ESSURE
Report
- Report Number
- 2951250-2024-00507
- 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 RADIATING TO THE RIGHT ILIAC FOSSA SINCE THE INSERTION") IN A 38 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 NICKEL ALLERGY AND MULTIPAROUS. NO PERSONAL HISTORY OF INTEREST, WITHOUT KNOWN ALLERGIES. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY WAS PERFORMED BY LAPAROSCOPY). ESSURE WAS REMOVED. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: THE PATIENT WAS DISCHARGED WITHIN THE NEXT 24 HOURS AND IS CURRENTLY ASYMPTOMATIC. THE TUBES WERE SENT TO THE PATHOLOGY DEPARTMENT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ABDOMINAL X-RAY] (DATE UNKNOWN): NOT REPORTED [GYNAECOLOGICAL EXAMINATION] (DATE UNKNOWN): NORMAL [PHYSICAL 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 ESSURE IS THE FIRST INTRATUBAL DEVICE FOR PERMANENT CONTRACEPTION INSERTED UNDER HYSTEROSCOPIC GUIDANCE. A RARE COMPLICATION OF THIS DEVICE IS PELVIC PAIN, WHICH CAN BE RELATED TO ALLERGY TO ONE OR MORE OF ITS COMPONENTS, MAINLY NICKEL. NICKEL IS THE MOST COMMON CONTACT ALLERGEN IN THE INDUSTRIALIZED WORLD, AND CONSEQUENTLY THE NUMBER OF PUBLISHED REPORTS MAY NOT REFLECT THE TRUE EXTENT OF THIS COMPLICATION IN WOMEN WITH AN ESSURE® DEVICE. WE REPORT 3 CASES OF PELVIC PAIN IN PATIENTS WITH NICKEL ALLERGY THAT WAS NOT DETECTED BEFORE ESSURE® INSERTION. THE PAIN RESOLVED AFTER REMOVAL OF THE DEVICE IN 2 WOMEN. AN EXPECTANT ATTITUDE WAS ADOPTED IN THE THIRD WOMAN. CURRENTLY, FEW CASES HAVE BEEN REPORTED ON THIS TOPIC. IT IS GENERALLY ACCEPTED THAT THE DEVICE SHOULD BE REMOVED IN WOMEN WITH PELVIC PAIN LASTING FOR MORE THAN 6 WEEKS. IN ADDITION, THESE WOMEN SHOULD ALSO UNDERGO TESTING FOR NICKEL ALLERGY. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 12-AUG-2024: 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 LITERATURE CASE WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN RADIATING TO THE RIGHT ILIAC FOSSA SINCE THE INSERTION") IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 NICKEL ALLERGY AND MULTIPAROUS. NO PERSONAL HISTORY OF INTEREST, WITHOUT KNOWN ALLERGIES. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY WAS PERFORMED BY LAPAROSCOPY). ESSURE WAS REMOVED. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: THE PATIENT WAS DISCHARGED WITHIN THE NEXT 24 HOURS AND IS CURRENTLY ASYMPTOMATIC. THE TUBES WERE SENT TO THE PATHOLOGY DEPARTMENT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ABDOMINAL X-RAY] (DATE UNKNOWN): NOT REPORTED. [GYNAECOLOGICAL EXAMINATION] (DATE UNKNOWN): NORMAL. [PHYSICAL 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: ESSURE IS THE FIRST INTRATUBAL DEVICE FOR PERMANENT CONTRACEPTION INSERTED UNDER HYSTEROSCOPIC GUIDANCE. A RARE COMPLICATION OF THIS DEVICE IS PELVIC PAIN, WHICH CAN BE RELATED TO ALLERGY TO ONE OR MORE OF ITS COMPONENTS, MAINLY NICKEL. NICKEL IS THE MOST COMMON CONTACT ALLERGEN IN THE INDUSTRIALIZED WORLD, AND CONSEQUENTLY THE NUMBER OF PUBLISHED REPORTS MAY NOT REFLECT THE TRUE EXTENT OF THIS COMPLICATION IN WOMEN WITH AN ESSURE® DEVICE. WE REPORT (B)(4) CASES OF PELVIC PAIN IN PATIENTS WITH NICKEL ALLERGY THAT WAS NOT DETECTED BEFORE ESSURE® INSERTION. THE PAIN RESOLVED AFTER REMOVAL OF THE DEVICE IN (B)(4) WOMEN. AN EXPECTANT ATTITUDE WAS ADOPTED IN THE THIRD WOMAN. CURRENTLY, FEW CASES HAVE BEEN REPORTED ON THIS TOPIC. IT IS GENERALLY ACCEPTED THAT THE DEVICE SHOULD BE REMOVED IN WOMEN WITH PELVIC PAIN LASTING FOR MORE THAN 6 WEEKS. IN ADDITION, THESE WOMEN SHOULD ALSO UNDERGO TESTING FOR NICKEL ALLERGY. THE FOLLOWING AMENDMENT WAS MADE: UPON INTERNAL VERIFICATION ARGUS (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 ("PELVIC PAIN RADIATING TO THE RIGHT ILIAC FOSSA SINCE THE INSERTION") IN A 38 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 NICKEL ALLERGY AND MULTIPAROUS. NO PERSONAL HISTORY OF INTEREST, WITHOUT KNOWN ALLERGIES. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY WAS PERFORMED BY LAPAROSCOPY). ESSURE WAS REMOVED. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: THE PATIENT WAS DISCHARGED WITHIN THE NEXT 24 HOURS AND IS CURRENTLY ASYMPTOMATIC. THE TUBES WERE SENT TO THE PATHOLOGY DEPARTMENT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ABDOMINAL X-RAY] (DATE UNKNOWN): NOT REPORTED [GYNAECOLOGICAL EXAMINATION] (DATE UNKNOWN): NORMAL [PHYSICAL 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: ESSURE IS THE FIRST INTRATUBAL DEVICE FOR PERMANENT CONTRACEPTION INSERTED UNDER HYSTEROSCOPIC GUIDANCE. A RARE COMPLICATION OF THIS DEVICE IS PELVIC PAIN, WHICH CAN BE RELATED TO ALLERGY TO ONE OR MORE OF ITS COMPONENTS, MAINLY NICKEL. NICKEL IS THE MOST COMMON CONTACT ALLERGEN IN THE INDUSTRIALIZED WORLD, AND CONSEQUENTLY THE NUMBER OF PUBLISHED REPORTS MAY NOT REFLECT THE TRUE EXTENT OF THIS COMPLICATION IN WOMEN WITH AN ESSURE® DEVICE. WE REPORT 3 CASES OF PELVIC PAIN IN PATIENTS WITH NICKEL ALLERGY THAT WAS NOT DETECTED BEFORE ESSURE® INSERTION. THE PAIN RESOLVED AFTER REMOVAL OF THE DEVICE IN 2 WOMEN. AN EXPECTANT ATTITUDE WAS ADOPTED IN THE THIRD WOMAN. CURRENTLY, FEW CASES HAVE BEEN REPORTED ON THIS TOPIC. IT IS GENERALLY ACCEPTED THAT THE DEVICE SHOULD BE REMOVED IN WOMEN WITH PELVIC PAIN LASTING FOR MORE THAN 6 WEEKS. IN ADDITION, THESE WOMEN SHOULD ALSO UNDERGO TESTING FOR NICKEL ALLERGY. 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 |
|---|---|---|---|---|---|---|---|
| 517134 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female | Required Intervention |