BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3983190 · Received August 6, 2014

    Report

    Report Number
    MW5037599
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    January 15, 2008
    Report Date
    June 25, 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). I HAD AN APPENDECTOMY ON (B)(6) 2014. WITHIN THE CT SCAN FOR THAT PROCEDURE A METAL FRAGMENT WAS FOUND IN MY UTERUS. I WAS SEEN BY A DIFFERENT GYNECOLOGIST THAT SHOWED CONCERN FOR MY GROWING LIST OF SYMPTOMS AND ON (B)(6) 2015 I HAD AN ABDOMINAL HYSTERECTOMY ALSO REMOVING OVARIES (DUE TO EXTREME ADHESIVE DISORDER) AND WHAT WAS LEFT OF MY TUBES. ENDOMETRIOSIS AND ADENOMYOSIS WERE DISCOVERED AT THAT TIME. SINCE THE SURGERY MY SYMPTOMS HAVE RESOLVED. I AM NOT HAVING THE GENERALIZED EDEMA, I'M NOT HAVING THE CHRONIC FATIGUE. I AM EXERCISING AND LOSING WEIGHT. GASTRO INTESTINAL ISSUES HAVE IMPROVED. IT IS STILL BELIEVED THAT THE EXPOSURE OF THE COIL AND PET FIBERS HAVE CAUSED THESE SYMPTOMS AND CONDITIONS FROM THE MIGRATED COIL.

    Description of Event or Problem · 1

    (B)(4). SURGERY DATES WERE WRONG IN THE FOLLOW UP. APPY WAS DONE ON (B)(6) 2013 AND HYSTERECTOMY WAS (B)(6) 2014. ALL OTHER INFORMATION IS CORRECT.

    Description of Event or Problem · 1

    (B)(4). ESSURE COILS WERE PLACED ON (B)(6) 2008. I HAD EXTREME PAIN LASTING FOR APPROXIMATELY 2 WEEKS. I HAD THE HSG TEST DONE (B)(6) 2008. "BOTH ESSURE TUBES ARE PROJECTED CAUDAL TO THE FILLING FALLOPIAN TUBES. THEIR PLACEMENT IS UNCERTAIN BUT NEITHER APPEARS TO LIE WITHIN EITHER TUBE." THE COILS HAD MIGRATED AND "INAPPROPRIATE POSITIONING" WAS NOTED. ON/ABOUT (B)(6) I HAD AN EXCEPTIONALLY HIGH WBC. WAS SEEN BY A GASTROENTEROLOGIST AND PLACED ON ANTIBIOTICS. ON (B)(6) I ATTEMPTED A LAPAROSCOPIC TUBAL LIGATION. THE SURGERY WAS ABANDONED POSSIBLY DUE TO SCAR TISSUE. ON (B)(6) I HAD AN OPEN TUBAL LIGATION WHERE THE RIGHT FALLOPIAN TUBE WAS FOUND "TANGLED WITH AN ESSURE COIL." SINCE THE COILS WERE PLACED I HAVE HAD AND CONTINUE TO HAVE THESE SIDE EFFECTS: HOT FLASHES, NIGHT SWEATS, MOOD SWINGS, SUDDEN TEARS, LOSS OF LIBIDO, DRY VAGINA, ITCHY VAGINA-WITH ABSENCE OF YEAST INFECTIONS, CHRONIC FATIGUE, ITCHY, CRAWLY SKIN, ACHING, SORE INFLAMED JOINTS, FLATULENCE, SUDDEN BOUTS OF GENERALIZED BLOATING/EDEMA- THIS IS EXTREME AND VERY UNCOMFORTABLE, SWELLING OF LEGS/FEET/ARMS/JOINTS, WEIGHT GAIN- DESPITE EATING CLEANER AND EXERCISING, INCREASE IN FACIAL HAIR; NEW GROWTH UNDER CHIN, STABBING PAINS IN PELVIC AREA AT TIME OF OVULATION- CAN LAST 2-12 HOURS, HURTS TO WALK- ON RIGHT SIDE- EVERY MONTH, RINGING IN EARS, DRY SKIN/HAIR/EYES, NAUSEA, OCCASIONAL URINE LEAKAGE, PAINFUL PERIODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460635 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 40.000 YR Hospitalization| O