BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3961151 · Received July 23, 2014

    Report

    Report Number
    MW5037442
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD ESSURE IMPLANTED IN 2008. DURING THE IMPLANTATION, ONE OF THE COILS BROKE, THE DOCTOR WAS ABLE TO RETRIEVE IT, AND INSERT ANOTHER ONE. IMMEDIATELY FOLLOWING THE PROCEDURE, I BECAME VERY LIGHTHEADED, ALMOST PASSED OUT, AND MY BLOOD PRESSURE SPIKED. SHORTLY AFTER, I STARTED HAVING LEFT SIDE PELVIC PAIN WHICH I REPORTED TO MY GYNECOLOGIST, AND WAS TOLD IT WAS NORMAL. PAIN HAS SINCE PROGRESSED INTO LEFT SIDE PELVIC PAIN, BACK PAIN, HIP PAIN, AND PAIN GOING DOWN MY LEFT LEG TO THE KNEE AND SOMETIMES FOOT. I EXPERIENCE CONSTANT MUSCLE SPASMS IN THESE AREAS AS WELL, CAUSING A SIGNIFICANT AMOUNT OF PAIN. SINCE HAVING THE IMPLANTS, I AM NORMALLY BLOATED AROUND THE MIDSECTION. THIS BLOATING CAN DISAPPEAR FOR A FEW DAYS, AND RETURN WITHIN A DAY SO IT'S NOT WEIGHT GAIN. MY PERIODS HAVE BEEN IRREGULAR, AND I HAVE EXPERIENCED FATIGUE DUE TO HYPOTHYROIDISM DIAGNOSED AFTER ESSURE COILS WERE IMPLANTED. I HAVE HAD SEVERAL IMAGING TESTS, NONE OF WHICH CAN PINPOINT A SOURCE OF THE PAIN. I HAVE HAD THREE CORTISONE SHOTS TO TRY TO DIAGNOSE AND RELIEVE PAIN, ALL UNSUCCESSFUL. I AM HAVING COILS REMOVED ON (B)(6), 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432195 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention| S