BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6568570 · Received May 16, 2017

    Report

    Report Number
    2951250-2017-01932
    Event Type
    Injury
    Date Received
    May 16, 2017
    Report Date
    June 20, 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

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (B)(6) - HEATH AUTHORITIES IN FRANCE (REFERENCE NUMBER: (B)(4)) ON (B)(6) 2017. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2017. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("LONG HAEMORRHAGIC MENSTRUAL PERIODS") IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 623816) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION") WITH FATIGUE, DISTURBANCE IN ATTENTION, APHASIA, COGNITIVE DISORDER AND AMNESIA, DYSMENORRHOEA ("PAINFUL MENSTRUAL PERIODS"), OVULATION PAIN ("PAIN DURING OVULATION"), VISUAL IMPAIRMENT ("RAPID REDUCTION IN VISION / OPHTHALMOLOGICAL FOLLOW-UP WITH FREQUENT CHANGES IN CORRECTIVE LENSES") AND MALAISE ("FEELING UNWELL, ACCENTUATED AT TIME OF MENSTRUAL PERIOD AND WEEK BEFORE"). THE PATIENT WAS TREATED WITH HORMONES NOS, LEVONORGESTREL (MIRENA), ANTIDEPRESSANTS AND SURGERY (NOVASURE ENDOMETRIAL ABLATION AND SALPINGECTOMY PERFORMED ON (B)(6) 2017). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MENORRHAGIA, DEPRESSION, DYSMENORRHOEA, OVULATION PAIN, VISUAL IMPAIRMENT AND MALAISE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEPRESSION, DYSMENORRHOEA, MALAISE, MENORRHAGIA, OVULATION PAIN AND VISUAL IMPAIRMENT TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: ON AN UNSPECIFIED DATE THE MIRENA IUD WAS INSERTED AS TREATMENT FOR MENORRHAGIA, WITH NO EFFECT (CASE (B)(4) WAS CREATED FOR MIRENA). DIAGNOSTIC RESULTS: ON AN UNSPECIFIED DATE BRAIN MRI (NUCLEAR MAGNETIC RESONANCE IMAGING) WAS PERFORMED. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: MENORRHAGIA. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 400 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. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-JUN-2017: QUALITY SAFETY EVALUATION OF PTC. ESSURE MODEL UPDATED. COMPANY CAUSALITY COMMENT. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (B)(4) ON 28-APR-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("LONG HAEMORRHAGIC MENSTRUAL PERIODS") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 623816) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2007, THE PATIENT HAD ESSURE INSERTED. IN 2007, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION") WITH FATIGUE, DISTURBANCE IN ATTENTION, APHASIA, COGNITIVE DISORDER AND AMNESIA, DYSMENORRHOEA ("PAINFUL MENSTRUAL PERIODS"), OVULATION PAIN ("PAIN DURING OVULATION"), VISUAL IMPAIRMENT ("RAPID REDUCTION IN VISION / OPHTHALMOLOGICAL FOLLOW-UP WITH FREQUENT CHANGES IN CORRECTIVE LENSES") AND MALAISE ("FEELING UNWELL, ACCENTUATED AT TIME OF MENSTRUAL PERIOD AND WEEK BEFORE"). THE PATIENT WAS TREATED WITH HORMONES NOS, LEVONORGESTREL (MIRENA), ANTIDEPRESSANTS AND SURGERY (NOVASURE ENDOMETRIAL ABLATION AND SALPINGECTOMY PERFORMED ON (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MENORRHAGIA, DEPRESSION, DYSMENORRHOEA, OVULATION PAIN, VISUAL IMPAIRMENT AND MALAISE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEPRESSION, DYSMENORRHOEA, MALAISE, MENORRHAGIA, OVULATION PAIN AND VISUAL IMPAIRMENT TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON AN UNSPECIFIED DATE THE MIRENA IUD WAS INSERTED AS TREATMENT FOR MENORRHAGIA, WITH NO EFFECT (CASE (B)(4) WAS CREATED FOR MIRENA) DIAGNOSTIC RESULTS: ON AN UNSPECIFIED DATE BRAIN MRI (NUCLEAR MAGNETIC RESONANCE IMAGING) WAS PERFORMED. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED CASE REPORT RECEIVED FROM THE REGULATORY AUTHORITY REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED LONG HAEMORRHAGIC MENSTRUAL PERIODS AMONGST OTHER NON-SERIOUS EVENTS. SHE UNDERWENT A NOVASURE ENDOMETRIAL ABLATION AND SALPINGECTOMY FOR ESSURE REMOVAL 10 YEARS AFTER INSERTION. THE EVENT IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. AFTER ESSURE INSERTION ABNORMAL GENITAL BLEEDING AND MENSES PATTERN CHANGES MAY OCCUR. IN THIS CASE, ALTHOUGH THERE IS NO INFORMATION ABOUT THE CONSUMER'S HISTORICAL AND CONCOMITANT MEDICAL CONDITIONS, THE EVENT WAS REPORTED TO START AFTER ESSURE INSERTION. CONSIDERING THE NATURE OF THE EVENT, THE TEMPORAL RELATIONSHIP AND LACK OF ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED (RELATED). THIS CASE WAS REGARDED AS INCIDENT AS A DEVICE REMOVAL WAS REQUIRED. NO FURTHER INFORMATION IS EXPECTED SINCE THE FRENCH HEALTH AUTHORITIES DO NOT ALLOW ACTIVE FOLLOW-UP. A PRODUCT TECHNICAL ANALYSIS IS AWAITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351731 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS205 623816

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R