BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 22409935 · Received July 7, 2025

    Report

    Report Number
    2951250-2025-00455
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 15, 2025
    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) MEDICAL DEVICE REMOVAL [MEDICAL DEVICE REMOVAL], MUSCLE PAIN IN ARM , KNEE & FOOT [MUSCLE PAIN] , JOINT PAIN IN THE ARMS, KNEES AND FEET [PAINFUL JOINTS], I CAN NO LONGER BEND MY KNEES, HAVE A LOT OF DIFFICULTY GETTING ABOUT [JOINT RANGE OF MOTION DECREASED] , BURNING SENSATION [BURNING SENSATION] . CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 02-JUL-2025. THE MOST RECENT INFORMATION WAS RECEIVED ON 14-JUL-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 43 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. C68790) 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. IN (B)(6) 2015 SHE EXPERIENCED MYALGIA ("MUSCLE PAIN IN ARM , KNEE & FOOT"), ARTHRALGIA ("JOINT PAIN IN THE ARMS, KNEES AND FEET"), JOINT RANGE OF MOTION DECREASED ("I CAN NO LONGER BEND MY KNEES, HAVE A LOT OF DIFFICULTY GETTING ABOUT") AND BURNING SENSATION ("BURNING SENSATION"). ON (B)(6) 2025 SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). AT THE TIME OF THE REPORT, THE MYALGIA, ARTHRALGIA, JOINT RANGE OF MOTION DECREASED AND BURNING SENSATION HAD NOT RESOLVED. THE OUTCOME OF MEDICAL DEVICE REMOVAL WAS UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO MYALGIA, ARTHRALGIA, JOINT RANGE OF MOTION DECREASED, BURNING SENSATION OR MEDICAL DEVICE REMOVAL. THE REPORTER COMMENTED: VARIOUS X-RAYS HAVE BEEN PERFORMED BUT OF COURSE NOTHING IS VISIBLE SINCE I THINK IT WOULD BE NECESSARY TO LOOK FOR THE PRESENCE OF METALS IN THE BLOOD. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 95 KG. [X-RAY] (DATE UNKNOWN): OF COURSE NOTHING IS VISIBLE SINCE I THINK IT WOULD BE NECESSARY TO LOOK FOR THE PRESENCE OF METALS IN THE BLOOD. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 14-JUL-2025: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. CASE COMMENTS: A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAIN RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS 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) MEDICAL DEVICE REMOVAL [MEDICAL DEVICE REMOVAL], MUSCLE PAIN IN ARM , KNEE & FOOT [MUSCLE PAIN] , JOINT PAIN IN THE ARMS, KNEES AND FEET [PAINFUL JOINTS] , I CAN NO LONGER BEND MY KNEES, HAVE A LOT OF DIFFICULTY GETTING ABOUT [JOINT RANGE OF MOTION DECREASED], BURNING SENSATION [BURNING SENSATION] . CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 02-JUL-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 43-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. C68790) 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. IN (B)(6) 2015 SHE EXPERIENCED MYALGIA ("MUSCLE PAIN IN ARM, KNEE & FOOT"), ARTHRALGIA ("JOINT PAIN IN THE ARMS, KNEES AND FEET"), JOINT RANGE OF MOTION DECREASED ("I CAN NO LONGER BEND MY KNEES, HAVE A LOT OF DIFFICULTY GETTING ABOUT") AND BURNING SENSATION ("BURNING SENSATION"). ON (B)(6) 2025 SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). AT THE TIME OF THE REPORT, THE MYALGIA, ARTHRALGIA, JOINT RANGE OF MOTION DECREASED AND BURNING SENSATION HAD NOT RESOLVED. THE OUTCOME OF MEDICAL DEVICE REMOVAL WAS UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO MYALGIA, ARTHRALGIA, JOINT RANGE OF MOTION DECREASED, BURNING SENSATION OR MEDICAL DEVICE REMOVAL. THE REPORTER COMMENTED: VARIOUS X-RAYS HAVE BEEN PERFORMED BUT OF COURSE NOTHING IS VISIBLE SINCE I THINK IT WOULD BE NECESSARY TO LOOK FOR THE PRESENCE OF METALS IN THE BLOOD. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 95 KG. [X-RAY] (DATE UNKNOWN): NOTHING IS VISIBLE SINCE I THINK IT WOULD BE NECESSARY TO LOOK FOR THE PRESENCE OF METALS IN THE BLOOD CASE COMMENTS: A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAIN RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS 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
    1039139 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 C68790 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention