INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2024-09630
- Event Type
- Injury
- Date Received
- June 6, 2024
- Report Date
- December 5, 2024
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 05060191606394
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
THE EVENT OF LYMPHOMA 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: LYMPHOMA-ALCL-SUSPECTED.
SINCE THE AFFECTED SIDE IS NOT SPECIFIED. PROVIDING DEVICE INFORMATION FOR BOTH SIDES: LEFT: INSPIRA TRX. REF: N-TRX400. LOT: 2791442. SN: (B)(6). RIGHT: INSPIRA TRX. REF: N-TRX400. LOT: 2871964. SN: (B)(6). ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B2, H6.
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. CLARIFICATION TO FURTHER INVESTIGATION AND DEVICE INFORMATION: DEVICE DETAILS FOR BOTH SIDES WERE PROVIDED, BUT AFFECTED SIDE IS UNKNOWN. FI SUMMARY (LEFT INSPIRA TRX, REF: (B)(4), LOT: 2791442, SN: (B)(6) , D4 EXPIRY DATE: 8/24/2020, H4 MANUF. DATE: 8/24/2015) THE REVIEW OF THE DOCUMENTATION ASSOCIATED TO THE MANUFACTURING PROCESS INDICATES THAT ALL DEVICES WITH LOT NUMBER 2791442 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 REPORTED MEDICAL EVENTS ARE UNABLE TO OBSERVE, THEREFORE THEY ARE NOT 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. FI SUMMARY (RIGHT INSPIRA TRX, REF: (B)(4), LOT: 2871964, SN: (B)(6), D4 EXPIRY DATE: 2/20/2021, H4 MANUF. DATE: 2/20/2016). THE REVIEW OF THE DOCUMENTATION ASSOCIATED TO THE MANUFACTURING PROCESS INDICATES THAT ALL DEVICES WITH LOT NUMBER 2871964 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 REPORTED EVENT IS CLASSIFIED AS MEDICAL, AND THESE EVENTS ARE UNABLE TO CONFIRM. 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 UNKNOWN SIDE 'CONFIRMED DIAGNOSIS OF BIA-ALCL.' PATHOLOGICAL MARKERS HAVE NOT BEEN PROVIDED. DEVICE REMAINS IMPLANTED.
PATIENT REPRESENTATIVE REPORTED UNKNOWN SIDE 'CONFIRMED DIAGNOSIS OF BIA-ALCL.' PATHOLOGICAL MARKERS HAVE NOT BEEN PROVIDED. DEVICE REMAINS IMPLANTED.
PATIENT REPRESENTATIVE REPORTED UNKNOWN SIDE 'CONFIRMED DIAGNOSIS OF BIA-ALCL' WHICH WILL BE REPORTED AS LYMPHOMA-ALCL-SUSPECTED. PATHOLOGICAL MARKERS HAVE NOT BEEN PROVIDED. DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2054589 | INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | NI | 05060191606394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Life Threatening| R |