BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE (ESS205)

    MDR report key: 22640752 · Received July 29, 2025

    Report

    Report Number
    2951250-2025-00509
    Event Type
    Injury
    Date Received
    July 29, 2025
    Report Date
    August 12, 2025
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BAYER CASE NUMBER: (B)(4). I¿M GOING FOR A HYSTERECTOMY, I¿VE HAD THE ENSURE IMPLANTS FOR CLOSE TO 25 YRS [MEDICAL DEVICE REMOVAL]. CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("I¿M GOING FOR A HYSTERECTOMY, I¿VE HAD THE ENSURE IMPLANTS FOR CLOSE TO 25 YRS") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE (ESS205) WITH REGARD TO MEDICAL DEVICE REMOVAL. THE REPORTER COMMENTED: I¿M GOING FOR A HYSTERECTOMY, I¿VE HAD THE ESSURE IMPLANTS FOR CLOSE TO 25 YRS, DO I NEED TO TELL THE SURGEON TO KEEP THE ENSURE IMPLANTS FOR STUDY OR WILL THEY KNOW WHAT TO DO? I HAD A FORM AS TO WHAT TO DO BUT IT¿S BEEN MISPLACED. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE (ESS205): 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: 10-AUG-2025: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. CASE COMMENTS: 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. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4) I¿M GOING FOR A HYSTERECTOMY; I¿VE HAD THE ENSURE IMPLANTS FOR CLOSE TO 25 YRS [MEDICAL DEVICE REMOVAL] . CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("I¿M GOING FOR A HYSTERECTOMY; I¿VE HAD THE ENSURE IMPLANTS FOR CLOSE TO 25 YRS") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE (ESS205) WITH REGARD TO MEDICAL DEVICE REMOVAL. THE REPORTER COMMENTED: I¿M GOING FOR A HYSTERECTOMY, I¿VE HAD THE ESSURE IMPLANTS FOR CLOSE TO 25 YRS, DO I NEED TO TELL THE SURGEON TO KEEP THE ENSURE IMPLANTS FOR STUDY OR WILL THEY KNOW WHAT TO DO? I HAD A FORM AS TO WHAT TO DO BUT IT¿S BEEN MISPLACED. CASE COMMENTS: 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. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2750840 ESSURE (ESS205) TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention