BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 20083877 · Received August 28, 2024

    Report

    Report Number
    2951250-2024-00541
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    September 25, 2020
    Report Date
    September 3, 2024
    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

    THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 23-AUG-2024. THE MOST RECENT INFORMATION WAS RECEIVED ON 03-SEP-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 852008) 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) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2020, 3306 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), MYALGIA ("CHRONIC MUSCULAR PAIN"), ARTHRALGIA ("CHRONIC JOINT PAIN"), LIGAMENT PAIN ("CHRONIC LIGAMENT PAIN"), COGNITIVE DISORDER ("COGNITIVE DISORDER"), MIGRAINE ("MIGRAINES"), MUSCULOSKELETAL STIFFNESS ("MUSCULAR STIFFNESS WITH DIFFICULTY WALKING"), GAIT DISTURBANCE ("DIFFICULTY WALKING"), PARAESTHESIA ("PARAESTHESIA"), MEMORY IMPAIRMENT ("MEMORY PROBLEMS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEM"), LOSS OF LIBIDO ("LOSS OF LIBIDO") AND EMOTIONAL DISORDER ("A PHYSICAL WRECK"). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO MYALGIA, ARTHRALGIA, LIGAMENT PAIN, COGNITIVE DISORDER, MIGRAINE, HEAVY MENSTRUAL BLEEDING, MUSCULOSKELETAL STIFFNESS, GAIT DISTURBANCE, PARAESTHESIA, MEMORY IMPAIRMENT, DISTURBANCE IN ATTENTION, LOSS OF LIBIDO OR EMOTIONAL DISORDER. THE REPORTER COMMENTED: PERIOD OF ONSET: SINCE 2020 WITH DRAMATIC EVOLUTION OF SYMPTOMS PATIENT¿S CURRENT STATUS: A PHYSICAL AND EMOTIONAL WRECK!!!. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 74 KG. LOT NUMBER: 852008 MANUFACTURE DATE:2011-04, EXPIRATION DATE:2014-04. 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: 03-SEP-2024: QUALITY SAFETY EVALUATION OF PTC. 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

    THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 23-AUG-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 852008) 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) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2020, 3306 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), MYALGIA ("CHRONIC MUSCULAR PAIN"), ARTHRALGIA ("CHRONIC JOINT PAIN"), LIGAMENT PAIN ("CHRONIC LIGAMENT PAIN"), COGNITIVE DISORDER ("COGNITIVE DISORDER"), MIGRAINE ("MIGRAINES"), MUSCULOSKELETAL STIFFNESS ("MUSCULAR STIFFNESS WITH DIFFICULTY WALKING"), GAIT DISTURBANCE ("DIFFICULTY WALKING"), PARAESTHESIA ("PARAESTHESIA"), MEMORY IMPAIRMENT ("MEMORY PROBLEMS"), DISTURBANCE IN ATTENTION ("CONCENTRATION PROBLEM"), LOSS OF LIBIDO ("LOSS OF LIBIDO") AND EMOTIONAL DISORDER ("A PHYSICAL WRECK"). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ARTHRALGIA, LIGAMENT PAIN, COGNITIVE DISORDER, MIGRAINE, HEAVY MENSTRUAL BLEEDING, MUSCULOSKELETAL STIFFNESS, GAIT DISTURBANCE, PARAESTHESIA, MEMORY IMPAIRMENT, DISTURBANCE IN ATTENTION, LOSS OF LIBIDO OR EMOTIONAL DISORDER. THE REPORTER COMMENTED: PERIOD OF ONSET: SINCE 2020 WITH DRAMATIC EVOLUTION OF SYMPTOMS PATIENT¿S CURRENT STATUS: A PHYSICAL AND EMOTIONAL WRECK. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 74 KG. 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
    1464786 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 852008 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other