Description of Event or Problem · 1
THIS LITERATURE CASE WAS REPORTED IN A LITERATURE ARTICLE AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("RIGHT TUBA PERVIOUS WITH DISLOCATION OF THE DEVICE") IN AN ADULT FEMALE PATIENT WHO RECEIVED ESSURE. 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) 2005, THE PATIENT STARTED ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY). ESSURE WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 2 TC BILATERAL APPLICATION 6 COMPLEX ON THE RIGHT, 2 ON THE LEFT. AT LAPAROSCOPY IS VISIBLE ESSURE COVERED BY SEROUS TUBAL: SALPINGECTOMY. 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): ON AN UNKNOWN DATE: HYSTEROSALPINGOGRAM RESULT WAS LEFT TUBA CLOSED AND RIGHT TUBA WITH DISLOCATION. 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: DEVICE DISLOCATION. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 920 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: (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 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 IT WAS REPORTED THAT RIGHT TUBA PERVIOUS WITH DISLOCATION OF THE DEVICE. A SALPINGECTOMY WAS PERFORMED. ESSURE WAS REMOVED. THIS EVENT IS REGARDED AS ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. DURING ESSURE MICRO-INSERT THERAPY THERE IS A RISK THAT THE DEVICE COULD MOVE OUT OF FALLOPIAN TUBES, THIS MOVEMENT COULD BE AN EXPULSION (INTO UTERUS OR OUT OF THE BODY), DISLOCATION (DISTAL FALLOPIAN TUBE OR PERITONEAL CAVITY) OR OCCUR AS A RESULT OF UTERINE PERFORATION, MAINLY DURING INSERTION. IN THIS CASE, THE EXACT DATE AND MECHANISM OF DEVICE DISLOCATION 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. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS, PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION IS EXPECTED.