BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE COILS

    MDR report key: 3080342 · Received April 22, 2013

    Report

    Report Number
    MW5029920
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    December 1, 2012
    Report Date
    April 22, 2013
    Manufacturer
    CONCEPTUS, INC
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD ESSURE PLACED IN (B)(6) 2012. I WENT BACK IN FOR THE CONFIRMATION SCAN -VERY UNCOMFORTABLE TEST- AND WAS TOLD THAT ONE SIDE LOOKED GREAT WHILE THE OTHER WAS IN THE CORRECT SPOT BUT HAD NOT CAUSED ENOUGH SCAR TISSUE TO FORM AT THAT POINT. IN (B)(6), I BEGAN HAVING SEVERE ABDOMINAL PAIN THAT MOVED EVEN LOWER IF I ATTEMPTED TO DO ANYTHING ACTIVE. I WENT AND HAD AN MRI AND THEY DISCOVERED THAT THE ESSURE HAD MOVED UP IN MY TUBE AND WAS PROTRUDING INTO MY UTERUS. I THEN SIGNED UP FOR A TUBAL LIGATION -LAPAROSCOPIC- INCLUDING THE ESSURE COIL REMOVAL ON THAT SIDE. ONCE THE DOCTOR GOT IN, HE DISCOVERED THAT THE ESSURE WAS IMBEDDED IN MY UTERINE WALL AND ACTUALLY HAD TO OPEN ME UP TO GET THE COIL REMOVED. I HAD A HORRENDOUS RECOVERY POST SURGERY, COULDN'T LIFT MY BREASTFEEDING (B)(6) OLD, AND HAD TO MISS MULTIPLE DAYS OF WORK. I ALSO HAD WORKED HARD TO MAKE SURE THAT DURING MY SECOND PREGNANCY, I WOULD NOT HAVE TO HAVE A C-SECTION UNLESS NECESSARY. I SUCCESSFULLY HAD THAT BABY VAGINALLY, ONLY TO BE CUT OPEN WITH MORE OF A RECOVERY DUE TO ESSURE LATER THE SAME YR. I LIVE IN FEAR KNOWING THAT THE OTHER COIL IS STILL IN PLACE IN MY RIGHT SIDE. WHAT IF IT DECIDES TO MOVE AND CAUSES ME FURTHER DAMAGE OR ANOTHER SURGERY. ESSURE BY CONCEPTUS INC. HAS ME VERY CONCERNED ABOUT THE FUTURE OF MY HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172142 ESSURE COILS ESSURE HHS CONCEPTUS, INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other