ESSURE
Report
- Report Number
- 2951250-2022-00180
- Event Type
- Injury
- Date Received
- March 3, 2022
- Date of Event
- January 29, 2020
- Report Date
- June 10, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY AEMPS (REFERENCE NUMBER: PS/CH/72611 AND PS/EML/101643.) ON 01-MAR-2022. THE MOST RECENT INFORMATION WAS RECEIVED ON 10-JAN-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN FEMALE") AND DEVICE BREAKAGE ("INCOMPLETE REMOVAL; A TINY PORTION WAS LEFT IN THE LEFT UTERINE HORN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: COMPLICATION OF DEVICE REMOVAL ("INCOMPLETE REMOVAL"). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2020, 1016 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. AN UNKNOWN TIME LATER SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND HEAVY MENSTRUAL BLEEDING ("HYPERMENORRHOEA"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL BY LAPAROSCOPIC SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOMES FOR PELVIC PAIN AND HEAVY MENSTRUAL BLEEDING WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO PELVIC PAIN, HEAVY MENSTRUAL BLEEDING OR DEVICE BREAKAGE. THE REPORTER COMMENTED: SYMPTOMATIC ESSURES, THEY ARE REMOVED BY MEANS OF A BILATERAL LAPAROSCOPIC SALPINGECTOMY WITH PROVEN COMPLETE EXTRACTION OF BOTH DEVICES NEED FOR SURGICAL INTERVENTION TO TREAT THE SYMPTOMS PRESENTED BY THE PATIENT ASSOCIATED WITH THE DEVICES. CORRESPONDING TO THE PLATE OF THE LEFT ESSURE; NO COIL OR ANY OTHER PORTION OF THE RIGHT ESSURE WAS LEFT AND REMOVED COMPLETELY; LEFT ONE WAS REMOVED COMPLETELY EXCEPT FOR THE PLATE. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 10-JAN-2024: EVENT MEDICAL DEVICE IS REPLACED WITH EVENT DEVICE BREAKAGE, NEW EVENT PELVIC PAIN, POLYMENORRHIA & COMPLICATION OF DEVICE REMOVAL ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY AEMPS (REFERENCE NUMBER: (B)(4)) ON 01-MAR-2022. THE MOST RECENT INFORMATION WAS RECEIVED ON 27-JAN-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN FEMALE") AND DEVICE BREAKAGE ("INCOMPLETE REMOVAL; A TINY PORTION WAS LEFT IN THE LEFT UTERINE HORN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: CONTRACEPTIVE DEVICE REMOVAL INCOMPLETE ("INCOMPLETE REMOVAL"). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2020, 1016 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. ON UNKNOWN DATE SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND HEAVY MENSTRUAL BLEEDING ("HYPERMENORRHOEA"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL BY LAPAROSCOPIC SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOMES FOR PELVIC PAIN AND HEAVY MENSTRUAL BLEEDING WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO PELVIC PAIN, HEAVY MENSTRUAL BLEEDING OR DEVICE BREAKAGE. THE REPORTER COMMENTED: SYMPTOMATIC ESSURES, THEY ARE REMOVED BY MEANS OF A BILATERAL LAPAROSCOPIC SALPINGECTOMY WITH PROVEN COMPLETE EXTRACTION OF BOTH DEVICES NEED FOR SURGICAL INTERVENTION TO TREAT THE SYMPTOMS PRESENTED BY THE PATIENT ASSOCIATED WITH THE DEVICES CORRESPONDING TO THE PLATE OF THE LEFT ESSURE; NO COIL OR ANY OTHER PORTION OF THE RIGHT ESSURE WAS LEFT AND REMOVED COMPLETELY; LEFT ONE WAS REMOVED COMPLETELY EXCEPT FOR THE PLATE. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 27-JAN-2024: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY AEMPS (REFERENCE NUMBER: (B)(4)) ON 01-MAR-2022. THE MOST RECENT INFORMATION WAS RECEIVED ON 27-JAN-2024. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("REMOVED BY MEANS OF A BILATERAL LAPAROSCOPIC SALPINGECTOMY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2020, 1016 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL BY LAPAROSCOPIC SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO MEDICAL DEVICE REMOVAL. THE REPORTER COMMENTED: SYMPTOMATIC ESSURES, THEY ARE REMOVED BY MEANS OF A BILATERAL LAPAROSCOPIC SALPINGECTOMY WITH PROVEN COMPLETE EXTRACTION OF BOTH DEVICES NEED FOR SURGICAL INTERVENTION TO TREAT THE SYMPTOMS PRESENTED BY THE PATIENT ASSOCIATED WITH THE DEVICES. CORRESPONDING TO THE PLATE OF THE LEFT ESSURE; NO COIL OR ANY OTHER PORTION OF THE RIGHT ESSURE WAS LEFT AND REMOVED COMPLETELY; LEFT ONE WAS REMOVED COMPLETELY EXCEPT FOR THE PLATE. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE FOLLOWING AMENDMENT WAS MADE: EVENTS (PELVIC PAIN, DEVICE BREAKAGE, HEAVY MENSTRUAL BLEEDING AND COMPLICATION OF DEVICE REMOVAL) REMOVED WHICH ALREADY CAPTURED IN ANOTHER CASE (B)(4). NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (AEMPS, REFERENCE NUMBER: (B)(4)) ON 01-MAR-2022. THE MOST RECENT INFORMATION WAS RECEIVED ON 11-MAR-2022. THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('REMOVED BY MEANS OF A BILATERAL LAPAROSCOPIC SALPINGUECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2020, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED), 2 YEARS 9 MONTHS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL BY LAPAROSCOPIC SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR MEDICAL DEVICE REMOVAL WITH ESSURE. THE REPORTER COMMENTED: SYMPTOMATIC ESSURES, THEY ARE REMOVED BY MEANS OF A BILATERAL LAPAROSCOPIC SALPINGECTOMY WITH PROVEN COMPLETE EXTRACTION OF BOTH DEVICES NEED FOR SURGICAL INTERVENTION TO TREAT THE SYMPTOMS PRESENTED BY THE PATIENT ASSOCIATED WITH THE DEVICES. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-MAR-2022: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (AEMPS, REFERENCE NUMBER: (B)(4)) ON 01-MAR-2022. THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('REMOVED BY MEANS OF A BILATERAL LAPAROSCOPIC SALPINGUECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2020, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED), 2 YEARS 9 MONTHS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR MEDICAL DEVICE REMOVAL WITH ESSURE. THE REPORTER COMMENTED: SYMPTOMATIC ESSURES, THEY ARE REMOVED BY MEANS OF A BILATERAL LAPAROSCOPIC SALPINGECTOMY WITH PROVEN COMPLETE EXTRACTION OF BOTH DEVICES NEED FOR SURGICAL INTERVENTION TO TREAT THE SYMPTOMS PRESENTED BY THE PATIENT ASSOCIATED WITH THE DEVICES BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1337989 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |