BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3855697 · Received May 7, 2014

    Report

    Report Number
    2951250-2014-00145
    Event Type
    Injury
    Date Received
    May 7, 2014
    Report Date
    December 8, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INSTRUMENT WAS RETURNED TO LIFE TECHNOLOGIES CORP AND REPAIRED BY REPLACING POWER AMPLIFIER & DAMPER. AFTER REPAIR, THE INSTRUMENT PASSED ALL THE CALIBRATION, FINAL TESTS, PERFORMANCE SPECIFICATIONS. THE INSTRUMENT WAS SENT BACK TO THE CUSTOMER. THE DEVICE WAS USED AS A DIAGNOSTIC. DEVICE INTENDED USE CAN BE FOUND ON PAGE 3 OTHER REMARKS. DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS VERITI DX THERMAL CYCLER AMPLIFIES HUMAN NUCLEIC ACID SAMPLES FOR DIAGNOSTIC APPLICATIONS. THE VERITI DX THERMAL CYCLER IS TO BE USED ONLY BY OPERATORS TRAINED IN LAB TECHNIQUES AND PROCEDURES.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA REGULATORY AUTHORITY (CASE# (B)(4)) IN THE UNITED STATES ON (B)(4) 2014 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED EXCRUCIATING PAIN / DEBILITATING PAIN THAT STAYED AND BECAME CHRONIC / STABBING PAIN, DEBILITATING TO MANAGEABLE CRAMPS, DEBILITATING DURING MENSTRUATION, PAINS PRIOR MENSTRUAL CYCLE, BOUTS OF VOMITING, CRYING, LESIONS, RIGHT INFLAMED OVARIES, LESIONS OF UTERUS, INFLAMED UTERUS, CYST SO BIG AND FLUID FILLED THAT IT TOTALLY TOOK OVER MY LEFT OVARY/ RIGHT OVARY WITH FLUID FILLED CYSTS, IN CONTINENCE, BLOATING, DIZZY, METAL TASTE, MOOD SWINGS, HAIR LOSS, TEETH AND GUMS SENSITIVE, SKIN CHANGED, HIVES, RASHES, ITCHY BURNING SKIN, ODD PERIODS, FORGETFULNESS, SHARP PAINS IN BACK, SHARP PAINS IN HIP, SHARP PAIN IN LEG, INSOMNIA, CHRONIC FATIGUE, WEIGHT GAIN, NAUSEA, MIGRAINES, BLEEDING / SPOTTING, AND UMBILICAL HERNIA. NO INFORMATION GIVEN ON CONSUMER'S HISTORY, PAST DRUGS AND CONCURRENT CONDITIONS. IT WAS NOT REPORTED WHETHER THE CONSUMER RECEIVED ANY CONCOMITANT MEDICATION. IN 2008, THE CONSUMER HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED WITH LOT NUMBER 626159. IN 2008 SINCE HAVING ESSURE INSERTED, THE CONSUMER EXPERIENCED EXCRUCIATING PAIN, DEBILITATING PAIN THAT STAYED AND BECAME CHRONIC. AFTER SOME TIME WENT BY, SHE HAD DAYS THAT THE PAIN WOULD SUBSIDE FROM DEBILITATING TO MANAGEABLE CRAMPS, THEN BACK TO DEBILITATING PAINS DURING MENSTRUATION TIMES. SHE WAS BED RIDDEN THE WEEK PRIOR TO HER MENSTRUAL CYCLE, THE WEEK OF MENSTRUAL CYCLE AND A FEW DAYS AFTER MENSTRUAL CYCLE, THE PAINS STARTED TO SUBSIDE A LITTLE ENOUGH THAT SHE COULD MOVE AROUND A LITTLE BETTER. THE PAINS NEVER TOTALLY GO AWAY. DURING MENSTRUAL CYCLE THE PAIN WAS SO STRONG AND STABBING THAT SHE WOULD HAVE BOUTS OF VOMITING, AND CRYING. HER LIFE HAD CHANGED AND SHE BECAME MORE AND MORE UNABLE TO PERFORM DAILY LIVING TASKS. SHE WENT TOT SEVERAL DOCTORS AND EMERGENCY ROOM VISITS. DOCTORS COULD NOT EXPLAIN WHAT WAS WRONG WITH HER, THEY PRESCRIBED PAIN KILLERS AND SENT HER HOME. SHE HAD SUFFERED WITH THIS AFFLICTION FOR MANY YEARS SINCE BEING IMPLANTED WITH THE ESSURE MICRO INSERTS. AS I KEPT GETTING WORSE AND SUFFERING TO THE POINT I THOUGHT I WAS GOING TO DIE, FINALLY FOUND A DOCTOR TO DO AN MRI (MAGNETIC RESONANCE IMAGE) AND RUN MORE TESTS. THE RESULTS WERE LESIONS, INFLAMED OVARIES AND UTERUS, CYST SO BIG AND FLUID FILLED THAT IT TOTALLY TOOK OVER HER LEFT OVARY, PRESSED ON HER BLADDER CAUSING INCONTINENCE AND PUSHING ON HER ABDOMEN CAUSING ADDITIONAL PAINS AND BLOATING; THE RIGHT OVARY WAS INFLAMED AND WITH FLUID FILLED CYSTS. IN 2013 THE DOCTOR SAID SHE COULD NOT REMOVE ESSURE. THE ONLY WAY TO GET THEM OUT WAS TO PERFORM A HYSTERECTOMY. SHE HAD A HYSTERECTOMY ON (B)(6) 2013 TO REMOVE THE ESSURE COILS. SINCE THE REMOVAL, THE CHRONIC PAIN HAS GONE. BUT AS A RESULT OF GETTING THE COILS OUT OF HER, SHE HAS HAD TO HAVE HER HEALTHY UTERUS AND OVARY AND TUBES REMOVED. THE OTHER SYMPTOMS DURING THE TIME THE ESSURE IN WERE PAINS, DIZZY, METAL TASTE, MOOD SWINGS, HAIR LOSS, STABBING PAIN, TEETH AND GUMS SENSITIVE, SKIN CHANGED, HIVES AND RASHES, ITCHY BURNING SKIN, ODD PERIODS, FORGETFULNESS, SHARP PAINS IN BACK, HIP AND LEG, INSOMNIA, CHRONIC FATIGUE, BLOATED, WEIGHT GAIN, NAUSEA, MIGRAINES, BLEEDING, SPOTTING, UMBILICAL HERNIA. REPORTER CAUSALITY: THE RELATIONSHIP BETWEEN EVENTS AND ESSURE IS NOT REPORTED. DESPITE SEVERAL FOLLOW-UP ATTEMPTS NO NEW INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276704 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 626159

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R