BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3900267 · Received June 27, 2014

    Report

    Report Number
    MW5036855
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    January 1, 2009
    Report Date
    June 24, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ALMOST IMMEDIATELY AFTER HAVING ESSURE PLACED MY MENSTRUAL CYCLE BECAME VERY IRREGULAR, HEAVY, AND DOUBLED IN THE TIME. MY MONTHLY CYCLE LASTS AT LEAST 2 WEEKS IF NOT LONGER. THE LONGER THE COILS ARE IN THE MORE I NOTICE. I DEVELOPED FIBROMYALGIA DUE TO THE COILS. MY TEETH HAVE BEEN ROTTING AND BREAKING AND HAVE HAD MANY PULLED. MOOD SWINGS, IRRITABILITY, SEVERE ABDOMINAL CRAMPING WITH MENSTRUATION, ABNORMAL PAP. DEPRESSION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376795 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 31.000 YR Other| S ANTIDEPRESSANT