BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4346895 · Received December 19, 2014

    Report

    Report Number
    MW5039656
    Event Type
    Injury
    Date Received
    December 19, 2014
    Date of Event
    January 1, 2013
    Report Date
    November 14, 2014
    Manufacturer
    BAYER
    Product Code
    HHS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE ABOVE DATE IS A GUESS. I HAD ESSURE IMPLANTED BEFORE THEN, AND UPON IMPLANTATION, I HAD A PERSISTENT ACHE IN MY PELVIC AREA. WHEN I COUGHED I COULD FEEL THE COILS. NOW, IN 2014, WHEN I SIT AROUND THE HOUSE I FEEL THEM, WHEN I GO TO BED, WHEN I GO FOR A WALK WHEN I DO ANYTHING I FEEL THEM. SOMETIMES MY PELVIS IS SO INFLAMED THAT IT HURTS TO HAVE A BOWEL MOVEMENT. I AM ALMOST ALWAYS BLOATED, AND DURING THE WEEK OF MY MENSTRUAL CYCLE IT IS THE WORST. NONE OF MY CLOTHES WILL FIT, I AM UNCOMFORTABLE. ON TOP OF THE BLOATING, I AM IN EXCRUCIATING PAIN THE ENTIRE TIME OF MY CYCLE. I HAVE TO DOUBLE UP ON PROTECTION ESPECIALLY WHEN I GO TO BED AT NIGHT, SO THAT I DON'T DESTROY MY CLOTHES/SHEETS. MY HORMONAL BALANCE IS OUT OF WHACK NOW. I'M GROWING HAIR ON MY CHIN, AND I HAVE AWFUL MOOD SWINGS DURING MENSES. I AM CONSTANTLY TIRED. I NEVER HAVE ENERGY. I FALL ASLEEP AT INAPPROPRIATE TIMES IN INAPPROPRIATE PLACES. I AM CONSTANTLY SORE. MY JOINTS ACHE, I'VE BURNING FEELINGS LIKE "HOT SPOTS" THROUGHOUT MY BODY AT TIMES, I HAVE A DIMINISHED SEX DRIVE, AND VAGINAL DRYNESS, MY EYES BLUR TO THE POINT THAT I CAN'T FOCUS SEVERAL TIMES A DAY. THESE ARE ALL THEY SYMPTOMS THAT I CAN THINK OF AT THE MOMENT. I'M SURE THERE ARE MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836398 ESSURE HHS BAYER

    Patients

    Seq Age Sex Outcome Treatment
    1 31.000 YR Disability