Description of Event or Problem · 0
BAYER CASE NUMBER: (B)(4) PELVIC PAIN, [PELVIC PAIN FEMALE] , IMPLANTS STARTED TO MIGRATE [DEVICE MIGRATION] , DYSPAREUNIA [DYSPAREUNIA] , HEADACHES [HEADACHE] , TUBA ERECTA (FALLOPIAN TUBE RIGIDITY) [FALLOPIAN TUBE DISORDER] , JOINT PAIN AND MUSCLE PAIN, [ARTHROMYALGIA] , RECURRING TENDINITIS, [TENDINITIS] , RECURRING SCIATICA, [SCIATICA] , DIFFUSE PAIN THROUGHOUT THE BODY 24 HOURS A DAY/7 DAYS A WEEK [GENERAL BODY PAIN] , IMPAIRED MEMORY [MEMORY IMPAIRED], IMPAIRED CONCENTRATION [CONCENTRATION IMPAIRED] , GASTROINTESTINAL ISSUES (INTESTINAL AND LIVER PROBLEMS) [GASTROINTESTINAL DISORDER] , TINGLING [TINGLING] , SLEEP DISTURBANCE [SLEEP DISTURBANCE] , DIZZINESS [DIZZINESS] , NAUSEA [NAUSEA] , SIGMOIDITIS [SIGMOIDITIS] , BLOOD IN STOOL [BLOOD IN STOOL] , URINARY TRACT INFECTIONS [RECURRENT URINARY TRACT INFECTION] , PYELONEPHRITIS [PYELONEPHRITIS] , DEPRESSION [DEPRESSION] , MOOD SWINGS [MOOD SWINGS] , SUICIDAL THOUGHTS [SUICIDAL IDEATION] VISUAL IMPAIRMENT [VISUAL IMPAIRMENT] , WEAKENED TEETH [DISORDER TOOTH] , CHRONIC FATIGUE [CHRONIC FATIGUE] . CASE NARRATIVE: THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 15-APR-2026. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN,") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 855621) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2011, 65 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA"), ARTHRALGIA ("JOINT PAIN AND MUSCLE PAIN,"), TENDONITIS ("RECURRING TENDINITIS,"), SCIATICA ("RECURRING SCIATICA,"), PAIN ("DIFFUSE PAIN THROUGHOUT THE BODY 24 HOURS A DAY/7 DAYS A WEEK"), MEMORY IMPAIRMENT ("IMPAIRED MEMORY"), DISTURBANCE IN ATTENTION ("IMPAIRED CONCENTRATION"), GASTROINTESTINAL DISORDER ("GASTROINTESTINAL ISSUES (INTESTINAL AND LIVER PROBLEMS)"), PARAESTHESIA ("TINGLING"), SLEEP DISORDER ("SLEEP DISTURBANCE"), DIZZINESS ("DIZZINESS"), NAUSEA ("NAUSEA"), COLITIS ("SIGMOIDITIS"), HAEMATOCHEZIA ("BLOOD IN STOOL"), FALLOPIAN TUBE DISORDER ("TUBA ERECTA (FALLOPIAN TUBE RIGIDITY)"), DEVICE DISLOCATION ("IMPLANTS STARTED TO MIGRATE"), URINARY TRACT INFECTION ("URINARY TRACT INFECTIONS"), PYELONEPHRITIS ("PYELONEPHRITIS"), DEPRESSION ("DEPRESSION"), MOOD SWINGS ("MOOD SWINGS"), SUICIDAL IDEATION ("SUICIDAL THOUGHTS"), VISUAL IMPAIRMENT ("VISUAL IMPAIRMENT"), HEADACHE ("HEADACHES"), TOOTH DISORDER ("WEAKENED TEETH") AND FATIGUE ("CHRONIC FATIGUE"). ESSURE WAS REMOVED ON (B)(6) 2019. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). AT THE TIME OF THE REPORT, THE ARTHRALGIA, TENDONITIS, SCIATICA, PAIN, MEMORY IMPAIRMENT, DISTURBANCE IN ATTENTION, GASTROINTESTINAL DISORDER, DEPRESSION AND FATIGUE HAD NOT RESOLVED. THE OUTCOMES FOR PELVIC PAIN, DYSPAREUNIA, PARAESTHESIA, SLEEP DISORDER, DIZZINESS, NAUSEA, COLITIS, HAEMATOCHEZIA, FALLOPIAN TUBE DISORDER, DEVICE DISLOCATION, URINARY TRACT INFECTION, PYELONEPHRITIS, MOOD SWINGS, SUICIDAL IDEATION, VISUAL IMPAIRMENT, HEADACHE AND TOOTH DISORDER WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO PELVIC PAIN, PAIN, MEMORY IMPAIRMENT, DISTURBANCE IN ATTENTION, GASTROINTESTINAL DISORDER, DIZZINESS, NAUSEA, DYSPAREUNIA, ARTHRALGIA, TENDONITIS, SCIATICA, PARAESTHESIA, SLEEP DISORDER, COLITIS, HAEMATOCHEZIA, FALLOPIAN TUBE DISORDER, DEVICE DISLOCATION, URINARY TRACT INFECTION, MOOD SWINGS, PYELONEPHRITIS, DEPRESSION, SUICIDAL IDEATION, HEADACHE, TOOTH DISORDER, VISUAL IMPAIRMENT OR FATIGUE. THE REPORTER COMMENTED: IN GREAT SHAPE BEFORE THE ESSURE IMPLANTS, LIFE NOW IN PIECES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 48 KG. CASE COMMENTS: A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAIN RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.