BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3913300 · Received June 27, 2014

    Report

    Report Number
    MW5037036
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD ESSURE PLACED IN (B)(6) OF 2008. SINCE HAVING THIS PLACED I HAVE EXPERIENCED VERY PAINFUL AND HEAVY PERIODS. THE LAST 4 YEARS IT HAS BECOME WORSE. I HAVE SEVERE ABDOMINAL PAIN, MAINLY THE RIGHT SIDE AND TAMPON AT THE SAME TIME AND HAVING TO CHANGE EVERY 10-15 MINUTES AS WELL AS CLOTHING) PASSING OF CLOTS RANGE FROM A QUARTER SIZE TO THE SIZE OF MY PALM. VERY PAINFUL! IT AFFECTS ME AT WORK AND HOME. IRREGULAR LONG LASTING PERIODS. BREAST TENDERNESS, AND AT TIMES LEAKING. LOTS OF HAIR LOSS. WAY MORE THAN NORMAL@ I HAVE BEEN TO THE EMERGENCY ROOM MANY TIMES WITH SEVERE ABDOMINAL PAIN AND VOMITING. HAD CT SCANS DONE AND ALL THAT EVER COMES ABOUT IT THEY GIVE ME PAIN PILLS AND SEND ME HOME. I HAVE NEVER HAD A PROBLEM WITH CYSTS UNTIL ESSURE. I HAVE NOW BEEN DIAGNOSED WITH POLYCYSTIC OVARIAN SYNDROME AND PELVIC INFLAMMATORY DISEASE. I HAVE NO ENERGY AND I AM A DIFFERENT PERSON. I HAVE GAINED QUITE A BIT OF WEIGHT AND I HAVE HEADACHES A LOT. SOME ARE MIGRAINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376047 ESSURE NONE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR