BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6659681 · Received June 22, 2017

    Report

    Report Number
    2951250-2017-02254
    Event Type
    Injury
    Date Received
    June 22, 2017
    Report Date
    August 1, 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 SPONTANEOUS CASE WAS REPORTED BY A GYNECOLOGIST/OBSTETRICIAN AND DESCRIBES THE OCCURRENCE OF HYPOTHYROIDISM ("HYPOTHYROIDISM") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: NO PAST MEDICAL HISTORY AND NO GYNAECOLOGICAL CONCOMITANT DISEASE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED HYPOTHYROIDISM (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN EPISODES"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY AND OPERATIVE HYSTEROSCOPY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE HYPOTHYROIDISM AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HYPOTHYROIDISM TO BE RELATED TO ESSURE. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ARTHRALGIA WITH ESSURE. THE REPORTER COMMENTED: REMOVAL WAS PERFORMED AT THE PATIENT'S REQUEST AND DUE TO MEDICAL REASON (MEDICALLY NECESSARY) - HYPOTHYROIDISM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 19.7 KG/SQM. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDDRA PREFERRED TERM (PT). IN THIS PARTICULAR CASE A SEARCH IN THE GLOBAL SAFETY DATABASE WAS PERFORMED ON (B)(4) 2017 FOR THE FOLLOWING MEDDRA PT: HYPOTHYROIDISM: N° 6 (EXCLUDING THIS CASE). 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JUL-2017: LOT NUMBER PREVIOUSLY REPORTED C133149 IS INVALID. LOT NUMBER CHANGED TO UNKNOWN. INCIDENT: NO VALID LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A GYNECOLOGIST/OBSTETRICIAN AND DESCRIBES THE OCCURRENCE OF HYPOTHYROIDISM ("HYPOTHYROIDISM") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C133149) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: NO PAST MEDICAL HISTORY AND NO GYNAECOLOGICAL CONCOMITANT DISEASE. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2014, THE PATIENT EXPERIENCED HYPOTHYROIDISM (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN EPISODES"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY AND OPERATIVE HYSTEROSCOPY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE HYPOTHYROIDISM AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED HYPOTHYROIDISM TO BE RELATED TO ESSURE. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ARTHRALGIA WITH ESSURE. THE REPORTER COMMENTED: REMOVAL WAS PERFORMED AT THE PATIENT'S REQUEST AND DUE TO MEDICAL REASON (MEDICALLY NECESSARY) - HYPOTHYROIDISM. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 19.7 KG/SQM. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDDRA PREFERRED TERM (PT). IN THIS PARTICULAR CASE A SEARCH IN THE GLOBAL SAFETY DATABASE WAS PERFORMED ON (B)(6) 2017 FOR THE FOLLOWING MEDDRA PT: HYPOTHYROIDISM: N° 6 (EXCLUDING THIS CASE). 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: GYNECOLOGIST ANSWERED QUERIES: PATIENT (WEIGHT (B)(6), HEIGHT 167CM) HAD NO PAST MEDICAL HISTORY AND NO GYNAECOLOGICAL CONCOMITANT DISEASE. ESSURE (LOT# C133149) INSERTED ON (B)(6) 2014, REMOVED ON (B)(6) 2017. REMOVAL (METHOD: SALPINGECTOMY AND OPERATIVE HYSTEROSCOPY) WAS PERFORMED AT THE PATIENT'S REQUEST AND DUE TO MEDICAL REASON (MEDICALLY NECESSARY). PRIMARY REASON FOR REMOVAL: ADVERSE EVENT SPECIFIED AS HYPOTHYROIDISM (STARTED IN 2014). NO OTHER NEW MEDICAL INFORMATION WAS PROVIDED AND IS EXPECTED. COMPANY CAUSALITY COMMENT: 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 IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A GYNECOLOGIST/OBSTETRICIAN AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("DEVICE REMOVAL") IN A (B)(6)-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2017, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED HYPOTHYROIDISM ("HYPOTHYROIDISM") AND ARTHRALGIA ("JOINT PAIN EPISODES"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED IN (B)(6) 2017. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL, HYPOTHYROIDISM AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ARTHRALGIA, HYPOTHYROIDISM AND MEDICAL DEVICE REMOVAL WITH ESSURE. THE LIST OF DEVICE SIMILAR INCIDENTS 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 (B)(6) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: MEDICAL DEVICE REMOVAL. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(6) 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: INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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
    441490 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 C133149

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R