ESSURE
Report
- Report Number
- 2951250-2024-00508
- Event Type
- Injury
- Date Received
- August 7, 2024
- Report Date
- August 16, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS LITERATURE CASE WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY") AND PROCEDURAL PAIN ("INTENSE PAIN WHEN CANNULATING THE TUBES.") IN A 40 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. LITERATURE REFERENCE: VICO ZÚNIGA, A.J. RODRÍGUEZ OLIVER J. FERNÁNDEZ PARRA, A. GONZÁLEZ PAREDES AND M.T. AGUILAR ROMERO. PELVIC PAIN ASSOCIATED WITH ESSURE DEVICE PLACEMENT AND NICKEL ALLERGY. GYNAECOLOGY AND OBSTETRICS CLINIC AND RESEARCH. 2015; 42(1): 35-37 THE PATIENT HAD A MEDICAL HISTORY OF ALLERGY TO METALS AND MULTIPAROUS. NO RELEVANT PERSONAL OR FAMILY HISTORY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: ORAL CONTRACEPTIVE NOS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON UNKNOWN DATES SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALISATION AND INTERVENTION REQUIRED), ALLERGY TO METALS (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PROCEDURAL PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), FALLOPIAN TUBE ENLARGEMENT ("OEDEMATOUS TUBES"), ABDOMINAL DISCOMFORT ("DISCOMFORT IN THE HYPOGASTRIUM"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("LIMITING HER DAILY LIFE") AND DEVICE DISLOCATION ("LARGEST PORTION IN THE LEFT HORN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY WITH EXTRACTION OF THE RIGHT ESSURE HYSTEROSCOPIC EXTRACTION OF LEFT ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND PROCEDURAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO PROCEDURAL PAIN, FALLOPIAN TUBE ENLARGEMENT, ABDOMINAL DISCOMFORT, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES OR DEVICE DISLOCATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ABDOMINAL X-RAY] (DATE UNKNOWN): NOT REPORTED [GYNAECOLOGICAL EXAMINATION] (DATE UNKNOWN): NORMAL 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: A 40-YEAR-OLD MULTIPAROUS PATIENT WITH NO RELEVANT PERSONAL OR FAMILY HISTORY CAME TO THE GYNAECOLOGY CONSULTATION FOR DEFINITIVE CONTRACEPTION METHOD. UNTIL THEN, SHE HAD BEEN TAKING ORAL HORMONAL CONTRACEPTIVES. THE GYNAECOLOGICAL EXAMINATION WAS NORMAL AND THE PLACEMENT OF THE ESSURE INTRATUBAL DEVICE WAS INDICATED VIA OUTPATIENT HYSTEROSCOPY WITHOUT INCIDENTS, EXCEPT FOR INTENSE PAIN WHEN CANNULATING THE TUBES. AT 4 MONTHS, A SIMPLE ABDOMINAL X-RAY WAS PERFORMED TO CONFIRM THAT THE DEVICES WERE PLACED IN THEIR CORRECT POSITION. ONE MONTH AFTER THE REVIEW, THE PATIENT REPORTED DISCOMFORT IN THE HYPOGASTRIUM, LIMITING HER DAILY LIFE, AND WHICH SHE RELATED TO THE PLACEMENT OF ESSURE. SHE WAS EVALUATED BY SEVERAL GYNAECOLOGISTS, BUT NO DISEASES WERE FOUND DURING THE EXAMINATION. AFTER THOROUGHLY REPEATING THE MEDICAL HISTORY, THE PATIENT REPORTS THAT SHE IS ALLERGIC TO METALS, SO IT IS DECIDED TO REMOVE THE ESSURE DEVICE. LAPAROSCOPY WAS PERFORMED, VISUALISING BOTH OEDEMATOUS TUBES, WITH NO OTHER FINDINGS. BILATERAL SALPINGECTOMY WAS PERFORMED WITH EXTRACTION OF THE RIGHT ESSURE ALONG WITH THE TUBE AND REQUIRING HYSTEROSCOPIC EXTRACTION OF THE CONTRALATERAL INTRATUBAL DEVICE, WHICH HAD ITS LARGEST PORTION IN THE LEFT HORN. THE PATIENT WAS DISCHARGED AFTER 24 HOURS AND THE PELVIC PAIN HAD DISAPPEARED DURING SUBSEQUENT CHECK-UPS. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 09-AUG-2024: 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 WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN"), ALLERGY TO METALS ("NICKEL ALLERGY") AND PROCEDURAL PAIN ("INTENSE PAIN WHEN CANNULATING THE TUBES.") IN A 40 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. LITERATURE REFERENCE: VICO ZÚNIGA, A.J. RODRÍGUEZ OLIVER J. FERNÁNDEZ PARRA, A. GONZÁLEZ PAREDES AND M.T. AGUILAR ROMERO. PELVIC PAIN ASSOCIATED WITH ESSURE DEVICE PLACEMENT AND NICKEL ALLERGY. GYNAECOLOGY AND OBSTETRICS CLINIC AND RESEARCH. 2015; 42(1): 35-37 THE PATIENT HAD A MEDICAL HISTORY OF ALLERGY TO METALS AND MULTIPAROUS. NO RELEVANT PERSONAL OR FAMILY HISTORY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: ORAL CONTRACEPTIVE NOS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON UNKNOWN DATES SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA HOSPITALISATION AND INTERVENTION REQUIRED), ALLERGY TO METALS (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PROCEDURAL PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), FALLOPIAN TUBE ENLARGEMENT ("OEDEMATOUS TUBES"), ABDOMINAL DISCOMFORT ("DISCOMFORT IN THE HYPOGASTRIUM"), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("LIMITING HER DAILY LIFE") AND DEVICE DISLOCATION ("LARGEST PORTION IN THE LEFT HORN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY WITH EXTRACTION OF THE RIGHT ESSURE HYSTEROSCOPIC EXTRACTION OF LEFT ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND PROCEDURAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ALLERGY TO METALS AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO PROCEDURAL PAIN, FALLOPIAN TUBE ENLARGEMENT, ABDOMINAL DISCOMFORT, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES OR DEVICE DISLOCATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ABDOMINAL X-RAY] (DATE UNKNOWN): NOT REPORTED [GYNAECOLOGICAL EXAMINATION] (DATE UNKNOWN): NORMAL 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 A 40-YEAR-OLD MULTIPAROUS PATIENT WITH NO RELEVANT PERSONAL OR FAMILY HISTORY CAME TO THE GYNAECOLOGY CONSULTATION FOR DEFINITIVE CONTRACEPTION METHOD. UNTIL THEN, SHE HAD BEEN TAKING ORAL HORMONAL CONTRACEPTIVES. THE GYNAECOLOGICAL EXAMINATION WAS NORMAL AND THE PLACEMENT OF THE ESSURE INTRATUBAL DEVICE WAS INDICATED VIA OUTPATIENT HYSTEROSCOPY WITHOUT INCIDENTS, EXCEPT FOR INTENSE PAIN WHEN CANNULATING THE TUBES. AT 4 MONTHS, A SIMPLE ABDOMINAL X-RAY WAS PERFORMED TO CONFIRM THAT THE DEVICES WERE PLACED IN THEIR CORRECT POSITION. ONE MONTH AFTER THE REVIEW, THE PATIENT REPORTED DISCOMFORT IN THE HYPOGASTRIUM, LIMITING HER DAILY LIFE, AND WHICH SHE RELATED TO THE PLACEMENT OF ESSURE. SHE WAS EVALUATED BY SEVERAL GYNAECOLOGISTS, BUT NO DISEASES WERE FOUND DURING THE EXAMINATION. AFTER THOROUGHLY REPEATING THE MEDICAL HISTORY, THE PATIENT REPORTS THAT SHE IS ALLERGIC TO METALS, SO IT IS DECIDED TO REMOVE THE ESSURE DEVICE. LAPAROSCOPY WAS PERFORMED, VISUALISING BOTH OEDEMATOUS TUBES, WITH NO OTHER FINDINGS. BILATERAL SALPINGECTOMY WAS PERFORMED WITH EXTRACTION OF THE RIGHT ESSURE ALONG WITH THE TUBE AND REQUIRING HYSTEROSCOPIC EXTRACTION OF THE CONTRALATERAL INTRATUBAL DEVICE, WHICH HAD ITS LARGEST PORTION IN THE LEFT HORN. THE PATIENT WAS DISCHARGED AFTER 24 HOURS AND THE PELVIC PAIN HAD DISAPPEARED DURING SUBSEQUENT CHECK-UPS. THE FOLLOWING AMENDMENT WAS MADE: UPON INTERNAL VERIFICATION ARGUS CASES (B)(4) ARE FOUND TO BE DUPLICATE OF EACH OTHER THEREFORE ARGUS CASE (B)(4) NEEDS TO NULLIFY FROM ARGUS DATABASE. ALL RELEVANT INFORMATION INCLUDING, EVENTS, SOURCE DOCUMENTS, REFERENCES ARE TRANSFERRED FROM NULLIFIED CASE TO RETENTION CASE. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("INTENSE PAIN WHEN CANNULATING THE TUBES.") IN A 40 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. LITERATURE REFERENCE: VICO ZÚNIGA, A.J. RODRÍGUEZ OLIVER J. FERNÁNDEZ PARRA, A. GONZÁLEZ PAREDES AND M.T. AGUILAR ROMERO. PELVIC PAIN ASSOCIATED WITH ESSURE DEVICE PLACEMENT AND NICKEL ALLERGY. GYNAECOLOGY AND OBSTETRICS CLINIC AND RESEARCH. 2015; 42(1): 35-37. THE PATIENT HAD A MEDICAL HISTORY OF ALLERGY TO METALS AND MULTIPAROUS. NO RELEVANT PERSONAL OR FAMILY HISTORY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: ORAL CONTRACEPTIVE NOS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON UNKNOWN DATES SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND ABDOMINAL DISCOMFORT ("DISCOMFORT IN THE HYPOGASTRIUM, LIMITING HER DAILY LIFE, AND WHICH SHE RELATED TO THE PLACEMENT OF ESSURE"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY WAS PERFORMED WITH EXTRACTION OF THE RIGHT ESSURE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PELVIC PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: REQUIRING HYSTEROSCOPIC EXTRACTION OF THE CONTRALATERAL INTRATUBAL DEVICE, WHICH HAD ITS LARGEST PORTION IN THE LEFT HORN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ABDOMINAL X-RAY] (DATE UNKNOWN): NOT REPORTED. [GYNAECOLOGICAL EXAMINATION] (DATE UNKNOWN): NORMAL. 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: A 40-YEAR-OLD MULTIPAROUS PATIENT WITH NO RELEVANT PERSONAL OR FAMILY HISTORY CAME TO THE GYNAECOLOGY CONSULTATION FOR DEFINITIVE CONTRACEPTION METHOD. UNTIL THEN, SHE HAD BEEN TAKING ORAL HORMONAL CONTRACEPTIVES. THE GYNAECOLOGICAL EXAMINATION WAS NORMAL AND THE PLACEMENT OF THE ESSURE® INTRATUBAL DEVICE WAS INDICATED VIA OUTPATIENT HYSTEROSCOPY WITHOUT INCIDENTS, EXCEPT FOR INTENSE PAIN WHEN CANNULATING THE TUBES. AT 4 MONTHS, A SIMPLE ABDOMINAL X-RAY WAS PERFORMED TO CONFIRM THAT THE DEVICES WERE PLACED IN THEIR CORRECT POSITION. ONE MONTH AFTER THE REVIEW, THE PATIENT REPORTED DISCOMFORT IN THE HYPOGASTRIUM, LIMITING HER DAILY LIFE, AND WHICH SHE RELATED TO THE PLACEMENT OF ESSURE®. SHE WAS EVALUATED BY SEVERAL GYNAECOLOGISTS, BUT NO DISEASES WERE FOUND DURING THE EXAMINATION. AFTER THOROUGHLY REPEATING THE MEDICAL HISTORY, THE PATIENT REPORTS THAT SHE IS ALLERGIC TO METALS, SO IT IS DECIDED TO REMOVE THE ESSURE® DEVICE. LAPAROSCOPY WAS PERFORMED, VISUALISING BOTH OEDEMATOUS TUBES, WITH NO OTHER FINDINGS. BILATERAL SALPINGECTOMY WAS PERFORMED WITH EXTRACTION OF THE RIGHT ESSURE® ALONG WITH THE TUBE AND REQUIRING HYSTEROSCOPIC EXTRACTION OF THE CONTRALATERAL INTRATUBAL DEVICE, WHICH HAD ITS LARGEST PORTION IN THE LEFT HORN. THE PATIENT WAS DISCHARGED AFTER 24 HOURS AND THE PELVIC PAIN HAD DISAPPEARED DURING SUBSEQUENT CHECK-UPS. 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 |
|---|---|---|---|---|---|---|---|
| 579969 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | Other| H| R |