BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9757500 · Received February 26, 2020

    Report

    Report Number
    2951250-2020-01735
    Event Type
    Injury
    Date Received
    February 26, 2020
    Report Date
    April 20, 2026
    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

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4) ON (B)(6) 2020. THE MOST RECENT INFORMATION WAS RECEIVED ON 11-MAR-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('METAL ALLERGY'), DEVICE BREAKAGE ('THE IMPLANTS WERE EXTRACTED BY PULLING ON THEM, LEAVING ME WITH SHARDS OF METAL IN TUBES') AND DEVELOPMENTAL HIP DYSPLASIA ('DYSPLASIA ON RIGHT HIP') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 932158) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PARAESTHESIA ("PARAESTHESIA") AND DEVELOPMENTAL HIP DYSPLASIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL / DEVICE REMOVAL INCOMPLETE"), PELVIC PAIN ("PAIN IN THE PELVIS"), ARTHRALGIA ("PAIN IN HIPS"), PAIN IN EXTREMITY ("LEG AND FEET PAIN"), MEMORY IMPAIRMENT ("MEMORY IMPAIRMENT"), COGNITIVE DISORDER ("COGNITIVE IMPAIRMENT") AND FATIGUE ("INTENSE FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ON (B)(6) 2017 AND SAPLINGECTOMY ON (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, DEVICE BREAKAGE, PARAESTHESIA, DEVELOPMENTAL HIP DYSPLASIA AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ARTHRALGIA, PAIN IN EXTREMITY, MEMORY IMPAIRMENT, COGNITIVE DISORDER AND FATIGUE HAD NOT RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ARTHRALGIA, COGNITIVE DISORDER, COMPLICATION OF DEVICE REMOVAL, DEVELOPMENTAL HIP DYSPLASIA, DEVICE BREAKAGE, FATIGUE, MEMORY IMPAIRMENT, PAIN IN EXTREMITY, PARAESTHESIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE IMPLANTS WERE REMOVED, AND AN ALLERGY TEST PERFORMED AFTERWARDS WHICH WAS POSITIVE FOR ALLERGIES FROM THE ALLOYS IN THE ESSURE DEVICES. LOT NUMBER: 932158, MANUFACTURING DATE: 2011-12, EXPIRATION DATE: 2014-12. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-MAR-2020: 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 · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ((B)(6), REFERENCE NUMBER: (B)(4)) ON 24-FEB-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ('METAL ALLERGY'), DEVICE BREAKAGE ('THE IMPLANTS WERE EXTRACTED BY PULLING ON THEM, LEAVING ME WITH SHARDS OF METAL IN TUBES') AND DEVELOPMENTAL HIP DYSPLASIA ('DYSPLASIA ON RIGHT HIP') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 932158) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PARAESTHESIA ("PARAESTHESIA") AND DEVELOPMENTAL HIP DYSPLASIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL / DEVICE REMOVAL INCOMPLETE"), PELVIC PAIN ("PAIN IN THE PELVIS"), ARTHRALGIA ("PAIN IN HIPS"), PAIN IN EXTREMITY ("LEG AND FEET PAIN"), MEMORY IMPAIRMENT ("MEMORY IMPAIRMENT"), COGNITIVE DISORDER ("COGNITIVE IMPAIRMENT") AND FATIGUE ("INTENSE FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL ON (B)(6) 2017 AND SAPLINGECTOMY ON (B)(6) 2018). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, DEVICE BREAKAGE, PARAESTHESIA, DEVELOPMENTAL HIP DYSPLASIA AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ARTHRALGIA, PAIN IN EXTREMITY, MEMORY IMPAIRMENT, COGNITIVE DISORDER AND FATIGUE HAD NOT RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS, ARTHRALGIA, COGNITIVE DISORDER, COMPLICATION OF DEVICE REMOVAL, DEVELOPMENTAL HIP DYSPLASIA, DEVICE BREAKAGE, FATIGUE, MEMORY IMPAIRMENT, PAIN IN EXTREMITY, PARAESTHESIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE IMPLANTS WERE REMOVED, AND AN ALLERGY TEST PERFORMED AFTERWARDS WHICH WAS POSITIVE FOR ALLERGIES FROM THE ALLOYS IN THE ESSURE DEVICES. 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
    529054 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 932158 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention| O