BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6157614 · Received December 7, 2016

    Report

    Report Number
    MW5066599
    Event Type
    Injury
    Date Received
    December 7, 2016
    Report Date
    December 7, 2016
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD ESSURE COILS PLACED IN (B)(6) 2013. SINCE HAVING THESE PLACED, I LIVE WITH CONSTANT PELVIC PAIN, PAINFUL SEX, AND IRREGULAR BLEEDING. THE PAIN IS EXCRUCIATING WHEN I OVULATE, THE PAIN REMIND ME OF WHEN I HAVE HAD KIDNEY STRESS IN THE PAST. I AM LEFT IN BED DUE TO THE PAIN. I ALSO HAVE VERY HEAVY PERIODS AND AM NOW HAVING TWO PERIODS PER MONTH. THE ESSURE COIL ON THE LEFT SIDE OF MY BODY MOVED, AND IS NOW IN MY FALLOPIAN TUBE AND UTERUS. IN (B)(6) 2016, I WAS DIAGNOSED WITH RENAL CELL CARCINOMA REQUIRING ME TO HAVE A PARTIAL NEPHRECTOMY. I ALSO LIVE WITH MULTIPLE SCLEROSIS. OVER THE PAST TWO YEARS, I HAVE HAD A DECREASED IN COGNITIVE FUNCTION AND INCREASED BRAIN FOG, ALTHOUGH MY MS IS STABLE AND THE MRIS SHOW NO NEW OR ACTIVE LESIONS. I AM NOW REQUESTING FOR MY OB TO REMOVE THESE COILS IN LIGHT OF THE NEW WARNING, PEOPLE WITH AUTOIMMUNE DISEASE SHOULD NOT HAVE THEM INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801434 ESSURE ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S ATIVAN| BACLOFEN| MOTRIN| PROZAC