BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3913185 · Received June 27, 2014

    Report

    Report Number
    MW5037020
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    February 25, 2013
    Report Date
    June 26, 2014
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE ESSURE PRODUCT IMPLANTED IN (B)(6) 2013. SINCE IMPLANTING, PERIODS HAVE BECOME SO HEAVY I HAVE HAD TO GO TO THE EMERGENCY ROOM NUMEROUS TIMES DUE TO FAINTING AND SERIOUS PAIN. I CONSTANTLY FEEL SEVERE CRAMPING, ESPECIALLY DURING SEX; WHICH IS NOW ALMOST IMPOSSIBLE AND NO LONGER ENJOYABLE. THERE HAVE BEEN DAYS I HAD TO LEAVE WORK EARLY BECAUSE OF THE PAIN. A LOT OF THE TIME IT FEELS LIKE A STABBING PAIN, ALMOST LIKE SOMEONE IS SHOVING A KNIFE THROUGH MY ABDOMEN AND TWISTING IT VIGOROUSLY. MIGRAINES HAVE STARTED AND SEEM TO GET WORSE AS TIME GOES ON. DID I MENTION THE CONSTANT PAIN. THERE IS ALSO A LOT OF ABDOMINAL SWELLING, SOME DAYS IT LOOKS AS THOUGH I AM 3 OR 4 MONTHS PREGNANT. THIS PRODUCT HAS CAUSED ME NOTHING BUT DISCOMFORT, PAIN, STRESS, ANGER, AND BORDERLINE DEPRESSION. HOW IN GOD'S NAME IT WAS ABLE TO BE CLASSIFIED AS A LIFESAVING DEVICE IS BEYOND ME. IT'S BIRTH CONTROL, OR STERILIZATION, THE ONLY THING IT HAS DONE IS RUINED MY LIFE. AND MY HUSBAND'S, AND MY CHILDREN'S, AND WHILE WE ARE AT IT, PROBABLY MY BOSS'S TOO SINCE I'M ALWAYS GONE FROM WORK. PLEASE RE-THINK THIS CLASSIFICATION SO THOSE OF US WHO HAVE SUFFERED CAN AT THE LEAST HAVE THE SURGERY EXPENSES COVERED TO REMOVE THESE PIECES FROM OUR BODIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376049 ESSURE ESSURE HHS CONCEPTUS ESS305 A64633

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| O| S