BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5110290 · Received September 29, 2015

    Report

    Report Number
    2951250-2015-01155
    Event Type
    Injury
    Date Received
    September 29, 2015
    Report Date
    January 20, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT TECHNICAL COMPLAINT (PTC) INVESTIGATION RESULT RECEIVED ON 02-OCT-2015: PTC GLOBAL NUMBER: (B)(4). FINAL ASSESSMENT: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: NO PRODUCT QUALITY DEFECT WAS CONFIRMED THEREFORE A RELATIONSHIP TO THE REPORTED MEDICAL EVENTS IS EXCLUDED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS, THE REPORTED LACK OF EFFICACY AND A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE CONSUMER, WHO HAD AN UNEXPECTED CHILD AFTER GETTING ESSURE (FALLOPIAN TUBE OCCLUSION INSERT). ADDITIONALLY, SHE WAS SUBMITTED TO MULTIPLE SURGERIES (UNSPECIFIED) TO LOCATE THE FRAGMENTS THROUGHOUT HER ABDOMEN AND COLON (REGARDED AS DEVICE BREAKAGE WITH DISLOCATION OF ESSURE FRAGMENTS INTO PERITONEAL CAVITY). DEVICE BREAKAGE IS LISTED ACCORDING TO THE TECHNICAL ANALYSIS, WHILE PREGNANCY AND DISLOCATION ARE LISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE AND HAVE BEEN REPORTED IN WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. SOME OF THESE PREGNANCIES OCCURRED DUE TO PATIENT NON-COMPLIANCE INCLUDING FAILURE TO RETURN FOR THE ESSURE CONFIRMATION TEST (HSG). IN THIS PARTICULAR CASE, NO INFORMATION WAS PROVIDED ABOUT HSG. THE CONSUMER WAS SUBMITTED TO UNSPECIFIED IMAGES AND FRAGMENTS OF ESSURE WERE FOUND IN HER ABDOMEN AND COLON. THIS DEVICE BREAKAGE/DISLOCATION COULD BE ALTERNATIVE EXPLANATIONS FOR THE REPORTED ESSURE FAILURE (PREGNANCY). HOWEVER, SINCE THEIR MECHANISM IS UNKNOWN (IF BREAKAGE OCCURRED BEFORE OR AFTER PREGNANCY ONSET); CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS, THE REPORTED LACK OF EFFICACY AND A QUALITY DEFECT. NO ACTIVE FOLLOW-UP WILL BE PURSUED (CASE IDENTIFIED DURING HEALTH AUTHORITY WEBSITE MONITORING).

    Description of Event or Problem · 1

    THIS CASE HAS BEEN IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE, WHICH HAS BEEN ESTABLISHED IN PREPARATION OF A PUBLIC FDA ADVISORY COMMITTEE MEETING TAKING PLACE IN SEPTEMBER 2015 (CASE# FDA-2014-N-0736-1066, AWARENESS DATE 01-SEP-2015). CASE WAS RECEIVED FROM CONSUMER'S FRIEND IN UNITED STATES AND REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. CONSUMER'S FRIEND REPORTED THAT, FOR YEARS SHE HAS WATCHED HER BEST FRIEND, WHO SHE GREW UP WITH, SUFFER GREATLY AFTER GETTING THE ESSURE BIRTH CONTROL. SHE HAS WATCHED HER HAVE AN UNEXPECTED CHILD AFTER GETTING ESSURE, SHE HAS WATCHED HER HAVE MULTIPLE SURGERIES, MULTIPLE IMAGES TO LOCATE THE FRAGMENTS THROUGHOUT HER ABDOMEN AND COLON. SHE HAS WATCHED HER HAVE TO GET A HYSTERECTOMY (2 WEEKS AGO; (B)(6) 2015) BECAUSE OF ESSURE AND STATES THAT HER FRIEND STILL HAS FRAGMENTS THROUGHOUT HER ABDOMEN. ACCORDING TO REPORTER, CONSUMER HAS SEEN MANY SPECIALISTS AND SURGEONS AND WAS TOLD THAT SHE HAS TO LIVE WITH THIS PAIN FOR THE REST OF HER LIFE BECAUSE THEY CANNOT BE SAFELY REMOVED. IN ADDITION, REPORTER INFORMED THAT SHE HAS WATCHED MANY OTHER FRIENDS SUFFER FROM ESSURE AS WELL. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE CONSUMER, WHO HAD AN UNEXPECTED CHILD AFTER GETTING ESSURE (FALLOPIAN TUBE OCCLUSION INSERT). ADDITIONALLY, SHE WAS SUBMITTED TO MULTIPLE SURGERIES (UNSPECIFIED) TO LOCATE THE FRAGMENTS THROUGHOUT HER ABDOMEN AND COLON (REGARDED AS DEVICE BREAKAGE WITH DISLOCATION OF ESSURE FRAGMENTS INTO PERITONEAL CAVITY) ONLY DEVICE BREAKAGE IS UNLISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE AND HAVE BEEN REPORTED IN WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. SOME OF THESE PREGNANCIES OCCURRED DUE TO PATIENT NON-COMPLIANCE INCLUDING FAILURE TO RETURN FOR THE ESSURE CONFIRMATION TEST (HSG). IN THIS PARTICULAR CASE, NO INFORMATION WAS PROVIDED ABOUT HSG. THE CONSUMER WAS SUBMITTED TO UNSPECIFIED IMAGES AND FRAGMENTS OF ESSURE WERE FOUND IN HER ABDOMEN AND COLON. THIS DEVICE BREAKAGE/DISLOCATION COULD BE ALTERNATIVE EXPLANATIONS FOR THE REPORTED ESSURE FAILURE (PREGNANCY). HOWEVER, SINCE THEIR MECHANISM IS UNKNOWN (IF BREAKAGE OCCURRED BEFORE OR AFTER PREGNANCY ONSET); CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. NO ACTIVE FOLLOW-UP WILL BE PURSUED (CASE IDENTIFIED DURING HEALTH AUTHORITY WEBSITE MONITORING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640696 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other| R