ESSURE
Report
- Report Number
- 2951250-2018-04527
- Event Type
- Injury
- Date Received
- November 1, 2018
- Report Date
- March 3, 2021
- 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
Narratives
THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF ADVERSE DRUG REACTION ("ADVERSE DRUG REACTION NOS"), PROCEDURAL COMPLICATION ('INTRAOPERATIVE COMPLICATION") AND RECTAL INJURY ("RECTUM INJURY WITHOUT PERFORATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCES: FRANCINI SARAH; CROCHET PATRICE; COMPAN CLARA; CHARAVIL AXELLE; MANNA FEDERICO; AGOSTINI AUBERT, SURGICAL REMOVAL OF ESSURE FOR DEVICE-ATTRIBUTED SYMPTOMS IMPROVES QUALITY OF LIFE: A BEFORE AND AFTER STUDY, 27TH ANNUAL MEETING OF THE EUROPEAN SOCIETY FOR GYNAECOLOGICAL ENDOSCOPY, 2018, XX:ES27-0424. FRANCINI S, DURAES M, CHARAVIL A, MANNA F, DUFLOS C, COMPAN C, ET. AL., ESSURE REMOVAL FOR DEVICE-ATTRIBUTED SYMPTOMS: QUALITY OF LIFE EVALUATION BEFORE AND AFTER SURGICAL REMOVAL, JOURNAL OF GYNECOLOGY OBSTETRICS AND HUMAN REPRODUCTION, 2020:101772. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ADVERSE DRUG REACTION (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PROCEDURAL COMPLICATION (SERIOUSNESS CRITERION HOSPITALIZATION) AND RECTAL INJURY (SERIOUSNESS CRITERION HOSPITALIZATION). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL PROCEDURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ADVERSE DRUG REACTION, PROCEDURAL COMPLICATION AND RECTAL INJURY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADVERSE DRUG REACTION, PROCEDURAL COMPLICATION AND RECTAL INJURY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SURGERY PERFORMED TO REMOVE ESSURE WAS A LAPAROSCOPIC SALPINGECTOMY, CORNUOTOMY OR LAPAROSCOPIC HYSTERECTOMY OR VAGINAL HYSTERECTOMY. PATIENT EXPERIENCED AN IMPROVEMENT IN QUALITY OF LIFE AFTER SURGERY. QUALITY-SAFETY EVALUATION OF PTC: 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. SURGICAL REMOVAL OF ESSURE FOR DEVICE-ATTRIBUTED SYMPTOMS IMPROVES QUALITY OF LIFE: A BEFORE AND AFTER STUDY: BACKGROUND: THE ESSURE SYSTEM OFFERS AN EFFECTIVE METHOD FOR HYSTEROSCOPIC STERILIZATION. INCREASING REPORTS OF COMPLICATIONS HAVE RAISED CONCERNS ABOUT THE DEVICE'S SAFETY. THUS FAR, THE UNDERLYING MECHANISMS FOR THESE SYMPTOMS ARE UNKNOWN. WOMEN SUFFERING ALLEGED COMPLICATIONS OF THE ESSURE DEVICE OFTEN SEEK SURGICAL REMOVAL. THE AIM WAS TO EVALUATE QUALITY OF LIFE (QOL) AND POSTOPERATIVE OUTCOMES IN WOMEN UNDERGOING ESSURE SURGICAL REMOVAL. RESULTS: NINETY-FIVE PATIENTS WERE INCLUDED IN THE STUDY. THEY WERE 64 LAPAROSCOPIC SALPINGECTOMYCORNUOTOMY, 23 LAPAROSCOPIC HYSTERECTOMY AND 8 VAGINAL HYSTERECTOMY. ALL PATIENTS HAD A FOLLOW-UP CONSULTATION AT ONE MONTH. INTRAOPERATIVE COMPLICATION OCCURRED IN 5 CASES (1 CONVERSION FROM CORNUOTOMY TO LAPAROSCOPIC HYSTERECTOMY, 1 SKIN BURN, 2 BLADDER INJURIES AND 1 RECTUM INJURY WITHOUT PERFORATION). SEVEN POST-OPERATIVE COMPLICATIONS OCCURRED (CLAVIEN DINDO GRADE 1 IN SIX CASES AND GRADE 2 IN ONE CASE). REGARDING QOL ASSESSMENT, THERE WERE 12 PATIENTS LOST FOLLOW-UP AT 3 MONTHS. PCS SCORES WERE SIGNIFICANTLY LOWER PREOPERATIVELY THAN POSTOPERATIVELY [37.6 (31-44.2) VS 50.7 (44.9-59.9); P<0.001]. MCS SCORES WERE SIGNIFICANTLY LOWER PREOPERATIVELY THAN POSTOPERATIVELY [29 (23.1-35.7) VS 52.4 (43.8-62.1); P<0.001). EXTRA-GYNECOLOGIC SYMPTOMS (I.E ASTHENIA, SKIN LESIONS, HEADACHE, MUSCULAR OR JOINT PAIN) WERE MORE FREQUENT BEFORE THAN AFTER SURGERY (96.4% VS 47.6%; P<0.001). GYNECOLOGIC SYMPTOMS (PELVIC PAIN OR MENSTRUAL BLEEDING OR DYSPAREUNIA) WERE MORE FREQUENT BEFORE THAN AFTER SURGERY (70% VS 18%; P<0.001).CONCLUSIONS: PATIENTS WHO UNDERWENT ESSURE SURGICAL REMOVAL FOR ALLEGED ADVERSE REACTION TO THE DEVICE EXPERIENCED A SIGNIFICANT QOL IMPROVEMENT AT 3 MONTHS. THE RATE OF SURGICAL COMPLICATIONS WAS LOW. THESE FINDINGS WILL HELP CLINICIANS TO INFORM THEIR PATIENTS ABOUT EXPECTED QOL. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: REPUBLICATION ARTICLE RECEIVED. REPUBLICATION ARTICLE RECEIVED. REPORTER INFORMATION, LITERATURE INFORMATION, LITERATURE REFERENCE NUMBER AND SD ADDED. ON (B)(6) 2021: NO FURTHER INFORMATION WAS OBTAINED. ON (B)(6) 2021: QUALITY SAFETY EVALUATION OF PTC. 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 LITERATURE CASE DESCRIBES THE OCCURRENCE OF ADVERSE DRUG REACTION ('ADVERSE DRUG REACTION NOS'), PROCEDURAL COMPLICATION ('INTRAOPERATIVE COMPLICATION') AND RECTAL INJURY ('RECTUM INJURY WITHOUT PERFORATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCES: FRANCHINII SARAH; CROCHET PATRICE; COMPAN CLARA; CHARAVIL AXELLE; MANNA FEDERICO; AGOSTINI AUBERT, SURGICAL REMOVAL OF ESSURE FOR DEVICE-ATTRIBUTED SYMPTOMS IMPROVES QUALITY OF LIFE: A BEFORE AND AFTER STUDY, 27TH ANNUAL MEETING OF THE EUROPEAN SOCIETY FOR GYNAECOLOGICAL ENDOSCOPY, 2018, XX:ES27-0424. FRANCINI S, DURAES M, CHARAVIL A, MANNA F, DUFLOS C, COMPAN C, ET. AL., ESSURE REMOVAL FOR DEVICE-ATTRIBUTED SYMPTOMS: QUALITY OF LIFE EVALUATION BEFORE AND AFTER SURGICAL REMOVAL, JOURNAL OF GYNECOLOGY OBSTETRICS AND HUMAN REPRODUCTION, 2020:101772. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ADVERSE DRUG REACTION (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PROCEDURAL COMPLICATION (SERIOUSNESS CRITERION HOSPITALIZATION) AND RECTAL INJURY (SERIOUSNESS CRITERION HOSPITALIZATION). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL PROCEDURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ADVERSE DRUG REACTION, PROCEDURAL COMPLICATION AND RECTAL INJURY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADVERSE DRUG REACTION, PROCEDURAL COMPLICATION AND RECTAL INJURY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SURGERY PERFORMED TO REMOVE ESSURE WAS A LAPAROSCOPIC SALPINGECTOMY OR LAPAROSCOPIC HYSTERECTOMY OR VAGINAL HYSTERECTOMY. PATIENT EXPERIENCED AN IMPROVEMENT IN QUALITY OF LIFE AFTER SURGERY. SURGICAL REMOVAL OF ESSURE FOR DEVICE-ATTRIBUTED SYMPTOMS IMPROVES QUALITY OF LIFE: A BEFORE AND AFTER STUDY: BACKGROUND: THE ESSURE SYSTEM OFFERS AN EFFECTIVE METHOD FOR HYSTEROSCOPIC STERILIZATION. INCREASING REPORTS OF COMPLICATIONS HAVE RAISED CONCERNS ABOUT THE DEVICE'S SAFETY. THUS FAR, THE UNDERLYING MECHANISMS FOR THESE SYMPTOMS ARE UNKNOWN. WOMEN SUFFERING ALLEGED COMPLICATIONS OF THE ESSURE DEVICE OFTEN SEEK SURGICAL REMOVAL. THE AIM WAS TO EVALUATE QUALITY OF LIFE (QOL) AND POSTOPERATIVE OUTCOMES IN WOMEN UNDERGOING ESSURE SURGICAL REMOVAL. RESULTS: NINETY-FIVE PATIENTS WERE INCLUDED IN THE STUDY. THEY WERE 64 LAPAROSCOPIC SALPINGECTOMY, 23 LAPAROSCOPIC HYSTERECTOMY AND 8 VAGINAL HYSTERECTOMY. ALL PATIENTS HAD A FOLLOW-UP CONSULTATION AT ONE MONTH. INTRAOPERATIVE COMPLICATION OCCURRED IN 5 CASES (1 CONVERSION FROM CORNUOTOMY TO LAPAROSCOPIC HYSTERECTOMY, 1 SKIN BURN, 2 BLADDER INJURIES AND 1 RECTUM INJURY WITHOUT PERFORATION). SEVEN POST-OPERATIVE COMPLICATIONS OCCURRED (CLAVINE DINDO GRADE 1 IN SIX CASES AND GRADE 2 IN ONE CASE). REGARDING QOL ASSESSMENT, THERE WERE 12 PATIENTS LOST FOLLOW-UP AT 3 MONTHS. PCS SCORES WERE SIGNIFICANTLY LOWER PREOPERATIVELY THAN POSTOPERATIVELY [37.6 (31-44.2) VS 50.7 (44.9-59.9); P<0.001]. MCS SCORES WERE SIGNIFICANTLY LOWER PREOPERATIVELY THAN POSTOPERATIVELY [29 (23.1-35.7) VS 52.4 (43.8-62.1); P<0.001). EXTRA-GYNECOLOGIC SYMPTOMS (I.E ASTHENIA, SKIN LESIONS, HEADACHE, MUSCULAR OR JOINT PAIN) WERE MORE FREQUENT BEFORE THAN AFTER SURGERY (96.4% VS 47.6%; P<0.001). GYNECOLOGIC SYMPTOMS (PELVIC PAIN OR MENSTRUAL BLEEDING OR DYSPAREUNIA) WERE MORE FREQUENT BEFORE THAN AFTER SURGERY (70% VS 18%; P<0.001).CONCLUSIONS: PATIENTS WHO UNDERWENT ESSURE SURGICAL REMOVAL FOR ALLEGED ADVERSE REACTION TO THE DEVICE EXPERIENCED A SIGNIFICANT QOL IMPROVEMENT AT 3 MONTHS. THE RATE OF SURGICAL COMPLICATIONS WAS LOW. THESE FINDINGS WILL HELP CLINICIANS TO INFORM THEIR PATIENTS ABOUT EXPECTED QOL MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: REPUBLICATION ARTICLE RECEIVED; REPUBLICATION ARTICLE RECEIVED; REPORTER INFORMATION, LITERATURE INFORMATION, LITERATURE REFERENCE NUMBER AND SD ADDED. 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. - ATTACHMENT: [LIT 2018-202805.PDF]
THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF ADVERSE DRUG REACTION ("ADVERSE DRUG REACTION NOS"), PROCEDURAL COMPLICATION ("INTRAOPERATIVE COMPLICATION") AND RECTAL INJURY ("RECTUM INJURY WITHOUT PERFORATION") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: FRANCINI SARAH; CROCHET PATRICE; COMPAN CLARA; CHARAVIL AXELLE; MANNA FEDERICO; AGOSTINI AUBERT, SURGICAL REMOVAL OF ESSURE FOR DEVICE-ATTRIBUTED SYMPTOMS IMPROVES QUALITY OF LIFE: A BEFORE AND AFTER STUDY, 27TH ANNUAL MEETING OF THE EUROPEAN SOCIETY FOR GYNAECOLOGICAL ENDOSCOPY, 2018, XX:ES27-0424. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ADVERSE DRUG REACTION (SERIOUSNESS CRITERIA HOSPITALIZATION, MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PROCEDURAL COMPLICATION (SERIOUSNESS CRITERION HOSPITALIZATION) AND RECTAL INJURY (SERIOUSNESS CRITERION HOSPITALIZATION). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL PROCEDURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE ADVERSE DRUG REACTION, PROCEDURAL COMPLICATION AND RECTAL INJURY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADVERSE DRUG REACTION, PROCEDURAL COMPLICATION AND RECTAL INJURY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SURGERY PERFORMED TO REMOVE ESSURE WAS A LAPAROSCOPIC SALPINGECTOMYCORNUOTOMY OR LAPAROSCOPIC HYSTERECTOMY OR VAGINAL HYSTERECTOMY. PATIENT EXPERIENCED AN IMPROVEMENT IN QUALITY OF LIFE AFTER SURGERY. SURGICAL REMOVAL OF ESSURE FOR DEVICE-ATTRIBUTED SYMPTOMS IMPROVES QUALITY OF LIFE: A BEFORE AND AFTER STUDY: BACKGROUND: THE ESSURE SYSTEM OFFERS AN EFFECTIVE METHOD FOR HYSTEROSCOPIC STERILIZATION. INCREASING REPORTS OF COMPLICATIONS HAVE RAISED CONCERNS ABOUT THE DEVICE'S SAFETY. THUS FAR, THE UNDERLYING MECHANISMS FOR THESE SYMPTOMS ARE UNKNOWN. WOMEN SUFFERING ALLEGED COMPLICATIONS OF THE ESSURE DEVICE OFTEN SEEK SURGICAL REMOVAL. THE AIM WAS TO EVALUATE QUALITY OF LIFE (QOL) AND POSTOPERATIVE OUTCOMES IN WOMEN UNDERGOING ESSURE SURGICAL REMOVAL. RESULTS: NINETY-FIVE PATIENTS WERE INCLUDED IN THE STUDY. THEY WERE 64 LAPAROSCOPIC SALPINGECTOMYCORNUOTOMY, 23 LAPAROSCOPIC HYSTERECTOMY AND 8 VAGINAL HYSTERECTOMY. ALL PATIENTS HAD A FOLLOW-UP CONSULTATION AT ONE MONTH. INTRAOPERATIVE COMPLICATION OCCURRED IN 5 CASES (1 CONVERSION FROM CORNUOTOMY TO LAPAROSCOPIC HYSTERECTOMY, 1 SKIN BURN, 2 BLADDER INJURIES AND 1 RECTUM INJURY WITHOUT PERFORATION). SEVEN POST-OPERATIVE COMPLICATIONS OCCURRED (CLAVIEN DINDO GRADE 1 IN SIX CASES AND GRADE 2 IN ONE CASE). REGARDING QOL ASSESSMENT, THERE WERE 12 PATIENTS LOST FOLLOW-UP AT 3 MONTHS. PCS SCORES WERE SIGNIFICANTLY LOWER PREOPERATIVELY THAN POSTOPERATIVELY [37.6 (31-44.2) VS 50.7 (44.9-59.9); P<0.001]. MCS SCORES WERE SIGNIFICANTLY LOWER PREOPERATIVELY THAN POSTOPERATIVELY [29 (23.1-35.7) VS 52.4 (43.8-62.1); P<0.001). EXTRA-GYNECOLOGIC SYMPTOMS (I.E ASTHENIA, SKIN LESIONS, HEADACHE, MUSCULAR OR JOINT PAIN) WERE MORE FREQUENT BEFORE THAN AFTER SURGERY (96.4% VS 47.6%; P<0.001). GYNECOLOGIC SYMPTOMS (PELVIC PAIN OR MENSTRUAL BLEEDING OR DYSPAREUNIA) WERE MORE FREQUENT BEFORE THAN AFTER SURGERY (70% VS 18%; P<0.001).CONCLUSIONS: PATIENTS WHO UNDERWENT ESSURE SURGICAL REMOVAL FOR ALLEGED ADVERSE REACTION TO THE DEVICE EXPERIENCED A SIGNIFICANT QOL IMPROVEMENT AT 3 MONTHS. THE RATE OF SURGICAL COMPLICATIONS WAS LOW. THESE FINDINGS WILL HELP CLINICIANS TO INFORM THEIR PATIENTS ABOUT EXPECTED QOL 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 |
|---|---|---|---|---|---|---|---|
| 870368 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O| R |