BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3907108 · Received July 1, 2014

    Report

    Report Number
    MW5036953
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    February 1, 2011
    Report Date
    October 10, 2016
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS IMPLANTED WITH A MEDICAL DEVICE IMPLANT CALLED ESSURE IN 2007. THIS MEDICAL DEVICE IMPLANT IS NOW MANUFACTURED BY BAYER, FORMALLY BY CONCEPTUS INC. MY LOT NUMBER IS623822. MY MODEL NUMBER IS ESS205 . THIS DEVICE HAS A THREE YEAR SHELF LIFE; HOWEVER I DO NOT HAVE THAT EXPIRATION DATE. THE ONSET OF MY COMPLAINT STARTED IN 2011 THIS IS A LIST OF MY SIDE EFFECTS AND SYMPTOMS THAT I HAVE EXPERIENCED DUE TO ESSURE. PANIC ATTACKS, HEART PALPITATIONS, BACK PAIN, CHEST PAIN( EVEN HAD HEART TESTS DONE), FORGETFULNESS, DIZZINESS, FATIGUE, UNEXPLAINED FEVER, HEADACHES, SHARP STABBING PAINS IN ABDOMEN, URGENCY TO URINATE, SPASMS IN LOWER ABDOMEN, CRAMPING, HOT FLASHES, PAINFUL OVULATION, LOSS OF LIBIDO, PAINFUL INTERCOURSE (DYSPAREUNIA) , BREAST PAIN, ABDOMINAL SPASMS/ TWITCHING/ FLUTTERING, METAL ALLERGIES (NICKEL), HEIGHTENED ALLERGIES/ ALLERGIC REACTIONS , RASHES/HIVES, SEVERE ABDOMINAL TENDERNESS AND BLOATING, DENTAL ISSUES, INSOMNIA, MUSCLE SPASMS, HIP PAIN , MOOD SWINGS, RHEUMATOID ARTHRITIS. I HAD HEAVY PAINFUL PERIODS UNTIL 2010 WHEN I HAD NOVASURE ABLASION. I HAVE BEEN SEEN BY 3 DIFFERENT OF DOCTORS. THE DEVICE IS STILL INSIDE OF ME BUT I AM ON WAITING LIST FINALLY FOR REMOVAL (WHICH IS 12 MONTH LIST). (B)(4).

    Description of Event or Problem · 1

    (B)(4). (B)(6) 2014, I HAD MY TUBES REMOVED LAPAROSCOPICALLY. ACCORDING TO OPERATIVE REPORT COILS WERE REMOVED INSIDE TUBES. SHORT TIME LATER I STARTED HAVING CHRONIC PAIN ONCE AGAIN. FATIGUE WAS WORSE THEN EVER. WENT MANY TIMES TO DOCTOR TO TRY FIND THE CAUSE OF PAIN, DOCTORS THOUGHT MAYBE I HAD INTESTINE OR BOWEL ISSUES AS COULD NOT FIND ANYTHING IN TESTS. (B)(6) 2016 DOCTOR DID AN X-RAY. I CRIED WHEN I FOUND OUT COILS WERE STILL EMBEDDED IN MY UTERUS! TURNS OUT COILS HAD MIGRATED INTO MY UTERUS, DOCTOR DID NOT KNOW THIS WHEN REMOVING COILS, AS A RESULTS COILS WERE CUT! (B)(6) 2016 I AM HAVING A COMPLETE HYSTERECTOMY AS THIS IS THE ONLY WAY TO REMOVE EMBEDDED COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382204 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 42.000 YR Other