STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-21929
- Event Type
- Injury
- Date Received
- December 16, 2025
- Date of Event
- April 11, 2025
- Report Date
- February 20, 2026
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- UDI-DI
- 5060191601023
- PMA / PMN Number
- P040046
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENTS RUPTURE, CAPSULAR CONTRACTURE AND CREASE/FOLDING OF IMPLANT WAS RECEIVED ON FEBRUARY 05, 2026, WITH LOT NUMBER 2794063. PER THE INVESTIGATION PROCEDURE, THE DEVICE IS ANALYZED THROUGH VISUAL INSPECTION MICROSCOPIC INSPECTION IF OPENINGS ARE OBSERVED AND A WEIGHT VERIFICATION. PER THE ANALYSIS PERFORMED, THE ASSESSMENTS OF THE COMPLAINTS AND ANY POTENTIAL MANUFACTURING ISSUE ARE DISPLAYED ALONG WITH ANY FURTHER ACTIONS REQUIRED: RUPTURE: OBSERVED AN OPENING THROUGH MICROSCOPIC INSPECTION ASSESSED AS UNIDENTIFIED (TEAR) OPENING. NO FURTHER ACTIONS ARE REQUIRED AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. CREASE / FOLDING OF IMPLANT: OBSERVED CREASES ON DEVICE THROUGH VISUAL INSPECTION. NO FURTHER ACTIONS ARE REQUIRED AS IT IS NOT RELATED TO THE MANUFACTURING PROCESS. CAPSULAR CONTRACTURE: UNABLE TO OBSERVE THROUGH VISUAL INSPECTION AS IT IS A PHYSIOLOGICAL PHENOMENON. NONE OF THE OTHER OBSERVATIONS PERFORMED DURING THE DEVICE ANALYSIS (WEAR ABRASION) ARE FOUND TO BE POTENTIALLY RELATED TO THE MANUFACTURING PROCESS, AND, THEREFORE, NO FURTHER ACTIONS ARE REQUIRED FOR THESE OBSERVATIONS. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D.9., H.2., H.3., H.6.
CLARIFICATION TO D4 DEVICE INFORMATION: SERIAL/LOT NUMBERS WERE PROVIDED FOR UNKNOWN SIDES AS: SN (B)(6) / LOT 2760604 SN (B)(6) / LOT 2794063 AS THE SIDES ARE UNKNOWN, SPECIFIC DEVICE INFORMATION WAS NOT POPULATED. DEVICES SHARE THE SAME CATALOG NUMBER, WHICH HAS BEEN INCLUDED IN THIS MEDWATCH. ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B5, D1, D2A, D2B, D4, G4, H11.
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: RUPTURE.
HEALTHCARE PROFESSIONAL REPORTED "PROSTHETIC FOLDS" CONFIRMED BY ULTRASOUND. LATER HEALTHCARE PROFESSIONAL REPORTED "STAGE II CAPSULE AND INTRACAPSULAR RUPTURE WITHOUT ASSOCIATED EFFUSION" CONFIRMED BY INTRAOPERATIVE PROCEDURE. LATER HEALTHCARE PROFESSIONAL REPORTED THROUGH REGULATORY AGENCY "INTRACAPSULAR RUPTURE, FOLDS, WAVES, ROTATION, CAPSULAR CONTRACTURE BAKER GRADE II". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
HEALTHCARE PROFESSIONAL REPORTED "PROSTHETIC FOLDS" CONFIRMED BY ULTRASOUND. LATER HEALTHCARE PROFESSIONAL REPORTED "STAGE II CAPSULE AND INTRACAPSULAR RUPTURE WITHOUT ASSOCIATED EFFUSION" CONFIRMED BY INTRAOPERATIVE PROCEDURE. LATER HEALTHCARE PROFESSIONAL REPORTED THROUGH REGULATORY AGENCY "INTRACAPSULAR RUPTURE, FOLDS, WAVES, ROTATION, CAPSULAR CONTRACTURE BAKER GRADE II". THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED.
HEALTHCARE PROFESSIONAL REPORTED "PROSTHETIC FOLDS" CONFIRMED BY ULTRASOUND. LATER HEALTHCARE PROFESSIONAL REPORTED "STAGE II CAPSULE AND INTRACAPSULAR RUPTURE WITHOUT ASSOCIATED EFFUSION" CONFIRMED BY INTRAOPERATIVE PROCEDURE. THIS RECORD IS FOR THE RIGHT SIDE. DEVICE WAS EXPLANTED AND WILL BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2281810 | STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2794063 | 5060191601023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Female | Required Intervention |