BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6990007 · Received October 31, 2017

    Report

    Report Number
    2951250-2017-05816
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    January 1, 2011
    Report Date
    January 5, 2022
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4)) ON 06-OCT-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 04-JAN-2022. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HYSTEROSALPINGO-OOPHORECTOMY ('REMOVAL OF OVARY, TUBE AND UTERUS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810874) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" ON (B)(6) 2011. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY") AND EXPERIENCED DIZZINESS ("DIZZINESS"), TINNITUS ("TINNITUS"), AMNESIA ("MEMORY LOSS") AND FIBROMYALGIA ("FIBROMYALGIA"). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT HYSTEROSALPINGO-OOPHORECTOMY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TUBES, UTERUS AND OVARIES REMOVED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE HYSTEROSALPINGO-OOPHORECTOMY, PREGNANCY WITH CONTRACEPTIVE DEVICE, DIZZINESS, TINNITUS, AMNESIA AND FIBROMYALGIA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR AMNESIA, DIZZINESS, FIBROMYALGIA, HYSTEROSALPINGO-OOPHORECTOMY, PREGNANCY WITH CONTRACEPTIVE DEVICE AND TINNITUS WITH ESSURE. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDDRA PREFERRED TERMS. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERMS: HYSTEROSALPINGO-OOPHORECTOMY: THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 2 CASES. PREGNANCY WITH CONTRACEPTIVE DEVICE: THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 3474 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THESE MEDDRA PTS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-JAN-2022: HEALTH AUTHORITY REPORTED THAT THIS RECORD IS A DUPLICATE TO HEALTH AUTHORITY NUMBER (BAYER REPORT # (B)(4)), THEREFORE THIS BAYER RECORD # (B)(4) WILL BE DELETED IN BAYER SAFETY DATABASE, ALL INFORMATION WILL BE RETAINED IN DUPLICATE BAYER RECORD NUMBER (B)(4) WHICH WILL BE RETAINED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ANSM. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2017. THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HYSTEROSALPINGO-OOPHORECTOMY ("REMOVAL OF OVARY, TUBE AND UTERUS") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810874) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" ON (B)(6) 2011. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DIZZINESS ("DIZZINESS"), TINNITUS ("TINNITUS"), AMNESIA ("MEMORY LOSS") AND FIBROMYALGIA ("FIBROMYALGIA"). ON AN UNKNOWN DATE, THE PATIENT UNDERWENT HYSTEROSALPINGO-OOPHORECTOMY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (TUBES, UTERUS AND OVARIES REMOVED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE HYSTEROSALPINGO-OOPHORECTOMY, PREGNANCY WITH CONTRACEPTIVE DEVICE, DIZZINESS, TINNITUS, AMNESIA AND FIBROMYALGIA OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR AMNESIA, DIZZINESS, FIBROMYALGIA, HYSTEROSALPINGO-OOPHORECTOMY, PREGNANCY WITH CONTRACEPTIVE DEVICE AND TINNITUS WITH ESSURE. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDDRA PREFERRED TERMS. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 11-OCT-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERMS: HYSTEROSALPINGO-OOPHORECTOMY: THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 2 CASES. PREGNANCY WITH CONTRACEPTIVE DEVICE: THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 3474 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THESE MEDDRA PTS. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDDRA PREFERRED TERMS. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERMS: HYSTEROSALPINGO-OOPHORECTOMY: THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 2 CASES. PREGNANCY WITH CONTRACEPTIVE DEVICE: THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 3474 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THESE MEDDRA PTS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-OCT-2017: QUALITY-SAFETY EVALUATION OF PTC COMPANY CAUSALITY COMMENT. INCIDENT. AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769159 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 810874

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O