BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 24386052 · Received February 19, 2026

    Report

    Report Number
    2951250-2026-00056
    Event Type
    Injury
    Date Received
    February 19, 2026
    Date of Event
    January 1, 2010
    Report Date
    February 23, 2026
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    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) MUSCLE & JOINT PAIN [ARTHROMYALGIA] , CONSTANT FATIGUE [CHRONIC FATIGUE] . CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 13-FEB-2026. THE MOST RECENT INFORMATION WAS RECEIVED ON 20-FEB-2026. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ARTHRALGIA ("MUSCLE & JOINT PAIN") AND FATIGUE ("CONSTANT FATIGUE") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, 634 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED ARTHRALGIA (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND FATIGUE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. THE REPORTER CONSIDERED ARTHRALGIA AND FATIGUE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: PERIOD OF OCCURRENCE: 15 YEARS. MY LIFE HAS BEEN HELL SINCE THE INSERTION OF THE ESSURE IMPLANTS. WE SHOULD HAVE BEEN WARNED BY MAIL THAT THERE WERE SIDE EFFECTS THAT MAKE OUR LIVES HELL!!! THEY'VE BEEN BANNED SINCE 2017 IN FRANCE AND I ONLY LEARNED ABOUT THIS AT THE END OF 2025. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 KG. THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 13-FEB-2026. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF FATIGUE ("CONSTANT FATIGUE") IN A 41-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) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, 634 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED FATIGUE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND ARTHRALGIA ("MUSCLE & JOINT PAIN"). AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. THE REPORTER CONSIDERED ARTHRALGIA AND FATIGUE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: PERIOD OF OCCURRENCE: 15 YEARS. MY LIFE HAS BEEN HELL SINCE THE INSERTION OF THE ESSURE IMPLANTS. WE SHOULD HAVE BEEN WARNED BY MAIL THAT THERE WERE SIDE EFFECTS THAT MAKE OUR LIVES HELL!!! THEY'VE BEEN BANNED SINCE 2017 IN FRANCE AND I ONLY LEARNED ABOUT THIS AT THE END OF 2025. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 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 REASON FOR THE REPORTED COMPLAINT. 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: 20-FEB-2026: 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) MUSCLE & JOINT PAIN [ARTHROMYALGIA] , CONSTANT FATIGUE [CHRONIC FATIGUE] . CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 13-FEB-2026. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ARTHRALGIA ("MUSCLE & JOINT PAIN") AND FATIGUE ("CONSTANT FATIGUE") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, 634 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED ARTHRALGIA (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND FATIGUE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. THE REPORTER CONSIDERED ARTHRALGIA AND FATIGUE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: PERIOD OF OCCURRENCE: 15 YEARS. MY LIFE HAS BEEN HELL SINCE THE INSERTION OF THE ESSURE IMPLANTS. WE SHOULD HAVE BEEN WARNED BY MAIL THAT THERE WERE SIDE EFFECTS THAT MAKE OUR LIVES HELL!!! THEY'VE BEEN BANNED SINCE 2017 IN FRANCE AND I ONLY LEARNED ABOUT THIS AT THE END OF 2025. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 KG. THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 13-FEB-2026. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF FATIGUE ("CONSTANT FATIGUE") IN A 41-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) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, 634 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED FATIGUE (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND ARTHRALGIA ("MUSCLE & JOINT PAIN"). AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. THE REPORTER CONSIDERED ARTHRALGIA AND FATIGUE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: PERIOD OF OCCURRENCE: 15 YEARS. MY LIFE HAS BEEN HELL SINCE THE INSERTION OF THE ESSURE IMPLANTS. WE SHOULD HAVE BEEN WARNED BY MAIL THAT THERE WERE SIDE EFFECTS THAT MAKE OUR LIVES HELL!!! THEY'VE BEEN BANNED SINCE 2017 IN FRANCE AND I ONLY LEARNED ABOUT THIS AT THE END OF 2025. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 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
    311369 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Other