BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5574285 · Received April 13, 2016

    Report

    Report Number
    2951250-2016-00272
    Event Type
    Injury
    Date Received
    April 13, 2016
    Report Date
    January 23, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION BASED ON INFORMATION RECEIVED ON 10-FEB-2016: AFTER A COMPANY INTERNAL REVIEW THE FOLLOWING INFORMATION WAS ADDED (FROM INITIAL REPORT): CONSUMER'S SYMPTOMS IMPROVED BUT SOME FRAGMENTS STILL REMAINED AND SYMPTOMS CONTINUE. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD GENERALIZED PAIN AND HEMORRHAGIC PERIODS WITH CLOTS AFTER ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION. ESSURE WAS REMOVED BY LAPAROSCOPY (APPROXIMATELY 4.5 YEARS AFTER ITS INSERTION). ACCORDING TO THE CONSUMER, SOME FRAGMENTS STILL REMAINED (EVENT REGARDED AS A POSSIBLE ESSURE DEVICE BREAKAGE) AND HER SYMPTOMS CONTINUED. THE REPORTED EVENTS ARE LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE, EXCEPT FOR DEVICE BREAKAGE WHICH IS UNLISTED. AFTER ESSURE INSERTION, ABNORMAL GENITAL BLEEDING, MENSES PATTERN CHANGES AND ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR. IN THIS CASE, LIMITED INFORMATION WAS PROVIDED. NEVERTHELESS, CONSIDERING EVENTS' NATURE AND IN THE LACK OF ALTERNATIVE EXPLANATIONS, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. REGARDING THE POSSIBLE DEVICE BREAKAGE, ALTHOUGH ITS EXACT MECHANISM WAS NOT REPORTED (IF IT OCCURRED IN ASSOCIATION WITH ESSURE REMOVAL); BASED ON EVENT'S NATURE AND ON ESSURE SAFETY PROFILE, CAUSALITY CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS AND FOLLOW-UP INFORMATION ARE BEING SOUGHT.

    Additional Manufacturer Narrative · 1

    QUALITY-SAFETY EVALUATION OF PTC RECEIVED ON 06-MAY-2016: PTC GLOBAL NUMBER: (B)(4). LOT NUMBER: 645013. MANUFACTURING DATE: MAY-2009; EXPIRATION DATE: MAY-2012. FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. IN THIS CASE, NO PRODUCT WAS RETURNED. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. 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. BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT. FOLLOW UP 06-MAY-2016: DUPLICATE QUALITY-SAFETY EVALUATION OF PTC WAS RECEIVED. NO CHANGES. DEVICE SIMILAR CASE LISTING THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 09-MAY-2016 FOR THE FOLLOWING MEDDRA PREFERRED TERMS: PAIN: THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) CASES; DEVICE BREAKAGE: THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THESE MEDDRA PT. COMPANY CAUSALITY COMMENT THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD GENERALIZED PAIN AND HEMORRHAGIC PERIODS WITH CLOTS AFTER ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION. ESSURE WAS REMOVED BY LAPAROSCOPY (APPROXIMATELLY 4.5 YEARS AFTER ITS INSERTION). ACCORDING TO THE CONSUMER, SOME FRAGMENTS STILL REMAINED (EVENT REGARDED AS A POSSIBLE ESSURE DEVICE BREAKAGE) AND HER SYMPTOMS CONTINUED. THE REPORTED EVENTS ARE LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE, EXCEPT FOR DEVICE BREAKAGE WHICH IS UNLISTED. AFTER ESSURE INSERTION, ABNORMAL GENITAL BLEEDING, MENSES PATTERN CHANGES AND ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR. IN THIS CASE, LIMITED INFORMATION WAS PROVIDED. NEVERTHELESS, CONSIDERING EVENTS' NATURE AND IN THE LACK OF ALTERNATIVE EXPLANATIONS, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. REGARDING THE POSSIBLE DEVICE BREAKAGE, ALTHOUGH ITS EXACT MECHANISM WAS NOT REPORTED (IF IT OCCURRED IN ASSOCIATION WITH ESSURE REMOVAL); BASED ON EVENT'S NATURE AND ON ESSURE SAFETY PROFILE, CAUSALITY CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED AND THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A (B)(6) FEMALE CONSUMER VIA REGULATORY AUTHORITY (CASE# (B)(4)) IN (B)(6) ON (B)(6) 2016. IT REFERS TO HERSELF, WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2011, WITH LOT NUMBER 645013. THE CONSUMER EXPERIENCED GENERALIZED PAIN, HEMORRHAGIC PERIODS WITH CLOTS, LUMBAR PAIN, ITCHING, HEADACHE, NAUSEA, DIZZINESS, AND DIARRHEA. ESSURE WAS REMOVED BY LAPAROSCOPY ON (B)(6) 2015. THE SYMPTOMS GET BETTER BUT SOME OF THEM KEEP IT. ALL EVENTS WERE CONSIDERED RELATED TO ESSURE. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD GENERALIZED PAIN AND HEMORRHAGIC PERIODS WITH CLOTS AFTER ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION. ESSURE WAS REMOVED BY LAPAROSCOPY (APPROXIMATELY 4.5 YEARS AFTER ITS INSERTION). THE REPORTED EVENTS ARE LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. AFTER ESSURE INSERTION, ABNORMAL GENITAL BLEEDING, MENSES PATTERN CHANGES AND ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR. IN THIS CASE, LIMITED INFORMATION WAS PROVIDED. NEVERTHELESS, CONSIDERING EVENTS NATURE AND IN THE LACK OF ALTERNATIVE EXPLANATIONS, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT, SINCE DEVICE REMOVAL WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS AND FOLLOW-UP INFORMATION ARE BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230537 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 645013

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R