STYLE 115 SILICONE GEL FILLED BREAST IMPLANT
Report
- Report Number
- 9617229-2025-07766
- Event Type
- Injury
- Date Received
- May 12, 2025
- Report Date
- August 8, 2025
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- FTR
- PMA / PMN Number
- P020056
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: D6B
THIS IS A FOLLOW-UP REPORT TO A MEDWATCH SUBMITTED UNDER MANUFACTURE REPORT NUMBER 9617229-2025-0000066. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCE'S NOTED. 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.
PATIENT REPORTED "ITCHING ON THE BREASTS" AND "A RED RASH" AND QUESTIONS REGARDING THE REMOVAL OF THE IMPLANTS DUE TO CONCERN. HEALTHCARE PROFESSIONAL LATER REPORTED "POSSIBLE RUPTURE WITH MRI" AND REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
PATIENT REPORTED "ITCHING ON THE BREASTS" AND "A RED RASH" AND QUESTIONS REGARDING THE REMOVAL OF THE IMPLANTS DUE TO CONCERN. HEALTHCARE PROFESSIONAL LATER REPORTED "POSSIBLE RUPTURE WITH MRI" AND REMOVAL FROM TEXTURED TO SMOOTH DUE TO THE CONCERNS OF THE PRODUCT. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1032693 | STYLE 115 SILICONE GEL FILLED BREAST IMPLANT | PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED | FTR | ALLERGAN (COSTA RICA) | 2251960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |