ESSURE

Report

Report Number: 2951250-2018-04721
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
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("SEPARATION OR FRAGMENTATION OF THE MEDIAL TERMINAL MARKER") AND PELVIC PAIN ("PELVIC PAIN") IN A 43-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: DEVICE MONITORING PROCEDURE NOT PERFORMED "HSG THREE MONTHS LATER WAS NOT DONE" AND DEVICE USE ISSUE "ANOTHER IMPLANT WAS PLACED ON THIS SAME SIDE". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 AND SPONTANEOUS ABORTION. IN 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ASTHENIA ("GENERALIZED WEAKNESS"), FATIGUE ("FATIGUE"), ABDOMINAL DISCOMFORT ("RIGHT LOWER QUADRANT DISCOMFORT"), MUSCULOSKELETAL DISCOMFORT ("HIP DISCOMFORT"), DYSPAREUNIA ("DYSPAREUNIA") AND ABDOMINAL DISTENSION ("ABDOMINAL DISTENTION") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN OF APPROXIMATELY 35LBS"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE DEVICES AND BILATERAL PARTIAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, PELVIC PAIN, ASTHENIA, FATIGUE, ABDOMINAL DISCOMFORT, MUSCULOSKELETAL DISCOMFORT, DYSPAREUNIA, ABDOMINAL DISTENSION AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISCOMFORT, ABDOMINAL DISTENSION, ASTHENIA, DEVICE BREAKAGE, DYSPAREUNIA, FATIGUE, MUSCULOSKELETAL DISCOMFORT, PELVIC PAIN AND WEIGHT INCREASED WITH ESSURE. THE REPORTER COMMENTED: LAPAROSCOPIC CORNUAL DISSECTION, MODIFIED PARTIAL BILATERAL SALPINGECTOMY, AND FOREIGN BODY REMOVAL UNDER FLUOROSCOPY AND/OR RADIOGRAPHIC GUIDANCE. DIAGNOSTIC RESULTS: HSG (OBTAINED SEVEN YEARS AFTER ESSURE) ESTABLISHED THE PRESENCE OF THREE DEVICES WITHIN THE PELVIS, ONE OF WHICH DEMONSTRATED SEPARATION OR FRAGMENTATION OF THE MEDIAL TERMINAL MARKER. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. OBJECTIVE: TO DESCRIBE A NON-HYSTERECTOMY SURGICAL TECHNIQUE FOR SYMPTOMATIC PATIENTS WITH MORE THAN 2 SURE 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 PTC. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. 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.

Description of Event or Problem · 1

THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("SEPARATION OR FRAGMENTATION OF THE MEDIAL TERMINAL MARKER") AND PELVIC PAIN ("PELVIC PAIN") IN A (B)(6) 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: DEVICE MONITORING PROCEDURE NOT PERFORMED "HSG THREE MONTHS LATER WAS NOT DONE" AND DEVICE USE ISSUE "ANOTHER IMPLANT WAS PLACED ON THIS SAME SIDE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 AND SPONTANEOUS ABORTION. IN 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ASTHENIA ("GENERALIZED WEAKNESS"), FATIGUE, ABDOMINAL DISCOMFORT ("RIGHT LOWER QUADRANT DISCOMFORT"), MUSCULOSKELETAL DISCOMFORT ("HIP DISCOMFORT"), DYSPAREUNIA, ABDOMINAL DISTENSION ("ABDOMINAL DISTENTION") AND WEIGHT INCREASED ("WEIGHT GAIN OF APPROXIMATELY 35LBS"). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE DEVICES AND BILATERAL PARTIAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, PELVIC PAIN, ASTHENIA, FATIGUE, ABDOMINAL DISCOMFORT, MUSCULOSKELETAL DISCOMFORT, DYSPAREUNIA, ABDOMINAL DISTENSION AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ABDOMINAL DISCOMFORT, ABDOMINAL DISTENSION, ASTHENIA, DEVICE BREAKAGE, DYSPAREUNIA, FATIGUE, MUSCULOSKELETAL DISCOMFORT, PELVIC PAIN AND WEIGHT INCREASED WITH ESSURE. THE REPORTER COMMENTED: LAPAROSCOPIC CORNUAL DISSECTION, MODIFIED PARTIAL BILATERAL SALPINGECTOMY, AND FOREIGN BODY REMOVAL UNDER FLUOROSCOPY AND/OR RADIOGRAPHIC GUIDANCE. DIAGNOSTIC RESULTS: HSG (OBTAINED SEVEN YEARS AFTER ESSURE) ESTABLISHED THE PRESENCE OF THREE DEVICES WITHIN THE PELVIS, ONE OF WHICH DEMONSTRATED SEPARATION OR FRAGMENTATION OF THE MEDIAL TERMINAL MARKER. OBJECTIVE: TO DESCRIBE A NON-HYSTERECTOMY SURGICAL TECHNIQUE FOR SYMPTOMATIC PATIENTS WITH MORE THAN 2 SURE 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
915072	ESSURE	TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE	HHS	BAYER PHARMA AG	ESS305		10888853003051

Patients

Seq	Age	Sex	Outcome	Treatment
1	43 YR		Other\| R