BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5443100 · Received February 17, 2016

    Report

    Report Number
    MW5060243
    Event Type
    Injury
    Date Received
    February 17, 2016
    Date of Event
    March 15, 2009
    Report Date
    May 7, 2016
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). I WAS IMPLANTED WITH A MEDICAL DEVICE IMPLANT CALLED ESSURE ON (B)(6) 2008, AND IT HAS NOT YET BEEN REMOVED. THIS MEDICAL DEVICE/IMPLANT, WHICH WAS FORMERLY MANUFACTURED BY CONCEPTUS INC, IS NOW MANUFACTURED BY BAYER. THE ONSET OF MY COMPLAINT STARTED IN 2009. THIS IS A LIST OF MY SIDE EFFECTS AND SYMPTOMS THAT I HAVE EXPERIENCED DUE TO ESSURE: CRAMPING, SHARP/STABBING PELVIC PAIN, ABNORMAL MENSES, OVARIAN CYSTS, DISCHARGE, HOT FLASHES, OVARIAN CYSTS, UTERINE FIBROIDS, EXCESSIVE BLEEDING DURING PERIOD (MENORRHAGIA), PAINFUL OVULATION (MITTELSCHMERZ), NIGHT SWEATS, HOT FLASHES, PAINFUL PERIODS (DYSMENORRHEA), YEAST INFECTIONS (CANDIDA), URGENT/FREQUENT URINATION,UTI (URINARY TRACT INFECTION), ITCHING, BURNING, STINGING, STABBING OF VAGINAL ENTRANCE, CHRONIC LOWER ABDOMINAL PAIN, JOINT PAIN, GAS, SEVERE BLOAT, CONSTIPATION, HEARTBURN, ICEPICK HEADACHES AND MIGRAINES, ANEMIA, VITAMIN D DEFICIENCY, EASILY BRUISING, WEIGHT GAIN. I AM CURRENTLY BEING SEEN BY TWO DOCTORS, SOON TO BE THREE, AS WE ARE TRYING TO FIGURE OUT WHY I AM HAVING ALL OF THESE SYMPTOMS, INCLUDING THE OBSCENE LOWER ABDOMINAL PAIN THAT CAUSES ME TO DOUBLE OVER, AND REQUIRES NARCOTIC PAIN MEDICATION TO DULL THE PAIN ENOUGH TO STILL FUNCTION AT A LIMITED CAPACITY. MY MOST RECENT TESTS (A CT SCAN WITH CONTRAST AND A TRANSVAGINAL ULTRASOUND) HAVE SHOWN THAT I HAVE FIBROIDS, OVARIAN CYSTS, A SEVERE THICKENING OF THE UTERINE WALL, AND A MASS IN THE UTERINE LINING WHICH WE HAVE NOT YET BEEN ABLE TO IDENTIFY ITS CAUSE. WE ARE ALSO TRYING TO VALIDATE THE LOCATION OF ALL 3 ESSURE COILS THAT WERE IMPLANTED BACK IN 2008, AS I HAVE ONLY SEEN 2 CALLED OUT TO ME ON THE MOST RECENT TEST IMAGES. PRIOR MEDICAL HISTORY INCLUDES BREAST CANCER OF THE RIGHT BREAST, STAGE IIA, THAT WAS DIAGNOSED IN (B)(6) OF 2007 AND WAS TREATED WITH ACT CHEMOTHERAPY FROM (B)(6) 2007 - (B)(6) 2008, THEN RADIATION THERAPY FROM (B)(6) 2008-(B)(6) 2008. I WAS ALSO DIAGNOSED WITH FABRY DISEASE IN (B)(6) OF 2006, AND STARTED ENZYME REPLACEMENT THERAPY IN (B)(6) 2012.

    Description of Event or Problem · 1

    #MEDWATCHER #FOLLOWUP 1 #FDA MW5060243 #(B)(4). AS AN UPDATE TO MY ADVERSE EVENTS REPORT ABOVE, ON (B)(6) 2016, I UNDERWENT A DAVINCI ASSISTED HYSTERECTOMY AND BILATERAL SALPINGECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97174 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 43.000 YR Other| S