Description of Event or Problem · 1
THIS LITERATURE CASE WAS REPORTED IN A LITERATURE ARTICLE AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("TUBAL PERFORATION DURING PLACEMENT.") 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. IN (B)(6) 2006, THE PATIENT STARTED ESSURE. IN (B)(6) 2006, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED) AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION"). THE PATIENT WAS TREATED WITH SURGERY (THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY IN THE SAME SESSION WITH RECOVERY OF ESSURE DEVICE). ESSURE WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED FALLOPIAN TUBE PERFORATION AND COMPLICATION OF DEVICE INSERTION 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. 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: FALLOPIAN TUBE PERFORATION. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 520 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: 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 12-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 TUBAL PERFORATION DURING PLACEMENT. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY IN THE SAME SESSION WITH RECOVERY OF ESSURE DEVICE (INTERPRETED AS DEVICE WAS REMOVED). THIS EVENT IS REGARDED AS ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THIS CASE, FALLOPIAN TUBE PERFORATION OCCURRED AT TIME OF ESSURE INSERTION. THE FALLOPIAN TUBE PERFORATION IS CONSIDERED A COMPLICATION OF THE INSERTION PROCEDURE. A CAUSAL RELATIONSHIP WITH ESSURE CAN THEREFORE NOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT BECAUSE DEVICE REMOVAL WAS REQUIRED AND SURGICAL INTERVENTION WAS PERFORMED. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS, PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION IS EXPECTED.