ESSURE
Report
- Report Number
- 2951250-2019-05574
- Event Type
- Injury
- Date Received
- September 6, 2019
- Report Date
- February 15, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRIOSIS. CONCURRENT CONDITIONS INCLUDED CERVICITIS, UTERINE BLEEDING AND PELVIC CONGESTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL),SALPING. (BILATERAL)/LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA, FATIGUE, WEIGHT INCREASED, UTERINE LEIOMYOMA AND ABDOMINAL DISTENSION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, FATIGUE, MENORRHAGIA, PELVIC PAIN, UTERINE LEIOMYOMA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), FATIGUE, WEIGHT GAIN, FIBROIDS, BLOATING. ESSURE REMOVAL DATE PROVIDED IN PIF: (B)(6) 2016. TRAILING COILS: RIGHT: THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 2. LEFT: THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 2. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, UTERINE LEIOMYOMA. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-FEB-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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED ENDOMETRIOSIS. CONCURRENT CONDITIONS INCLUDED CERVICITIS, UTERINE BLEEDING AND PELVIC CONGESTION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL),SALPING. (BILATERAL)/LAPAROSCOPICALLY-ASSISTED VAGINAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA, FATIGUE, WEIGHT INCREASED, UTERINE LEIOMYOMA AND ABDOMINAL DISTENSION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, FATIGUE, MENORRHAGIA, PELVIC PAIN, UTERINE LEIOMYOMA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), FATIGUE, WEIGHT GAIN, FIBROIDS, BLOATING. ESSURE REMOVAL DATE PROVIDED IN PIF : (B)(6) 2016. TRAILING COILS: RIGHT: THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 2. LEFT: THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 2. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: MENORRHAGIA, UTERINE LEIOMYOMA . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-FEB-2021: MR RECEIVED. REPORTER INFORMATION, PATIENT'S MEDICAL HISTORY, LOT NUMBER, AUTO NARRATIVE SUPPLEMENT WERE ADDED. RCC WERE UPDATED. 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 ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO CONFIRMATION TEST". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), FATIGUE ("FATIGUE") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND UTERINE LEIOMYOMA ("FIBROIDS"). THE PATIENT WAS TREATED WITH SURGERY (HYST. (FULL), SALPING. (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA, FATIGUE, WEIGHT INCREASED, UTERINE LEIOMYOMA AND ABDOMINAL DISTENSION HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, FATIGUE, MENORRHAGIA, PELVIC PAIN, UTERINE LEIOMYOMA AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), FATIGUE, WEIGHT GAIN, FIBROIDS, BLOATING. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED. REPORTER INFORMATION UPDATED. CASE IS INCIDENT. PREVIOUSLY REPORTED EVENT INJURY IS REPLACED WITH NEW EVENTS: PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), FATIGUE, WEIGHT GAIN, FIBROIDS, BLOATING, SHE DID NOT UNDERGO CONFIRMATION TEST. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 |
|---|---|---|---|---|---|---|---|
| 762091 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880433 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |