ESSURE
Report
- Report Number
- 2951250-2022-00616
- Event Type
- Injury
- Date Received
- May 31, 2022
- Date of Event
- January 1, 2012
- Report Date
- November 14, 2022
- 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 AFSSAPS (REFERENCE NUMBER: (B)(4)) ON 25-MAY-2022. THE MOST RECENT INFORMATION WAS RECEIVED ON 09-NOV-2022. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("HEMORRHAGIC PERIODS") AND ANKYLOSING SPONDYLITIS ("ANKYLOSING SPONDYLITIS") IN A 39 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 31 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION INTERVENTION REQUIRED), FATIGUE ("CHRONIC FATIGUE SINCE INSERTION"), VISUAL IMPAIRMENT ("DECREASED VISION") AND MUSCULOSKELETAL PAIN ("JOINT AND MUSCLE PAIN"). IN (B)(6) 2019 SHE EXPERIENCED ANKYLOSING SPONDYLITIS (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). ESSURE WAS REMOVED ON (B)(6) 2019. AN UNKNOWN TIME LATER SHE EXPERIENCED ADENOMYOSIS ("ADENOMYOSIS"), ENDOMETRIOSIS ("ENDOMETRIOSIS"), MIGRAINE ("MIGRAINE") AND AMNESIA ("MEMORY LOSS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND SALPINGECTOMY IN (B)(6) 2019). AT THE TIME OF THE REPORT, THE FATIGUE, VISUAL IMPAIRMENT AND MUSCULOSKELETAL PAIN HAD NOT RESOLVED. THE OUTCOME OF HEAVY MENSTRUAL BLEEDING WAS UNKNOWN. THE REPORTER CONSIDERED ADENOMYOSIS, AMNESIA, ANKYLOSING SPONDYLITIS, ENDOMETRIOSIS AND MIGRAINE TO BE RELATED TO ESSURE ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO HEAVY MENSTRUAL BLEEDING, FATIGUE, VISUAL IMPAIRMENT OR MUSCULOSKELETAL PAIN. THE REPORTER COMMENTED: DAYS PUNCTUATED BY PAIN, A SPA REPORTED IN (B)(6) 2019. NUMEROUS SYMPTOMS STILL PRESENT DESPITE A HYSTERECTOMY SALPINGECTOMY UNDERGONE IN (B)(6) 2019. SOME IMPROVEMENTS SINCE BUT A LOT OF AGGRAVATION WHICH LED TO STOPPING WORK A YEAR AGO. ESSURE INSERTION DATE ALSO REPORTED ON (B)(6) 2012. MEDICAL WANDERING SINCE 2012, ON LONG TERM SICK LEAVE SINCE (B)(6) 2021. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 43 KG. 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: 09-NOV-2022: EVENTS ADDED: ADENOMYOSIS, ENDOMETRIOSIS, MIGRAINE, MEMORY LOSS. RCC UPDATED. 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 AFSSAPS (REFERENCE NUMBER: (B)(4)) ON 25-MAY-2022. THE MOST RECENT INFORMATION WAS RECEIVED ON 07-JUN-2022. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("HEMORRHAGIC PERIODS") IN A 39 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 31 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION INTERVENTION REQUIRED), FATIGUE ("CHRONIC FATIGUE SINCE INSERTION"), VISUAL IMPAIRMENT ("DECREASED VISION") AND MUSCULOSKELETAL PAIN ("JOINT AND MUSCLE PAIN"). ESSURE WAS REMOVED ON (B)(6) 2019. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND SALPINGECTOMY IN (B)(6) 2019). AT THE TIME OF THE REPORT, THE FATIGUE, VISUAL IMPAIRMENT AND MUSCULOSKELETAL PAIN HAD NOT RESOLVED. THE OUTCOME OF HEAVY MENSTRUAL BLEEDING WAS UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO HEAVY MENSTRUAL BLEEDING, FATIGUE, VISUAL IMPAIRMENT OR MUSCULOSKELETAL PAIN. THE REPORTER COMMENTED: DAYS PUNCTUATED BY PAIN, A SPA REPORTED IN (B)(6) 2019. NUMEROUS SYMPTOMS STILL PRESENT DESPITE A HYSTERECTOMY SALPINGECTOMY UNDERGONE IN (B)(6) 2019. SOME IMPROVEMENTS SINCE BUT A LOT OF AGGRAVATION WHICH LED TO STOPPING WORK A YEAR AGO. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 43 KG. 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: 07-JUN-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.
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY AFSSAPS (REFERENCE NUMBER: (B)(4)) ON (B)(6) 2022. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF HEAVY MENSTRUAL BLEEDING ("HEMORRHAGIC PERIODS") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 31 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED HEAVY MENSTRUAL BLEEDING (SERIOUSNESS CRITERION INTERVENTION REQUIRED), FATIGUE ("CHRONIC FATIGUE SINCE INSERTION"), VISUAL IMPAIRMENT ("DECREASED VISION") AND MUSCULOSKELETAL PAIN ("JOINT AND MUSCLE PAIN"). ESSURE WAS REMOVED ON (B)(6) 2019. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND SALPINGECTOMY IN (B)(6) 2019). AT THE TIME OF THE REPORT, THE FATIGUE, VISUAL IMPAIRMENT AND MUSCULOSKELETAL PAIN HAD NOT RESOLVED. THE OUTCOME OF HEAVY MENSTRUAL BLEEDING WAS UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO HEAVY MENSTRUAL BLEEDING, FATIGUE, VISUAL IMPAIRMENT OR MUSCULOSKELETAL PAIN. THE REPORTER COMMENTED: DAYS PUNCTUATED BY PAIN, A SPA REPORTED IN (B)(6) 2019. NUMEROUS SYMPTOMS STILL PRESENT DESPITE A HYSTERECTOMY SALPINGECTOMY UNDERGONE IN (B)(6) 2019. SOME IMPROVEMENTS SINCE BUT A LOT OF AGGRAVATION WHICH LED TO STOPPING WORK A YEAR AGO. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE (B)(6). 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 |
|---|---|---|---|---|---|---|---|
| 2679660 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female | Required Intervention |