Description of Event or Problem · 1
THIS LITERATURE CASE WAS REPORTED IN A LITERATURE ARTICLE AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("PERFORATION") IN A FEMALE PATIENT WHO RECEIVED ESSURE FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. LITERATURE REFERENCE(S): FRANCHINI MARIO; BORSELLINO GIOVANNI; LITTA PIETRO; DI SPIEZIO SARDO ATTILIO; SCRIMIN FEDERICA; ET.AL, HYSTEROSCOPIC ESSURE® STERILIZATION: RESULTS OF ITALIAN MULTICENTER EXPERIENCE, GYNECOLOGICAL SURGERY, 2016, 13 (1):XX. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II AND TERMINATION OF PREGNANCY - ELECTIVE. IN (B)(6) 2012, THE PATIENT STARTED ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PROCEDURAL PAIN ("DIFFICULTY AND PAIN AT INSERTION") AND DEVICE DIFFICULT TO USE ("DIFFICULTY AND PAIN AT INSERTION"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA"). IN (B)(6) 2012, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC ADHESIONS ("ADHESIONS AFTER LYSIS SYNDROME"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY (LPS) TOGETHER WITH BILATERAL SALPINGECTOMY). ESSURE WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE PROCEDURAL PAIN, DEVICE DIFFICULT TO USE, DYSPAREUNIA, UTERINE PERFORATION AND PELVIC ADHESIONS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED UTERINE PERFORATION, PROCEDURAL PAIN, DEVICE DIFFICULT TO USE, PELVIC ADHESIONS AND DYSPAREUNIA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CONCLUSIONS: THE FINDINGS FROM THE FOLLOW-UP IN THE ITALIAN STUDY OF ESSURE FURTHER SUPPORT THE EFFECTIVENESS, TOLERABILITY, AND SATISFACTION OF HYSTEROSCOPIC STERILIZATION WHEN MOTIVATED WOMEN ARE SELECTED AND WELL INFORMED OF THE POTENTIAL RISKS OF THE DEVICE. PATIENTS WITH A KNOWN HYPERSENSITIVITY TO NICKEL MAY BE LESS SUITABLE CANDIDATES FOR THE ESSURE SYSTEM. MOREOVER, THE RESULTS FROM THIS STUDY DID NOT DEMONSTRATE ANY INCREASED INCIDENCE OF PREGNANCY AND COMPLICATIONS ASSOCIATED WITH ESSURE LONG-TERM USE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IN (B)(6) 2012: HYSTEROSALPINGOGRAM RESULT WAS PERFORATION. IN (B)(6) 2012: ECO: PERFORATION. THE LIST OF DEVICE SIMILAR INCIDENTS 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 16-JAN-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: UTERINE PERFORATION. 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. QUALITY-SAFETY EVALUATION OF PTC: PTC GLOBAL NUMBER: (B)(4). SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MED DRA LLT CAN BE PROVIDED. BACKGROUND: ESSURE® IS A MINIMALLY INVASIVE OPTION FOR PERMANENT CONTRACEPTION WITH HIGH REPORTED RATES OF PATIENT SATISFACTION AND LOW RATES OF PREGNANCIES WHEN BILATERAL OCCLUSION IS CONFIRMED. A SMALL PERCENTAGE OF WOMEN HAVE REPORTED NEGATIVE EXPERIENCES WITH ESSURE AND SUBSEQUENTLY CHOOSE TO HAVE THE TUBAL INSERTS REMOVED. DEVICE FAILURE AND COMPLICATIONS (PERFORATION, MIGRATION, AND EXPULSION) OR PATIENT PROBLEMS REPORTED (PELVIC PAIN, HEAVIER MENSES/MENSTRUAL IRREGULARITIES, HEADACHE, FATIGUE, WEIGHT FLUCTUATIONS, AND HYPERSENSITIVITY TO NICKEL) BECAME A SUBJECT OF LITIGATION IN 2014. THE PRESENT ITALIAN RETROSPECTIVE MULTICENTER STUDY ANALYZED SAFETY, TOLERABILITY, AND EFFECTIVENESS OF ESSURE INSERTS DURING SHORT AND LONG-TERM FOLLOW UP MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JAN-2017: QUALITY SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED CASE WAS REPORTED IN A LITERATURE ARTICLE AND REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED PERFORATION. A LAPAROSCOPY TOGETHER WITH BILATERAL SALPINGECTOMY WAS PERFORMED. THIS EVENT, SEEN AS UTERINE PERFORATION, IS REGARDED AS ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. UTERINE/FALLOPIAN PERFORATION MAY OCCUR WITH TRANS-CERVICAL INTRAUTERINE PROCEDURE (E.G. HYSTEROSCOPY, CURETTAGE). UTERINE/FALLOPIAN PERFORATION WITH ESSURE MAY OCCUR, MOST OFTEN DURING INSERTION. IN THIS CASE, THE EXACT DATE AND MECHANISM OF PERFORATION WAS NOT KNOWN. HOWEVER, BASED ON ITS NATURE, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT BECAUSE DEVICE REMOVAL WAS REQUIRED AND SURGICAL INTERVENTION WAS PERFORMED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS, PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION IS EXPECTED.