ESSURE
Report
- Report Number
- 2951250-2017-03190
- Event Type
- Injury
- Date Received
- August 28, 2017
- Date of Event
- April 6, 2012
- Report Date
- July 19, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
THIS 40-YEAR-OLD FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: 16974). THE SUBJECT (PATIENT ID: 16-019) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. 901330) INSERTED. THE REPORT DESCRIBES A CASE OF ADNEXA UTERI PAIN ("LEFT FALLOPIAN TUBE PAIN") AND MEDICAL DEVICE SITE DISCOMFORT ("DISCOMFORT RELATED TO ESSURE DEVICE IN RIGHT FALLOPIAN TUBE"). THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I IN 1998 AND PARITY 1 IN 1998. NO ANESTHESIA METHOD USED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NAPROXEN. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2012, 1 MONTH 29 DAYS AFTER INSERTION OF FALLOPIAN TUBE OCCLUSION INSERT, THE SUBJECT EXPERIENCED ADNEXA UTERI PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). ON (B)(6) 2016, THE SUBJECT EXPERIENCED MEDICAL DEVICE SITE DISCOMFORT (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). THE SUBJECT WAS HOSPITALIZED ON (B)(6) 2012. THE SUBJECT WAS TREATED WITH SURGERY (HYSTEROSCOPY, LAPAROSCOPIC SALPINGOTOMY WITH REMOVAL OF LEFT ESSURE ON (B)(6) 2012) AND SURGERY (HYSTEROSCOPY, LAPAROSCOPIC SALPINGECTOMY WITH REMOVAL OF RIGHT ESSURE DEVICE ON (B)(6) 2016). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2012. ON (B)(6) 2012, THE ADNEXA UTERI PAIN HAD RESOLVED. ON (B)(6) 2016, THE MEDICAL DEVICE SITE DISCOMFORT HAD RESOLVED. THE INVESTIGATOR CONSIDERED ADNEXA UTERI PAIN AND MEDICAL DEVICE SITE DISCOMFORT TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: THE LEFT DEVICE WAS REMOVED ON (B)(6) 2012 AT THE SITE AND THE RIGHT DEVICE WAS REMOVED ON (B)(6) 2016 IN ANOTHER HOSPITAL. LEFT ESSURE WAS REMOVED ON (B)(6) 2012 BY HYSTEROSCOPY, OPERATIVE SALPINGOTOMY LAPAROSCOPIC. DEVICE REMOVAL WAS INTENDED. PRIMARY REASON FOR REMOVAL WAS SUBJECT REQUEST. UNIPOLAR AND BIPOLAR ENERGY WERE USED. NO VASOCONSTRICTIVE AGENT WAS USED DURING REMOVAL. PREOPERATIVE ULTRASOUND WAS PERFORMED. TOTAL NUMBER OF DEVICES REMOVED: 1. THE STATUS OF LEFT TUBE WAS INTACT. ON (B)(6) 2016 RIGHT ESSURE WAS REMOVED. DEVICE REMOVAL WAS INTENDED. PRIMARY REASON FOR REMOVAL WAS SUBJECT REQUEST. PROCEDURE: HYSTEROSCOPY, OPERATIVE SALPINGOTOMY LAPAROSCOPIC. TYPES OF ENERGY SOURCES USED ARE UNKNOWN. NO IMAGING PROCEDURE WAS PERFORMED TO LOCALIZE THE INSERT PRIOR TO REMOVAL AND NO VASOCONSTRICTIVE AGENT WAS USED DURING REMOVAL. TOTAL NUMBER OF DEVICES REMOVED: 1. THE STATUS OF RIGHT TUBE WAS INTACT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.7 KG/SQM. PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE. ON (B)(6) 2012: TRANSVAGINAL ULTRASOUND WAS PERFORMED - BILATERAL ¿SATISFACTORY¿ PLACEMENT OF THE ESSURE INSERTS. REVEALED ANTEVERTED UTERUS, REGULAR ENDOMETRIUM, NORMAL UTERINE CAVITY, NORMAL RIGHT AND LEFT OVARIES, AN OVARIAN CYST OF 1 CM DIAMETER, AND NO FREE FLUID. ON (B)(6) 2012: HYSTEROSALPINGOGRAM WAS PERFORMED - BILATERAL SATISFACTORY PLACEMENT AND OCCLUSION. ON (B)(6) 2012: HYSTEROCOPY SHOWED THAT THE PROXIMAL END OF ESSURE MICRO-INSERT WAS NOT VISIBLE. THERE WAS ALSO NO PERFORATION, ENDOMETRIOSIS, OR ADHESIONS; THE OVARIES WERE NORMAL. ON UNSPECIFIED DATE, TVU REVEALED ANTEVERTED UTERUS, REGULAR ENDOMETRIUM, NORMAL UTERINE CAVITY, NORMAL RIGHT AND LEFT OVARIES, AN OVARIAN CYST OF 1 CM DIAMETER, AND NO FREE FLUID. LEUKOCYTE COUNT (REFERENCE RANGE: 4.0-10.0) WAS 17.1 × 109/L, AND NEUTROPHILS (REFERENCE RANGE: 1.5-9) WERE 13.7 × 109/L. URINE EXAMINATION SHOWED PRESENCE OF ERYTHROCYTES (2+, NORMALLY NOT PRESENT IN URINE) AND LEUKOCYTES (2+, REFERENCE RANGE: 0-25). PREOPERATIVE ULTRASOUND WAS PERFORMED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JUL-2018: AFTER CLINICAL RESEARCH REVIEW, THE SAE "UNEASINESS ABOUT ESSURE DEVICE IN RIGHT FALLOPIAN TUBE" WAS UPDATED TO ¿DISCOMFORT RELATED TO ESSURE DEVICE IN RIGHT FALLOPIAN TUBE¿. INCIDENT AT THE TIME OF REPORTING, 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.
THIS (B)(6) YEAR-OLD FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: (B)(4)). THE SUBJECT (PATIENT ID: (B)(6)) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. 901330) INSERTED. THE REPORT DESCRIBES A CASE OF ADNEXA UTERI PAIN ("LEFT FALLOPIAN TUBE PAIN"). THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I IN 1998 AND PARITY 1 IN 1998. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2012, 1 MONTH 29 DAYS AFTER INSERTION OF FALLOPIAN TUBE OCCLUSION INSERT, THE SUBJECT EXPERIENCED ADNEXA UTERI PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). THE SUBJECT WAS HOSPITALIZED ON (B)(6) 2012. FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2012. ON (B)(6) 2012, THE ADNEXA UTERI PAIN HAD RESOLVED. THE INVESTIGATOR CONSIDERED ADNEXA UTERI PAIN TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: ON (B)(6) 2012, ONE INTACT DEVICE OF LEFT SIDE WAS REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.7 KG/SQM. ON (B)(6) 2012: TRANSVAGINAL ULTRASOUND WAS PERFORMED - BILATERAL "SATISFACTORY" PLACEMENT OF THE ESSURE INSERTS. REVEALED ANTEVERTED UTERUS, REGULAR ENDOMETRIUM, NORMAL UTERINE CAVITY, NORMAL RIGHT AND LEFT OVARIES, AN OVARIAN CYST OF 1 CM DIAMETER, AND NO FREE FLUID. ON (B)(6) 2012: HYSTEROSALPINGOGRAM WAS PERFORMED - BILATERAL SATISFACTORY PLACEMENT AND OCCLUSION. ON (B)(6) 2012: HYSTEROCOPY SHOWED THAT THE PROXIMAL END OF ESSURE MICRO-INSERT WAS NOT VISIBLE. THERE WAS ALSO NO PERFORATION, ENDOMETRIOSIS, OR ADHESIONS; THE OVARIES WERE NORMAL. ON UNSPECIFIED DATE, TVU REVEALED ANTEVERTED UTERUS, REGULAR ENDOMETRIUM, NORMAL UTERINE CAVITY, NORMAL RIGHT AND LEFT OVARIES, AN OVARIAN CYST OF 1 CM DIAMETER, AND NO FREE FLUID. LEUKOCYTE COUNT (REFERENCE RANGE: 4.0-10.0) WAS 17.1 × 109/L, AND NEUTROPHILS (REFERENCE RANGE: 1.5-9) WERE 13.7 × 109/L. URINE EXAMINATION SHOWED PRESENCE OF ERYTHROCYTES (2+, NORMALLY NOT PRESENT IN URINE) AND LEUKOCYTES (2+, REFERENCE RANGE: 0-25). THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: ADNEXA UTERI PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 59 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-AUG-2017: QUALITY-SAFETY EVALUATION OF PTC INCIDENT: AT THE TIME OF REPORTING, 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.
THIS (B)(6) YEAR-OLD FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: 16974). THE SUBJECT (PATIENT ID: (B)(6)) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. 901330) INSERTED. THE REPORT DESCRIBES A CASE OF ADNEXA UTERI PAIN ("LEFT FALLOPIAN TUBE PAIN") AND PATIENT DISSATISFACTION WITH DEVICE ("UNEASINESS ABOUT ESSURE DEVICE REGARDING RIGHT FALLOPIAN TUBE"). THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I IN 1998 AND PARITY 1 IN 1998. NO ANESTHESIA METHOD USED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NAPROXEN. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2012, 1 MONTH 29 DAYS AFTER INSERTION OF FALLOPIAN TUBE OCCLUSION INSERT, THE SUBJECT EXPERIENCED ADNEXA UTERI PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). ON (B)(6) 2016, THE SUBJECT EXPERIENCED PATIENT DISSATISFACTION WITH DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). THE SUBJECT WAS HOSPITALIZED ON (B)(6) 2012. THE SUBJECT WAS TREATED WITH SURGERY (LAPAROSCOPIC REMOVAL OF THE ESSURE DEVICE ON (B)(6) 2016). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED. ON (B)(6) 2012, THE ADNEXA UTERI PAIN HAD RESOLVED. ON (B)(6) 2016, THE PATIENT DISSATISFACTION WITH DEVICE HAD RESOLVED. THE INVESTIGATOR CONSIDERED ADNEXA UTERI PAIN AND PATIENT DISSATISFACTION WITH DEVICE TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: THE LEFT DEVICE WAS REMOVED ON (B)(6) 2012 AT THE SITE AND THE RIGHT DEVICE WAS REMOVED ON (B)(6) 2016 IN ANOTHER HOSPITAL AND ACCORDING TO THE SUBJECT THE RIGHT TUBE WAS INTACT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.7 KG/SQM. PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE. ON (B)(6) 2012: TRANSVAGINAL ULTRASOUND WAS PERFORMED - BILATERAL "SATISFACTORY" PLACEMENT OF THE ESSURE INSERTS. REVEALED ANTEVERTED UTERUS, REGULAR ENDOMETRIUM, NORMAL UTERINE CAVITY, NORMAL RIGHT AND LEFT OVARIES, AN OVARIAN CYST OF 1 CM DIAMETER, AND NO FREE FLUID. ON (B)(6) 2012: HYSTEROSALPINGOGRAM WAS PERFORMED - BILATERAL SATISFACTORY PLACEMENT AND OCCLUSION. ON (B)(6) 2012: HYSTEROCOPY SHOWED THAT THE PROXIMAL END OF ESSURE MICRO-INSERT WAS NOT VISIBLE. THERE WAS ALSO NO PERFORATION, ENDOMETRIOSIS, OR ADHESIONS; THE OVARIES WERE NORMAL. ON UNSPECIFIED DATE, TVU REVEALED ANTEVERTED UTERUS, REGULAR ENDOMETRIUM, NORMAL UTERINE CAVITY, NORMAL RIGHT AND LEFT OVARIES, AN OVARIAN CYST OF 1 CM DIAMETER, AND NO FREE FLUID. LEUKOCYTE COUNT (REFERENCE RANGE: 4.0-10.0) WAS 17.1 × 109/L, AND NEUTROPHILS (REFERENCE RANGE: 1.5-9) WERE 13.7 × 109/L. URINE EXAMINATION SHOWED PRESENCE OF ERYTHROCYTES (2+, NORMALLY NOT PRESENT IN URINE) AND LEUKOCYTES (2+, REFERENCE RANGE: 0-25). THE UPDATED LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 18-SEP-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERMS: ADNEXA UTERI PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 60 CASES. PATIENT DISSATISFACTION WITH DEVICE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 0 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 THESE MEDDRA PTS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 15-SEP-2017: ESSURE REMOVAL DATES WERE CONFIRMED AND UPDATED. INCIDENT: AT THE TIME OF REPORTING, 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.
THIS (B)(6) YEAR-OLD FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: (B)(4)). THE SUBJECT (PATIENT ID: (B)(6)) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. 901330) INSERTED. THE REPORT DESCRIBES A CASE OF ADNEXA UTERI PAIN ("LEFT FALLOPIAN TUBE PAIN") AND PATIENT DISSATISFACTION WITH DEVICE ("UNEASINESS ABOUT ESSURE DEVICE REGARDING RIGHT FALLOPIAN TUBE"). THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I IN 1998 AND PARITY 1 IN 1998. NO ANESTHESIA METHOD USED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NAPROXEN. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2012, 1 MONTH 29 DAYS AFTER INSERTION OF FALLOPIAN TUBE OCCLUSION INSERT, THE SUBJECT EXPERIENCED ADNEXA UTERI PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). ON (B)(6) 2016, THE SUBJECT EXPERIENCED PATIENT DISSATISFACTION WITH DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). THE SUBJECT WAS HOSPITALIZED ON (B)(6) 2012. THE SUBJECT WAS TREATED WITH SURGERY (LAPAROSCOPIC REMOVAL OF THE ESSURE DEVICE ON (B)(6) 2016). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED. ON (B)(6) 2012, THE ADNEXA UTERI PAIN HAD RESOLVED. ON (B)(6) 2016, THE PATIENT DISSATISFACTION WITH DEVICE HAD RESOLVED. THE INVESTIGATOR CONSIDERED ADNEXA UTERI PAIN AND PATIENT DISSATISFACTION WITH DEVICE TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: ON (B)(6) 2012, ONE INTACT DEVICE OF LEFT SIDE WAS REMOVED. ACCORDING TO INVESTIGATOR ONE DEVICE WAS REMOVED ON (B)(6) 2016 AND THE RIGHT TUBE WAS INTACT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.7 KG/SQM. PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE. (B)(6) 2012: TRANSVAGINAL ULTRASOUND WAS PERFORMED - BILATERAL "SATISFACTORY" PLACEMENT OF THE ESSURE INSERTS. REVEALED ANTEVERTED UTERUS, REGULAR ENDOMETRIUM, NORMAL UTERINE CAVITY, NORMAL RIGHT AND LEFT OVARIES, AN OVARIAN CYST OF 1 CM DIAMETER, AND NO FREE FLUID. (B)(6) 2012: HYSTEROSALPINGOGRAM WAS PERFORMED - BILATERAL SATISFACTORY PLACEMENT AND OCCLUSION. (B)(6) 2012: HYSTEROSCOPY SHOWED THAT THE PROXIMAL END OF ESSURE MICRO-INSERT WAS NOT VISIBLE. THERE WAS ALSO NO PERFORATION, ENDOMETRIOSIS, OR ADHESIONS; THE OVARIES WERE NORMAL. ON UNSPECIFIED DATE, TVU REVEALED ANTEVERTED UTERUS, REGULAR ENDOMETRIUM, NORMAL UTERINE CAVITY, NORMAL RIGHT AND LEFT OVARIES, AN OVARIAN CYST OF 1 CM DIAMETER, AND NO FREE FLUID. LEUKOCYTE COUNT (REFERENCE RANGE: 4.0-10.0) WAS 17.1 × 109/L, AND NEUTROPHILS (REFERENCE RANGE: 1.5-9) WERE 13.7 × 109/L. URINE EXAMINATION SHOWED PRESENCE OF ERYTHROCYTES (2+, NORMALLY NOT PRESENT IN URINE) AND LEUKOCYTES (2+, REFERENCE RANGE: 0-25). THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 13-SEP-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERMS: ADNEXA UTERI PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 60 CASES. PATIENT DISSATISFACTION WITH DEVICE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 0 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 THESE MEDDRA PTS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-SEP-2017: NEW EVENT ADDED: "UNEASINESS ABOUT ESSURE DEVICE REGARDING RIGHT FALLOPIAN TUBE"; DATE OF ESSURE REMOVAL UPDATED. INCIDENT: AT THE TIME OF REPORTING, 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.
THIS (B)(6) FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: (B)(6)). THE SUBJECT (PATIENT ID: (B)(6)) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. 901330) INSERTED. THE REPORT DESCRIBES A CASE OF ADNEXA UTERI PAIN ("LEFT FALLOPIAN TUBE PAIN") AND PATIENT DISSATISFACTION WITH DEVICE ("UNEASINESS ABOUT ESSURE DEVICE REGARDING RIGHT FALLOPIAN TUBE"). THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I IN 1998 AND PARITY 1 IN 1998. NO ANESTHESIA METHOD USED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: NAPROXEN. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2012, 1 MONTH 29 DAYS AFTER INSERTION OF FALLOPIAN TUBE OCCLUSION INSERT, THE SUBJECT EXPERIENCED ADNEXA UTERI PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). ON (B)(6) 2016, THE SUBJECT EXPERIENCED PATIENT DISSATISFACTION WITH DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). THE SUBJECT WAS HOSPITALIZED ON (B)(6) 2012. THE SUBJECT WAS TREATED WITH SURGERY (HYSTEROSCOPY, LAPAROSCOPIC SALPINGOTOMY WITH REMOVAL OF LEFT ESSURE ON (B)(6) 2012) AND SURGERY (HYSTEROSCOPY, LAPAROSCOPIC SALPINGECTOMY WITH REMOVAL OF RIGHT ESSURE DEVICE ON (B)(6) 2016). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2012. ON (B)(6) 2012, THE ADNEXA UTERI PAIN HAD RESOLVED. ON (B)(6) 2016, THE PATIENT DISSATISFACTION WITH DEVICE HAD RESOLVED. THE INVESTIGATOR CONSIDERED ADNEXA UTERI PAIN AND PATIENT DISSATISFACTION WITH DEVICE TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: THE LEFT DEVICE WAS REMOVED ON (B)(6) 2012 AT THE SITE AND THE RIGHT DEVICE WAS REMOVED ON (B)(6) 2016 IN ANOTHER HOSPITAL. LEFT ESSURE WAS REMOVED ON (B)(6) 2012 BY HYSTEROSCOPY, OPERATIVE SALPINGOTOMY LAPAROSCOPIC. DEVICE REMOVAL WAS INTENDED. PRIMARY REASON FOR REMOVAL WAS SUBJECT REQUEST. UNIPOLAR AND BIPOLAR ENERGY WERE USED. NO VASOCONSTRICTIVE AGENT WAS USED DURING REMOVAL. PREOPERATIVE ULTRASOUND WAS PERFORMED. TOTAL NUMBER OF DEVICES REMOVED: 1. THE STATUS OF LEFT TUBE WAS INTACT. ON (B)(6) 2016 RIGHT ESSURE WAS REMOVED. DEVICE REMOVAL WAS INTENDED. PRIMARY REASON FOR REMOVAL WAS SUBJECT REQUEST. PROCEDURE: HYSTEROSCOPY, OPERATIVE SALPINGOTOMY LAPAROSCOPIC. TYPES OF ENERGY SOURCES USED ARE UNKNOWN. NO IMAGING PROCEDURE WAS PERFORMED TO LOCALIZE THE INSERT PRIOR TO REMOVAL AND NO VASOCONSTRICTIVE AGENT WAS USED DURING REMOVAL. TOTAL NUMBER OF DEVICES REMOVED: 1. THE STATUS OF RIGHT TUBE WAS INTACT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 20.7 KG/SQM. PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE. (B)(6) 2012: TRANSVAGINAL ULTRASOUND WAS PERFORMED - BILATERAL ¿SATISFACTORY¿ PLACEMENT OF THE ESSURE INSERTS. REVEALED ANTEVERTED UTERUS, REGULAR ENDOMETRIUM, NORMAL UTERINE CAVITY, NORMAL RIGHT AND LEFT OVARIES, AN OVARIAN CYST OF 1 CM DIAMETER, AND NO FREE FLUID. (B)(6) 2012: HYSTEROSALPINGOGRAM WAS PERFORMED - BILATERAL SATISFACTORY PLACEMENT AND OCCLUSION. (B)(6) 2012: HYSTEROCOPY SHOWED THAT THE PROXIMAL END OF ESSURE MICRO-INSERT WAS NOT VISIBLE. THERE WAS ALSO NO PERFORATION, ENDOMETRIOSIS, OR ADHESIONS; THE OVARIES WERE NORMAL. ON UNSPECIFIED DATE, TVU REVEALED ANTEVERTED UTERUS, REGULAR ENDOMETRIUM, NORMAL UTERINE CAVITY, NORMAL RIGHT AND LEFT OVARIES, AN OVARIAN CYST OF 1 CM DIAMETER, AND NO FREE FLUID. LEUKOCYTE COUNT (REFERENCE RANGE: 4.0-10.0) WAS 17.1 × 109/L, AND NEUTROPHILS (REFERENCE RANGE: 1.5-9) WERE 13.7 × 109/L. URINE EXAMINATION SHOWED PRESENCE OF ERYTHROCYTES (2+, NORMALLY NOT PRESENT IN URINE) AND LEUKOCYTES (2+, REFERENCE RANGE: 0-25). PREOPERATIVE ULTRASOUND WAS PERFORMED. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 31-OCT-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERMS: ADNEXA UTERI PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 64 CASES. PATIENT DISSATISFACTION WITH DEVICE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 0 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 THESE MEDDRA PTS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-OCT-2017: DEVICE REMOVAL DETAILS WERE PROVIDED. INCIDENT: AT THE TIME OF REPORTING, 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.
THIS (B)(6)-YEAR-OLD FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: (B)(4)). THE SUBJECT (PATIENT ID: (B)(6)) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. 901330) INSERTED. THE REPORT DESCRIBES A CASE OF ADNEXA UTERI PAIN ("LEFT FALLOPIAN TUBE PAIN"). THE SUBJECT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I IN 1998 AND PARITY 1 IN 1998. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2012, 1 MONTH 29 DAYS AFTER INSERTION OF FALLOPIAN TUBE OCCLUSION INSERT, THE SUBJECT EXPERIENCED ADNEXA UTERI PAIN (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). THE SUBJECT WAS HOSPITALIZED ON (B)(6) 2012. FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2012. ON (B)(6) 2012, THE ADNEXA UTERI PAIN HAD RESOLVED. THE INVESTIGATOR CONSIDERED ADNEXA UTERI PAIN TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED ON (B)(6) 2012, ONE INTACT DEVICE OF LEFT SIDE WAS REMOVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). (B)(6) 2012: TRANSVAGINAL ULTRASOUND WAS PERFORMED - BILATERAL "SATISFACTORY" PLACEMENT OF THE ESSURE INSERTS. REVEALED ANTEVERTED UTERUS, REGULAR ENDOMETRIUM, NORMAL UTERINE CAVITY, NORMAL RIGHT AND LEFT OVARIES, AN OVARIAN CYST OF 1 CM DIAMETER, AND NO FREE FLUID. (B)(6) 2012: HYSTEROSALPINGOGRAM WAS PERFORMED - BILATERAL SATISFACTORY PLACEMENT AND OCCLUSION. (B)(6) 2012: HYSTEROSCOPY SHOWED THAT THE PROXIMAL END OF ESSURE MICRO-INSERT WAS NOT VISIBLE. THERE WAS ALSO NO PERFORATION, ENDOMETRIOSIS, OR ADHESIONS; THE OVARIES WERE NORMAL. ON UNSPECIFIED DATE, TVU REVEALED ANTEVERTED UTERUS, REGULAR ENDOMETRIUM, NORMAL UTERINE CAVITY, NORMAL RIGHT AND LEFT OVARIES, AN OVARIAN CYST OF 1 CM DIAMETER, AND NO FREE FLUID. LEUKOCYTE COUNT (REFERENCE RANGE: 4.0-10.0) WAS 17.1 × 109/L, AND NEUTROPHILS (REFERENCE RANGE: 1.5-9) WERE 13.7 × 109/L. URINE EXAMINATION SHOWED PRESENCE OF ERYTHROCYTES (2+, NORMALLY NOT PRESENT IN URINE) AND LEUKOCYTES (2+, REFERENCE RANGE: 0-25). THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: ADNEXA UTERI PAIN. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 59 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-AUG-2017: THIS CASE WAS CONVERTED FROM THE CONCEPTUS DATABASE INTO (B)(4) ON 07-APR-2014. FURTHER INFORMATION WAS RECEIVED ON 10-AUG -2017 AND QUALIFIES THIS PREVIOUS CONCEPTUS CASE AS REPORTABLE CASE BY BAYER. NEW INFORMATION ADDED: ESSURE WAS REMOVED ON (B)(6) 2012. METHOD OF REMOVAL WAS REPORTED. INCIDENT: AT THE TIME OF REPORTING, 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 603906 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 901330 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Hospitalization| R |