BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6827565 · Received August 29, 2017

    Report

    Report Number
    2951250-2017-03215
    Event Type
    Injury
    Date Received
    August 29, 2017
    Date of Event
    April 6, 2017
    Report Date
    September 21, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 09-AUG-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A GYNECOLOGIST AND DESCRIBES THE OCCURRENCE OF PELVIC DISCOMFORT ("PELVIC SYMPTOMS, I.E. HEAVINESS") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841395) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, THE PATIENT EXPERIENCED PELVIC DISCOMFORT (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEPRESSION ("DEPRESSION"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY UNDER GENERAL ANAESTHESIA FOR BILATERAL SALPINGECTOMY AND REMOVAL OF ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC DISCOMFORT AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEPRESSION AND PELVIC DISCOMFORT 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 01-SEP-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: PELVIC DISCOMFORT. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 28 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. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-SEP-2017: QUALITY-SAFETY EVALUATION OF PTC. 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)(6) ON 09-AUG-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A GYNECOLOGIST/OBSTETRICIAN AND DESCRIBES THE OCCURRENCE OF PELVIC DISCOMFORT ("PELVIC SYMPTOMS, I.E. HEAVINESS") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841395) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, THE PATIENT EXPERIENCED PELVIC DISCOMFORT (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEPRESSION ("DEPRESSION"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY UNDER GENERAL ANAESTHESIA FOR BILATERAL SALPINGECTOMY AND REMOVAL OF ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC DISCOMFORT AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEPRESSION AND PELVIC DISCOMFORT 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 10-AUG-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: PELVIC DISCOMFORT. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 27 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. 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
    608380 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 841395

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R