BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 20682457 · Received November 14, 2024

    Report

    Report Number
    2951250-2024-00701
    Event Type
    Injury
    Date Received
    November 14, 2024
    Report Date
    November 19, 2024
    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

    BAYER CASE NUMBER:(B)(4). SERIOUS ADVERSE EFFECTS, INCLUDING SUBSEQUENT SURGICAL REMOVAL OF THE IMPLANTS [MEDICAL DEVICE REMOVAL] CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("SERIOUS ADVERSE EFFECTS, INCLUDING SUBSEQUENT SURGICAL REMOVAL OF THE IMPLANTS") IN A FEMALE PATIENT WHO HAD ESSURE 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 INSERTED. ON AN UNKNOWN DATE SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: IN FRANCE, HOWEVER, UP TO THE 2010S, IT WAS WOMEN WHO TURNED TO STERILIZATION MORE. FIRSTLY AND ABOVE ALL BY TUBAL LIGATION; THEN BY ESSURE TUBAL IMPLANTS (UNTIL THEIR REMOVAL FROM THE MARKET IN 2017), EXPOSING A LOT OF WOMEN TO SERIOUS ADVERSE EFFECTS, INCLUDING SUBSEQUENT SURGICAL REMOVAL OF THE IMPLANTS. 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: 15-NOV-2024: QUALITY SAFETY EVALUATION OF PTC. FURTHER COMPANY FOLLOW-UP WITH THE HEALTHCARE PROFESSIONAL IS NOT POSSIBLE. 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.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4). SERIOUS ADVERSE EFFECTS, INCLUDING SUBSEQUENT SURGICAL REMOVAL OF THE IMPLANTS [MEDICAL DEVICE REMOVAL] CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("SERIOUS ADVERSE EFFECTS, INCLUDING SUBSEQUENT SURGICAL REMOVAL OF THE IMPLANTS") IN A FEMALE PATIENT WHO HAD ESSURE 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 INSERTED. ON AN UNKNOWN DATE SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: IN FRANCE, HOWEVER, UP TO THE 2010S, IT WAS WOMEN WHO TURNED TO STERILIZATION MORE. FIRSTLY, AND ABOVE ALL BY TUBAL LIGATION; THEN BY ESSURE TUBAL IMPLANTS (UNTIL THEIR REMOVAL FROM THE MARKET IN 2017), EXPOSING A LOT OF WOMEN TO SERIOUS ADVERSE EFFECTS, INCLUDING SUBSEQUENT SURGICAL REMOVAL OF THE IMPLANTS. FURTHER COMPANY FOLLOW-UP WITH THE HEALTHCARE PROFESSIONAL IS NOT POSSIBLE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350024 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention