INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2024-19447
- Event Type
- Injury
- Date Received
- August 23, 2024
- Date of Event
- May 10, 2024
- Report Date
- July 15, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INVESTIGATION: THE REVIEW OF THE DOCUMENTATION ASSOCIATED TO THE MANUFACTURING PROCESS INDICATES THAT ALL DEVICES WITH LOT NUMBER 2872657 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. A REVIEW OF THE CURRENT RISK DOCUMENTS WAS PERFORMED IN CHL-BI FAMILY (V14.0), 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-SUSPECT WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE. PER EVALUATION PERFORMED IN THIS INVESTIGATION AND, BASED ON THE CODING MATRIX FOR MEDICAL DEVICES AND HUMAN TISSUE QPP07-01-003-G17 (V3.0) THIS CODE IS CLASSIFIED AS MEDICAL EVENT; ALSO, ACCORDING TO THE PROCEDURE QPP07-01-003-W37 (V5.0) THIS EVENT IS NOT CLASSIFIED AS A POTENTIAL HIGH IMPACT COMPLAINT, THEREFORE THIS CASE IS NOT CONFIRMED AS HIGH IMPACT COMPLAINT, AND NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. 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. 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"; "FOREIGN AND ADULTERATED SILICONE PARTICLES IN BODY".
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: A4; A5; A6; B7; G2.
PATIENT REPRESENTATIVE REPORTED LEFT SIDE "DIAGNOSIS OF BIA-ALCL, RISK OF BIA-ALCL, RECURRENCE, EMOTIONAL DISTRESS, ACCUMULATION OF FOREIGN AND ADULTERATED SILICONE PARTICLES IN BODY, PAST AND FUTURE MEDICAL EXPENSES, PHYSICAL PAIN AND SUFFERING FROM EXPLANATION" PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED. PATIENT REPRESENTATIVE ADDITIONALLY REPORTED "SCARRING AND DISFIGUREMENT" DEEMED NOT RELATED TO THE DEVICE. DEVICE HAS BEEN EXPLANTED.
PATIENT REPRESENTATIVE REPORTED LEFT SIDE "DIAGNOSIS OF BIA-ALCL, RISK OF BIA-ALCL, RECURRENCE, EMOTIONAL DISTRESS, ACCUMULATION OF FOREIGN AND ADULTERATED SILICONE PARTICLES IN BODY, PAST AND FUTURE MEDICAL EXPENSES, PHYSICAL PAIN AND SUFFERING FROM EXPLANATION" PATHOLOGICAL MARKERS CONFIRMING ALCL HAVE NOT BEEN RECEIVED. PATIENT REPRESENTATIVE ADDITIONALLY REPORTED "SCARRING AND DISFIGUREMENT" DEEMED NOT RELATED TO THE DEVICE. DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1380902 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2872657 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Female | Required Intervention |