BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE BIRTH CONTROL NICKEL-TITANIUM CONCEPTUS ALLOY

    MDR report key: 3212655 · Received July 1, 2013

    Report

    Report Number
    MW5030777
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    November 20, 2007
    Report Date
    July 1, 2013
    Manufacturer
    CONCEPTUS
    Product Code
    HHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE ESSURE PROCEDURE DONE IN 2007 FOR STERILIZATION. SINCE THEN, MY HEALTH HAS GOTTEN SO THAT I CAN BARELY FUNCTION DAY TO DAY. LIST OF SYMPTOMS INCLUDE HAIR LOSS, WEIGHT GAIN, SKIN RASHES, MENTAL FOG, CONFUSION, STOMACH PAINS, SEVERE MENSTRUAL, CRAMPS AND EXTREME BLEEDING, SHARP PAINS IN REPRODUCTIVE AREAS, BLURRY VISION, UNSTEADY GAIT, LOSS OF LIBIDO, FATIGUE, JOINT PAIN, CHEST PAIN, SHORTNESS OF BREATH, AND MAY OTHER SYMPTOMS. MY PERIODS HAVE GONE FROM NORMAL TO EVERY TWO WEEKS WITH LARGE AMOUNTS OF BLEEDING AND CLOTTING FOR A MINIMUM OF 6 DAYS. MY MARRIAGE AND MY RELATIONSHIP WITH MY CHILDREN HAVE SUFFERED DRAMATICALLY, AND I AM ONE OF THE UNFORTUNATE WOMEN WHO DO NOT HAVE HEALTH INSURANCE ANYMORE AND CANNOT AFFORD THE SURGERY FOR REMOVAL. DOCTOR VISITS OVER THE YEARS HAVE BEEN INCONCLUSIVE OR NORMAL FINDINGS. THERE HAS BEEN ONE TRIP TO THE EMERGENCY ROOM FOR POSSIBLE PULMONARY EMBOLISM, ALSO INCONCLUSIVE, 2 YEARS AGO. I WAS NOT AFFECTED BY ANY OF THESE PROBLEMS BEFORE THE INSERTION OF THE ESSURE COILS.

    Description of Event or Problem · 1

    ADD'L INFO REC'D ON 1/15/2014 FOR REPORT # MW5030777: IN (B)(6) OF 2008, I GOT THE ESSURE STERILIZATION PROCEDURE. IMMEDIATELY AFTERWARDS, I BEGAN EXPERIENCING PROBLEMS AND COMPLAINED TO MY DOCTOR. NOW, OVER 5 YRS LATER, I HAVE HAD MY DOCTOR AGREE I HAD A REACTION TO THE ESSURE PROCEDURE AND HAVE HAD TO HAVE A HYSTERECTOMY TO REMOVE THE ESSURE COILS, MY FALLOPIAN TUBES, UTERUS, AND CERVIX, AND IT WAS FOUND THAT I ALSO HAD ENDOMETRIOSIS AND ADENOMYOSIS AND OVARIAN CYSTS, NONE OF WHICH I HAVE EVER HAD UNTIL ESSURE IMPLANTATION. I HAD HORRIBLE SKIN AND EAR RASHES THAT LASTED FOR MONTHS, REQUIRING HOSPITAL VISITS, I BLEED UNCONTROLLABLY EVERY TWO WEEKS WITH HEAVY BLEEDING AND LARGE CLOTS, I HAVE SUFFERED HAIR LOSS, WEIGHT GAIN, FATIGUE, CHEST PAINS, BRAIN FOG, INSOMNIA, DEPRESSION, PAINFUL INTERCOURSE, LOSS OF LIBIDO, SHARP STABBING PAINS IN MY PELVIC AREA, VIBRATIONS IN MY PELVIC AREA, BACK AND HIP PAIN, SEVERE JOINT PAIN, AND MANY OTHER SYMPTOMS. I HAVE ALREADY FILED ONE REPORT WITH THE FDA. I GOT MY HYSTERECTOMY IN (B)(6) OF 2013, AND HAVE FELT SO MUCH BETTER SINCE! I STILL HAVE WAYS TO GO, BUT MOST OF MY JOINT PAIN AND OTHER PAIN IS GONE AND I HAVE NOT HAD ANY RASHES SINCE. THE BLEEDING IS GONE, I'M SLEEPING A LITTLE BETTER, AND MY HAIR LOSS SEEMS TO BE SLOWING DOWN SOME. I DO NOT RECOMMEND THIS PRODUCT FOR ANYBODY! IT IS DANGEROUS AND NEEDS TO BE RECALLED! I BELIEVE THAT IS FOR A LAWYER TO DISCUSS, NOT FOR ME TO POST ONLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299521 ESSURE BIRTH CONTROL NICKEL-TITANIUM CONCEPTUS ALLOY ESSURE HHS CONCEPTUS 626806

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other