BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 16706597 · Received April 10, 2023

    Report

    Report Number
    2951250-2023-01762
    Event Type
    Injury
    Date Received
    April 10, 2023
    Date of Event
    January 1, 2022
    Report Date
    April 21, 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 28-MAR-2023. THE MOST RECENT INFORMATION WAS RECEIVED ON 20-APR-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DIZZINESS ("FEELING DIZZY") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. MEDICAL CONDITIONS: NO DIABETES OR KIDNEY HISTORY. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN 2016, SHE EXPERIENCED AUTOIMMUNE THYROIDITIS ("HASHIMOTO'S HYPOTHYROIDISM"). IN 2020, SHE WAS FOUND TO HAVE GLOMERULAR FILTRATION RATE ABNORMAL ("ALTERATION OF GLOMERULAR FILTRATION RATE"). IN 2022, SHE EXPERIENCED DIZZINESS (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). IN (B)(6) 2023 SHE EXPERIENCED APTYALISM ("NOCTURNAL HYPOSALIVATION"), DRY EYE ("DRY EYES") AND VISION BLURRED ("BLURRED VISION"). AN UNKNOWN TIME LATER SHE EXPERIENCED HYPERPROTEINAEMIA ("VERY MILD HYPERPROTEINEMIA PROBABLY CAUSED BY THE GFR DECREASE") AND INSOMNIA ("INSOMNIA"). AT THE TIME OF THE REPORT, THE GLOMERULAR FILTRATION RATE ABNORMAL, VISION BLURRED AND INSOMNIA HAD NOT RESOLVED. THE OUTCOMES FOR DIZZINESS, AUTOIMMUNE THYROIDITIS, HYPERPROTEINAEMIA, APTYALISM AND DRY EYE WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO AUTOIMMUNE THYROIDITIS, GLOMERULAR FILTRATION RATE ABNORMAL, HYPERPROTEINAEMIA, DIZZINESS, APTYALISM, DRY EYE, VISION BLURRED OR INSOMNIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 53 KG. [GLOMERULAR FILTRATION RATE] IN 2020: 103; IN 2021: 94; ON (B)(6) 2023: 86. [INVESTIGATION] (DATE UNKNOWN): NORMAL LAB TESTS FOR EVERYTHING ELSE. 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: 20-APR-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 ANSM (REFERENCE NUMBER: (B)(4)) ON 28-MAR-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DIZZINESS ("FEELING DIZZY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. MEDICAL CONDITIONS: NO DIABETES OR KIDNEY HISTORY. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN 2016 SHE EXPERIENCED AUTOIMMUNE THYROIDITIS ("HASHIMOTO'S HYPOTHYROIDISM"). IN 2020 SHE WAS FOUND TO HAVE GLOMERULAR FILTRATION RATE ABNORMAL ("ALTERATION OF GLOMERULAR FILTRATION RATE"). IN 2022 SHE EXPERIENCED DIZZINESS (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). IN (B)(6) 2023 SHE EXPERIENCED APTYALISM ("NOCTURNAL HYPOSALIVATION"), DRY EYE ("DRY EYES") AND VISION BLURRED ("BLURRED VISION"). AN UNKNOWN TIME LATER SHE EXPERIENCED HYPERPROTEINAEMIA ("VERY MILD HYPERPROTEINEMIA PROBABLY CAUSED BY THE GFR DECREASE") AND INSOMNIA ("INSOMNIA"). AT THE TIME OF THE REPORT, THE GLOMERULAR FILTRATION RATE ABNORMAL, VISION BLURRED AND INSOMNIA HAD NOT RESOLVED. THE OUTCOMES FOR DIZZINESS, AUTOIMMUNE THYROIDITIS, HYPERPROTEINAEMIA, APTYALISM AND DRY EYE WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO AUTOIMMUNE THYROIDITIS, GLOMERULAR FILTRATION RATE ABNORMAL, HYPERPROTEINAEMIA, DIZZINESS, APTYALISM, DRY EYE, VISION BLURRED OR INSOMNIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 53 KG. [GLOMERULAR FILTRATION RATE] IN 2020: 103; IN 2021: 94; ON (B)(6) 2023: 86. 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
    548906 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other