BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE TUBAL LIGATION

    MDR report key: 2220376 · Received August 17, 2011

    Report

    Report Number
    MW5021801
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    December 27, 2006
    Report Date
    August 17, 2011
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ESSURE TUBAL LIGATION. WITHIN ONE YEAR OF GETTING THE ESSURE PRODUCT, I STARTED EXPERIENCING TERRIBLE CHANGES IN MY BODY. SHARP PAINS IN STOMACH AND LOWER LEFT SIDE. STARTED BECOMING UNBEARABLY AGGRAVATED, TERRIBLE MOOD CHANGES AND OUT OF NOWHERE CRYING SPELLS. AS THE CHANGES HAPPENED, I WENT TO MY DOCTOR THAT PERFORMED THE PROCEDURE AND QUESTIONED IF I COULD BE EXPERIENCING ANY SIDE EFFECTS FROM ESSURE. HE STATED "NO WAY AT ALL." HE SAID THAT I WAS GOING THROUGH PMDD, WHICH I WAS ONLY (B)(6) AT THE TIME, BUT I FELT THAT MY DOCTOR KNEW BETTER THAN MYSELF. HE GAVE ME ANTIDEPRESSANTS. I WENT TO SEVERAL MORE DOCTORS AND AS SOON AS I SAY THE WORD ESSURE THEY CUT ME OFF AND SAY " NO WAY THAT ESSURE CAN CAUSE ANY PAINS AT ALL OR THAT THEY CAN EVER MOVE." BUT THAT IS NOT A TRUE STATEMENT. MY MAIN PROBLEM IS THE DOCTORS ARE REFUSING TO EVEN LOOK INTO THIS AT ALL. IT MAKES ME WONDER HOW MUCH OF A BONUS ARE THESE DOCTORS REALLY GETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSURE TUBAL LIGATION ESSURE METAL COILS HHS CONCEPTUS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other