BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3781517 · Received April 30, 2014

    Report

    Report Number
    MW5035830
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    November 7, 2009
    Report Date
    April 14, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    I HAD THIS DEVICE PROCEDURE FOR STERILIZATION. PRIOR TO THIS MY MENSES WERE NORMAL. AFTER THE DEVICE WAS PLACED IN MY BODY I BEGAN TO EXPERIENCE UNUSUAL MENSES. VERY HEAVY AT TIMES WITH SEVERE CRAMPING. I THEN WOULD HAVE MENSES EVERY TWO WEEKS. I EXPERIENCE CRAMPING IN THE PELVIC AREA AND INTO MY LOWER BACK. THESE ARE INTENSE AT TIMES AND FEEL LIKE LABOR. I WENT TO THE GYN AND HE STATED MAYBE PERIMENOPAUSE BUT NO EVIDENCE OF THAT. I WENT ON THE EXPERIENCE ALL THESE SYMPTOMS ON TOP OF DEPRESSION, WEIGHT GAIN, BLOATING, JOINT PAIN THROUGHOUT MY BODY, HEADACHES, AND TIREDNESS. I CHANGED GYN DOCTORS DUE TO INSURANCE CHANGES. I BEGAN TO HAVE NO MENSES FOR FIVE MONTHS. AFTER THAT I HAD ONE WHICH WAS VERY ABNORMAL. MY FAMILY DOCTOR ALSO HAS NOT ADDRESSED ALL OF THESE SYMPTOMS AS IT IS NOT IN HER LINE OF CARE. AFTER MANY TESTS NOTHING ELSE HAS BEEN IDENTIFIED. I AM GOING FOR YET ANOTHER OPINION TO SEE WHY. I AM ALSO GOING TO UNDERGO ALLERGY TESTING TO SEE IF IT IS THE NICKEL/METAL COMPONENT. THIS DEVICE HAS CHANGED MY LIFE FOR THE WORSE. IT IS IN NO MEAN WHAT I THOUGHT IT WOULD BE AFTER CONSULTING MY DOCTOR IN THE BEGINNING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260641 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 41.000 YR Hospitalization| L