BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE PERMANENT BIRTH CONTROL

    MDR report key: 4916252 · Received July 7, 2015

    Report

    Report Number
    MW5044160
    Event Type
    Other
    Date Received
    July 7, 2015
    Date of Event
    August 11, 2014
    Report Date
    July 7, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    HHS
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I WENT TO AN OUT-PATIENT SERVICE AT (B)(6) HOSP TO GET THE ESSURE PROCEDURE FOR PERMANENT BIRTH CONTROL. I WAS TOLD THERE WOULD BE MILD CRAMPING AFTER THE PROCEDURE FOR A FEW HOURS AND WAS PRESCRIBED IBUPROFEN FOR PAIN. THE CAMPING LASTED LONGER THAN EXPECTED AND SOON STARTED TO CAUSE LOWER BACK PAIN AS WELL. I HAVE BEEN TO MY PRIMARY PHYSICIAN FOR UNEXPLAINED SYMPTOMS. I HAVE A HISTORY OF BACTERIAL DIAGNOSIS AND UNDERSTAND THE SYMPTOMS FROM EXPERIENCE. I WOULD HAVE SWOLLEN LYMPH NODES OR SWELLING ON THE LEFT SIDE. MY DOCTOR WOULD RUN SOME TEST FOR CHLAMYDIA AND GONORRHEA AND TREAT THOSE CONDITIONS. RESULT WILL ALWAYS COME BACK NEGATIVE. IN WHICH I KNEW THEY WOULD. MY MENSTRUAL CYCLE HAS CHANGED WITH HEAVIER FLOW. I NEVER HAVE CRAMPS BUT SINCE THE INSTALLMENT OF THE DEVICE I CRAMP WEEKS BEFORE MY CYCLE STARTS. THESE CRAMPS RANGE FROM MILD TO SEVERE. I WAS NOT MADE AWARE OF THE OPTIONS FOR REMOVAL AND AT THIS POINT WILL BE DISCUSSING THOSE OPTIONS WITH MY PHYSICIAN. MY HUSBAND HATES THAT WE MADE THE DECISION FOR ME TO GET THE DEVICE AND WISHED HE WOULD HAVE GOTTEN A VASECTOMY INSTEAD. I HAVE DONE A LOT OF RESEARCH LOOKING FOR OTHERS WHICH SYMPTOMS SIMILAR TO MINE AFTER THE PROCEDURE. I HAVE ALSO EXPERIENCED SEVERE SWELLING IN THE LEFT KNEE CAP WHICH HINDERED ME FROM WORK FOR A FEW DAYS. JUST WOKE UP ONE MORNING AND COULD NOT WALK ON THE LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437701 ESSURE PERMANENT BIRTH CONTROL ESSURE PERMANENT BIRTH CONTROL HHS BAYER HEALTHCARE LLC ESS305 C06466

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other VALTREX| IBUPROFEN| LOSARTAN/HCTZ| SOMA