BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 15043127 · Received July 18, 2022

    Report

    Report Number
    2951250-2022-00855
    Event Type
    Injury
    Date Received
    July 18, 2022
    Report Date
    August 10, 2022
    Manufacturer
    BAYER AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF PROCEDURAL PAIN ('PAIN DURING INSERTION') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: ZEGURA ANDRIC B; ROSIC M; SERDINSEK T; SUMAK R, LONG-TERM PATIENT SATISFACTION AND REMOVAL RATE AFTER ESSURE STERILIZATION: A FOLLOW-UP STUDY, BMC WOMEN'S HEALTH, 2022, 22(250):1-6. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "UNILATERAL ESSURE INSERTION / A TWO-SIDED INSERTION WAS NOT POSSIBLE". ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PROCEDURAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO ESSURE REMOVAL). ESSURE WAS REMOVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR PROCEDURAL PAIN WITH ESSURE. THE REPORTER COMMENTED: REGARDING THE COMPLICATIONS AND MICRO-INSERT-REMOVAL RATE, WE DISCOVERED THAT TEN OF OUR PATIENTS (3%) HAD ESSURE REMOVAL AND OF THOSE ONLY TWO REMOVALS WERE PAIN RELATED (0.6%). IN COMPARISON, IN THE POST-MARKET SURVEILLANCE STUDY, ORDERED BY FDA, THE REMOVAL RATE OF ESSURE MICRO-INSERT WAS 6.8%. WE PERFORMED TWO ESSURE REMOVALS BECAUSE THE TUBES WERE STILL PATENT ON ROUTINE CHECK-UP 12 WEEKS AFTER THE INSERTION (0.6%), TWO BECAUSE A TWO SIDED INSERTION WAS NOT POSSIBLE (0.6%) AND FOUR WERE REMOVED DURING GYNECOLOGICAL PROCEDURES THAT WERE UNRELATED TO THE ESSURE. OUR RESULTS DEMONSTRATE THAT THE ESSURE® HYSTEROSCOPIC STERILIZATION IS A PROCEDURE WITH A VERY HIGH SATISFACTION RATE. MOST OF THE ESSURE® REMOVALS IN OUR POPULATION WERE PERFORMED DUE TO ESSURE® UNRELATED COMPLAINTS. QUALITY-SAFETY EVALUATION OF PTC: 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. BACKGROUND: THE OBJECTIVE OF OUR STUDY WAS TO ASSESS THE RATE AND CAUSES FOR ESSURE® MICRO-INSERT SYSTEM REMOVAL AND PATIENTS' LONG TERM SATISFACTION RATE WITH THE PROCEDURE. METHODS: ALL PATIENTS WHO UNDERWENT ESSURE® HYSTEROSCOPIC STERILIZATION AT OUR TERTIARY CENTRE BETWEEN YEARS 2007 AND 2018 WERE INCLUDED IN THIS FOLLOW-UP STUDY. A QUESTIONNAIRE WAS SENT TO ALL PATIENTS PER STANDARD MAIL. PATIENTS WHO DID NOT RESPOND TO QUESTIONNAIRES PER MAIL, WERE CALLED BY PHONE. THE SATISFACTION WITH THE ESSURE® STERILIZATION, AS WELL AS ANY ADDITIONAL PROCEDURES AFTER THE INSERTION OR INSERTION-RELATED COMPLICATIONS WERE ANALYSED. RESULTS: FROM THE YEAR 2007 TO 2018, WE PERFORMED 427 ESSURE® HYSTEROSCOPIC STERILIZATIONS AND OF THESE, 329 PATIENTS RESPONDED TO THE QUESTIONNAIRE (RESPONSE RATE 77%). TEN PATIENTS (3%) HAD ESSURE® REMOVAL, TWO OF THEM DUE TO PAIN (0.6%). PATIENTS WERE VERY SATISFIED WITH THE PROCEDURE (9.5 ON SCALE 0-10). MOST PATIENTS (95.3%) WOULD RECOMMEND THE PROCEDURE TO THEIR FRIEND. CONCLUSIONS: ESSURE® HYSTEROSCOPIC STERILIZATION IS A PROCEDURE WITH A VERY HIGH SATISFACTION RATE AND A VERY LOW REMOVAL RATE DUE TO STERILIZATION-RELATED COMPLICATIONS. TRIAL REGISTRATION INSTITUTIONAL REVIEW BOARD OF UNIVERSITY MEDICAL CENTRE MARIBOR APPROVED THE STUDY, APPROVAL NUMBER UKC-MB-KME-73/19. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-AUG-2022: 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 CASE INFORMATION FROM A PUBLISHED STUDY WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PAIN DURING INSERTION") IN A 37 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: ZEGURA ANDRIC B; ROSIC M; SERDINSEK T; SUMAK R. LONG-TERM PATIENT SATISFACTION AND REMOVAL RATE AFTER ESSURE STERILIZATION: A FOLLOW-UP STUDY. BMC WOMEN'S HEALTH. 2022; 22(250): 1-6. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR ("UNILATERAL ESSURE INSERTION / A TWO-SIDED INSERTION WAS NOT POSSIBLE"). 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 EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO ESSURE REMOVAL). ESSURE WAS REMOVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO PELVIC PAIN. THE REPORTER COMMENTED: REGARDING THE COMPLICATIONS AND MICRO-INSERT-REMOVAL RATE, WE DISCOVERED THAT TEN OF OUR PATIENTS (3%) HAD ESSURE REMOVAL AND OF THOSE ONLY TWO REMOVALS WERE PAIN RELATED (0.6%). IN COMPARISON, IN THE POST-MARKET SURVEILLANCE STUDY, ORDERED BY FDA, THE REMOVAL RATE OF ESSURE MICRO-INSERT WAS 6.8%. WE PERFORMED TWO ESSURE REMOVALS BECAUSE THE TUBES WERE STILL PATENT ON ROUTINE CHECK-UP 12 WEEKS AFTER THE INSERTION (0.6%), TWO BECAUSE A TWO SIDED INSERTION WAS NOT POSSIBLE (0.6%) AND FOUR WERE REMOVED DURING GYNECOLOGICAL PROCEDURES THAT WERE UNRELATED TO THE ESSURE. OUR RESULTS DEMONSTRATE THAT THE ESSURE® HYSTEROSCOPIC STERILIZATION IS A PROCEDURE WITH A VERY HIGH SATISFACTION RATE. MOST OF THE ESSURE® REMOVALS IN OUR POPULATION WERE PERFORMED DUE TO ESSURE® UNRELATED COMPLAINTS. ABSTRACT. LITERATURE ABSTRACT. BACKGROUND: THE OBJECTIVE OF OUR STUDY WAS TO ASSESS THE RATE AND CAUSES FOR ESSURE® MICRO-INSERT SYSTEM REMOVAL AND PATIENTS' LONG TERM SATISFACTION RATE WITH THE PROCEDURE. METHODS: ALL PATIENTS WHO UNDERWENT ESSURE® HYSTEROSCOPIC STERILIZATION AT OUR TERTIARY CENTRE BETWEEN YEARS 2007 AND 2018 WERE INCLUDED IN THIS FOLLOW-UP STUDY. A QUESTIONNAIRE WAS SENT TO ALL PATIENTS PER STANDARD MAIL. PATIENTS WHO DID NOT RESPOND TO QUESTIONNAIRES PER MAIL, WERE CALLED BY PHONE. THE SATISFACTION WITH THE ESSURE® STERILIZATION, AS WELL AS ANY ADDITIONAL PROCEDURES AFTER THE INSERTION OR INSERTION-RELATED COMPLICATIONS WERE ANALYSED. RESULTS: FROM THE YEAR 2007 TO 2018, WE PERFORMED 427 ESSURE® HYSTEROSCOPIC STERILIZATIONS AND OF THESE, 329 PATIENTS RESPONDED TO THE QUESTIONNAIRE (RESPONSE RATE 77%). TEN PATIENTS (3%) HAD ESSURE® REMOVAL, TWO OF THEM DUE TO PAIN (0.6%). PATIENTS WERE VERY SATISFIED WITH THE PROCEDURE (9.5 ON SCALE 0-10). MOST PATIENTS (95.3%) WOULD RECOMMEND THE PROCEDURE TO THEIR FRIEND. CONCLUSIONS: ESSURE® HYSTEROSCOPIC STERILIZATION IS A PROCEDURE WITH A VERY HIGH SATISFACTION RATE AND A VERY LOW REMOVAL RATE DUE TO STERILIZATION-RELATED COMPLICATIONS. TRIAL REGISTRATION INSTITUTIONAL REVIEW BOARD OF UNIVERSITY MEDICAL CENTRE MARIBOR APPROVED THE STUDY, APPROVAL NUMBER UKC-MB-KME-73/19. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2883694 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Other| R