BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 17820752 · Received September 26, 2023

    Report

    Report Number
    2951250-2023-02960
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    July 20, 2012
    Report Date
    October 16, 2023
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("PROLONGED HEAVY PERIODS /BLOOD CLOTS DURING PERIODS"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER"), HEADACHE ("HEADACHE") AND ARTHRALGIA ("HIP PAIN") IN A 48 YEAR-OLD 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. THE ONLY CONCOMITANT PRODUCT MENTIONED WAS LEVOTHYROXINE FOR THYROID DISORDER SINCE (B)(6) 2002. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 46 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ON (B)(6) 2013, SHE EXPERIENCED HEADACHE (SERIOUSNESS CRITERION HOSPITALISATION), RASH ("RASHES/SEVERE RASHES ON EYELIDS AND HANDS") AND BRAIN FOG ("BRAIN FOG"). ON (B)(6) 2021, SHE EXPERIENCED ARTHRALGIA (SERIOUSNESS CRITERION HOSPITALISATION). ON (B)(6) 2021, SHE EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION HOSPITALISATION). ESSURE WAS REMOVED ON (B)(6) 2023. AN UNKNOWN TIME LATER SHE EXPERIENCED MIXED CONNECTIVE TISSUE DISEASE ("MIXED CONNECTIVE DISEASE") AND RAYNAUD'S PHENOMENON ("RAYNAUDS WITHOUT GANGRENE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROCTOMY). ON (B)(6) 2022, THE HEAVY MENSTRUAL BLEEDING HAD RESOLVED. ON (B)(6) 2023, THE HEADACHE HAD RESOLVED WITH SEQUELAE. ON (B)(6) 2023, THE RASH HAD RESOLVED WITH SEQUELAE. AT THE TIME OF THE REPORT, THE ARTHRALGIA AND BRAIN FOG WERE RESOLVING AND THE AUTOIMMUNE DISORDER HAD NOT RESOLVED. THE OUTCOMES FOR MIXED CONNECTIVE TISSUE DISEASE AND RAYNAUD'S PHENOMENON WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO HEADACHE, RASH, BRAIN FOG, HEAVY MENSTRUAL BLEEDING, AUTOIMMUNE DISORDER, ARTHRALGIA, MIXED CONNECTIVE TISSUE DISEASE OR RAYNAUD'S PHENOMENON. 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: 11-OCT-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

    THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("PROLONGED HEAVY PERIODS /BLOOD CLOTS DURING PERIODS"), HEADACHE ("HEADACHE"), AUTOIMMUNE DISORDER ("AUTOIMMUNE DISORDER") AND ARTHRALGIA ("HIP PAIN") IN A 48 YEAR-OLD 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. THE ONLY CONCOMITANT PRODUCT MENTIONED WAS LEVOTHYROXINE FOR THYROID DISORDER SINCE (B)(6) 2002. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 46 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ON (B)(6) 2013 SHE EXPERIENCED HEADACHE (SERIOUSNESS CRITERION HOSPITALISATION), RASH ("RASHES / SEVERE RASHES ON EYELIDS & HANDS") AND BRAIN FOG ("BRAIN FOG"). ON (B)(6) 2021 SHE EXPERIENCED ARTHRALGIA (SERIOUSNESS CRITERION HOSPITALISATION). ON (B)(6) 2021 SHE EXPERIENCED AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION HOSPITALISATION). ESSURE WAS REMOVED ON (B)(6) 2023. AN UNKNOWN TIME LATER SHE EXPERIENCED MIXED CONNECTIVE TISSUE DISEASE ("MIXED CONNECTIVE DISEASE") AND RAYNAUD'S PHENOMENON ("RAYNAUDS WITHOUT GANGRENE"). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROCTOMY). ON (B)(6) 2022, THE HEAVY MENSTRUAL BLEEDING HAD RESOLVED. ON (B)(6) 2023, THE HEADACHE HAD RESOLVED WITH SEQUELAE. ON (B)(6) 2023, THE RASH HAD RESOLVED WITH SEQUELAE. AT THE TIME OF THE REPORT, THE BRAIN FOG AND ARTHRALGIA WERE RESOLVING AND THE AUTOIMMUNE DISORDER HAD NOT RESOLVED. THE OUTCOMES FOR MIXED CONNECTIVE TISSUE DISEASE AND RAYNAUD'S PHENOMENON WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO HEADACHE, RASH, BRAIN FOG, HEAVY MENSTRUAL BLEEDING, AUTOIMMUNE DISORDER, ARTHRALGIA, MIXED CONNECTIVE TISSUE DISEASE OR RAYNAUD'S PHENOMENON. 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. 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
    984515 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention| H LEVOTHYROXINE| LEVOTHYROXINE