ESSURE
Report
- Report Number
- 2951250-2016-02261
- Event Type
- Injury
- Date Received
- October 19, 2016
- Report Date
- March 31, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN / INCREASINGLY SEVERE PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B30422) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ESSURE AND THERMACHOICE DONE SIMULTANEOUSLY". THE PATIENT'S MEDICAL HISTORY INCLUDED MENORRHAGIA, DYSMENORRHEA, ENDOMETRIOSIS, UTERINE LEIOMYOMA AND ADENOMYOSIS. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("CHRONIC BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), RASH ("EXCESSIVE RASHES"), DISCOMFORT ("DISCOMFORT"), ALOPECIA ("EXCESSIVE HAIR LOSS") AND TOOTH DISORDER ("DENTAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, DYSPAREUNIA, RASH, DISCOMFORT, ALOPECIA AND TOOTH DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DISCOMFORT, DYSPAREUNIA, PELVIC PAIN, RASH AND TOOTH DISORDER TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-MAR-2021: MEDICAL RECORD RECEIVED - LOT NUMBER, REPORTER INFORMATION AND MEDICAL HISTORY ADDED. NEW EVENT ADDED- ESSURE AND THERMACHOICE DONE SIMULTANEOUSLY. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER, AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN/INCREASINGLY SEVERE PAIN'). IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B30422), INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ESSURE AND THERMACHOICE DONE SIMULTANEOUSLY". THE PATIENT'S MEDICAL HISTORY INCLUDED: MENORRHAGIA, DYSMENORRHEA, ENDOMETRIOSIS, UTERINE LEIOMYOMA AND ADENOMYOSIS. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), BACK PAIN ("CHRONIC BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), RASH ("EXCESSIVE RASHES"), DISCOMFORT ("DISCOMFORT"), ALOPECIA ("EXCESSIVE HAIR LOSS") AND TOOTH DISORDER ("DENTAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, BACK PAIN, ABDOMINAL PAIN, DYSPAREUNIA, RASH, DISCOMFORT, ALOPECIA AND TOOTH DISORDER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BACK PAIN, DISCOMFORT, DYSPAREUNIA, PELVIC PAIN, RASH AND TOOTH DISORDER TO BE RELATED TO ESSURE. LOT NUMBER#: B30422, MANUFACTURING DATE: 2013-05, EXPIRATION DATE: 2016-05-31. 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 27-MAR-2021, QUALITY SAFETY EVALUATION OF PTC. 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.
FOLLOW-UP RECEIVED ON 08-NOV-2016: PTC INVESTIGATION RESULT WAS PROVIDED. (B)(4). QUALITY SAFETY EVALUATION OF PTC: NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. 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. 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. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. COMPANY CAUSALITY COMMENT: THIS CASE REPORT RECEIVED FROM A LAWYER ON BEHALF OF AN ADULT FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED CHRONIC PELVIC PAIN (INCREASINGLY SEVERE PAIN). TWO (2) YEARS AND 10 MONTHS AFTER PLACEMENT, HYSTERECTOMY WAS PERFORMED TO REMOVE THE DEVICES. THIS EVENT IS ANTICIPATED ACCORDING TO REFERENCE SAFETY INFORMATION FOR ESSURE. ABDOMINAL AND PELVIC PAIN MAY OCCUR DURING ESSURE USE. CONSIDERING THE ABSENCE OF ALTERNATIVE EXPLANATION AND ITS NATURE, CAUSAL RELATIONSHIP BETWEEN THIS EVENT AND ESSURE USE CANNOT BE EXCLUDED. SINCE DEVICE REMOVAL WAS REQUIRED, THIS CASE IS REGARDED AS INCIDENT. OTHER NON-SERIOUS EVENTS WERE REPORTED. PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE, A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A LAWYER IN THE UNITED STATES, ON BEHALF OF A PLAINTIFF IN UNITED STATES ON 23-SEP-2016 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2013 FOR PERMANENT STERILIZATION. CONSUMER'S POST-PROCEDURE PERIOD HAS BEEN MARKED BY INCREASINGLY SEVERE PAIN AND DISCOMFORT, INCLUDING CHRONIC PELVIC PAIN, CHRONIC BACK PAIN, ABDOMINAL PAIN, EXCESSIVE HAIR LOSS, PAIN DURING INTERCOURSE, EXCESSIVE RASHES, AND DENTAL PROBLEMS. SHE NEVER EXPERIENCED ANY OF THESE CONDITIONS PRIOR TO UNDERGOING THE ESSURE PROCEDURE. ON (B)(6) 2016, HYSTERECTOMY WAS PERFORMED TO REMOVE HER ESSURE. SHE IS PREVENTED FROM PRACTICING AND ENJOYING THE ACTIVITIES OF DAILY LIFE SHE ENJOYED PRE-OPERATIVELY, AND SHE HAS OTHERWISE SUFFERED SERIOUS AND PERMANENT INJURIES. COMPANY CAUSALITY COMMENT: THIS CASE REPORT RECEIVED FROM A LAWYER ON BEHALF OF AN ADULT FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED CHRONIC PELVIC PAIN (INCREASINGLY SEVERE PAIN). 2 YEARS AND 10 MONTHS AFTER PLACEMENT, HYSTERECTOMY WAS PERFORMED TO REMOVE THE DEVICES. THIS EVENT IS ANTICIPATED ACCORDING TO REFERENCE SAFETY INFORMATION FOR ESSURE. ABDOMINAL AND PELVIC PAIN MAY OCCUR DURING ESSURE USE. CONSIDERING THE ABSENCE OF ALTERNATIVE EXPLANATION AND ITS NATURE, CAUSAL RELATIONSHIP BETWEEN THIS EVENT AND ESSURE USE CANNOT BE EXCLUDED. SINCE DEVICE REMOVAL WAS REQUIRED, THIS CASE IS REGARDED AS INCIDENT. OTHER NON-SERIOUS EVENTS WERE REPORTED. FURTHER INFORMATION WILL BE OBTAINED THROUGH LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 690540 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B30422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |