BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 16058909 · Received December 28, 2022

    Report

    Report Number
    2951250-2022-01580
    Event Type
    Injury
    Date Received
    December 28, 2022
    Date of Event
    September 4, 2012
    Report Date
    January 6, 2023
    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-DEC-2022. THE MOST RECENT INFORMATION WAS RECEIVED ON 03-JAN-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("LUMBAR PAIN") IN A 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) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 734 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), FATIGUE ("MAJOR FATIGUE"), HERNIA ("HERNIA"), INTERVERTEBRAL DISC DISORDER ("DISCOPATHY"), MIGRAINE ("MIGRAINES"), PERIARTHRITIS ("CAPSULITIS"), TENDONITIS ("TENDINITIS") AND DISTURBANCE IN ATTENTION ("CONCENTRATION AND ATTENTION DIFFICULTY"). ESSURE WAS REMOVED ON (B)(6) 2022. AN UNKNOWN TIME LATER SHE EXPERIENCED ALLERGY TO METALS ("SEVERE NICKEL ALLERGY") AND DEPRESSION ("DEPRESSION"). THE PATIENT WAS TREATED WITH SURGERY (TUBES AND OVARIES REMOVED IN 2013, ESSURE REMOVAL BY HYSTERECTOMY ON (B)(6) 2022). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ALLERGY TO METALS, FATIGUE, BACK PAIN, HERNIA, INTERVERTEBRAL DISC DISORDER, MIGRAINE, PERIARTHRITIS, TENDONITIS, DISTURBANCE IN ATTENTION OR DEPRESSION. THE REPORTER COMMENTED: IN (B)(6) 2022, THE DOCTOR REALIZED THAT I STILL HAD ESSURES EVEN THOUGH MY TUBES AND OVARIES WERE REMOVED IN 2013. SINCE THE REMOVAL OPERATION, GIANT URTICARIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 70 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: 03-JAN-2023: QUALITY SAFETY EVALUATION OF PTC. 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.

    Description of Event or Problem · 0

    THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY (B)(6) (REFERENCE NUMBER: (B)(4)) ON 23-DEC-2022. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("LUMBAR PAIN") IN A 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) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 734 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), FATIGUE ("MAJOR FATIGUE"), HERNIA ("HERNIA"), INTERVERTEBRAL DISC DISORDER ("DISCOPATHY"), MIGRAINE ("MIGRAINES"), PERIARTHRITIS ("CAPSULITIS"), TENDONITIS ("TENDINITIS") AND DISTURBANCE IN ATTENTION ("CONCENTRATION AND ATTENTION DIFFICULTY"). ESSURE WAS REMOVED ON (B)(6) 2022. AN UNKNOWN TIME LATER SHE EXPERIENCED ALLERGY TO METALS ("SEVERE NICKEL ALLERGY") AND DEPRESSION ("DEPRESSION"). THE PATIENT WAS TREATED WITH SURGERY (TUBES AND OVARIES REMOVED IN 2013, ESSURE REMOVAL BY HYSTERECTOMY ON (B)(6) 2022). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO ALLERGY TO METALS, FATIGUE, BACK PAIN, HERNIA, INTERVERTEBRAL DISC DISORDER, MIGRAINE, PERIARTHRITIS, TENDONITIS, DISTURBANCE IN ATTENTION OR DEPRESSION. THE REPORTER COMMENTED: IN (B)(6) 2022, THE DOCTOR REALIZED THAT I STILL HAD ESSURES EVEN THOUGH MY TUBES AND OVARIES WERE REMOVED IN 2013. SINCE THE REMOVAL OPERATION, GIANT URTICARIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 70 KG. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740731 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention