ESSURE
Report
- Report Number
- 2951250-2018-04733
- Event Type
- Injury
- Date Received
- November 15, 2018
- Report Date
- November 29, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PROGRESSIVELY WORSENING PELVIC CRAMPING") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. LITERATURE REFERENCE: SILLS ES, RICKERS NS, LI X, SURGICAL MANAGEMENT AFTER HYSTEROSCOPIC STERILIZATION: MINIMALLY INVASIVE APPROACH INCORPORATING INTRAOPERATIVE FLUOROSCOPY FOR SYMPTOMATIC PATIENTS WITH >2 ESSURE® DEVICES, SURGICAL TECHNOLOGY INTERNATIONAL, 2018, 21:156-161. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: WRONG TECHNIQUE IN DEVICE USAGE PROCESS "SURGEON CUT THIS "DANGLING WIRE" WITH HYSTEROSCOPIC SCISSORS", DEVICE INEFFECTIVE "LEFT TUBE WAS NOT FULLY OCCLUDED" AND DEVICE DEPLOYMENT ISSUE "INCOMPLETE PASSAGE OF THE EXTRA DEVICE THROUGH THE LEFT TUBE". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND MULTIPAROUS. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("FATIGUE") AND BACK PAIN ("SEVERE BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE DEVICES AND BILATERAL PARTIAL SALPINGECTOMY.). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FATIGUE AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR BACK PAIN, FATIGUE AND PELVIC PAIN WITH ESSURE. THE REPORTER COMMENTED: SECOND ESSURE PROCEDURE WAS DONE IN (B)(6) 2013. THIS ADDITIONAL PROCEDURE WAS CHARACTERIZED BY INCOMPLETE PASSAGE OF THE EXTRA DEVICE THROUGH THE LEFT TUBE (WHERE A PREVIOUS ATTEMPT TO PLACE A DEVICE HAD ALREADY BEEN MADE). THE MEDIAL ASPECT OF THE AFTERCOMING ESSURE THEREFORE COULD NOT BE FULLY ADVANCED, RESULTING IN PART OF THE DEVICE EXTENDING INTO THE UTERINE COMPARTMENT. THE SURGEON CUT THIS "DANGLING WIRE" WITH HYSTEROSCOPIC SCISSORS, APPARENTLY ATTEMPTING TO NORMALIZE THE ENDOMETRIAL CAVITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN 2013: RESULTS: LEFT TUBE WAS NOT OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. OBJECTIVE: TO DESCRIBE A NON-HYSTERECTOMY SURGICAL TECHNIQUE FOR SYMPTOMATIC PATIENTS WITH MORE THAN 2 DEVICES. DESIGN: PATIENTS (N=4) PRESENTED WITH SHARP PELVIC PAIN, IRREGULAR VAGINAL BLEEDING, DYSPAREUNIA, WEIGHT GAIN, HAIR LOSS, FATIGUE, AND/OR DIFFUSE SKIN RASH, ALL OF WHICH WERE ABSENT BEFORE UNDERGOING HYSTEROSCOPIC STERILIZATION (HS). HYSTEROSALPINGOGRAM OBTAINED BEFORE SURGICAL EXCISION OF CONTRACEPTIVE TUBAL IMPLANTS CONFIRMED MORE THAN TWO ESSURE DEVICES IN ALL PATIENTS. EXCEPT FOR HS-ASSOCIATED COMPLAINTS, ALL PATIENTS WERE IN OTHERWISE GOOD GENERAL HEALTH AND NONE HAD ANY HISTORY OF PRIOR PELVIC PATHOLOGY. HYSTEROSCOPY WAS FOLLOWED BY 5MM TRIPLE-PORT LAPAROSCOPIC CORNUAL DISSECTION, MODIFIED PARTIAL BILATERAL SALPINGECTOMY, AND FOREIGN BODY REMOVAL UNDER FLUOROSCOPY AND/OR RADIOGRAPHIC GUIDANCE. RESULTS: IN THIS GROUP, MEAN±SD PATIENT AGE WAS 41±8YRS AND INTERVAL BETWEEN HS AND DEVICE REMOVAL WAS 6.4±2.7YRS. AT THE CONCLUSION OF EACH CASE (MEAN±SD OPERATIVE TIME=179±11MIN), IMAGING STUDIES WERE REVIEWED BY AN ATTENDING RADIOLOGIST AND VERIFIED NO RETAINED METAL IN THE ABDOMEN. CONVERSION TO LAPAROTOMY, HYSTERECTOMY, OR BLOOD TRANSFUSION WAS UNNECESSARY FOR ANY PATIENTS, AND ALL WERE DISCHARGED HOME WITHIN THREE HOURS. THEIR POSTOPERATIVE COURSE CONTINUES TO BE SATISFACTORY. CONCLUSION: PATIENTS WITH MORE THAN TWO ESSURE DEVICES COMPRISE AN UNUSUAL GROUP WITH A COMPLEX PELVIC FOREIGN BODY PRESENTATION. THIS IS THE FIRST REPORT ON SURGICAL MANAGEMENT FOR SUCH PATIENTS, UNDERSCORING THE IMPORTANCE OF LOCALIZING THESE CONTRACEPTIVE DEVICES WITH CAREFUL IMAGING BEFORE, DURING, AND AFTER SURGERY. MOREOVER, HYSTERECTOMY IS NOT ABSOLUTELY MANDATORY IN THIS SETTING AND INTRAOPERATIVE FLUOROSCOPY/RADIOGRAPHY CAN FACILITATE COMPLETE, SAFE REMOVAL OF ALL IMPLANTS ON AN OUT-PATIENT BASIS. CREATION OF ICD-10 MODIFIERS FOR VARIOUS POST-HS COMPLAINTS WOULD ALLOW FOR IMPROVED SURVEILLANCE OF THE ESSURE PHENOMENON. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-NOV-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: 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 THEIR NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PROGRESSIVELY WORSENING PELVIC CRAMPING") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. LITERATURE REFERENCE: SILLS ES, RICKERS NS, LI X, SURGICAL MANAGEMENT AFTER HYSTEROSCOPIC STERILIZATION: MINIMALLY INVASIVE APPROACH INCORPORATING INTRAOPERATIVE FLUOROSCOPY FOR SYMPTOMATIC PATIENTS WITH >2 ESSURE® DEVICES, SURGICAL TECHNOLOGY INTERNATIONAL, 2018, 21:156-161. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: WRONG TECHNIQUE IN DEVICE USAGE PROCESS "SURGEON CUT THIS "DANGLING WIRE" WITH HYSTEROSCOPIC SCISSORS", DEVICE INEFFECTIVE "LEFT TUBE WAS NOT FULLY OCCLUDED" AND DEVICE DEPLOYMENT ISSUE "INCOMPLETE PASSAGE OF THE EXTRA DEVICE THROUGH THE LEFT TUBE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND MULTIPAROUS. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FATIGUE ("FATIGUE") AND BACK PAIN ("SEVERE BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE DEVICES AND BILATERAL PARTIAL SALPINGECTOMY.). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN, FATIGUE AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR BACK PAIN, FATIGUE AND PELVIC PAIN WITH ESSURE. THE REPORTER COMMENTED: SECOND ESSURE PROCEDURE WAS DONE IN (B)(6) 2013. THIS ADDITIONAL PROCEDURE WAS CHARACTERIZED BY INCOMPLETE PASSAGE OF THE EXTRA DEVICE THROUGH THE LEFT TUBE (WHERE A PREVIOUS ATTEMPT TO PLACE A DEVICE HAD ALREADY BEEN MADE). THE MEDIAL ASPECT OF THE AFTERCOMING ESSURE THEREFORE COULD NOT BE FULLY ADVANCED, RESULTING IN PART OF THE DEVICE EXTENDING INTO THE UTERINE COMPARTMENT. THE SURGEON CUT THIS "DANGLING WIRE" WITH HYSTEROSCOPIC SCISSORS, APPARENTLY ATTEMPTING TO NORMALIZE THE ENDOMETRIAL CAVITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN 2013: LEFT TUBE WAS NOT OCCLUDED. OBJECTIVE: TO DESCRIBE A NON-HYSTERECTOMY SURGICAL TECHNIQUE FOR SYMPTOMATIC PATIENTS WITH MORE THAN 2 DEVICES DESIGN: PATIENTS (N=4) PRESENTED WITH SHARP PELVIC PAIN, IRREGULAR VAGINAL BLEEDING, DYSPAREUNIA, WEIGHT GAIN, HAIR LOSS, FATIGUE, AND/OR DIFFUSE SKIN RASH, ALL OF WHICH WERE ABSENT BEFORE UNDERGOING HYSTEROSCOPIC STERILIZATION (HS). HYSTEROSALPINGOGRAM OBTAINED BEFORE SURGICAL EXCISION OF CONTRACEPTIVE TUBAL IMPLANTS CONFIRMED MORE THAN TWO ESSURE DEVICES IN ALL PATIENTS. EXCEPT FOR HS-ASSOCIATED COMPLAINTS, ALL PATIENTS WERE IN OTHERWISE GOOD GENERAL HEALTH AND NONE HAD ANY HISTORY OF PRIOR PELVIC PATHOLOGY. HYSTEROSCOPY WAS FOLLOWED BY 5MM TRIPLE-PORT LAPAROSCOPIC CORNUAL DISSECTION, MODIFIED PARTIAL BILATERAL SALPINGECTOMY, AND FOREIGN BODY REMOVAL UNDER FLUOROSCOPY AND/OR RADIOGRAPHIC GUIDANCE. RESULTS: IN THIS GROUP, MEAN±SD PATIENT AGE WAS 41±8YRS AND INTERVAL BETWEEN HS AND DEVICE REMOVAL WAS 6.4±2.7YRS. AT THE CONCLUSION OF EACH CASE (MEAN±SD OPERATIVE TIME=179±11MIN), IMAGING STUDIES WERE REVIEWED BY AN ATTENDING RADIOLOGIST AND VERIFIED NO RETAINED METAL IN THE ABDOMEN. CONVERSION TO LAPAROTOMY, HYSTERECTOMY, OR BLOOD TRANSFUSION WAS UNNECESSARY FOR ANY PATIENTS, AND ALL WERE DISCHARGED HOME WITHIN THREE HOURS. THEIR POSTOPERATIVE COURSE CONTINUES TO BE SATISFACTORY. CONCLUSION: PATIENTS WITH MORE THAN TWO ESSURE DEVICES COMPRISE AN UNUSUAL GROUP WITH A COMPLEX PELVIC FOREIGN BODY PRESENTATION. THIS IS THE FIRST REPORT ON SURGICAL MANAGEMENT FOR SUCH PATIENTS, UNDERSCORING THE IMPORTANCE OF LOCALIZING THESE CONTRACEPTIVE DEVICES WITH CAREFUL IMAGING BEFORE, DURING, AND AFTER SURGERY. MOREOVER, HYSTERECTOMY IS NOT ABSOLUTELY MANDATORY IN THIS SETTING AND INTRAOPERATIVE FLUOROSCOPY/RADIOGRAPHY CAN FACILITATE COMPLETE, SAFE REMOVAL OF ALL IMPLANTS ON AN OUT-PATIENT BASIS. CREATION OF ICD-10 MODIFIERS FOR VARIOUS POST-HS COMPLAINTS WOULD ALLOW FOR IMPROVED SURVEILLANCE OF THE ESSURE PHENOMENON. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 913685 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R |