BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5950581 · Received September 14, 2016

    Report

    Report Number
    2951250-2016-01937
    Event Type
    Injury
    Date Received
    September 14, 2016
    Report Date
    October 18, 2016
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY-SAFETY EVALUATION OF PTC RECEIVED ON 19-SEP-2016: THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS (B)(4). NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. 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, ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. FOLLOW-UP RECEIVED ON 05-OCT-2016 FOLLOW-UP ATTEMPTS WERE DONE BUT NO ANSWER WAS RECEIVED. 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 05-OCT-2016 FOR THE FOLLOWING MEDDRA PREFERRED TERM: PELVIC PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 1701 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 THIS MEDDRA PT. COMPANY CAUSALITY COMMENT: THIS CASE REPORT DERIVED FROM MEDICAL LITERATURE REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND REQUIRED HYSTERECTOMY DUE TO PELVIC PAIN. THIS EVENT IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PELVIC PAIN IS HIGHLY PREVALENT IN WOMEN, AND MAY HAVE GYNAECOLOGICAL AND NON-GYNAECOLOGICAL CAUSES. IN THE PRESENT CASE, LIMITED INFORMATION WAS PROVIDED. PATIENT'S MEDICAL HISTORY AND CONCOMITANT CONDITIONS WERE NOT MENTIONED. THE EXACT TEMPORAL RELATIONSHIP BETWEEN ESSURE INSERTION AND EVENT ONSET WAS NOT PROVIDED. DESPITE THE LIMITED INFORMATION, GIVEN THE NATURE OF THE REPORTED EVENT AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE SURGICAL INTERVENTION WAS REQUIRED. NO SAMPLE AVAILABLE FOR THIS INVESTIGATION AND NO VALID LOT NUMBER. THEREFORE, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION COULD NOT BE OBTAINED, DESPITE FOLLOW-UP ATTEMPTS.

    Description of Event or Problem · 1

    THIS CASE REPORT FROM (B)(6) WAS DERIVED FROM THE MEDICAL LITERATURE ON 17-AUG-2016, ARTICLE ENTITLED ESSURE: ISN'T IT TIME FOR SOME REASSURANCE?. IT REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED FOR HYSTEROSCOPIC STERILISATION. THIS PATIENT REQUIRED HYSTERECTOMY DUE TO PELVIC PAIN. INTRODUCTION: HYSTEROSCOPIC STERILISATION (ESSURE) HAS BEEN IN THE SPOTLIGHT DUE TO CONCERNS ABOUT ALLERGIC REACTIONS AND REPORTS THAT WOMEN ARE MORE LIKELY TO NEED A LATER OPERATION THAN IF THEY HAD UNDERGONE LAPAROSCOPIC STERILISATION. WE REPORT OUR EXPERIENCE WITH A SERIES OF 350 WOMEN. OBJECTIVES: SERVICE REVIEW OF HYSTEROSCOPIC STERILISATION. CONCLUSION: HYSTEROSCOPIC STERILISATION IS SAFE AND EFFECTIVE WITH 95% WOMEN REPORTING NO COMPLICATIONS. ALLERGIC REACTION AND INCREASED RISK OF ADDITIONAL SURGICAL PROCEDURES WERE RARELY ENCOUNTERED. PATIENTS MUST BE GIVEN WRITTEN INFORMATION REGARDING THE USE OF ADDITIONAL CONTRACEPTION TILL CONFIRMATORY IMAGING. CURRENT EVIDENCE ON THE SAFETY AND EFFICACY OF HYSTEROSCOPIC STERILISATION SUPPORTS ITS ONGOING USE. OUR OBSERVATIONS CONFIRM THIS AND HIGHLIGHT THE IMPORTANCE OF ENSURING ARRANGEMENTS ARE IN PLACE FOR CLINICAL GOVERNANCE AND AUDIT. OTHER RELATED CASES FROM THE SAME ARTICLE: 2016-160758, 2016-160775, 2016-160776, 2016-160777. FOLLOW-UP RECEIVED ON 23-AUG-2016. NCA NUMBER: (B)(4). COMPANY CAUSALITY COMMENT: THIS CASE REPORT DERIVED FROM MEDICAL LITERATURE REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND REQUIRED HYSTERECTOMY DUE TO PELVIC PAIN. THIS EVENT IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. PELVIC PAIN IS HIGHLY PREVALENT IN WOMEN, AND MAY HAVE GYNAECOLOGICAL AND NON-GYNAECOLOGICAL CAUSES. IN THE PRESENT CASE, LIMITED INFORMATION WAS PROVIDED. PATIENT'S MEDICAL HISTORY AND CONCOMITANT CONDITIONS WERE NOT MENTIONED. THE EXACT TEMPORAL RELATIONSHIP BETWEEN ESSURE INSERTION AND EVENT ONSET WAS NOT PROVIDED. DESPITE THE LIMITED INFORMATION, GIVEN THE NATURE OF THE REPORTED EVENT AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE SURGICAL INTERVENTION WAS REQUIRED. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600591 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER HEALTHCARE LLC ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R