ESSURE
Report
- Report Number
- 2951250-2017-00628
- Event Type
- Injury
- Date Received
- February 21, 2017
- Date of Event
- January 28, 2017
- Report Date
- March 14, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- 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: R1701091, R1903437) ON 31-JAN-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 07-FEB-2019.) THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ("PATCH TESTS POSITIVE TO CHROMIUM, NICKEL AND COBALT") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: C68116) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN 2015, THE PATIENT EXPERIENCED MUSCULOSKELETAL PAIN ("JOINT AND MUSCLE PAIN"), HOT FLUSH ("HOT FLUSHES"), PALPITATIONS ("PALPITATIONS"), MIDDLE INSOMNIA ("WAKING UP AT NIGHT"), EAR DISORDER ("ROTATORY ENT (EAR, NOSE AND THROAT) DISTURBANCES"), NASAL DISORDER ("ROTATORY ENT (EAR, NOSE AND THROAT) DISTURBANCES"), PHARYNGEAL DISORDER ("ROTATORY ENT (EAR, NOSE AND THROAT) DISTURBANCES"), SPEECH DISORDER ("SPEECH DISTURBANCES"), MEMORY IMPAIRMENT ("MEMORY DISTURBANCES"), LIMB DISCOMFORT ("HEAVINESS IN LEGS") AND LOSS OF LIBIDO ("LOSS OF LIBIDO"). ON (B)(6) 2017, THE PATIENT EXPERIENCED STRESS ("PSYCHOLOGICALLY EXHAUSTED BY THIS DEMANDING PROCEDURE"), 1 YEAR 11 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, MUSCULOSKELETAL PAIN, HOT FLUSH, PALPITATIONS, MIDDLE INSOMNIA, EAR DISORDER, NASAL DISORDER, PHARYNGEAL DISORDER, SPEECH DISORDER, MEMORY IMPAIRMENT, LIMB DISCOMFORT, LOSS OF LIBIDO AND STRESS OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR EAR DISORDER, HOT FLUSH, LIMB DISCOMFORT, LOSS OF LIBIDO, MEMORY IMPAIRMENT, MIDDLE INSOMNIA, MUSCULOSKELETAL PAIN, NASAL DISORDER, PALPITATIONS, PHARYNGEAL DISORDER AND SPEECH DISORDER WITH ESSURE. THE REPORTER CONSIDERED ALLERGY TO METALS AND STRESS TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST: ON (B)(6) 2017: 3 PATCH TESTS (CHROMIUM, NICKEL AND COBALT). RESULTS OF THESE 3 TESTS WERE POSITIVE AT 48 HOURS AND 72 HOURS: CHROMIUM (+), NICKEL (++) AND COBALT (++), THIS GIVE EVIDENCE OF SENSITIVITY TO THESE 3 METALS. QUALITY-SAFETY EVALUATION OF PTC: LOT NUMBER: C68116, PRODUCTION DATE: 17-JUN-2014, EXPIRATION DATE: 30-JUN-2017. SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MED DRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY, CONSUMER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-FEB-2019: AFTER REVIEW AND CONFIRMATION FROM FRENCH HEALTH AUTHORITY, CASE: (B)(4) WAS FOUND TO BE A DUPLICATE OF THIS CASE AND THEREFORE CASE:(B)(4) WILL BE DELETED FROM BAYER DATABASE; ALL ITS CONTENT WAS TRANSFERRED TO THIS REMAINING CASE: (B)(4). ESSURE TREATMENT DATES WERE ADDED (INSERTION AND REMOVAL). NEW EVENTS WERE ALSO PROVIDED: METAL ALLERGY AND STRESS. WE RECEIVED A LOT NUMBER IN THIS CASE. 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.
THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4)) ON 31-JAN-2017. THE MOST RECENT INFORMATION WAS RECEIVED ON 08-MAR-2019. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ("PATCH TESTS POSITIVE TO CHROMIUM, NICKEL AND COBALT") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. C68116) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, C-SECTION AND MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED OBESITY. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. IN 2015, THE PATIENT EXPERIENCED MUSCULOSKELETAL PAIN ("JOINT AND MUSCLE PAIN"), HOT FLUSH ("HOT FLUSHES"), PALPITATIONS ("PALPITATIONS"), MIDDLE INSOMNIA ("WAKING UP AT NIGHT/ INSOMNIA"), EAR DISORDER ("ROTATORY ENT (EAR, NOSE AND THROAT) DISTURBANCES"), NASAL DISORDER ("ROTATORY ENT (EAR, NOSE AND THROAT) DISTURBANCES"), PHARYNGEAL DISORDER ("ROTATORY ENT (EAR, NOSE AND THROAT) DISTURBANCES"), SPEECH DISORDER ("SPEECH DISTURBANCES"), MEMORY IMPAIRMENT ("MEMORY DISTURBANCES"), LIMB DISCOMFORT ("HEAVINESS IN LEGS") AND LOSS OF LIBIDO ("LOSS OF LIBIDO"). ON (B)(6) 2017, THE PATIENT EXPERIENCED STRESS ("PSYCHOLOGICALLY EXHAUSTED BY THIS DEMANDING PROCEDURE"), 1 YEAR 11 MONTHS AFTER INSERTION OF ESSURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED TACHYCARDIA ("TACHYCARDIA"), VERTIGO ("ROTATORY VERTIGO"), TENDONITIS ("TENDONITIS"), SPINAL PAIN ("RACHIS PAIN"), ADENOMYOSIS ("SLIGHT SIGNS OF ADENOMYOSIS ON ULTRASOUND") AND UTERINE DISORDER ("ISTHMOCELE"). THE PATIENT WAS TREATED WITH SURGERY (INTERADNEXIAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY VIA LAPARSCOPY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE ALLERGY TO METALS, MUSCULOSKELETAL PAIN, HOT FLUSH, PALPITATIONS, MIDDLE INSOMNIA, EAR DISORDER, NASAL DISORDER, PHARYNGEAL DISORDER, SPEECH DISORDER, MEMORY IMPAIRMENT, LIMB DISCOMFORT, LOSS OF LIBIDO, STRESS, TACHYCARDIA, VERTIGO, TENDONITIS, SPINAL PAIN, ADENOMYOSIS AND UTERINE DISORDER OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR EAR DISORDER, HOT FLUSH, LIMB DISCOMFORT, LOSS OF LIBIDO, MEMORY IMPAIRMENT, MIDDLE INSOMNIA, MUSCULOSKELETAL PAIN, NASAL DISORDER, PHARYNGEAL DISORDER AND SPEECH DISORDER WITH ESSURE. THE REPORTER CONSIDERED ADENOMYOSIS, ALLERGY TO METALS, PALPITATIONS, SPINAL PAIN, STRESS, TACHYCARDIA, TENDONITIS, UTERINE DISORDER AND VERTIGO TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ON (B)(6) 2015, INSERTION OF ESSURE HAD BEEN PERFORMED: 4 TRAILING COILS ON LEFT AND 6 ON RIGHT. REMOVAL OF ESSURE WAS PERFORMED ON (B)(6) 2017 WITH INTERADNEXIAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY VIA LAPAROSCOPY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ALLERGY TEST - ON (B)(6) 2017: 3 PATCH TESTS (CHROMIUM, NICKEL AND COBALT). RESULTS OF THESE 3 TESTS WERE POSITIVE AT 48 HOURS AND 72 HOURS: CHROMIUM (+), NICKEL (++) AND COBALT (++), THIS GIVE EVIDENCE OF SENSITIVITY TO THESE 3 METALS. ULTRASOUND ABDOMEN - ON AN UNKNOWN DATE: INSERT IN CORRECT POSITION; ON (B)(6) 2017: SLIGHT SIGNS OF ADENOMYOSIS. ULTRASOUND SCAN - ON AN UNKNOWN DATE: COMPLETE REMOVAL OF ESSURE INSERTS CONFIRMED. QUALITY-SAFETY EVALUATION OF PTC: LOT NUMBER: C68116 - PRODUCTION DATE: 17-JUN-2014 - EXPIRATION DATE: 30-JUN-2017 SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MED DRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. FURTHER COMPANY FOLLOW-UP WITH THE REGULATORY AUTHORITY, CONSUMER OR LAWYER IS NOT POSSIBLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-MAR-2019: PATIENT'S RELEVANT HISTORY AND LAB TESTS WERE ADDED; INSERTION AND REMOVAL DATE OF DEVICE WERE UPDATED. NEW EVENTS ADDED: TACHYCARDIA, ROTATORY VERTIGO, TENDONITIS, RACHIS PAIN, SLIGHT SIGNS OF ADENOMYOSIS ON ULTRASOUND AND ISTHIMOCELE. WE RECEIVED A LOT NUMBER IN THIS CASE. 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.
QUALITY-SAFETY EVALUATION OF PTC: LOT NUMBER: C68116 - PRODUCTION DATE: 17-JUN-2014 - EXPIRATION DATE: 30-JUN-2017. SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MED DRA LLT CAN BE PROVIDED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-MAR-2017: QUALITY SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: A FEMALE CONSUMER HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED MUSCLE PAIN. A SALPINGECTOMY WAS PLANNED. MUSCLE PAIN IS REGARDED AS UNANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. THE MOST COMMON CAUSES OF MUSCLE PAIN ARE TENSION, STRESS, OVERUSE AND MINOR INJURIES. AS THIS CASE WAS REPORTED WITH LIMITED INFORMATION, IN LINE WITH HEALTH AUTHORITY'S ASSESSMENT, COMPANY CONSIDERS THIS CASE AS INCIDENT. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE.
THIS CASE WAS REPORTED VIA (B)(4) (REFERENCE NUMBER: (B)(4)) ON 31-JAN-2017. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF MYALGIA ("MUSCLE PAIN") IN A FEMALE PATIENT WHO RECEIVED ESSURE (BATCH NO. C68116). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT STARTED ESSURE. ON (B)(6) 2015, THE PATIENT EXPERIENCED MYALGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), HOT FLUSH ("HOT FLUSHES"), PALPITATIONS ("PALPITATIONS"), MIDDLE INSOMNIA ("WAKING UP AT NIGHT"), EAR DISORDER ("ROTATORY ENT (EAR, NOSE AND THROAT) DISTURBANCES"), NASAL DISORDER ("ROTATORY ENT (EAR, NOSE AND THROAT) DISTURBANCES"), PHARYNGEAL DISORDER ("ROTATORY ENT (EAR, NOSE AND THROAT) DISTURBANCES"), SPEECH DISORDER ("SPEECH DISTURBANCES"), MEMORY IMPAIRMENT ("MEMORY DISTURBANCES"), LIMB DISCOMFORT ("HEAVINESS IN LEGS"), LOSS OF LIBIDO ("LOSS OF LIBIDO") AND ARTHRALGIA ("JOINT PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY PLANNED FOR (B)(6) 2017). AT THE TIME OF THE REPORT, THE MYALGIA, HOT FLUSH, PALPITATIONS, MIDDLE INSOMNIA, EAR DISORDER, NASAL DISORDER, PHARYNGEAL DISORDER, SPEECH DISORDER, MEMORY IMPAIRMENT, LIMB DISCOMFORT, LOSS OF LIBIDO AND ARTHRALGIA OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR MYALGIA, HOT FLUSH, PALPITATIONS, MIDDLE INSOMNIA, EAR DISORDER, NASAL DISORDER, PHARYNGEAL DISORDER, SPEECH DISORDER, MEMORY IMPAIRMENT, LIMB DISCOMFORT, LOSS OF LIBIDO AND ARTHRALGIA WITH ESSURE. COMPANY CAUSALITY COMMENT: A FEMALE CONSUMER HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED MUSCLE PAIN. A SALPINGECTOMY WAS PLANNED. MUSCLE PAIN IS REGARDED AS UNANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. THE MOST COMMON CAUSES OF MUSCLE PAIN ARE TENSION, STRESS, OVERUSE AND MINOR INJURIES. AS THIS CASE WAS REPORTED WITH LIMITED INFORMATION, IN LINE WITH HEALTH AUTHORITY'S ASSESSMENT, COMPANY CONSIDERS THIS CASE AS INCIDENT. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128899 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C68116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other| R |