STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-05487
- Event Type
- Injury
- Date Received
- April 3, 2025
- Date of Event
- January 1, 2022
- Report Date
- July 31, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 5060191601450
- PMA / PMN Number
- P040046
- Removal / Correction Number
- 2011068-7/2/19-001-R
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CLARIFICATION TO B3 DATE OF EVENT: PARTIAL DATE OF 2022 WAS PROVIDED FOR THE EVENT OF "INCREASE IN RIGHT BREAST VOLUME AND PERIPROSTHETIC EFFUSION" CLARIFICATION TO D4 DEVICE INFORMATION: SERIAL AND LOT NUMBER FOR ONE DEVICE WAS PROVIDED AS LOT 1860084, SN (B)(6), BUT IT IS UNKNOWN WHICH SIDE THIS DEVICE RELATES TO. CATALOG NUMBER HAS BEEN UPDATED. CLARIFICATION TO E.1. INITIAL REPORTER: IT IS UNKNOWN WHO PROVIDED THE INFORMATION IN THE INITIAL REPORT TO THE FRENCH REGULATORY AGENCY (ANSM). THE FOLLOWING INFORMATION IS FOR THE DIAGNOSING PHYSICIANS: (B)(6) FACILITY: (B)(6) ADDRESS:(B)(6) CITY: (B)(6) PHONE: (B)(6) FAX: (B)(6) (B)(6) FACILITY: (B)(6) ADDRESS: (B)(6) CITY: (B)(6) PHONE: (B)(6) FAX: (B)(6) THE EVENTS OF "LYMPHOMA-ALCL" AND "SEROMA-LATE" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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: BIA-ALCL; "PERIPROSTHETIC EFFUSION"
A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INVESTIGATION SUMMARY: 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 WILL NOT BE RETURNED FOR ANALYSIS IN THE DEVICE ANALYSIS LABORATORY. HOWEVER, THE REPORTED EVENTS ARE CLASSIFIED AS MEDICAL AND THEY ARE UNABLE TO OBSERVE, THEREFORE THEY ARE UNABLE TO BE CONFIRMED. A REVIEW OF THE CURRENT RISK DOCUMENTS WAS PERFORMED 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 WILL CONTINUE TO BE MONITORED AND CORRECTIVE ACTIONS WILL BE TAKEN IN THE FUTURE IF DEEMED APPROPRIATE.
HEALTHCARE PROFESSIONAL REPORTED PATIENT PRESENTED WITH RIGHT SIDE INCREASE BREAST VOLUME AND PERIPROSTHETIC EFFUSION. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE BIA-ALCL WAS DIAGNOSED FOLLOWING RIGHT BREAST MICROBIOPSY. PATHOLOGICAL MARKERS CD30+ AND ALK- HAVE BEEN RECEIVED. DEVICE STATUS IS UNKNOWN.
HEALTHCARE PROFESSIONAL REPORTED PATIENT PRESENTED WITH RIGHT SIDE INCREASE BREAST VOLUME AND PERIPROSTHETIC EFFUSION. HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE BIA-ALCL WAS DIAGNOSED FOLLOWING RIGHT BREAST MICROBIOPSY. PATHOLOGICAL MARKERS CD30+ AND ALK- HAVE BEEN RECEIVED. DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2372193 | STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 1860084 | 5060191601450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Female | Life Threatening| R |