BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3960365 · Received July 17, 2014

    Report

    Report Number
    2951250-2014-00288
    Event Type
    Injury
    Date Received
    July 17, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW UP RECEIVED ON 24-JUN-2014: PTC GLOBAL NO ADDED PRODUCT TECHNICAL COMPLAINT INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED ON 28-JUN-2014: THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: (B)(4). FINAL ASSESSMENT SINCE NO PRODUCT WAS RETURNED TO U.S 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 AT THIS TIME. NO CAPA INVESTIGATION IS REQUIRED AT THIS TIME PER CRITERIA ESTABLISHED IN (B)(4), "PROCESSING ESSURE CASES IN (B)(4)." MEDICAL ASSESSMENT THE MEDICAL EVENTS REPORTED IS NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. NO BATCH NUMBER WAS REPORTED. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE (B)(4) DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER. AT THE TIME OF THIS MEDICAL ASSESSMENT, THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS CASE REPORT WAS DERIVED FROM MEDICAL LITERATURE AND REFERS TO A (B)(6) YEARS-OLD FEMALE PATIENT WHO HAD FALLOPIAN TUBE OCCLUSION INSERT (ESSURE) INSERTED AND EXPERIENCED PELVIC PAIN IMMEDIATELY AFTER THE PROCEDURE, WHICH WAS CONSIDERED AS RELATED TO ESSURE BY THE REPORTER. THIS EVENT WAS CONSIDERED SERIOUS, DUE TO MEDICAL IMPORTANCE AND IT IS LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR WITH ESSURE THERAPY. IN THIS PARTICULAR CASE, IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PELVIC PAIN IMMEDIATELY AFTER THE PROCEDURE, THIS PAIN PERSISTED FOR 6 WEEKS, UNTIL THE DEVICES WERE REMOVED BY HYSTEROSCOPY AND A LAPAROSCOPIC TUBAL LIGATION WAS PERFORMED. HER PAIN SYMPTOMS RESOLVED AFTER THE PROCEDURE. CONSIDERING THIS POSITIVE TEMPORAL RELATIONSHIP AND DECHALLENGE, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT AND ESSURE CANNOT BE EXCLUDED AND DUE TO THE REQUIRED INSERT REMOVAL THIS CASE WAS REGARDED AS AN INCIDENT. A PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS WAS PERFORMED AND CONCLUDED THAT BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT OF THE PRODUCT. REPORT SOURCE LITERATURE DESCRIPTION: JOURNAL: LANNON AND LEE; AUTHOR: BENJAMIN M. LANNON, AND SHIAO-YU LEE; TITLE: TECHNIQUES FOR REMOVAL OF THE ESSURE HYSTEROSCOPIC TUBAL OCCLUSION DEVICE; VOLUME: 88 (2) YEAR: 2007 PAGES: 497-498; JOURNAL: J OBSTET GYNAECOL; AUTHOR: ARJONA BERRA! JE, RODRIGUEZ JIMENEZ B, VELASCO ET A;L TITLE: ESSURE AND CHRONIC PELVIC PAIN: A POPULATION-BASED COHORT; VOLUME: XX YEAR: 2014 PAGES: 1-2.

    Description of Event or Problem · 1

    THIS CASE REPORT FROM UNITED STATES WAS DERIVED FROM MEDICAL LITERATURE ON 17-JUN-2014 , ARTICLE ENTITLED "ESSURE AND CHRONIC PELVIC PAIN: A POPULATION-BASED COHORT". IT REFERS TO A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) IMPLANTED FOR HYSTEROSCOPIC STERILISATION AND EXPERIENCED PELVIC PAIN IMMEDIATELY AFTER THE PROCEDURE. CASE REPORT: CASE 1 WAS A (B)(6) YEAR-OLD WOMAN WHO HAD THE ESSURE INSERTS PLACED 43 DAYS PREVIOUSLY. SHE COMPLAINED OF PELVIC PAIN IMMEDIATELY AFTER THE PROCEDURE. THE PAIN WAS DULL AND BILATERAL, AND DID NOT IMPROVE WITH EMPIRIC ANTIBIOTIC THERAPY. AN ULTRASOUND AND DIAGNOSTIC HYSTEROSCOPY CONFIRMED APPROPRIATE PLACEMENT OF THE INSERTS. BECAUSE OF THE PERSISTENT PAIN, SHE REQUESTED REMOVAL OF THE DEVICES AS WELL AS PERMANENT SURGICAL STERILIZATION. A 5-MM HYSTEROSCOPE WAS USED WITH GLYCINE DISTENTION MEDIA. GLYCINE WAS SELECTED IN CASE ELECTROCAUTERY WAS NEEDED DURING THE REMOVAL PROCESS. THE ESSURE COILS WERE CLEARLY SEEN EXTENDING FROM BOTH OF THE TUBAL OSTIA. THE HYSTEROSCOPIC FORCEPS WAS USED TO GENTLY EXTRACT BOTH COILS UNDER DIRECT VISUALIZATION. THE COILS WERE EASILY REMOVED INTACT. A LAPAROSCOPIC TUBAL LIGATION WITH ELECTROCAUTERY WAS THEN PERFORMED. TEN DAYS AFTER THE PROCEDURE, THE PATIENT'S INITIAL SYMPTOMS OF PELVIC PAIN HAD RESOLVED. AUTHOR'S COMMENTS: IN THIS CASE DESCRIBED, AUTHOR DEMONSTRATED SUCCESSFUL REMOVAL OF THE ESSURE DEVICE AFTER PERSISTENT PELVIC PAIN. PELVIC PAIN AFTER PLACEMENT OF THE ESSURE DEVICE IS USUALLY TRANSIENT. IT WAS UNABLE TO IDENTIFY ANY SPECIFIC ETIOLOGY OF THE PAIN, SUCH AS INFECTION OR IMPROPER PLACEMENT. IN THIS, THE SYMPTOMS COMPLETELY RESOLVED AFTER REMOVAL OF THE DEVICE. IN SUCH CASES, IT WAS DEMONSTRATED THAT THE DEVICE CAN BE REMOVED BY HYSTEROSCOPY WITH GENTLE TRACTION, OR BY LAPAROSCOPY IN CASES WHERE NO COILS ARE VISIBLE AT THE TUBAL OSTIA. THIS CASE INDICATE THAT FOR CASES OF PERSISTENT PAIN UP TO 6 WEEKS AFTER THE PROCEDURE, REMOVAL BY HYSTEROSCOPY OR LAPAROSCOPY IS POSSIBLE. PUBLICATION ABSTRACT: OBJECTIVE: TO PRESENT TWO CASE REPORTS OF TECHNIQUES FOR REMOVAL OF THE ESSURE (CONCEPTUS, INC., MOUNTAIN VIEW,CA) HYSTEROSCOPIC TUBAL OCCLUSION DEVICE. DESIGN: CASE REPORT. SETTING: UNIVERSITY-AFFILIATED TEACHING HOSPITAL. PATIENT(S): TWO WOMEN REQUESTING REMOVAL OF ESSURE DEVICES BECAUSE OF PERSISTENT PELVIC PAIN UP TO 6 WEEKS AFTER PLACEMENT. INTERVENTION(S): HYSTEROSCOPIC AND LAPAROSCOPIC REMOVAL OF THE ESSURE MICROINSERTS. NO INSTITUTIONAL REVIEW BOARD APPROVAL WAS OBTAINED BECAUSE THE PROCEDURES WERE NOT PART OF A STUDY PROTOCOL. MAIN OUTCOME MEASURE(S): EFFECTIVE REMOVAL OF THE ESSURE DEVICE AND RESOLUTION OF PELVIC PAIN SYMPTOMS. RESULT(S): SUCCESSFUL REMOVAL OF THE DEVICE WAS ACHIEVED IN BOTH PATIENTS. IN ONE CASE, THE PROCEDURE WAS PERFORMED ENTIRELY BY HYSTEROSCOPY. IN THE OTHER CASE, A LAPAROSCOPIC APPROACH WAS REQUIRED BECAUSE OF A LACK OF VISUALIZATION OF THE DEVICE. PAIN SYMPTOMS RESOLVED WITHIN 2 WEEKS OF REMOVAL IN BOTH PATIENTS. CONCLUSION(S): THESE ARE THE FIRST REPORTED CASES OF SUCCESSFUL REMOVAL OF THE ESSURE TUBAL OCCLUSION DEVICES UP TO 6 WEEKS AFTER PLACEMENT. THIS PROCEDURE CAN BE SAFELY PERFORMED WITH THE USE OF HYSTEROSCOPY IF THE INSERTS ARE CLEARLY VISUALIZED. LAPAROSCOPY IS AN ALTERNATIVE WHEN THE DEVICE IS COMPLETELY WITHIN THE FALLOPIAN TUBE. FURTHER STUDY IS NEEDED TO ASSESS THE FUNCTIONALITY OF THE TUBE AFTER THE PROCEDURE, AS WELL AS FEASIBILITY OF REMOVAL BEYOND 6 WEEKS. OTHER CASE FROM THIS ARTICLE: 2014-092737. CORRECTION ON 17-JUN- 2014: THE ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) MODEL WAS AMENDED TO ES205.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420323 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS205

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other