE ASSISTED, VAGINAL ULTRASOUND, THE DOCTOR DIAGNOSED A UTERINE INFECTION WHICH WAS RESOLVED WITH ANTIBIOTICS. I ALSO HAVE BURNING/STINGING PAIN IN MY LEFT ABDOMEN AT THE TIME OF OVULATION WHICH HAS BECOME PROGRESSIVELY MORE PAINFUL AND LONGER LASTING. I ALSO HAVE PAIN IN MY LOWER BACK AND LEFT HIP/LEG. MY ONCE THICK HEAD OF HAIR HAS BECOME THIN. I HAVE GAINED A LOT OF WEIGHT IN MY BELLY REGION. I NOW HAVE HIGH ANXIETY, FATIGUE, AND TROUBLE CONCENTRATING. THE ESSURE PROCEDURE WAS LESS INVASIVE THAN A TUBAL LIGATION. HOWEVER, IT WAS EXCRUCIATINGLY PAINFUL. THE HSG CONFIRMATION TEST IS ALSO PAINFUL. THE REMOVAL OF THE ESSURE COILS IS COMPLEX AND REQUIRES FULL OR PARTIAL HYSTERECTOMY WHICH IS FAR MORE INVASIVE THAN TUBAL LIGATION. THE ESSURE COILS HAVE PET FIBERS WHICH ARE SUPPOSED TO CAUSE LOCALIZED INFLAMMATION, BUT I QUESTION THE SAFETY OF THIS. THE ESSURE LITERATURE DID NOT DISCLOSE THAT THE ESSURE COILS CONTAIN PET. THE ESSURE DEVICE HAS RESULTED IN ME HAVING SEVERAL PAINFUL, FEMALE PROCEDURES ALONG WITH THE LOSS OF MY BABY AND CONTINUED PHYSICAL AND EMOTIONAL PAIN AND SUFFERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745205 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 42.000 YR Death| H| O| R