BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7525438 · Received May 18, 2018

    Report

    Report Number
    2951250-2018-02248
    Event Type
    Injury
    Date Received
    May 18, 2018
    Date of Event
    March 21, 2017
    Report Date
    May 22, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: R1808222) ON 15-MAY-2018. THE MOST RECENT INFORMATION WAS RECEIVED ON 18-MAY-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("ESSURE REMOVAL") AND MULTIPLE SCLEROSIS ("SUSPICION OF MULTIPLE SCLEROSIS") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 024087) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON 30-SEP-2015, THE PATIENT EXPERIENCED AMENORRHOEA ("AMENORRHEA"), WEIGHT INCREASED ("WEIGHT GAIN (+10KG)"), PARAESTHESIA ("PARESTHESIA OF RIGHT ARM AND RIGHT HAND WITH BLOCKING"), LIVER DISORDER ("TROUBLED HEPATIC WORK-UP"), GENERAL PHYSICAL HEALTH DETERIORATION ("GENERAL STATE ALTERATION") AND ASTHENIA ("ASTHENIA"). IN DECEMBER 2016, THE PATIENT EXPERIENCED MULTIPLE SCLEROSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON 21-MAR-2017, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON 21-MAR-2017. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, MULTIPLE SCLEROSIS, AMENORRHOEA, WEIGHT INCREASED, PARAESTHESIA, LIVER DISORDER, GENERAL PHYSICAL HEALTH DETERIORATION AND ASTHENIA HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR AMENORRHOEA, ASTHENIA, GENERAL PHYSICAL HEALTH DETERIORATION, LIVER DISORDER, MEDICAL DEVICE REMOVAL, MULTIPLE SCLEROSIS, PARAESTHESIA AND WEIGHT INCREASED WITH ESSURE. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 18-MAY-2018 FOR THE FOLLOWING MEDDRA PREFERRED TERM: MEDICAL DEVICE REMOVAL. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 757 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 THIS MEDDRA PT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-MAY-2018: THIS CASE WAS IDENTIFIED AS DUPLICATE OF CASE 2018-068398 AND SHOULD BE DELETED FROM ARGUS. ALL INFORMATION WAS TRANSFERRED TO THE REMAINING CASE. 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 IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ((B)(6), (B)(4)) ON 15-MAY-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("ESSURE REMOVAL") AND MULTIPLE SCLEROSIS ("SUSPICION OF MULTIPLE SCLEROSIS") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 024087) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED AMENORRHOEA ("AMENORRHEA"), WEIGHT INCREASED ("WEIGHT GAIN (+10KG)"), PARAESTHESIA ("PARESTHESIA OF RIGHT ARM AND RIGHT HAND WITH BLOCKING"), LIVER DISORDER ("TROUBLED HEPATIC WORK-UP"), GENERAL PHYSICAL CONDITION ("GENERAL STATE ALTERATION") AND ASTHENIA ("ASTHENIA"). IN (B)(6) 2016, THE PATIENT EXPERIENCED MULTIPLE SCLEROSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2017, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, MULTIPLE SCLEROSIS, AMENORRHOEA, WEIGHT INCREASED, PARAESTHESIA, LIVER DISORDER, GENERAL PHYSICAL CONDITION AND ASTHENIA HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR AMENORRHOEA, ASTHENIA, GENERAL PHYSICAL CONDITION, LIVER DISORDER, MEDICAL DEVICE REMOVAL, MULTIPLE SCLEROSIS, PARAESTHESIA AND WEIGHT INCREASED WITH ESSURE. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 18-MAY-2018 FOR THE FOLLOWING MEDDRA PREFERRED TERM: MEDICAL DEVICE REMOVAL. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 757 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 THIS MEDDRA PT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. 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 IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367446 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG 024087

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R