ESSURE
Report
- Report Number
- 2951250-2021-03401
- Event Type
- Injury
- Date Received
- October 14, 2021
- Date of Event
- January 1, 2014
- Report Date
- October 22, 2021
- 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
Narratives
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4)) ON 13-OCT-2021. THE MOST RECENT INFORMATION WAS RECEIVED ON 22-OCT-2021. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 932158) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("LUMBAR PAIN"), TENDONITIS ("TENDINITIS"), HEADACHE ("HEADACHE"), VISION BLURRED ("BLURRED VISION"), SKIN DISORDER ("SKIN PROBLEMS"), MUSCULOSKELETAL PAIN ("JOINT AND MUSCLE PAIN"), TOOTHACHE ("TOOTHACHE"), DIZZINESS ("DIZZINESS"), FATIGUE ("CHRONIC FATIGUE"), EAR PRURITUS ("ITCHING OF THE EAR CANAL"), EYE IRRITATION ("BURNING EYES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), BURNING SENSATION ("BURNING SENSATION IN THE BODY") AND ECZEMA ("ECZEMA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND HEART RATE ABNORMAL ("HEART RATE DISORDER"), 1 YEAR 3 MONTHS AFTER INSERTION OF ESSURE. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, TENDONITIS, HEADACHE, VISION BLURRED, SKIN DISORDER, MUSCULOSKELETAL PAIN, WEIGHT INCREASED, TOOTHACHE, DIZZINESS, FATIGUE, EAR PRURITUS, EYE IRRITATION, VAGINAL DISCHARGE, HEART RATE ABNORMAL, ABDOMINAL PAIN UPPER, BURNING SENSATION AND ECZEMA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN UPPER, BACK PAIN, BURNING SENSATION, DIZZINESS, EAR PRURITUS, ECZEMA, EYE IRRITATION, FATIGUE, HEADACHE, HEART RATE ABNORMAL, MUSCULOSKELETAL PAIN, PELVIC PAIN, SKIN DISORDER, TENDONITIS, TOOTHACHE, VAGINAL DISCHARGE, VISION BLURRED AND WEIGHT INCREASED WITH ESSURE. THE REPORTER COMMENTED: NUMEROUS PAINS THAT PERSIST AND WORSEN, PATIENT IS WAITING TO HAVE THE ESSURE REMOVED. LOT NUMBER:932158 MANUFACTURING DATE:2011-12 EXPIRATION DATE: 2014-12. QUALITY-SAFETY EVALUATION OF PTC: 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-OCT-2021: QUALITY SAFETY EVALUATION OF PTC. 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 13-OCT-2021. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 932158) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), BACK PAIN ("LUMBAR PAIN"), TENDONITIS ("TENDINITIS"), HEADACHE ("HEADACHE"), VISION BLURRED ("BLURRED VISION"), SKIN DISORDER ("SKIN PROBLEMS"), MUSCULOSKELETAL PAIN ("JOINT AND MUSCLE PAIN"), TOOTHACHE ("TOOTHACHE"), DIZZINESS ("DIZZINESS"), FATIGUE ("CHRONIC FATIGUE"), EAR PRURITUS ("ITCHING OF THE EAR CANAL"), EYE IRRITATION ("BURNING EYES"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), ABDOMINAL PAIN UPPER ("STOMACH PAIN"), BURNING SENSATION ("BURNING SENSATION IN THE BODY") AND ECZEMA ("ECZEMA") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND HEART RATE ABNORMAL ("HEART RATE DISORDER"), 1 YEAR 3 MONTHS AFTER INSERTION OF ESSURE. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, TENDONITIS, HEADACHE, VISION BLURRED, SKIN DISORDER, MUSCULOSKELETAL PAIN, WEIGHT INCREASED, TOOTHACHE, DIZZINESS, FATIGUE, EAR PRURITUS, EYE IRRITATION, VAGINAL DISCHARGE, HEART RATE ABNORMAL, ABDOMINAL PAIN UPPER, BURNING SENSATION AND ECZEMA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL PAIN UPPER, BACK PAIN, BURNING SENSATION, DIZZINESS, EAR PRURITUS, ECZEMA, EYE IRRITATION, FATIGUE, HEADACHE, HEART RATE ABNORMAL, MUSCULOSKELETAL PAIN, PELVIC PAIN, SKIN DISORDER, TENDONITIS, TOOTHACHE, VAGINAL DISCHARGE, VISION BLURRED AND WEIGHT INCREASED WITH ESSURE. THE REPORTER COMMENTED: NUMEROUS PAINS THAT PERSIST AND WORSEN, PATIENT IS WAITING TO HAVE THE ESSURE REMOVED. 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 |
|---|---|---|---|---|---|---|---|
| 1528417 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 932158 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |