BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3833885 · Received May 27, 2014

    Report

    Report Number
    MW5036231
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    November 1, 2013
    Report Date
    March 14, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BEGAN GAINING WEIGHT EVEN THOUGH I WORK OUT 6 DAYS A WEEK AND EAT VERY HEALTHY. BLOOD PRESSURE WAS RISING EVEN THOUGH MY MEDICINE (BEFORE THE ESSURE) HAD CONTROLLED IT VERY WELL. BEGAN TO HAVE MORE HEART PALPITATIONS. BEGAN LOSING HAIR. INABILITY TO FALL ASLEEP FOR HOURS, AND THEN WHEN I FINALLY WOULD, I WOULD SLEEP FOR 8 HOURS AND THEN STILL NEED A NAP IN THE AFTERNOON. DRY SKIN. DIAGNOSED WITH HYPOTHYROIDISM THREE MONTHS AFTER IMPLANTATION OF ESSURE. NEVER HAD ANY ISSUES WITH MY THYROID BEFORE. (B)(4) UPDATE ON (B)(6) 2014: HAD SURGICAL REMOVAL OF BOTH COILS AND TUBES ON (B)(6) 2014. IT'S ONLY BEEN A COUPLE OF DAYS, BUT I HAVE NOT HAD ANY HEART PALPITATIONS. SWELLING/PUFFINESS AROUND BELLY HAS SUBSIDED DRAMATICALLY, ALTHOUGH I'M STILL SWOLLEN WHERE MY INCISION WAS MADE. NO LONGER LOOK 5 MONTHS PREGNANT. STILL HAVING SOME TROUBLE FALLING ASLEEP. DOCTOR WANTS ME TO GO OFF THYROID MEDICINE FOR 4-6 WEEKS AND THEN RECHECK TO SEE IF LEVELS RETURN TO NORMAL NOW THAT ESSURE IMPLANTS HAVE BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310926 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 45.000 YR Other| S NADOLOL FOR HIGH BLOOD PRESSURE