ESSURE
Report
- Report Number
- 2951250-2023-00570
- Event Type
- Injury
- Date Received
- February 21, 2023
- Date of Event
- January 1, 2012
- Report Date
- July 6, 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 16-FEB-2023. THE MOST RECENT INFORMATION WAS RECEIVED ON 03-JUL-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A 42 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 882189) 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. IN 2012 SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), RASH ("RASH"), FATIGUE ("CHRONIC FATIGUE/ ASTHENIC CONDITION"), ASTHENIA ("ASTHENIC CONDITION"), DERMATITIS ("GENERALISED SKIN INFLAMMATION"), PREMATURE MENOPAUSE ("EARLY MENOPAUSE"), MUCOSAL INFLAMMATION ("MUCOUS MEMBRANE INFLAMMATION"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), VENTRICULAR EXTRASYSTOLES ("PREMATURE VENTRICULAR CONTRACTION"), MUSCULOSKELETAL PAIN ("MUSCULOSKELETAL PAIN"), MUSCULAR WEAKNESS ("MUSCULAR WEAKNESS"), NEUROMUSCULAR PAIN ("NEUROMUSCULAR PAIN"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), FROSTBITE ("FROSTBITE"), MIGRAINE ("MIGRAINE"), DIZZINESS ("DIZZINESS") AND AMNESIA ("LOSS OF MEMORY"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL SCHEDULED WITH TOTAL HYSTERECTOMY ON (B)(6) 2023). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ASTHENIA HAD RESOLVED AND THE RASH, FATIGUE, DERMATITIS, PREMATURE MENOPAUSE, MUCOSAL INFLAMMATION, SYSTEMIC LUPUS ERYTHEMATOSUS, VENTRICULAR EXTRASYSTOLES, MUSCULOSKELETAL PAIN, MUSCULAR WEAKNESS, NEUROMUSCULAR PAIN, URINARY TRACT DISORDER, FROSTBITE, MIGRAINE, DIZZINESS AND AMNESIA HAD NOT RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO PELVIC PAIN, FATIGUE, DERMATITIS, MUCOSAL INFLAMMATION, RASH, SYSTEMIC LUPUS ERYTHEMATOSUS, MUSCULOSKELETAL PAIN, NEUROMUSCULAR PAIN, URINARY TRACT DISORDER, FROSTBITE, MIGRAINE, DIZZINESS, MUSCULAR WEAKNESS, PREMATURE MENOPAUSE, AMNESIA, VENTRICULAR EXTRASYSTOLES OR ASTHENIA. THE REPORTER COMMENTED: PATIENT¿S CURRENT CONDITION: IN ASTHENIC CONDITION, PERMANENT PAIN, PHYSICALLY HANDICAPPED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 KG. LOT NUMBER: 882189, MANUFACTURE DATE: 2011-07, AND EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 03-JUL-2023: EVENT OUTCOME UPDATED TO RECOVERED RESOLVED TO EVENT PELVIC PAIN & ASTHENIA, REMOVAL SURGERY DETAILS ADDED. ANNEX F CODES UPDATED. ACTION TAKEN WITH DRUG ADDED. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW AND REVIEW OF COMPLAINT RECORDS AND RECORDS OF NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4) ON 16-FEB-2023. THE MOST RECENT INFORMATION WAS RECEIVED ON 01-MAR-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A 42 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 882189) 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. IN 2012 SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), RASH ("RASH"), FATIGUE ("CHRONIC FATIGUE/ ASTHENIC CONDITION"), ASTHENIA ("ASTHENIC CONDITION"), DERMATITIS ("GENERALISED SKIN INFLAMMATION"), PREMATURE MENOPAUSE ("EARLY MENOPAUSE"), MUCOSAL INFLAMMATION ("MUCOUS MEMBRANE INFLAMMATION"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), VENTRICULAR EXTRASYSTOLES ("PREMATURE VENTRICULAR CONTRACTION"), MUSCULOSKELETAL PAIN ("MUSCULOSKELETAL PAIN"), MUSCULAR WEAKNESS ("MUSCULAR WEAKNESS"), NEUROMUSCULAR PAIN ("NEUROMUSCULAR PAIN"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), FROSTBITE ("FROSTBITE"), MIGRAINE ("MIGRAINE"), DIZZINESS ("DIZZINESS") AND AMNESIA ("LOSS OF MEMORY"). AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO PELVIC PAIN, FATIGUE, DERMATITIS, MUCOSAL INFLAMMATION, RASH, SYSTEMIC LUPUS ERYTHEMATOSUS, MUSCULOSKELETAL PAIN, NEUROMUSCULAR PAIN, URINARY TRACT DISORDER, FROSTBITE, MIGRAINE, DIZZINESS, MUSCULAR WEAKNESS, PREMATURE MENOPAUSE, AMNESIA, VENTRICULAR EXTRASYSTOLES OR ASTHENIA. THE REPORTER COMMENTED: PATIENT¿S CURRENT CONDITION: IN ASTHENIC CONDITION, PERMANENT PAIN, PHYSICALLY HANDICAPPED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 KG. LOT NUMBER:882189 MANUFACTURE DATE:2011-07 EXPIRATION DATE: 2014-07. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 01-MAR-2023: QUALITY SAFETY EVALUATION OF PTC. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW AND REVIEW OF COMPLAINT RECORDS AND RECORDS OF NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 16-FEB-2023. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN") IN A 42 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 882189) 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. IN 2012 SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), RASH ("RASH"), FATIGUE ("CHRONIC FATIGUE/ ASTHENIC CONDITION"), ASTHENIA ("ASTHENIC CONDITION"), DERMATITIS ("GENERALISED SKIN INFLAMMATION"), PREMATURE MENOPAUSE ("EARLY MENOPAUSE"), MUCOSAL INFLAMMATION ("MUCOUS MEMBRANE INFLAMMATION"), SYSTEMIC LUPUS ERYTHEMATOSUS ("LUPUS"), VENTRICULAR EXTRASYSTOLES ("PREMATURE VENTRICULAR CONTRACTION"), MUSCULOSKELETAL PAIN ("MUSCULOSKELETAL PAIN"), MUSCULAR WEAKNESS ("MUSCULAR WEAKNESS"), NEUROMUSCULAR PAIN ("NEUROMUSCULAR PAIN"), URINARY TRACT DISORDER ("URINARY PROBLEMS"), FROSTBITE ("FROSTBITE"), MIGRAINE ("MIGRAINE"), DIZZINESS ("DIZZINESS") AND AMNESIA ("LOSS OF MEMORY"). AT THE TIME OF THE REPORT, NONE OF THE EVENTS HAD RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO PELVIC PAIN, FATIGUE, DERMATITIS, MUCOSAL INFLAMMATION, RASH, SYSTEMIC LUPUS ERYTHEMATOSUS, MUSCULOSKELETAL PAIN, NEUROMUSCULAR PAIN, URINARY TRACT DISORDER, FROSTBITE, MIGRAINE, DIZZINESS, MUSCULAR WEAKNESS, PREMATURE MENOPAUSE, AMNESIA, VENTRICULAR EXTRASYSTOLES OR ASTHENIA. THE REPORTER COMMENTED: PATIENT¿S CURRENT CONDITION: IN ASTHENIC CONDITION, PERMANENT PAIN, PHYSICALLY HANDICAPPED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 55 KG. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW AND REVIEW OF COMPLAINT RECORDS AND RECORDS OF NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1643274 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 882189 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female | Other| R |