BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCEPTUS

    MDR report key: 3121856 · Received May 15, 2013

    Report

    Report Number
    MW5030216
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 15, 2013
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS IMPLANTED WITH ESSURE MADE BY CONCEPTUS AND THEIR INFORMATIONAL PAMPHLET LEFT OUT IMPORTANT DETAILS ABOUT CONTAINING NICKEL AND SAID NO SIDE EFFECTS, WHICH WAS UNTRUE, I SUFFERED MANY SIDE EFFECTS AND ULTIMATELY HAD A HYSTERECTOMY. THE WHOLE REASON FOR GETTING ESSURE AS MY FORM OF BIRTH CONTROL WAS BECAUSE IT REQUIRED NO SURGERY OR DOWN TIME AND HAD NO SIDE EFFECTS, YET I SUFFERED A LONG LIST OF SIDE EFFECTS AFTER THE IMPLANT; SUCH AS PAINFUL SEX, SHARP PAINS, MIGRAINES, CONFUSION, MIND FOG, DIFFICULTY SEEING, EXTREME WEIGHT GAIN IN ONLY MY ABDOMEN, INFLAMMATION AND MANY MORE PROBLEMS AND HAD TO HAVE SURGERY IN THE END AND DOWN TIME ANYWAYS. I WANT OTHER LADIES TO BE WARNED PLEASE. THIS COMPANY IS WRONG ALSO BECAUSE THEY PUT PET FIBERS IN THE COILS TO PURPOSELY CAUSE INFLAMMATION IN ORDER FOR FALLOPIAN TUBES TO SCAR AROUND THE DEVICES (ESSURE) AND PET FIBERS ARE NOT MEANT FOR MEDICAL DEVICES OR INSIDE THE HUMAN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214474 CONCEPTUS ESSURE HHS CONCEPTUS 886673
    214501 CONCEPTUS ESSURE HHS CONCEPTUS 886673

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| L| R