ESSURE
Report
- Report Number
- 2951250-2022-00479
- Event Type
- Injury
- Date Received
- May 7, 2022
- Report Date
- May 18, 2022
- 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 FALLOPIAN TUBE PERFORATION ("SIMPLE TUBAL PERFORATION - LEFT SIDE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: CHENE G; CERRUTO E; MORET S; NOHUZ E. COULD THE ANATOMIC LOCATION OF ESSURE® DEVICE EXPLAIN THE IMPAIRMENT OF QUALITY OF LIFE?. MINERVA OBSTETRICS AND GYNECOLOGY. 2022; 74:2: 123-129. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL VIA MINI-CORNUECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: IN GROUP B, THIRTEEN IMPLANTS WERE CORRECTLY PLACED AND WERE REMOVED BY MINI-CORNUECTOMY. TWENTY-SEVEN IMPLANTS WERE IN AN INCORRECT ANATOMICAL POSITION AND WERE REMOVED WITHOUT DIFFICULTY: THERE WERE 15 SIMPLE TUBAL PERFORATIONS (REMOVED BY MINI-CORNUECTOMY) AND 12 COMPLEX TUBULAR PERFORATIONS (9 SUBSEROSAL PLACEMENT, THE IMPLANT LOCATED IN THE EPIPLOON (2 CASES) AND 1 CASE IN THE FRINGES OF THE CAECAL FAT). ABSTRACT: 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: BACKGROUND: SINCE HEALTH-RELATED QUALITY OF LIFE (HRQL) COULD IMPROVE AFTER REMOVAL OF ESSURE (BAYER, LEVERKUSEN, GERMANY) INSERTS IN SYMPTOMATIC PATIENTS, WE AIMED TO ASSESS WHETHER SUCH POSTOPERATIVE ENHANCEMENT WAS LINKED TO THE ANATOMIC PLACEMENT OF THE DEVICE. METHODS: CORRECT AND INCORRECT PLACED ESSURE (BAYER) WERE IDENTIFIED IN THE ELECTRONIC DATABASE OF THE FRENCH COHORT ABLIMCO (COHORT OF CONSENTING PATIENTS WITH LAPAROSCOPIC ESSURE[BAYER] REMOVAL). HRQL, PAIN AND HEAVY MENSTRUAL BLEEDING WERE EVALUATED AFTER ESSURE (BAYER) REMOVAL WITH VALIDATED QUALITY OF LIFE QUESTIONNAIRES (SHORT FORM12 QUESTIONNAIRE, VISUAL ANALOGUE SCALE, FRENCH VERSION OF THE MCGILL PAIN QUESTIONNAIRE AND THE PICTORIAL BLOOD ASSESSMENT CHART PBAC). RESULTS: SIXTY-FIVE PATIENTS WERE INCLUDED IN THE STUDY DIVIDED IN TWO GROUPS (GROUP A WITH CORRECT PLACEMENT: 45 PATIENTS AND GROUP B WITH INCORRECT PLACEMENT: 20 PATIENTS). HRQL AND PAIN INDEX WERE IMPROVED IN BOTH GROUPS AT 6 MONTHS POST-SURGERY. THERE WAS NOT ANY STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN GROUP A AND B. THE PBAC SCORE INCREASED AT 6 MONTHS POSTOPERATIVELY IN GROUP A AND B WITHOUT ANY STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THEM. CONCLUSIONS: POSTOPERATIVE IMPROVEMENT OF QUALITY OF LIFE AND PAIN INDEX WAS SIMILAR WHATEVER THE POSITION OF THE IMPLANT. THIS SUGGESTS THAT SYMPTOMATOLOGY AND QUALITY OF LIFE ARE NOT RELATED TO THE ANATOMIC LOCATION OF THE ESSURE (BAYER) IMPLANTS. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 09-MAY-2022: 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 CASE INFORMATION FROM A PUBLISHED STUDY WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("SIMPLE TUBAL PERFORATION - LEFT SIDE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: CHENE G; CERRUTO E; MORET S; NOHUZ E. COULD THE ANATOMIC LOCATION OF ESSURE® DEVICE EXPLAIN THE IMPAIRMENT OF QUALITY OF LIFE?. MINERVA OBSTETRICS AND GYNECOLOGY. 2022; 74:2: 123-129 THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL VIA MINI-CORNUECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: IN GROUP B, THIRTEEN IMPLANTS WERE CORRECTLY PLACED AND WERE REMOVED BY MINI-CORNUECTOMY. TWENTY-SEVEN IMPLANTS WERE IN AN INCORRECT ANATOMICAL POSITION AND WERE REMOVED WITHOUT DIFFICULTY: THERE WERE 15 SIMPLE TUBAL PERFORATIONS (REMOVED BY MINI-CORNUECTOMY) AND 12 COMPLEX TUBULAR PERFORATIONS (9 SUBSEROSAL PLACEMENT, THE IMPLANT LOCATED IN THE EPIPLOON (2 CASES) AND 1 CASE IN THE FRINGES OF THE CAECAL FAT). ABSTRACT:. LITERATURE ABSTRACT BACKGROUND: SINCE HEALTH-RELATED QUALITY OF LIFE (HRQL) COULD IMPROVE AFTER REMOVAL OF ESSURE (BAYER, LEVERKUSEN, GERMANY) INSERTS IN SYMPTOMATIC PATIENTS, WE AIMED TO ASSESS WHETHER SUCH POSTOPERATIVE ENHANCEMENT WAS LINKED TO THE ANATOMIC PLACEMENT OF THE DEVICE. METHODS: CORRECT AND INCORRECT PLACED ESSURE (BAYER) WERE IDENTIFIED IN THE ELECTRONIC DATABASE OF THE FRENCH COHORT ABLIMCO (COHORT OF CONSENTING PATIENTS WITH LAPAROSCOPIC ESSURE[BAYER] REMOVAL). HRQL, PAIN AND HEAVY MENSTRUAL BLEEDING WERE EVALUATED AFTER ESSURE (BAYER) REMOVAL WITH VALIDATED QUALITY OF LIFE QUESTIONNAIRES (SHORT FORM12 QUESTIONNAIRE, VISUAL ANALOGUE SCALE, FRENCH VERSION OF THE MCGILL PAIN QUESTIONNAIRE AND THE PICTORIAL BLOOD ASSESSMENT CHART PBAC). RESULTS: SIXTY-FIVE PATIENTS WERE INCLUDED IN THE STUDY DIVIDED IN TWO GROUPS (GROUP A WITH CORRECT PLACEMENT: 45 PATIENTS AND GROUP B WITH INCORRECT PLACEMENT: 20 PATIENTS). HRQL AND PAIN INDEX WERE IMPROVED IN BOTH GROUPS AT 6 MONTHS POST-SURGERY. THERE WAS NOT ANY STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN GROUP A AND B. THE PBAC SCORE INCREASED AT 6 MONTHS POSTOPERATIVELY IN GROUP A AND B WITHOUT ANY STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THEM. CONCLUSIONS: POSTOPERATIVE IMPROVEMENT OF QUALITY OF LIFE AND PAIN INDEX WAS SIMILAR WHATEVER THE POSITION OF THE IMPLANT. THIS SUGGESTS THAT SYMPTOMATOLOGY AND QUALITY OF LIFE ARE NOT RELATED TO THE ANATOMIC LOCATION OF THE ESSURE (BAYER) IMPLANTS. 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 |
|---|---|---|---|---|---|---|---|
| 1280856 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE, | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |