BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4113775 · Received September 24, 2014

    Report

    Report Number
    MW5038270
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    November 18, 2011
    Report Date
    June 8, 2015
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). WAS NOT WARNED BY DOCTOR ABOUT CONTRAINDICATION FOR NICKEL ALLERGY (WHICH I HAVE). I WAS NOT AWARE THE DEVICE CONTAINED NICKEL. BEGINNING IN (B)(6) 2011, I EXPERIENCED HIVES, RASHES, PRURITIS ON ARMS, ARMPITS, HANDS, CHEST AND NECK. SAW DRS AND DERMATOLOGIST SEVERAL TIMES. TREATED WITH ORAL STEROIDS, STEROID CREAMS, ORAL ANTI FUNGAL MEDS AND ANTI FUNGAL CREAMS. NOTHING WORKED AND SYMPTOMS STILL EXIST TODAY. IRREGULAR PERIODS WITH HEAVY BLEEDING AND LOWER BACK PAIN STARTED (B)(6) 2011. I HAVE NOW HAD NO PERIODS SINCE (B)(6) 2014, YET HAVE MENSTRUAL CRAMPS AND LOWER BACK PAIN DAILY. I EXPERIENCED TUBAL SPASMS AT TIME OF IMPLANT AND COILS WERE NOT EASY TO IMPLANT. IT WAS EXTREMELY PAINFUL AND ONE COIL WAS BELIEVED TO HAVE PERFORATED THROUGH FALLOPIAN TUBE. I HAD THE TUBE REMOVED AND COIL IS NOW THOUGHT TO BE IN THE UTERINE WALL OR MAYBE INSIDE THE UTERUS. I WILL NEED A HYSTERECTOMY TO REMOVE IT.

    Description of Event or Problem · 1

    #MEDWATCHER #FOLLOWUP1 #FDAMW5038270 #(B)(4). MY ESSURE PLACEMENT TOOK PLACE ON (B)(6), 2010. ON (B)(6), 2010 I HAD RIGHT SALPINGECTOMY DUE TO PERFORATION/MISPLACED OR MIGRATED ESSURE COIL. COIL WAS NOT FOUND AT THE TIME. ANOTHER SIDE EFFECT I NEGLECTED TO MENTION WAS HAIR LOSS. THE LAST 2 YEARS I HAS ESSURE (2012-2014) I REGULARLY LOST A TON OF HAIR, IT WOULD COME OUT IN CLUMPS. ON (B)(6), 2014 I UNDERWENT A LAPAROSCOPIC ASSISTED TOTALING VAGINAL HYSTERECTOMY/LEFT SALPINGECTOMY ORDER TO SAFELY REMOVE THE COILS. THE "MISPLACED" COIL WAS FOUND IN THE MYOMETRIUM OF MY UTERUS NEAR THE CORNUA. IMMEDIATELY FOLLOWING SURGERY, MY RASHES STARTED TO GO AWAY AND I HAVE HAD NO RASHES, HIVES OR ITCHING SINCE THEN. MY HAIR IS NO LONGER FALLING OUT. I HAVE HAD NO PAIN SINCE ESSURE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594884 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 44.000 YR Hospitalization| O| S