BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5060835

    MDR report key: 5495281 · Received March 8, 2016

    Report

    Report Number
    MW5060835
    Event Type
    Injury
    Date Received
    March 8, 2016
    Date of Event
    March 8, 2016
    Report Date
    March 8, 2016
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE ESSURE PROCEDURE DONE IN (B)(6) 2014. PRIOR TO THAT I WAS OVERWEIGHT, BUT IT WAS MANAGEABLE, AND I WAS HEALTHY. BY (B)(6) 2014 I WAS ON ANTIDEPRESSANTS AND ANTI ANXIETY MEDICATION, I WAS GAINING WEIGHT, AND I WAS COMPLETELY AND THOROUGHLY EXHAUSTED ALL THE TIME, TIRED BEYOND WORDS, AND FOR NO APPARENT REASON. I ALSO STARTED HAVING EXTREME JOINT PAIN IN MY HANDS AND FEET. IN (B)(6) 2015 I WAS DIAGNOSED WITH RHEUMATOID ARTHRITIS. I MADE NO CONNECTION TO THE ESSURE PROCEDURES UNTIL A FEW MONTHS AGO ((B)(6) 2016) WHEN I CALLED MY MOM, WHO IS AN LPN, TO ASK ABOUT AN EXTREMELY UNUSUAL MENSTRUAL PERIOD, IT WAS HEAVIER I'D EVER HAD, EVEN AFTER HAVING MY SON, AND I WAS PASSING LARGE (3-5CM) CLOTS, IT ALSO LASTED 15 DAYS. IT WAS TO THE POINT THAT I WORRIED I NEEDED TO TAKE IRON SUPPLEMENTS BECAUSE I WAS LOSING SO MUCH BLOOD. MY MOM AND I DID SOME (B)(6) RESEARCH AND FOUND THAT BASICALLY EVERY HEALTH ISSUE I'VE DEVELOPED SINCE HAVING THE PROCEDURE DONE HAS BEEN LINKED TO SIDE EFFECTS OF THE ESSURE IMPLANT.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Disability