Description of Event or Problem · 1
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ) ON (B)(6) 2018. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("HIGH PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2006, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2006, 12 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), TENDONITIS ("SPONTANEOUS TENDONITIS ON ARMS AND ACHILLES TENDON"), MYALGIA ("MUSCULAR PAIN"), THE FIRST EPISODE OF ARTHRALGIA ("JOINT PAIN"), FATIGUE ("PERMANENT TIREDNESS"), WEIGHT INCREASED ("WEIGHT GAIN"), CARDIOVASCULAR DISORDER ("CIRCULATORY WEAKNESS"), PERIPHERAL COLDNESS ("COLD HAND AND RIGHT ARM"), OEDEMA PERIPHERAL ("ANKLES EDEMA"), FORMICATION ("FORMICATION IN HANDS"), TOOTHACHE, AMNESIA ("LOSS OF MEMORY"), VISUAL IMPAIRMENT, NAIL PSORIASIS ("NAIL PSORIASIS"), LOSS OF LIBIDO ("LOSS OF LIBIDO"), THE SECOND EPISODE OF ARTHRALGIA ("PELVIS AND HIP PAIN"), SYNCOPE ("REFLEX SYNCOPE") AND GENERAL PHYSICAL HEALTH DETERIORATION ("MEDIOCRE GENERAL STATE"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, TENDONITIS, MYALGIA, FATIGUE, WEIGHT INCREASED, CARDIOVASCULAR DISORDER, PERIPHERAL COLDNESS, OEDEMA PERIPHERAL, FORMICATION, AMNESIA, NAIL PSORIASIS, LOSS OF LIBIDO, THE LAST EPISODE OF ARTHRALGIA, SYNCOPE AND GENERAL PHYSICAL HEALTH DETERIORATION OUTCOME WAS UNKNOWN AND THE TOOTHACHE AND VISUAL IMPAIRMENT OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR AMNESIA, CARDIOVASCULAR DISORDER, FATIGUE, FORMICATION, GENERAL PHYSICAL HEALTH DETERIORATION, LOSS OF LIBIDO, MYALGIA, NAIL PSORIASIS, OEDEMA PERIPHERAL, PELVIC PAIN, PERIPHERAL COLDNESS, SYNCOPE, TENDONITIS, TOOTHACHE, VISUAL IMPAIRMENT, WEIGHT INCREASED, THE FIRST EPISODE OF ARTHRALGIA AND THE SECOND EPISODE OF ARTHRALGIA WITH ESSURE. THE REPORTER COMMENTED: ACTUAL STATE OF THE PATIENT: ESSURE WAS REMOVED WITH BILATERAL SALPINGECTOMY. NO FURTHER INFORMATION WAS EXPECTED. THE LIST OF SIMILAR CASES 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) 2018 FOR THE FOLLOWING MEDDRA PREFERRED TERM: PELVIC PAIN ¿ ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) 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 THESE MEDDRA PT. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. 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.