ESSURE
Report
- Report Number
- 2951250-2021-00438
- Event Type
- Injury
- Date Received
- February 4, 2021
- Date of Event
- June 1, 2014
- Report Date
- April 11, 2023
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 01-FEB-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 06-APR-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ("PERMANENT RIGHT SUBCOSTAL PAIN (WITH 3 CRISIS PERIODS OF TEN DAYS EACH TIME)") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. B44011). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, 164 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), EPIGASTRIC DISCOMFORT ("INCREASE IN GASTRIC PROBLEMS / INCREASED GASTRIC DISCOMFORT") AND HAEMORRHOIDS ("HAEMORRHOIDS"). ESSURE WAS REMOVED ON (B)(6) 2021. IN 2021 SHE EXPERIENCED TINNITUS ("BUZZING IN THE LEFT EAR"), HEADACHE ("HEADACHES"), BALANCE DISORDER ("LOSS OF BALANCE") AND VISUAL IMPAIRMENT ("LEFT-EYE VISION IMPAIRMENT"). AN UNKNOWN TIME LATER SHE EXPERIENCED BRAIN OEDEMA ("CEREBRAL OEDEMA") AND WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS") AND BRAIN NEOPLASM ("BRAIN TUMOUR"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). AT THE TIME OF THE REPORT, THE BACK PAIN, EPIGASTRIC DISCOMFORT, HAEMORRHOIDS AND UTERINE LEIOMYOMA HAD NOT RESOLVED. THE REPORTER CONSIDERED BACK PAIN, EPIGASTRIC DISCOMFORT, HAEMORRHOIDS AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO TINNITUS, HEADACHE, BALANCE DISORDER, VISUAL IMPAIRMENT, BRAIN OEDEMA OR BRAIN NEOPLASM. THE REPORTER COMMENTED: THE PATIENT HAS ONLY ONE ESSURE (RIGHT SIDE) INSERTED AND ON THE LEFT SIDE, SHE UNDERWENT A LIGATION UNDER LAPAROSCOPY. DIAGNOSIS IN (B)(6) 2023 UNDER MRI EXAMINATION FOR: CEREBRAL OEDEMA BRAIN TUMOUR (VENTRICULAR). SUSPICION OF A CAUSE-AND-EFFECT RELATIONSHIP BETWEEN THE REMOVAL OF THE MD (MEDICAL DEVICE) AND THE BRAIN TUMOUR / OEDEMA; REMOVAL RELEASED THE IMPLANT¿S STABILIZING COMPOUNDS (ORGANOTINS). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [MAGNETIC RESONANCE IMAGING] IN (B)(6) 2023: CEREBRAL OEDEMA, BRAIN TUMOUR (VENTRICULAR). BATCH NO: B44011. PRODUCTION DATE: 2013-06-24. EXPIRATION DATE: 2016-06-30. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: UNABLE TO CONFIRM COMPLAINT. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 06-APR-2023: EVENTS BUZZING IN THE LEFT EAR, HEADACHE, LEFT-EYE VISION IMPAIRMENT , CEREBRAL EDEMA & BRAIN TUMOR ADDED. LAB DATA ADDED. ESSURE REMOVAL DETAILS ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4) ON (B)(6) 2021. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2021. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('PERMANENT RIGHT SUBCOSTAL PAIN (WITH 3 CRISIS PERIODS OF TEN DAYS EACH TIME)') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B44011) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), EPIGASTRIC DISCOMFORT ("INCREASE IN GASTRIC PROBLEMS / INCREASED GASTRIC DISCOMFORT") AND HAEMORRHOIDS ("HAEMORRHOIDS"), 5 MONTHS 14 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE BACK PAIN, EPIGASTRIC DISCOMFORT, HAEMORRHOIDS AND UTERINE LEIOMYOMA HAD NOT RESOLVED. THE REPORTER CONSIDERED BACK PAIN, EPIGASTRIC DISCOMFORT, HAEMORRHOIDS AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT HAS ONLY ONE ESSURE (RIGHT SIDE) INSERTED AND ON THE LEFT SIDE, SHE UNDERWENT A LIGATION UNDER LAPAROSCOPY. BATCH NO B44011 PRODUCTION DATE 2013-06-24 EXPIRATION DATE 2016-06-30 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-FEB-2021: QUALITY-SAFETY EVALUATION OF PTC WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ((B)(6), REFERENCE NUMBER: (B)(4)) ON 01-FEB-2021. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BACK PAIN ('PERMANENT RIGHT SUBCOSTAL PAIN (WITH 3 CRISIS PERIODS OF TEN DAYS EACH TIME)') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B44011) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED BACK PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GASTRIC DISORDER ("INCREASE IN GASTRIC PROBLEMS / INCREASED GASTRIC DISCOMFORT") AND HAEMORRHOIDS ("HAEMORRHOIDS"), 5 MONTHS 14 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE UTERINE LEIOMYOMA ("FIBROIDS"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE BACK PAIN, GASTRIC DISORDER, HAEMORRHOIDS AND UTERINE LEIOMYOMA HAD NOT RESOLVED. THE REPORTER CONSIDERED BACK PAIN, GASTRIC DISORDER, HAEMORRHOIDS AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REPORTED THAT THE PATIENT HAS ONLY ONE ESSURE (RIGHT SIDE) INSERTED AND ON THE LEFT SIDE, SHE UNDERWENT A LIGATION UNDER LAPAROSCOPY. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 179274 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B44011 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female | Other| R |