BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5018401 · Received August 17, 2015

    Report

    Report Number
    MW5055557
    Event Type
    Injury
    Date Received
    August 17, 2015
    Date of Event
    February 3, 2013
    Report Date
    August 17, 2015
    Manufacturer
    BAYER CORP
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS DIAGNOSED WITH SINUS THROMBOSIS BACK IN 2004, THAT WITH THE MALPRACTICE OF MY DOCTORS, ALMOST KILLED ME. THE CAUSE OF MY CONDITION WAS (B)(6) BIRTH CONTROL PILLS. I AM THE MOTHER OF FOUR GIRLS AND DURING MY PREGNANCY I HAD TO TAKE FRAGMIN SHOTS. BECAUSE OF THIS I HAVE NOT BEEN ABLE TO USE HORMONAL BIRTH CONTROL. AFTER OUR YOUNGEST WAS BORN, MY HUSBAND AND I DECIDED TO HAVE ESSURE DONE. I HAD TO FIGHT OVER SIX MONTHS FOR THE DOCTORS TO ALLOW THIS PROCEDURE FOR ME (DUE TO YOUNG AGE I PRESUME). AFTER I WAS IMPLANTED WITH THE ESSURE DEVICE, I FELT OK FOR ABOUT 6 MONTHS, I HAD SOME MINOR PAINS BUT I JUST THOUGHT THEY WERE NORMAL REACTION TO HAVING THE COILS PUT IN. BUT NOW THAT THE PAIN HAS INCREASED I HAVE BEEN LEFT WONDERING. AT THIS MOMENT, I HAVE BEEN SUFFERING FROM TREMENDOUS AMOUNT OF STOMACH PAINS WITH SOME MENSTRUAL FLOW ABNORMALITIES. I HAVE HAD TO MISS WORK SEVERAL TIMES DUE TO THESE PAINS. THE DOCTORS HAVE EXAMINED ME, EVERYTHING SEEMS TO BE OK, AND THEY SAY IT'S NOT CAUSED BY ESSURE. I FEEL LIKE I HAVE BEEN LABELED 'CRAZY'. TO ADD INSULT TO MY INJURY, MY DOCTORS ARE REALLY PUSHING ME TO HAVE A (B)(6) WITH MY ESSURE. I REFUSE TO HAVE IT, ENOUGH IS ENOUGH! OTC MEDS: BURANA, PANADOL, LITALGIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541296 ESSURE ESSURE HHS BAYER CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| S