Description of Event or Problem · 1
THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("ESSURE REMOVAL DUE TO AILMENTS") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: GARRIGUET LOPEZ JOSE, MANRIQUE GOMEZ TM, EXOJO CANO GM, MONTILLA PRADOS IM, DURO GOMEZ J, TREJO BRAVO I, EXTRACTION TECHNIQUE OF ESSURE DEVICE AT OUR CENTER, 34TH NATIONAL EDITION TRAINING SEGO 12 - 16 JUNE 2017- OVIEDO, 2017:#267. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL DUE TO AILMENTS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY USING BIPOLAR-MONOPOLAR COAGULATION AND SECTION). ESSURE WAS REMOVED IN 2016. AT THE TIME OF THE REPORT, THE AILMENTS WERE RESOLVING. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. REPORTER'S COMMENT: FROM THIS ABSTRACT LINKED CASES RECORDS WERE CREATED: 2017-120601, 2017-120883, 2017-120885, 2017-120913, 2017-120980, 2017-120979, 2017-120977 DIAGNOSTIC RESULTS: IN 2016: HYSTEROSCOPIC FINDINGS (PRE AND POST-SURGERY): MATERIALS IN OSTIA OR OTHER PATHOLOGY WERE NOT OBSERVED, INTRACAVITARY ESSURE WAS NOT OBSERVED. THIS CASE REPORT REFERS TO ONE OF EIGHT WOMEN (MEAN AGE 39,8±3,6 YEARS) WHO UNDERWENT SURGERY FOR ESSURE REMOVAL IN 2016. ENDOSCOPIC PROTOCOL AS REMOVAL TECHNIQUE BASED ON THREE STAGES WAS APPLIED: HYSTEROSCOPY-LAPAROSCOPY-HYSTEROSCOPY. HYSTEROSCOPIC FINDINGS (PRE AND POST-SURGERY): MATERIALS IN OSTIA OR OTHER PATHOLOGY WERE NOT OBSERVED. THREE ESSURE COMPONENT WERE REMOVED: METALLIC SPIRAL, GUIDANCE ROD (ALSO METALLIC), AND PLASTIC (POLYESTER) COMPONENT. LAPAROSCOPIC EXTRACTION TECHNIQUE: AFTER HYSTEROSCOPY UNFEASIBILITY AS INTRACAVITARY ESSURE WAS NOT OBSERVED, IT CONSISTED ON BILATERAL SALPINGECTOMY USING BIPOLAR-MONOPOLAR COAGULATION AND SECTION, ENSURING TO AVOID DEVICE SECTION, IDENTIFYING AND HOLDING IT WITH GRASPING FORCEPS FOR ITS REMOVAL. THEN, WITH THE USE OF FINE DISSECTOR, THE SMALL INTRAMURAL ANATOMIC SPACE WHICH COMMUNICATES THE UTERUS WITH FALLOPIAN TUBE IS SECTIONED WITH THE OBJECTIVE OF ENSURING TOTAL EXTRACTION OF DEVICE AND AVOID LEAVING ANY MINUSCULE REMNANT OF IT. INTERVENTION IS FINALIZED BY VERIFYING HEMOSTASIS USING ELECTROCOAGULATION IF NEEDED IN THE INTERVENED CORNUAL ZONE. AILMENTS OF PATIENT IMPROVED AFTER PROCEDURE. THE LIST OF SIMILAR CASES 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 23-JUN-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: MEDICAL DEVICE REMOVAL -ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 665 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. COMPANY CAUSALITY COMMENT: NO LOT NUMBER OR SAMPLE 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 ON A SUPPLEMENTAL REPORT.