BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5237096 · Received November 19, 2015

    Report

    Report Number
    2951250-2015-01630
    Event Type
    Injury
    Date Received
    November 19, 2015
    Date of Event
    January 1, 2005
    Report Date
    March 21, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTION ON 30-NOV-2015 FOLLOWING COMPANY INTERNAL CODING REVIEW: THE EVENT SWELLING IN HANDS, ARM, SHOULDER, FEET, LEGS WAS SPLIT TO MEDDRA LLT SWELLING OF LIMBS AND MEDDRA LLT JOINT SWELLING; THE EVENT REPEAT AND MULTIPLE OVARIAN CYSTS WAS RECODED TO MEDDRA LLT POLYCYSTIC OVARY. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED REPEATED INFECTIONS AFTER ESSURE WERE IMPLANTED. A HYSTERECTOMY WAS PERFORMED AND DEVICE WAS REMOVED. THIS EVENT, INTERPRETED AS PELVIC INFECTIONS, IS SERIOUS DUE TO ITS MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. UPPER GENITAL TRACT INFECTIONS, ALSO REFERRED TO AS PELVIC INFLAMMATORY DISEASES (PIDS), OCCUR WHEN MICROORGANISMS ASCEND FROM THE LOWER GENITAL TRACT, INFECTING THE UTERUS, FALLOPIAN TUBES AND OVARIES. WHILE ESSURE SYSTEM IS STERILE IT MAY, DUE TO A BACTERIAL CONTAMINATION DURING INSERTION, BECOME A VEHICLE FOR MICROBIAL TRANSPORT IN THE UPPER GENITAL TRACT. THIS MAY EXPLAIN AN INCREASED RISK FOR PELVIC INFECTIONS AFTER INSERTION PROCEDURE. IN THIS CASE, IT WAS REPORTED THAT THIS EVENT OCCURRED AFTER ESSURE INSERTION. ALTHOUGH IT WAS UNKNOWN WHETHER THIS EVENT OCCURRED UP TO 4 WEEKS POST INSERTION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE FORMALLY EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE SURGICAL INTERVENTION WAS PERFORMED. ADDITIONALLY, OTHER SERIOUS EVENTS (UNLISTED AND UNRELATED) AND SEVERAL NON-SERIOUS EVENTS WERE REPORTED. PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS CONCLUDED THAT A RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENT(S) AND A QUALITY DEFECT IS EXCLUDED. NO ACTIVE FOLLOW-UP WILL BE PURSUED, AS THIS CASE WAS IDENTIFIED DURING (B)(4) WEBSITE MONITORING.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A REGULATORY AUTHORITY (CASE NUMBER FDA-2014-N-0736-1509 AND CASE NUMBER MW5057184) IN UNITED STATES ON 23-OCT-2015 IDENTIFIED DURING MONITORING OF POSTINGS AN FDA HOSTED DOCKET WEBSITE, WHICH HAS BEEN ESTABLISHED IN PREPARATION OF A PUBLIC FDA ADVISORY COMMITTEE MEETING TAKING PLACE IN SEPTEMBER 2015. IT REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO RECEIVED ESSURE (ESS205) (FALLOPIAN TUBE OCCLUSION INSERT) PLACED IN 2004. ADDITIONAL INFORMATION RECEIVED ON 05-NOV-2015 AND 15-NOV-2015 (PTC INVESTIGATION RESULT). CONSUMER STATED THERE ARE SO MANY HORRIBLE SIDE EFFECTS, EVEN AFTER REMOVAL. SHE WAS IMPLANTED IN 2004, HAD HYSTERECTOMY INCLUDING CERVIX REMOVAL IN 2011. AFTER ESSURE WERE IMPLANTED, SHE EXPERIENCED REPEAT INFECTIONS, EXTREMELY PAINFUL INTERCOURSE WITHIN 6 MONTHS, REPEAT AND MULTIPLE OVARIAN CYSTS (WITH NO PRIOR HISTORY OR PROBLEMS), BLOOD FILLED MASS ON OVARY, SWOLLEN INTESTINES, SWOLLEN LYMPH NODES IN INTESTINES, IRRITABLE BOWEL SYNDROME (IBS), ACID-REFLUX, HAD COLONOSCOPY AND ENDOSCOPY (THROAT SCOPE). SHE HAD ESSURE FOR 7 YEARS FOUR YEARS AGO, SHE BEGAN HAVING HORRIBLE PAIN UNDER HER BREASTBONE WAKING HER UP FROM A DEAD SLEEP. THE TIME THEY FIGURED OUT THE PROBLEM, SHE WAS SEPTIC AND HAD TO HAVE EMERGENCY GALLBLADDER SURGERY. SHE HAD TO STAY 4 DAYS IN THE HOSPITAL DUE TO INCREASING INFECTION. HER IMMUNE SYSTEM WAS SHOT WHICH LEAD TO PRECANCEROUS CELLS ON CERVIX THAT RAPIDLY PROGRESSED, SO SHE HAD TO HAVE A HYSTERECTOMY AND CERVIX REMOVED. SHE HAS CONTINUED TO DETERIORATE. SHE HAS HIGH BLOOD PRESSURE, SEVERE TOOTH DECAY, ANXIETY, DEPRESSION, BOUTS OF SUICIDAL (DEPRESSION SUICIDAL), SEVERE ABDOMINAL PAIN AND EXTREME BLOATING, JOINT PAIN/STIFFNESS, LOSING HER HAIR, EXTREME BRAIN FOG AND MEMORY LOSS, MEMORY ISSUES, UNEXPLAINED SWELLING IN HANDS, ARM, SHOULDER, FEET, LEGS AND HEADACHES/MIGRAINES. SHE ALSO EXPERIENCED STOMACH CRAMPING, EXTREME CRAMP/ PAINS IN OVARIES AND ABDOMINAL AREA, CHRONIC EXTREME FATIGUE, MOOD DISORDER AND SEVERE MOOD SWINGS WITH SNAPPINESS, BRUISING, PROLONGED HEALING, THYROID ISSUES THAT ARE DEBILITATING ON TOP OF ALL OTHER ISSUES. SHE HAS LOST HERSELF AND BEEN BLOWN OFF BY DOCTORS. SHE IS SURE SHE IS FORGETTING TO LIST OTHER PROBLEMS AS WELL SHE JUST HAVE A HARD TIME EVEN FUNCTIONING ANYMORE AND HER MEMORY IS SHOT. THE HARDEST PART IS WATCHING HER CHILDREN AND HUSBAND SEE SHE SUFFERING, DAY AFTER DAY AND LOSING HERSELF MORE AND MORE AND 95% OF HER LIFE AT THIS POINT IS IN HER BED. SHE HAS FORGOTTEN WHAT IT FEELS LIKE TO BE OK. SHE JUST TURNED (B)(6) AND FEELS LIKE DECADES ADDED TO THAT NUMBER AND ONLY GETTING WORSE. SHE NEVER HAD ANY OF THIS UNTIL ESSURE AND SHE KNOWS SHE IS FORGETTING OTHER ISSUES. PTC INVESTIGATION RESULT: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC GLOBAL NUMBER (B)(4). FINAL ASSESSMENT: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED. WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ARTY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: BASED ON THE AVAILABLE INFORMATION, NO PRODUCT QUALITY DEFECT WAS CONFIRMED, THEREFORE A RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT IS EXCLUDED. THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED REPEATED INFECTIONS AFTER ESSURE WERE IMPLANTED. A HYSTERECTOMY WAS PERFORMED AND DEVICE WAS REMOVED. THIS EVENT, INTERPRETED AS PELVIC INFECTIONS, IS SERIOUS DUE TO ITS MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. UPPER GENITAL TRACT INFECTIONS, ALSO REFERRED TO AS PELVIC INFLAMMATORY DISEASES (PIDS), OCCUR WHEN MICROORGANISMS ASCEND FROM THE LOWER GENITAL TRACT, INFECTING THE UTERUS, FALLOPIAN TUBES AND OVARIES. WHILE ESSURE SYSTEM IS STERILE IT MAY, DUE TO A BACTERIAL CONTAMINATION DURING INSERTION, BECOME A VEHICLE FOR MICROBIAL TRANSPORT IN THE UPPER GENITAL TRACT. THIS MAY EXPLAIN AN INCREASED RISK FOR PELVIC INFECTIONS AFTER INSERTION PROCEDURE. IN THIS CASE, IT WAS REPORTED THAT THIS EVENT OCCURRED AFTER ESSURE INSERTION. ALTHOUGH IT WAS UNKNOWN WHETHER THIS EVENT OCCURRED UP TO 4 WEEKS POST INSERTION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE FORMALLY EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE SURGICAL INTERVENTION WAS PERFORMED. ADDITIONALLY, OTHER SERIOUS EVENTS (UNLISTED AND UNRELATED) AND SEVERAL NON-SERIOUS EVENTS WERE REPORTED. PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS CONCLUDED THAT A RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENT(S) AND A QUALITY DEFECT IS EXCLUDED. NO ACTIVE FOLLOW-UP WILL BE PURSUED, AS THIS CASE WAS IDENTIFIED DURING HEALTH AUTHORITY WEBSITE MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767798 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 12265690

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| O| R