BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7689559 · Received July 16, 2018

    Report

    Report Number
    2951250-2018-03092
    Event Type
    Injury
    Date Received
    July 16, 2018
    Date of Event
    July 24, 2012
    Report Date
    August 16, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4)) ON 13-JUL-2018. THE MOST RECENT INFORMATION WAS RECEIVED ON 15-AUG-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DYSMENORRHOEA ("PELVIC PAIN UNBEARABLE DURING MRENSTRUAL PERIODS") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945070) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HAEMORRHAGIC MENSTRUAL PERIODS"), FATIGUE ("IMPORTANT FATIGUE"), DIZZINESS ("DIZZINESS"), VISUAL IMPAIRMENT ("VISUAL DISORDER"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), IRRITABILITY ("IRRITABILITY"), MYALGIA ("MUSCLE PAIN"), ARTHRALGIA ("JOINT PAIN"), ARTHROPATHY ("ARTHROPATHY") AND CHONDROPATHY ("CHONDROPATHY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE WAS TO BE REMOVED ON (B)(6) 2018.). AT THE TIME OF THE REPORT, THE DYSMENORRHOEA, MENORRHAGIA, FATIGUE, DIZZINESS, VISUAL IMPAIRMENT, HYPERSENSITIVITY, IRRITABILITY, MYALGIA, ARTHRALGIA, ARTHROPATHY AND CHONDROPATHY OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ARTHRALGIA, ARTHROPATHY, CHONDROPATHY, DIZZINESS, DYSMENORRHOEA, FATIGUE, HYPERSENSITIVITY, IRRITABILITY, MENORRHAGIA, MYALGIA AND VISUAL IMPAIRMENT WITH ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. FURTHER COMPANY FOLLOW-UP WITH THE CONSUMER OR REGULATORY AUTHORITY IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-AUG-2018: QUALITY SAFETY EVALUATION OF PTC ALSO BATCH INFORMATION (EXPIRATION AND MANUFACTURING DATES) ADDED. 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

    E WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (B)(6) ON 13-JUL-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DYSMENORRHOEA ("PELVIC PAIN UNBEARABLE DURING MENSTRUAL PERIODS") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 945070) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HAEMORRHAGIC MENSTRUAL PERIODS"), FATIGUE ("IMPORTANT FATIGUE"), DIZZINESS ("DIZZINESS"), VISUAL IMPAIRMENT ("VISUAL DISORDER"), HYPERSENSITIVITY ("HYPERSENSITIVITY"), IRRITABILITY ("IRRITABILITY"), MYALGIA ("MUSCLE PAIN"), ARTHRALGIA ("JOINT PAIN"), ARTHROPATHY ("ARTHROPATHY") AND CHONDROPATHY ("CHONDROPATHY"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE WAS TO BE REMOVED ON (B)(6) 2018.). AT THE TIME OF THE REPORT, THE DYSMENORRHOEA, MENORRHAGIA, FATIGUE, DIZZINESS, VISUAL IMPAIRMENT, HYPERSENSITIVITY, IRRITABILITY, MYALGIA, ARTHRALGIA, ARTHROPATHY AND CHONDROPATHY OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ARTHRALGIA, ARTHROPATHY, CHONDROPATHY, DIZZINESS, DYSMENORRHOEA, FATIGUE, HYPERSENSITIVITY, IRRITABILITY, MENORRHAGIA, MYALGIA AND VISUAL IMPAIRMENT WITH ESSURE. 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 16-JUL-2018 FOR THE FOLLOWING MEDDRA PREFERRED TERM: DYSMENORRHOEA: THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 314 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 CONSUMER OR REGULATORY AUTHORITY IS NOT POSSIBLE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534293 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 945070 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R