BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6797037 · Received August 16, 2017

    Report

    Report Number
    2951250-2017-02946
    Event Type
    Injury
    Date Received
    August 16, 2017
    Report Date
    September 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 ANSM (REFERENCE NUMBER: (B)(4)) ON 01-AUG-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 29-AUG-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IUD"), DEAFNESS ("HEARING LOSS") AND PERITONITIS ("APPENDICULAR PERITONITIS") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910516) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEAFNESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PERITONITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENERAL PHYSICAL HEALTH DETERIORATION ("DETERIORATION OF GENERAL HEALTH STATUS"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), MEMORY IMPAIRMENT ("MEMORY DISTURBANCES"), VISION BLURRED ("BLURRED VISION"), VISUAL IMPAIRMENT ("HALF OF VISUAL FIELD DARK"), THE FIRST EPISODE OF FEELING ABNORMAL ("STRANGE FEELING OF WARM WATER"), TINNITUS ("TINNITUS"), DIZZINESS ("DIZZINESS"), BACK PAIN ("LUMBAR PAIN / BACK ACHE"), NECK PAIN ("CERVICAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), MIGRAINE ("MIGRAINE/HEADACHES"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL REACTION"), FATIGUE ("FATIGUE") AND THE SECOND EPISODE OF FEELING ABNORMAL ("FOG"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEAFNESS, PERITONITIS, GENERAL PHYSICAL HEALTH DETERIORATION, DEPRESSION, ANXIETY, MEMORY IMPAIRMENT, VISION BLURRED, VISUAL IMPAIRMENT, BACK PAIN, NECK PAIN, ABDOMINAL PAIN LOWER, MIGRAINE AND GASTROINTESTINAL DISORDER OUTCOME WAS UNKNOWN, THE TINNITUS, FATIGUE AND THE LAST EPISODE OF FEELING ABNORMAL WAS RESOLVING AND THE DIZZINESS HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, DEAFNESS, DEPRESSION, DEVICE DISLOCATION, DIZZINESS, FATIGUE, GASTROINTESTINAL DISORDER, GENERAL PHYSICAL HEALTH DETERIORATION, MEMORY IMPAIRMENT, MIGRAINE, NECK PAIN, PERITONITIS, TINNITUS, VISION BLURRED, VISUAL IMPAIRMENT, THE FIRST EPISODE OF FEELING ABNORMAL AND THE SECOND EPISODE OF FEELING ABNORMAL WITH ESSURE. THE REPORTER COMMENTED: IN 2012, I HAD ASKED WHETHER MY SYMPTOMS COULD POSSIBLY COME FROM THE INSERTS AND WAS TOLD THAT THERE WAS NO CORRELATION AND THAT REMOVAL WAS NOT POSSIBLE SINCE IT WAS AN IRREVERSIBLE METHOD. DIAGNOSTIC RESULTS: ALLERGY TESTS ONGOING. DELAYED ALLERGY TO NICKEL TO BE CONFIRMED IN (B)(6). 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. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: DEVICE DISLOCATION. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 1.349 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 29-AUG-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 ANSM (REFERENCE NUMBER: (B)(4)) ON 01-AUG-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IUD"), DEAFNESS ("HEARING LOSS") AND PERITONITIS ("APPENDICULAR PERITONITIS") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910516) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEAFNESS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PERITONITIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENERAL PHYSICAL HEALTH DETERIORATION ("DETERIORATION OF GENERAL HEALTH STATUS"), DEPRESSION ("DEPRESSION"), ANXIETY ("ANXIETY"), MEMORY IMPAIRMENT ("MEMORY DISTURBANCES"), VISION BLURRED ("BLURRED VISION"), VISUAL IMPAIRMENT ("HALF OF VISUAL FIELD DARK"), THE FIRST EPISODE OF FEELING ABNORMAL ("STRANGE FEELING OF WARM WATER"), TINNITUS ("TINNITUS"), DIZZINESS ("DIZZINESS"), BACK PAIN ("LUMBAR PAIN / BACK ACHE"), NECK PAIN ("CERVICAL PAIN"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), MIGRAINE ("MIGRAINE/HEADACHES"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL REACTION"), FATIGUE ("FATIGUE") AND THE SECOND EPISODE OF FEELING ABNORMAL ("FOG"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEAFNESS, PERITONITIS, GENERAL PHYSICAL HEALTH DETERIORATION, DEPRESSION, ANXIETY, MEMORY IMPAIRMENT, VISION BLURRED, VISUAL IMPAIRMENT, BACK PAIN, NECK PAIN, ABDOMINAL PAIN LOWER, MIGRAINE AND GASTROINTESTINAL DISORDER OUTCOME WAS UNKNOWN, THE TINNITUS, FATIGUE AND THE LAST EPISODE OF FEELING ABNORMAL WAS RESOLVING AND THE DIZZINESS HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN LOWER, ANXIETY, BACK PAIN, DEAFNESS, DEPRESSION, DEVICE DISLOCATION, DIZZINESS, FATIGUE, GASTROINTESTINAL DISORDER, GENERAL PHYSICAL HEALTH DETERIORATION, MEMORY IMPAIRMENT, MIGRAINE, NECK PAIN, PERITONITIS, TINNITUS, VISION BLURRED, VISUAL IMPAIRMENT, THE FIRST EPISODE OF FEELING ABNORMAL AND THE SECOND EPISODE OF FEELING ABNORMAL WITH ESSURE. THE REPORTER COMMENTED: IN 2012, I HAD ASKED WHETHER MY SYMPTOMS COULD POSSIBLY COME FROM THE INSERTS AND WAS TOLD THAT THERE WAS NO CORRELATION AND THAT REMOVAL WAS NOT POSSIBLE SINCE IT WAS AN IRREVERSIBLE METHOD. DIAGNOSTIC RESULTS: ALLERGY TESTS ONGOING. DELAYED ALLERGY TO NICKEL TO BE CONFIRMED IN SEPTEMBER. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. 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. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 03-AUG-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: DEVICE DISLOCATION. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 1.272 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
    577204 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 910516

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other| R