BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 23154890 · Received September 26, 2025

    Report

    Report Number
    2951250-2025-00595
    Event Type
    Injury
    Date Received
    September 26, 2025
    Date of Event
    July 1, 2015
    Report Date
    October 6, 2025
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BAYER CASE NUMBER: (B)(4) BACK PAIN [BACK PAIN], ITHCY LEGS [ITCHY LEGS] , WEIGHT GAIN [WEIGHT GAIN] , REPEATED SINUSITIS NOT RESPONDING TO CORTICOSTEROIDS [SINUSITIS RECURRENT] , MAJOR ASTHENIA [ASTHENIA] , ACHILLES TENDONITIS WITHOUT TRAUMA [ACHILLES TENDONITIS] , CERVICOBRACHIAL NEURALGIA WITHOUT TRAUMA [CERVICOBRACHIALGIA] , COXALGIA [COXALGIA] , GONALGIA [GONALGIA] , MEMORY DISTURBANCES [MEMORY DISTURBANCE] , SLEEP DISTURBANCE [SLEEP DISTURBANCE] , ITCHY UPPER EYELIDS [EYELIDS PRURITUS] , VERY DISRUPTED SOCIAL LIFE [SOCIAL LIFE IMPAIRMENT] , RESTRICTED WALKING DISTANCE [DIFFICULTY IN WALKING] , LEAVE FROM WORK SOMETIMES [SICK LEAVE] RECOURSE TO TELEWORKING TO AVOID FATIGU,E, OTHERWISE THE PACE WOULD NOT BE SUSTAINABLE. [FATIGUE] . CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 22-SEP-2025. THE MOST RECENT INFORMATION WAS RECEIVED ON 01-OCT-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("BACK PAIN") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 91 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), SINUSITIS ("REPEATED SINUSITIS NOT RESPONDING TO CORTICOSTEROIDS"), ASTHENIA ("MAJOR ASTHENIA"), COXALGIA ("COXALGIA"), GONALGIA ("GONALGIA"), MEMORY IMPAIRMENT ("MEMORY DISTURBANCES"), SLEEP DISORDER ("SLEEP DISTURBANCE"), EYELIDS PRURITUS (" ITCHY UPPER EYELIDS"), PRURITUS ("ITHCY LEGS"), SOCIAL PROBLEM ("VERY DISRUPTED SOCIAL LIFE"), GAIT DISTURBANCE ("RESTRICTED WALKING DISTANCE"), SICK LEAVE ("LEAVE FROM WORK SOMETIMES") AND FATIGUE ("RECOURSE TO TELEWORKING TO AVOID FATIGUE, OTHERWISE THE PACE WOULD NOT BE SUSTAINABLE.") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2022 SHE EXPERIENCED TENDONITIS ("ACHILLES TENDONITIS WITHOUT TRAUMA"). IN 2024 SHE EXPERIENCED CERVICOBRACHIAL SYNDROME ("CERVICOBRACHIAL NEURALGIA WITHOUT TRAUMA"). AT THE TIME OF THE REPORT, THE SOCIAL PROBLEM, GAIT DISTURBANCE, SICK LEAVE AND FATIGUE HAD NOT RESOLVED. THE OUTCOMES FOR BACK PAIN, SINUSITIS, ASTHENIA, TENDONITIS, CERVICOBRACHIAL SYNDROME, COXALGIA, GONALGIA, MEMORY IMPAIRMENT, SLEEP DISORDER, EYELIDS PRURITUS AND PRURITUS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO WEIGHT INCREASED, SINUSITIS, ASTHENIA, TENDONITIS, CERVICOBRACHIAL SYNDROME, COXALGIA, GONALGIA, MEMORY IMPAIRMENT, BACK PAIN, SLEEP DISORDER, EYELIDS PRURITUS, PRURITUS, SOCIAL PROBLEM, GAIT DISTURBANCE, SICK LEAVE OR FATIGUE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 99 KG. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY; NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED, AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 01-OCT-2025: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. CASE COMMENTS: BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4). BACK PAIN [BACK PAIN] WEIGHT GAIN [WEIGHT GAIN] REPEATED SINUSITIS NOT RESPONDING TO CORTICOSTEROIDS [SINUSITIS RECURRENT] MAJOR ASTHENIA [ASTHENIA] ACHILLES TENDONITIS WITHOUT TRAUMA [ACHILLES TENDONITIS] CERVICOBRACHIAL NEURALGIA WITHOUT TRAUMA [CERVICOBRACHIALGIA] COXALGIA [COXALGIA] GONALGIA [GONALGIA] MEMORY DISTURBANCES [MEMORY DISTURBANCE] SLEEP DISTURBANCE [SLEEP DISTURBANCE] ITCHY UPPER EYELIDS [EYELIDS PRURITUS] ITHCY LEGS [ITCHY LEGS] VERY DISRUPTED SOCIAL LIFE [SOCIAL LIFE IMPAIRMENT] RESTRICTED WALKING DISTANCE [DIFFICULTY IN WALKING] LEAVE FROM WORK SOMETIMES [SICK LEAVE] RECOURSE TO TELEWORKING TO AVOID FATIGUE, OTHERWISE THE PACE WOULD NOT BE SUSTAINABLE. [FATIGUE] CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 22-SEP-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("BACK PAIN") IN A 33-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 91 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), SINUSITIS ("REPEATED SINUSITIS NOT RESPONDING TO CORTICOSTEROIDS"), ASTHENIA ("MAJOR ASTHENIA"), COXALGIA ("COXALGIA"), GONALGIA ("GONALGIA"), MEMORY IMPAIRMENT ("MEMORY DISTURBANCES"), SLEEP DISORDER ("SLEEP DISTURBANCE"), EYELIDS PRURITUS (" ITCHY UPPER EYELIDS"), PRURITUS ("ITHCY LEGS"), SOCIAL PROBLEM ("VERY DISRUPTED SOCIAL LIFE"), GAIT DISTURBANCE ("RESTRICTED WALKING DISTANCE"), SICK LEAVE ("LEAVE FROM WORK SOMETIMES") AND FATIGUE ("RECOURSE TO TELEWORKING TO AVOID FATIGUE, OTHERWISE THE PACE WOULD NOT BE SUSTAINABLE.") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). IN 2022 SHE EXPERIENCED TENDONITIS ("ACHILLES TENDONITIS WITHOUT TRAUMA"). IN 2024 SHE EXPERIENCED CERVICOBRACHIAL SYNDROME ("CERVICOBRACHIAL NEURALGIA WITHOUT TRAUMA"). AT THE TIME OF THE REPORT, THE SOCIAL PROBLEM, GAIT DISTURBANCE, SICK LEAVE AND FATIGUE HAD NOT RESOLVED. THE OUTCOMES FOR BACK PAIN, SINUSITIS, ASTHENIA, TENDONITIS, CERVICOBRACHIAL SYNDROME, COXALGIA, GONALGIA, MEMORY IMPAIRMENT, SLEEP DISORDER, EYELIDS PRURITUS AND PRURITUS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO WEIGHT INCREASED, SINUSITIS, ASTHENIA, TENDONITIS, CERVICOBRACHIAL SYNDROME, COXALGIA, GONALGIA, MEMORY IMPAIRMENT, BACK PAIN, SLEEP DISORDER, EYELIDS PRURITUS, PRURITUS, SOCIAL PROBLEM, GAIT DISTURBANCE, SICK LEAVE OR FATIGUE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 99 KG. CASE COMMENTS: BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112892 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other