BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 4883646 · Received June 25, 2015

    Report

    Report Number
    MW5043369
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    October 10, 2008
    Report Date
    June 25, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE ESSURE PROCEDURE DONE. AFTERWARDS, I HAD HORRENDOUS PAIN AND CRAMPING. I BLED MORE THAN I HAVE EVER BLED IN MY LIFE. I HAD WEIGHT GAIN AND MIGRAINE HEADACHES. WHEN I CONTACTED MY DOCTOR AND TOLD HIM I WANTED IT OUT, HE SAID HE COULDN'T TAKE IT OUT AND HE DIDN'T THINK MY SYMPTOMS HAD ANYTHING TO DO WITH THE ESSURE. I ENDED UP GOING TO ANOTHER DOCTOR AND SHE PUT ME BACK ON BIRTH CONTROL PILLS TO TRY TO HELP WITH THE PAIN, CRAMPING AND HEAVY BLEEDING. TAKING BIRTH CONTROL DEFEATED THE PURPOSE OF HAVING THE ESSURE PROCEDURE DONE. I DO NOT WANT TO HAVE THE ESSURE IN MY BODY ANY LONGER. IT IS A HEALTH RISK TO ANY WOMAN WHO HAS IT DONE. THE SIDE EFFECTS OUTWEIGH ANY POSITIVES ABOUT IT. PLEASE DO NOT ALLOW DOCTORS TO CONTINUE TO USE ESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411021 ESSURE ESSURE HHS BAYER HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other