INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2024-24355
- Event Type
- Injury
- Date Received
- November 14, 2024
- Report Date
- December 18, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
IMPLANTING INSTITUTION: (B)(6). 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: "DIAGNOSIS OF BIA-ALCL".
FURTHER INVESTIGATION: THE REVIEW OF THE DOCUMENTATION ASSOCIATED TO THE MANUFACTURING PROCESS INDICATES THAT ALL DEVICES WITH LOT NUMBER 2193319 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 THERE IS NO INFORMATION IF THE DEVICE WILL BE RETURNED FOR ANALYSIS IN THE DEVICE ANALYSIS LABORATORY. HOWEVER, THE EVENT OF LYMPHOMA - ALCL IS UNABLE TO OBSERVED, THEREFORE IT IS 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.
PATIENT REPRESENTATIVE REPORTED, RIGHT SIDE "DIAGNOSIS OF BIA-ALCL". PATHOLOGICAL MARKERS CONFIRMING, ALCL HAVE NOT BEEN RECEIVED. DEVICE STATUS IS UNKNOWN.
PATIENT REPRESENTATIVE REPORTED RIGHT SIDE "DIAGNOSIS OF BIA-ALCL". PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED. DEVICE STATUS IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2197676 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2193319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Life Threatening| R |