INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-08521
- Event Type
- Injury
- Date Received
- May 22, 2025
- Date of Event
- April 10, 2025
- Report Date
- June 17, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 5060191606738
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D9, H3, H6. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS LYMPHOMA WAS RECEIVED ON MAY 20, 2025, WITH LOT NUMBER 2942200. BASED ON THE PRODUCT ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS ARE: - LYMPHOMA: UNABLE TO OBSERVE SINCE IT IS A MEDICAL EVENT AND IS NOT RELATED TO THE DEVICE. AS PER THE INVESTIGATION PROCEDURE, CREASE WERE OBSERVED AND NONE OF THE OBSERVATIONS ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, NO FURTHER ACTIONS ARE REQUIRED. FURTHER INVESTIGATION: THE REVIEW OF THE DOCUMENTATION ASSOCIATED TO THE MANUFACTURING PROCESS INDICATES THAT ALL DEVICES INVOLVED IN THIS WORK ORDER WERE RELEASED IN ACCORDANCE WITH ABBVIE¿S PROCEDURES AND WERE NO DEFECTS/PROBLEMS/ISSUES FOUND IN THE DOCUMENTS OR IN THE PERSONNEL TRAINING RELATED TO THE REPORTED EVENT. ADDITIONALLY, NO ER/ NCR(S) WERE IDENTIFIED DURING THE INVESTIGATION ASSOCIATED WITH THIS LOT AND THE COMPLAINT. ACCORDING TO THE COMPLAINT REVIEW THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS IN THE DEVICE ANALYSIS LABORATORY YET. HOWEVER, THE REPORTED EVENT IS CLASSIFIED AS MEDICAL AND IT IS UNABLE TO OBSERVE, THEREFORE THEY ARE UNABLE TO BE CONFIRMED. A REVIEW OF THE CURRENT RISK DOCUMENTS WAS PERFORMED IN RMF-CHL-BI FAMILY (V15.0), AND THE EVENT OF BIA-ALCL IS A KNOWN HAZARD FOR BREAST IMPLANTS. CONSIDERING THAT THERE IS NO ADVERSE TREND FOR THIS TYPE OF EVENT, NO ADDITIONAL ACTIONS ARE DEEMED REQUIRED AT THIS TIME. THE ISSUE WITH LYMPHOMA ALCL SUSPECTED WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE EVENT OF LYMPHOMA - ALCL - SUSPECTED IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: "LUMP ON CAPSULE SENT FOR HISTOLOGICAL EXAMINATION AND DIAGNOSTIC TESTING. HISTOPATHOLOGICAL MARKERS CD30+ AND ALK- HAVE NOT BEEN RECEIVED".
HEALTHCARE PROFESSIONAL REPORTED LUMP ON CAPSULE SENT FOR HISTOLOGICAL EXAMINATION AND DIAGNOSTIC TESTING. HISTOPATHOLOGICAL MARKERS CD30+ AND ALK- HAVE NOT BEEN RECEIVED. THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.
HEALTHCARE PROFESSIONAL REPORTED LUMP ON CAPSULE SENT FOR HISTOLOGICAL EXAMINATION AND DIAGNOSTIC TESTING. HISTOPATHOLOGICAL MARKERS CD30+ AND ALK- HAVE NOT BEEN RECEIVED. THIS RECORD IS FOR RIGHT SIDE. THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 819182 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2942200 | 5060191606738 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female | Required Intervention| L |