BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5030686

    MDR report key: 3193616 · Received June 21, 2013

    Report

    Report Number
    MW5030686
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 21, 2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE ESSURE PROCEDURE FOR PERMANENT BIRTH CONTROL ON (B)(6) 2011. I HAD THE REQUIRED ESSURE "CONFIRMATION TEST" ON (B)(6) 2011. THE RESULTS OF THE HSG SHOWED THAT BOTH FALLOPIAN TUBES WERE FULLY BLOCKED AND THE PROCEDURE WAS SUCCESSFUL. ACCORDING TO ESSURE LITERATURE, "YOUR DOCTOR WILL DISCUSS THE RESULTS OF YOUR ESSURE CONFIRMATION TEST WITH YOU AS SOON AS THEY ARE AVAILABLE, USUALLY ON THE DAY OF YOUR TEST. UNTIL YOU RECEIVE CONFIRMATION DIRECTLY FROM YOUR DOCTOR, YOU MUST CONTINUE TO USE ANOTHER FORM OF BIRTH CONTROL. AFTER THAT, YOU CAN START ENJOYING THE FREEDOM THAT COMES FROM NEVER WORRYING ABOUT UNPLANNED PREGNANCY AGAIN." I SIGNED A CONSENT FORM ON (B)(6) 2011 STATING THAT I UNDERSTOOD THAT THE PROCEDURE MAY NOT BE SUCCESSFUL THE FIRST TIME AND MAY NEED TO BE REDONE AND ALSO THAT AN ALTERNATE FORM OF BIRTH CONTROL WOULD NEED TO BE USED UNTIL THE SUCCESSFUL "CONFIRMATION TEST". NOTHING IN THE CONSENT STATES THAT I MAY BECOME PREGNANT AFTER THE SUCCESSFUL CONFIRMATION TEST. AS A PT, AFTER HAVING A SUCCESSFUL HSG, I BEGAN TO RELY ON ESSURE AS MY SOLE FORM OF BIRTH CONTROL. ON (B)(6) 2013, I BEGAN THE START OF WHAT I BELIEVED TO BE MY PERIOD. ON (B)(6) 2013, I WENT TO THE EMERGENCY ROOM WITH SEVERE BLEEDING. IT WAS IN THE ER THAT THEY DISCOVERED THAT I WAS PREGNANT. THEY DID AN ULTRASOUND, DETERMINED THAT THE BABY/FETUS WAS DEAD, AND THE DOCTOR REMOVED THE GESTATIONAL SAC TO STOP THE MAJORITY OF THE BLEEDING. THE START OF MY PREVIOUS MENSTRUAL CYCLE WAS ON (B)(6) 2013, BUT SINCE I HAD BEEN HAVING IRREGULAR PERIODS THIS WAS NOT A CAUSE FOR CONCERN. THE REASON FOR FAILURE OF THE ESSURE PROCEDURE AFTER A SUCCESSFUL CONFIRMATION TEST STILL NEEDS TO BE DETERMINED. THE CAUSE OF MISCARRIAGE STILL NEEDS TO BE EVALUATED TO DETERMINE WHETHER IT WAS RELATED TO THE ESSURE IMPLANTS. FROM THE ESSURE PT INFO BOOKLET: "FREQUENTLY ASKED QUESTIONS: CAN I TRUST ESSURE TO PREVENT PREGNANCY - YES, THE ESSURE PROCEDURE IS 99.83% EFFECTIVE. IN FIVE YEARS OF CLINICAL TRIALS, THERE HAVE BEEN NO PREGNANCIES AMONG WOMEN WHO SUCCESSFULLY COMPLETED ALL 3 STEPS OF THE ESSURE PROCEDURE. A FEW PREGNANCIES HAVE BEEN REPORTED AMONG THE HUNDREDS OF THOUSANDS OF WOMEN WHO HAVE COMPLETED THE PROCEDURE SINCE IT BECAME COMMERCIALLY AVAILABLE. MOST OF THOSE PREGNANCIES WERE A RESULT OF NOT HAVING COMPLETED THE PROCEDURE OR NOT FOLLOWING INSTRUCTIONS." THEY ALSO STATE THAT THERE WERE NO PREGNANCIES IN THE MORE THAN 700 PERSON CLINICAL TRIAL OF WOMEN IN MY AGE RANGE (B)(6). MY HSG RESULTS HAVE AGAIN BEEN REVIEWED AND DETERMINED TO BE WITHIN THE ESSURE GUIDELINES. FROM THE ESSURE PT INFO BOOKLET: "UNK RISKS: THE RISKS TO YOU AND YOUR FETUS IF YOU GET PREGNANT AFTER THE ESSURE PROCEDURE ARE NOT KNOWN." I HAVE 5 CHILDREN WHICH WERE ALL HEALTHY, UNCOMPLICATED PREGNANCIES. I DID HAVE ONE MISCARRIAGE.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other