Description of Event or Problem · 1
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ANSM - HEALTH AUTHORITIES IN (B)(4)(REFERENCE NUMBER: (B)(4)) ON 22-SEP-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN"), ASTHMA ("ASTHMA ATTACKS"), PRESYNCOPE ("NUMEROUS EPISODES OF VAGAL MALAISE"), ARRHYTHMIA ("CARDIAC ARRHYTHMIA"), URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS WITH AND WITHOUT HIGH FEVERS") AND DEVICE BREAKAGE ("FRAGMENTS REMAINED") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 26 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ASTHMA (SERIOUSNESS CRITERION HOSPITALIZATION), MYALGIA ("MUSCLE PAIN"), ARTHRALGIA ("JOINT PAIN (HIPS, ELBOWS, CERVICAL SPINE)"), HYPERSENSITIVITY ("ALLERGIC REACTIONS"), ECZEMA ("ECZEMA"), ALOPECIA ("HAIR FALLING OUT"), FATIGUE ("EXTREME FATIGUE"), PRESYNCOPE (SERIOUSNESS CRITERION HOSPITALIZATION), ARRHYTHMIA (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VITREOUS FLOATERS ("FLOATERS"), VISION BLURRED ("BLURRY VISION"), BLADDER PAIN ("BLADDER PAIN"), URINARY TRACT INFECTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PYREXIA ("URINARY TRACT INFECTIONS WITH AND WITHOUT HIGH FEVERS"), HEADACHE ("HEADACHES"), GENITAL INFECTION FUNGAL ("RECURRENT GENITAL MYCOSES") AND MENORRHAGIA ("HEMORRHAGIC MENSTRUAL BLEEDING"). ON (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND COMPLICATION OF DEVICE REMOVAL ("FRAGMENTS REMAINED"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PUDENDAL CANAL SYNDROME ("PUDENDAL NEURALGIA WITH CLEAR AGGRAVATION OF PRE-EXISTING PATHOLOGY") AND ALLERGY TO METALS ("SEVERE NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY FOR ESSURE IMPLANT REMOVAL WAS PERFORMED ON (B)(6) 2017) AND SURGERY (HYSTERECTOMY PERFORMED ON (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ASTHMA, MYALGIA, ARTHRALGIA, HYPERSENSITIVITY, ECZEMA, ALOPECIA, FATIGUE, PRESYNCOPE, ARRHYTHMIA, VITREOUS FLOATERS, VISION BLURRED, BLADDER PAIN, URINARY TRACT INFECTION, PYREXIA, HEADACHE, GENITAL INFECTION FUNGAL, MENORRHAGIA, DEVICE BREAKAGE, COMPLICATION OF DEVICE REMOVAL AND ALLERGY TO METALS OUTCOME WAS UNKNOWN AND THE PUDENDAL CANAL SYNDROME HAD NOT RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ALLERGY TO METALS, ALOPECIA, ARRHYTHMIA, ARTHRALGIA, ASTHMA, BLADDER PAIN, COMPLICATION OF DEVICE REMOVAL, DEVICE BREAKAGE, ECZEMA, FATIGUE, GENITAL INFECTION FUNGAL, HEADACHE, HYPERSENSITIVITY, MENORRHAGIA, MYALGIA, PELVIC PAIN, PRESYNCOPE, PUDENDAL CANAL SYNDROME, PYREXIA, URINARY TRACT INFECTION, VISION BLURRED AND VITREOUS FLOATERS WITH ESSURE. THE REPORTER COMMENTED: ORTHOPEDIC, PAIN, GYNECOLOGICAL, ALLERGIST AND NUMEROUS GP CONSULTS WERE PERFORMED. HOSPITALIZATIONS/VISIT TO EMERGENCY DEPARTMENT AND REHABILITATION STAY WERE ALSO REPORTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE (B)(6). ON AN UNSPECIFIED DATE - X-RAY, CT SCAN, MRI, BLOOD TESTS, DERMATOLOGY MYCOSIS CULTURE, ALLERGY TESTING, ETC., WERE PERFORMED. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. 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) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: PELVIC PAIN- THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) CASES. DEVICE BREAKAGE- THE 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 THIS MEDDRA PT. COMPANY CAUSALITY 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.