Description of Event or Problem · 1
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (B)(6) ON 22-FEB-2018. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF ABDOMINAL PAIN ("BELLYACHE"), GENITAL HAEMORRHAGE ("HEMORRHAGIC BLEEDINGS") AND ADENOMYOSIS ("ADENOMYOSIS") IN A FEMALE PATIENT WHO HAD ESSURE 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 ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("PAIN IN LOWER BACK"), PRURITUS ("INTERNAL ITCHING ON TUBES ZONE"), MIGRAINE ("MIGRAINE"), PAIN IN EXTREMITY ("LEG PAIN"), ARTHRALGIA ("RIGHT WRIST PAIN AND LEFT ELBOW PAIN"), DYSPNOEA ("SIGNIFICANT BREATHLESSNESS"), PALPITATIONS ("PALPITATIONS"), AMNESIA ("LOSS OF MEMORY"), THINKING ABNORMAL ("THINKING DISTURBANCE"), FATIGUE ("SEVERE FATIGUE"), ADENOMYOSIS (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DIZZINESS ("DIZZINESS"). THE PATIENT WAS TREATED WITH SURGERY (THE IMPLANT WAS TO BE REMOVED BY TUBAL LIGATION ON (B)(6) 2018) AND SURGERY (A PART OF UTERUS WAS TO BE REMOVED IN THE SAME TIME IMPLANT REMOVAL). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE ABDOMINAL PAIN, GENITAL HAEMORRHAGE, BACK PAIN, PRURITUS, MIGRAINE, PAIN IN EXTREMITY, ARTHRALGIA, DYSPNOEA, PALPITATIONS, AMNESIA, THINKING ABNORMAL, FATIGUE, ADENOMYOSIS AND DIZZINESS OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN, ADENOMYOSIS, AMNESIA, ARTHRALGIA, BACK PAIN, DIZZINESS, DYSPNOEA, FATIGUE, GENITAL HAEMORRHAGE, MIGRAINE, PAIN IN EXTREMITY, PALPITATIONS, PRURITUS AND THINKING ABNORMAL WITH ESSURE. THE REPORTER COMMENTED: THE HEALTH STATE OF THE PATIENT HAD BEEN SIGNIFICANTLY DETERIORATED. THE IMPLANT WAS TO BE REMOVED BY TUBAL LIGATION ON (B)(6) 2018, AND A PART OF UTERUS WAS TO BE REMOVED IN THE SAME TIME BECAUSE OF ADENOMYOSIS. 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 26-FEB-2018 FOR THE FOLLOWING MEDDRA PTS: ABDOMINAL PAIN: THE ANALYSIS REVEALED 1970 CASES (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. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY IS NOT POSSIBLE. INCIDENT. NO LOT NUMBER OR SAMPLE WAS 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 IN A SUPPLEMENTAL REPORT.