BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3803001 · Received May 5, 2014

    Report

    Report Number
    MW5035956
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 13, 2012
    Report Date
    May 2, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MULTIPLE ENDOCRINE NEOPLASIA LEVEL 2A AT AGE (B)(6). THYROID CANCER WITH REMOVAL, LEFT AND RIGHT ADRENAL GLANDS SURGICALLY REMOVED, PHEOCHROMOCYTOMAS SURGICALLY REMOVED. HISTORY OF RARE ENDOCRINE TUMOR CONDITION. MEDICATIONS: SYNTHROID 175 MCG, FLUDROCORTISONE 0.1 MG, PREDNISONE 5 MG. AFTER IMPLANTATION, MY PERIODS INCREASED TO 14 DAYS OF BLEEDING WITH 3 DAYS OF HEAVY BLEEDING. I DEVELOPED DAILY SEVERE HEADACHES AND SIGNIFICANT CONSTANT PELVIC AND BACK PAIN. MY VISION BECAME BLURRY WITH WHITE FLASHES, AND CONFUSION FOR BRIEF SECONDS. IN (B)(6) 2013, I HAD A RAPID ONSET OF CRUSHING CHEST PAIN ALONG WITH SHORTNESS OF BREATH, WHITE FLASHES IN MY EYES AND A PINCHED NERVE FEELING ON THE SIDE OF MY NECK. I WAS SEEN IN THE EMERGENCY ROOM. THE CRUSHING CHEST PAIN AND SHORTNESS OF BREATH NEVER WENT AWAY. IN (B)(6) 2013, I BEGAN TO SUFFER FROM CHRONIC YEAST INFECTIONS WHICH I NEVER HAD BEFORE. I GET THEM ALMOST EVERY MONTH NOW. ALSO THIS IS WHEN THE SEVERE BLOATING OCCURRED CAUSING MY STOMACH TO EXTEND SIMILAR TO WHEN I WAS SEVEN MONTHS PREGNANT. I WAS SEEN IN THE EMERGENCY ROOM. MY SEXUAL DESIRE IS ALMOST NON-EXISTENT DUE TO THE CHRONIC PELVIC PAIN, PAIN DURING INTERCOURSE, AND RECURRING YEAST INFECTIONS. IN (B)(6) 2013, MY VISION IS WORSENING AND MY CONFUSION EPISODES ARE LASTING LONGER. THE HEADACHES ARE INCREASING IN INTENSITY REQUIRING MORE MOTRIN INTAKE. IN (B)(6) 2013, WHILE WALKING, I EXPERIENCED A SHARP STABBING ICE PICK CENTRALIZED PAIN ON MY LEFT SIDE, FOLLOWED BY WHITE FLASHES IN MY EYES, BLURRED VISION, AND CONFUSION WHICH BROUGHT ME TO MY KNEES. IN (B)(6) 2013, MY INNER LEFT KNEE BEGINS TO SWELL AND HURT. I BOUGHT A DRUGSTORE BRACE TO HELP WITH THE PAIN FROM WALKING AND DOING EVERY DAY TASKS. THE INTAKE OF MOTRIN INCREASED TO DEAL WITH THE KNEE PAIN, BACK PAIN, HEADACHES, AND PELVIC PAIN. IN (B)(6) 2013, I CAN NO LONGER WALK FOR LONG PERIODS OF TIME WITHOUT SHORTNESS OF BREATH AND SIGNIFICANT PAIN. THE BLOATING INCREASED AND NOW IS DIFFICULT AND PAINFUL TO SLEEP. MY VISION HAS WORSENED WITH INCREASED WHITE FLASHES, CONFUSION EPISODES ARE LASTING LONGER AND NOW THE SAME PAIN THAT IS IN MY KNEE IS NOW IN MY RIGHT ELBOW. IN (B)(6) 2014, I BEGIN GROWING DARK SIDEBURNS ON MY FACE ALONG WITH INCREASED WHITE FACIAL HAIR ON MY CHEEKS AND NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267857 ESSURE ESSURE HHS BAYER ESS305 810880

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| L| R| S