BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4177307 · Received October 16, 2014

    Report

    Report Number
    2951250-2014-00437
    Event Type
    Injury
    Date Received
    October 16, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    THIS CASE REPORT FROM (B)(6) WAS DERIVED FROM MEDICAL LITERATURE ON (B)(6) 2014, ARTICLE ENTITLED "PROXIMAL OCCLUSION OF HYDROSALPINGES BY ESSURE BEFORE ASSISTED REPRODUCTION TECHNIQUES: A FRENCH SURVEY". IT REFERS TO A ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (FALLOPIAN TUBE OCCLUSION INSERT) TO OCCLUDE HYDROSALPINGES BEFORE ASSISTED REPRODUCTIVE TECHNOLOGY (PRODUCT USED FOR UNAPPROVED INDICATION) AND EXPERIENCED PYOSALPINX. REPORTED TRADE NAME WAS ESSURE. THIS CASE REPORT CONCERNS 1 OUT OF 41 PATIENTS WITH A SUCCESSFUL ESSURE PLACEMENT. AFTER THE ESSURE PROCEDURE, THIS WOMAN DEVELOPED PYOSALPINX 7 DAYS AFTER THE PROCEDURE. IT RESOLVED FAVOURABLY UNDER COMBINED ANTIBIOTIC THERAPY AND RADIOLOGIC DRAINAGE. AUTHORS COMMENT: THE SURGICAL RISK DURING LAPAROSCOPY, ESPECIALLY FOR WOMEN WITH MAJOR PELVIC ADHESIONS, HAS LED SOME SURGEONS TO USE ESSURE FOR HYSTEROSCOPIC TUBAL OCCLUSION, AN OFF-LABEL USE DIFFERENT FROM ITS PRIMARY PURPOSE OF TUBAL STERILISATION. AUTHORS OBSERVED ONE CASE OF PYOSALPINX. THIS IS RARE BUT IN CASE OF HYDROSALPINX DUE TO PAST HISTORY OF PELVIC INFLAMMATORY DISEASE, THE INFORMATION MUST BE GIVEN TO THE PATIENT AS A RISK OF SIDE EFFECT. DATA WAS COLLECTED FROM ALL CASES IN WHICH DOCTORS ATTEMPTED TO PLACE ESSURE MICROINSERTS TO OCCLUDE ONE OR TWO HYDROSALPINGES BEFORE ASSISTED REPRODUCTIVE TECHNOLOGY (INCLUDING IVF, ICSI, AND EMBRYO OR OOCYTE DONATION). ABSTRACT: OBJECTIVES: TO STUDY THE FEASIBILITY AND RESULTS (LIVE-BIRTH AND COMPLICATION RATES) OF PLACEMENT OF ESSURE1 MICROINSERTS BEFORE ASSISTED REPRODUCTIVE TECHNOLOGY (ART) TREATMENT OF WOMEN WITH HYDROSALPINX WHEN LAPAROSCOPY SHOULD BE AVOIDED. STUDY DESIGN: NATIONAL SURVEY OF 45 FRENCH HOSPITAL CENTRES PROVIDING ART REPORTING A RETROSPECTIVE ANALYSIS OF 43 WOMEN WITH UNILATERAL OR BILATERAL HYDROSALPINGES AND ESSURE1 PLACEMENT. THE RESULTS OF THE FOLLOWING ART CYCLE WERE STUDIED FOR 54 EMBRYO TRANSFERS. RESULTS: THE PLACEMENT SUCCESS RATE REACHED 92.8 PERCENT (65/70 TUBES), AND THE MEAN NUMBER OF VISIBLE INTRAUTERINE COILS WAS 1.61 (RANGE: 0 TO 6). PYOSALPINX OCCURRED IN ONE CASE, AND EXPULSION OF THE DEVICE INTO THE UTERUS IN TWO OTHERS. OF 43 WOMEN, 29 (67.4 PERCENT) HAD A TOTAL OF 54 FRESH OR FROZEN EMBRYOS TRANSFERRED. THE CLINICAL PREGNANCY RATE WAS 40.7 PERCENT (22/54) AND THE LIVE-BIRTH RATE 25.9 PERCENT (14/54). THE IMPLANTATION RATE WAS 29.3 PERCENT (27/92). CONCLUSION: ESSURE1 PLACEMENT IS AN EFFECTIVE METHOD FOR OCCLUSION OF HYDROSALPINGES BEFORE IVF. MONITORING THE LIVE-BIRTH RATE CONFIRMS THAT THIS OPTION IS THE STRONGEST IN CASES WHEN LAPAROSCOPY IS IMPOSSIBLE OR CONTRAINDICATED. OTHER CASES FROM SAME ARTICLE ARE 2014-139928, 2014-140208, 2014-140209, 2014-140250, 2014-140161 AND 2014-140255. FOLLOW-UP RECEIVED ON 06-OCT-2014. PRODUCT TECHNICAL COMPLAINT INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (REQUEST FOR CONFIRMATION OF QUALITY AND OFF LABEL USE). (B)(4). FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE REPORTED ADVERSE EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. IN THIS PARTICULAR CASE, ALSO AN OFF LABEL USE WAS REPORTED. ACCORDING TO CASE INFORMATION THE PRODUCT WAS USED TO ASSISTED REPRODUCTIVE TECHNOLOGY. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. THE LIST OF SIMILAR CASES CONTAINS REPORTS WITH SIMILAR EVENTS CODED IN MEDDRA. IT INCLUDES RECENT CASES RECEIVED BY BAYER PHARMA AND OLDER CASES RECEIVED FROM THE PREVIOUS OWNER OF THE ESSURE PRODUCT (CONCEPTUS). THESE LEGACY REPORTS HAVE BEEN RE-CODED ACCORDING TO BAYER PHARMA STANDARDS. IN THIS PARTICULAR CASE, A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(4) 2014 FOR THE FOLLOWING MEDDRA PREFERRED TERM: SALPINGITIS. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. THIS INCLUDES CONSIDERATION OF THE LEGACY CASES IN SAFETY ANALYSES. THE CUMULATIVE REVIEW OF THE REPORTS HAS NOT YIELDED ANY NEW SAFETY SIGNAL. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED CASE REPORT WAS DERIVED FROM LITERATURE AND REFERS TO AN ADULT FEMALE PATIENT, WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED TO OCCLUDE HYDROSALPINX (OFF LABEL USE IN UNAPPROVED INDICATION) AND EXPERIENCED PIOSALPINX. PIOSALPINX WAS CONSIDERED SERIOUS, AS MEDICALLY SIGNIFICANT, IS LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. PYOSALPINX, ALSO REFERRED AS TUBOOVARIAN ABSCESS, IS AN INFLAMMATORY MASS INVOLVING THE FALLOPIAN TUBE, OVARY, AND, OCCASIONALLY, OTHER ADJACENT PELVIC ORGANS. THESE ABSCESSES TYPICALLY RESULT FROM UPPER GENITAL TRACT INFECTION (COMPLICATION OF PELVIC INFLAMMATORY DISEASE). WHILE ESSURE SYSTEM IS STERILE IT MAY, DUE TO A BACTERIAL CONTAMINATION DURING INSERTION, BECOME A VEHICLE FOR MICROBIAL TRANSPORT IN THE UPPER GENITAL TRACT. THIS MAY EXPLAIN AN INCREASED RISK FOR PELVIC INFECTIONS AFTER INSERTION PROCEDURE. IN THIS PARTICULAR CASE, 7 DAYS AFTER ESSURE INSERTION PATIENT DEVELOPED PYOSALPINX, WHICH WAS SUCCESSFULLY TREATED. GIVEN PYOSALPINX PHYSIOPATHOLOGY AND THE CLOSE TEMPORAL RELATIONSHIP WITH ESSURE INSERTION A CAUSAL RELATIONSHIP BETWEEN THIS EVENT AND THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE IT REQUIRED MEDICAL INTERVENTION (ANTIBIOTIC THERAPY AND RADIOLOGIC DRAINAGE). PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS CONCLUDED TO AN UNCONFIRMED QUALITY DEFECT. MEDICAL PTC ASSESSMENT CONSIDERED THAT, BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT QUALITY DEFECT OF THE PRODUCT. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658343 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other