FALLOPIAN TUBE OCCLUSION INSERT
Report
- Report Number
- 2951250-2023-00030
- Event Type
- Injury
- Date Received
- January 3, 2023
- Report Date
- January 9, 2023
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS CASE INFORMATION FROM A PUBLISHED STUDY WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") IN A FEMALE PATIENT WHO HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. LITERATURE REFERENCE: BIDEAU M; RATHAT G; FRANCINI S; RANISAVLJEVIC N; CROCHET P; COMPAN C; DUFLOS C; DURAES M. LONG-TERM QUALITY OF LIFE AFTER SURGICAL ESSURE REMOVAL FOR DEVICE-ATTRIBUTED SYMPTOMS. EUROPEAN JOURNAL OF OBSTETRICS, GYNECOLOGY, AND REPRODUCTIVE BIOLOGY. 2022; 280: 138-143. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON UNKNOWN DATES SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), GASTROINTESTINAL PROCEDURAL COMPLICATION ("ONE PATIENT EXPERIENCED SUPERFICIAL DIGESTIVE TRACT INJURY WHILE REMOVING ESSURE") AND DYSPAREUNIA ("DYSPAREUNIA"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED. AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR FALLOPIAN TUBE OCCLUSION INSERT WITH REGARD TO GASTROINTESTINAL PROCEDURAL COMPLICATION, PELVIC PAIN OR DYSPAREUNIA. THE REPORTER COMMENTED: ONE PATIENT EXPERIENCED SUPERFICIAL DIGESTIVE TRACT INJURY WHILE REMOVING ESSURE AND ALSO EXPERIENCED CHRONIC PELVIC PAIN AND DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: FOR FALLOPIAN TUBE OCCLUSION INSERT: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. LITERATURE ABSTRACT: TO ANALYZE QUALITY OF LIFE(QOL) AND SYMPTOM RESOLUTION AFTER SURGICAL REMOVAL OF ESSURE DEVICES. METHODS: SINGLE-CENTER COHORT STUDY WHICH INCLUDED PATIENTS WITH ESSURE REMOVAL BETWEEN FEBRUARY 2017 AND MARCH 2018. SURGERY WAS PERFORMED IN 65 PATIENTS BY LAPAROSCOPY (SALPINGECTOMY ONLY OR HYSTERECTOMY). QUESTIONNAIRES WERE USED TO ASSESS QOL(SF-36), EMOTIONAL DISORDERS(HAD) AND SYMPTOMS PREOPERATIVELY, AT 3 MONTHS AND 4 YEARS POSTOPERATIVELY. RESULTS: 4(6,1%) AND 16(24,6%) PATIENTS WERE LOST OF FOLLOW-UP AT THREE MONTHS AND 4 YEARS POSTOPERATIVELY RESPECTIVELY. FOUR(6,1%) INTRAOPERATIVE SURGICAL COMPLICATIONS OCCURRED. DURING THE THREE-MONTHS POSTOPERATIVE PERIOD, 3(4,6%) COMPLICATIONS OCCURRED: FIVE CLAVIEN DINDO GRADE 1 COMPLICATIONS (UMBILICAL HEMATOMA) AND ONE GRADE 2 COMPLICATION (HYPERTHERMIA AND DIGESTIVE DISORDER REQUIRING ANTIBIOTIC THERAPY). PREOPERATIVE QOL SCORES WERE LOWER THAN THOSE OF GENERAL POPULATION. SCORES WERE SIGNIFICANTLY IMPROVED AT 3 MONTHS AND 4 YEARS POSTOPERATIVELY. AT 4 YEARS POSTOPERATIVELY, 17/49(34,7%) HAD A COMPLETE REGRESSION OF SYMPTOMS, 21/49(42,8%) PARTIAL RESOLUTION AND 11/49(22,4%) NO IMPROVEMENT. 27/49(55,1%) PATIENTS MADE THE CONNECTION BETWEEN SYMPTOMS AND ESSURE DEVICE AFTER MEDIA COVERAGE. 22/49(44,89 %) WERE INFLUENCED BY MEDIA COVERAGE IN THEIR DECISION OF SURGERY. THERE WAS A HIGHER PERCENTAGE OF PATIENTS WITH ANXIETY DISORDER BEFORE ESSURE REMOVAL THAN 4 YEARS AFTER [22/44 (50 %) VERSUS 11/44 (25 %); P = 0.0045]. CONCLUSION: ESSURE REMOVAL HAS A RESTORATIVE ROLE IN TERMS OF QOL IN SHORT AND LONG-TERM. PATIENTS SHOULD BE INFORMED ABOUT POSSIBILITY OF NO IMPROVEMENT AFTER SURGERY AND SURGICAL MORBIDITY. LARGER PROSPECTIVE COHORT IS NEEDED TO MAKE A WELL-CONSIDERED DECISION ABOUT RISKS OF SURGERY COMPARED WITH EXPECTED BENEFITS. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 04-JAN-2023: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE INFORMATION FROM A PUBLISHED STUDY WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. LITERATURE REFERENCE: BIDEAU M; RATHAT G; FRANCINI S; RANISAVLJEVIC N; CROCHET P; COMPAN C; DUFLOS C; DURAES M. LONG-TERM QUALITY OF LIFE AFTER SURGICAL ESSURE REMOVAL FOR DEVICE-ATTRIBUTED SYMPTOMS. EUROPEAN JOURNAL OF OBSTETRICS, GYNECOLOGY, AND REPRODUCTIVE BIOLOGY. 2022; 280: 138-143. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON UNKNOWN DATES SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), GASTROINTESTINAL PROCEDURAL COMPLICATION ("ONE PATIENT EXPERIENCED SUPERFICIAL DIGESTIVE TRACT INJURY WHILE REMOVING ESSURE") AND DYSPAREUNIA ("DYSPAREUNIA"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO GASTROINTESTINAL PROCEDURAL COMPLICATION, PELVIC PAIN OR DYSPAREUNIA. THE REPORTER COMMENTED: ONE PATIENT EXPERIENCED SUPERFICIAL DIGESTIVE TRACT INJURY WHILE REMOVING ESSURE AND ALSO EXPERIENCED CHRONIC PELVIC PAIN AND DYSPAREUNIA. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. LITERATURE ABSTRACT TO ANALYZE QUALITY OF LIFE(QOL) AND SYMPTOM RESOLUTION AFTER SURGICAL REMOVAL OF ESSURE DEVICES. METHODS: SINGLE-CENTER COHORT STUDY WHICH INCLUDED PATIENTS WITH ESSURE REMOVAL BETWEEN FEBRUARY 2017 AND MARCH 2018. SURGERY WAS PERFORMED IN 65 PATIENTS BY LAPAROSCOPY (SALPINGECTOMY ONLY OR HYSTERECTOMY). QUESTIONNAIRES WERE USED TO ASSESS QOL(SF-36), EMOTIONAL DISORDERS(HAD) AND SYMPTOMS PREOPERATIVELY, AT 3 MONTHS AND 4 YEARS POSTOPERATIVELY. RESULTS: 4(6,1%) AND 16(24,6%) PATIENTS WERE LOST OF FOLLOW-UP AT THREE MONTHS AND 4 YEARS POSTOPERATIVELY RESPECTIVELY. FOUR(6,1%) INTRAOPERATIVE SURGICAL COMPLICATIONS OCCURRED. DURING THE THREE-MONTHS POSTOPERATIVE PERIOD, 3(4,6%) COMPLICATIONS OCCURRED: FIVE CLAVIEN DINDO GRADE 1 COMPLICATIONS (UMBILICAL HEMATOMA) AND ONE GRADE 2 COMPLICATION (HYPERTHERMIA AND DIGESTIVE DISORDER REQUIRING ANTIBIOTIC THERAPY). PREOPERATIVE QOL SCORES WERE LOWER THAN THOSE OF GENERAL POPULATION. SCORES WERE SIGNIFICANTLY IMPROVED AT 3 MONTHS AND 4 YEARS POSTOPERATIVELY. AT 4 YEARS POSTOPERATIVELY, 17/49(34,7%) HAD A COMPLETE REGRESSION OF SYMPTOMS, 21/49(42,8%) PARTIAL RESOLUTION AND 11/49(22,4%) NO IMPROVEMENT. 27/49(55,1%) PATIENTS MADE THE CONNECTION BETWEEN SYMPTOMS AND ESSURE DEVICE AFTER MEDIA COVERAGE. 22/49(44,89 %) WERE INFLUENCED BY MEDIA COVERAGE IN THEIR DECISION OF SURGERY. THERE WAS A HIGHER PERCENTAGE OF PATIENTS WITH ANXIETY DISORDER BEFORE ESSURE REMOVAL THAN 4 YEARS AFTER [22/44 (50 %) VERSUS 11/44 (25 %); P = 0.0045]. CONCLUSION: ESSURE REMOVAL HAS A RESTORATIVE ROLE IN TERMS OF QOL IN SHORT AND LONG-TERM. PATIENTS SHOULD BE INFORMED ABOUT POSSIBILITY OF NO IMPROVEMENT AFTER SURGERY AND SURGICAL MORBIDITY. LARGER PROSPECTIVE COHORT IS NEEDED TO MAKE A WELL-CONSIDERED DECISION ABOUT RISKS OF SURGERY COMPARED WITH EXPECTED BENEFITS THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 04-JAN-2023: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 04-JAN-2023: HEALTH AUTHORITY REFERENCE NUMBER UPDATED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS CASE INFORMATION FROM A PUBLISHED STUDY WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("CHRONIC PELVIC PAIN") IN A FEMALE PATIENT WHO HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. LITERATURE REFERENCE: BIDEAU M; RATHAT G; FRANCINI S; RANISAVLJEVIC N; CROCHET P; COMPAN C; DUFLOS C; DURAES M. LONG-TERM QUALITY OF LIFE AFTER SURGICAL ESSURE REMOVAL FOR DEVICE-ATTRIBUTED SYMPTOMS. EUROPEAN JOURNAL OF OBSTETRICS, GYNECOLOGY, AND REPRODUCTIVE BIOLOGY. 2022; 280: 138-143 THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON UNKNOWN DATES SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED), GASTROINTESTINAL INJURY ("ONE PATIENT EXPERIENCED SUPERFICIAL DIGESTIVE TRACT INJURY WHILE REMOVING ESSURE") AND DYSPAREUNIA ("DYSPAREUNIA"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED. AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR FALLOPIAN TUBE OCCLUSION INSERT WITH REGARD TO GASTROINTESTINAL INJURY, PELVIC PAIN OR DYSPAREUNIA. THE REPORTER COMMENTED: ONE PATIENT EXPERIENCED SUPERFICIAL DIGESTIVE TRACT INJURY WHILE REMOVING ESSURE AND ALSO EXPERIENCED CHRONIC PELVIC PAIN AND DYSPAREUNIA. ABSTRACT. LITERATURE ABSTRACT TO ANALYZE QUALITY OF LIFE(QOL) AND SYMPTOM RESOLUTION AFTER SURGICAL REMOVAL OF ESSURE DEVICES. METHODS: SINGLE-CENTER COHORT STUDY WHICH INCLUDED PATIENTS WITH ESSURE REMOVAL BETWEEN FEBRUARY 2017 AND MARCH 2018. SURGERY WAS PERFORMED IN 65 PATIENTS BY LAPAROSCOPY (SALPINGECTOMY ONLY OR HYSTERECTOMY). QUESTIONNAIRES WERE USED TO ASSESS QOL(SF-36), EMOTIONAL DISORDERS(HAD) AND SYMPTOMS PREOPERATIVELY, AT 3 MONTHS AND 4 YEARS POSTOPERATIVELY. RESULTS: 4(6,1%) AND 16(24,6%) PATIENTS WERE LOST OF FOLLOW-UP AT THREE MONTHS AND 4 YEARS POSTOPERATIVELY RESPECTIVELY. FOUR(6,1%) INTRAOPERATIVE SURGICAL COMPLICATIONS OCCURRED. DURING THE THREE-MONTHS POSTOPERATIVE PERIOD, 3(4,6%) COMPLICATIONS OCCURRED: FIVE CLAVIEN DINDO GRADE 1 COMPLICATIONS (UMBILICAL HEMATOMA) AND ONE GRADE 2 COMPLICATION (HYPERTHERMIA AND DIGESTIVE DISORDER REQUIRING ANTIBIOTIC THERAPY). PREOPERATIVE QOL SCORES WERE LOWER THAN THOSE OF GENERAL POPULATION. SCORES WERE SIGNIFICANTLY IMPROVED AT 3 MONTHS AND 4 YEARS POSTOPERATIVELY. AT 4 YEARS POSTOPERATIVELY, 17/49(34,7%) HAD A COMPLETE REGRESSION OF SYMPTOMS, 21/49(42,8%) PARTIAL RESOLUTION AND 11/49(22,4%) NO IMPROVEMENT. 27/49(55,1%) PATIENTS MADE THE CONNECTION BETWEEN SYMPTOMS AND ESSURE DEVICE AFTER MEDIA COVERAGE. 22/49(44,89 %) WERE INFLUENCED BY MEDIA COVERAGE IN THEIR DECISION OF SURGERY. THERE WAS A HIGHER PERCENTAGE OF PATIENTS WITH ANXIETY DISORDER BEFORE ESSURE REMOVAL THAN 4 YEARS AFTER [22/44 (50 %) VERSUS 11/44 (25 %); P = 0.0045]. CONCLUSION: ESSURE REMOVAL HAS A RESTORATIVE ROLE IN TERMS OF QOL IN SHORT AND LONG-TERM. PATIENTS SHOULD BE INFORMED ABOUT POSSIBILITY OF NO IMPROVEMENT AFTER SURGERY AND SURGICAL MORBIDITY. LARGER PROSPECTIVE COHORT IS NEEDED TO MAKE A WELL-CONSIDERED DECISION ABOUT RISKS OF SURGERY COMPARED WITH EXPECTED BENEFITS BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 503149 | FALLOPIAN TUBE OCCLUSION INSERT | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |