BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3811172 · Received April 16, 2014

    Report

    Report Number
    2951250-2014-00109
    Event Type
    Injury
    Date Received
    April 16, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE REPORT WAS RECEIVED ON (B)(4) 2014 FROM THE SAME CONSUMER VIA (B)(4) NEW CASE NUMBER (B)(4), RECEIVED AT FDA ON (B)(4) 2014). THE REPORTING FEMALE CONSUMER OF UNSPECIFIED AGE HAD ESSURE (ESS305, FALLOPIAN TUBE OCCLUSION INSERT), LOT NUMBER A96180, IMPLANTED. FDA FORM REPORTED REPORT TYPE WAS 'INJURY', AND OUTCOME OF EVENTS WAS NEWLY REPORTED AS 'REQUIRED INTERVENTION'. CONSUMER REPORT SHE HAD SYMPTOMS AND PAIN SINCE THE PLACEMENT OF ESSURE ON (B)(6) 2013. SHE FEELS SHE WAS MISLEAD WITH ESSURE, THERE ARE MORE SIDE EFFECTS THAN BENEFITS OF THIS DEVICE. THESE COILS HAVE ABSORBED A STERILIZING AGENT, ETHYLENE OXIDE (LISTED ON THE BACK OF ESSURE PACKAGE) DOES NOT DISSIPATE AND AN SEEP INTO YOUR BODY VIA THE COILS. THE STERILIZING AGENT IS A KNOWN CARCINOGEN AND CAN BE ABSORBED INTO PET FIBERS IN THE COILS AND WHEN PET FIBERS COME INTO CONTACT WITH SALT OR SALINE SOLUTION THIS CARCINOGEN AGENT CAN BE RELEASED EVEN FURTHER INTO THE BODY. CONSUMER HAS HAD WEIGHT GAIN (AT TIME OF REPORTING THE HEAVIEST SHE HAS EVER BEEN), HEAVY/SEVERE BLEEDING AND CLOTTING WHICH HAS SENT HER TO THE ER (EMERGENCY ROOM) TO THEN BE PLACED ON HORMONES FOR TEN DAYS TO STOP/CONTROL THE BLEEDING, SEVERE CRAMPING, HEADACHES/MIGRAINES WEEKLY, HAIR LOSS, SKIN SO DIFFERENT (BREAKING OUT/RASHES/BLISTERING UNDER JEWELRY), MOODY, EXHAUSTED DAILY, CANNOT SLEEP, HARD TO FOCUS (IN A FOG/DIZZY), SPASMS/VIBRATING (WHERE THE COILS ARE, ALMOST LIKE SHE HAS HER CELL PHONE ON HER), EMOTIONAL, EXTREMELY BLOATED, STABBING PAINS IN HER ABDOMINAL AREA, DIARRHEA CONSTANTLY. CONSUMER ASKED HER DOCTOR TO REMOVE THE COILS FROM HER BODY. ON (B)(6) 2014, CONSUMER HAD HER FALLOPIAN TUBES, COILS AND UTERUS REMOVED. SHE FELT THAT SHE WAS SLOWLY BEING POISED AND THAT IF SHE WANTED TO LIVE HEALTHY THIS WAS HER ONLY CHANCE. AT THE TIME OF REPORTING, TWO WEEKS AFTER THE OPERATION, ALL HER SYMPTOMS WERE GONE, DOWN 9 POUNDS, TOO. SHE FEELS LIKE HERSELF AGAIN. SADLY, IF SHE WANTED TO DO A REVERSAL TO BECOME PREGNANT AGAIN SADLY SHE CANNOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233431 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG A96180

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O| H