BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 20999290 · Received December 23, 2024

    Report

    Report Number
    2951250-2024-00847
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    January 1, 2010
    Report Date
    January 8, 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). PELVIC PAIN FEMALE [PELVIC PAIN FEMALE], JOINT PAIN [JOINT PAIN], MUSCLE PAIN [MUSCLE PAIN], EXTREME FATIGUE [FATIGUE EXTREME] , NEUROLOGICAL FUNCTION IMPAIRMENT [NEUROLOGICAL IMPAIRMENT] , DEPRESSION [DEPRESSION] , LOSS OF SLEEP [SLEEP LOSS]. CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 18-DEC-2024. THE MOST RECENT INFORMATION WAS RECEIVED ON 08-JAN-2025. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN FEMALE") IN A 53-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 626531) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF ENDOMETRIAL ABLATION. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, 522 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ARTHRALGIA ("JOINT PAIN"), MYALGIA ("MUSCLE PAIN"), FATIGUE ("EXTREME FATIGUE"), NERVOUS SYSTEM DISORDER (" NEUROLOGICAL FUNCTION IMPAIRMENT"), DEPRESSION ("DEPRESSION") AND INSOMNIA ("LOSS OF SLEEP"). ESSURE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY WITH BILATERAL LAPAROSCOPIC SALPINGECTOMY). AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ARTHRALGIA, MYALGIA, FATIGUE, NERVOUS SYSTEM DISORDER, DEPRESSION, INSOMNIA OR PELVIC PAIN. THE REPORTER COMMENTED: DATE OF OCCURRENCE: (B)(6) 2010. TUBAL IMPLANT FOLLOW-UP. THE TWO TUBAL IMPLANTS ARE VISIBLE, IN A SYMMETRICAL POSITION RELATIVE TO THE PROJECTION OF THE SACRUM. NO ABNORMALITIES OF THE SOFT TISSUE OTHERWISE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 63 KG. LOT NUMBER: 626531 MANUFACTURE DATE: 2008-02 EXPIRATION DATE: 2010-01. 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: 08-JAN-2025: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. CASE COMMENTS: A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4). PELVIC PAIN FEMALE [PELVIC PAIN FEMALE]. JOINT PAIN [JOINT PAIN]. MUSCLE PAIN [MUSCLE PAIN]. EXTREME FATIGUE [FATIGUE EXTREME]. NEUROLOGICAL FUNCTION IMPAIRMENT [NEUROLOGICAL IMPAIRMENT]. DEPRESSION [DEPRESSION]. LOSS OF SLEEP [SLEEP LOSS]. CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER:(B)(4) ) ON 18-DEC-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN FEMALE") IN A 53 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 626531) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF ENDOMETRIAL ABLATION. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, 522 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), ARTHRALGIA ("JOINT PAIN"), MYALGIA ("MUSCLE PAIN"), FATIGUE ("EXTREME FATIGUE"), NERVOUS SYSTEM DISORDER (" NEUROLOGICAL FUNCTION IMPAIRMENT"), DEPRESSION ("DEPRESSION") AND INSOMNIA ("LOSS OF SLEEP"). ESSURE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY WITH BILATERAL LAPAROSCOPIC SALPINGECTOMY). AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ARTHRALGIA, MYALGIA, FATIGUE, NERVOUS SYSTEM DISORDER, DEPRESSION, INSOMNIA OR PELVIC PAIN. THE REPORTER COMMENTED: TUBAL IMPLANT FOLLOW-UP. THE TWO TUBAL IMPLANTS ARE VISIBLE, IN A SYMMETRICAL POSITION RELATIVE TO THE PROJECTION OF THE SACRUM. NO ABNORMALITIES OF THE SOFT TISSUE OTHERWISE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 63 KG. CASE COMMENTS: A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109924 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 626531 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other