MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 10 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	10-240
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported ""suspected" intracapsular rupture" per mammogram and ultrasound.This relates to the left side.The device remains implanted and will be returned.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been/will be requested.No additional information is available at this time.Reason for reoperation: "suspected intracapsular rupture".
Event or Problem Description
Healthcare professional reported ""suspected" intracapsular rupture" per mammogram and ultrasound.This relates to the left side.The device has been explanted and replaced with another manufacturer´s device.The device will not be returned.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a5, b5, d6b, e1, h6.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, h6.The event of "capsular contracture" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: capsular contracture, baker grade unknown.
Event or Problem Description
Later healthcare professional reported "grossly rupture", "capsular contracture" baker grade unknown, "malposition" and "superomedial displacement of implant".
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5.
Event or Problem Description
Healthcare professional reported "intracapsular rupture".Later healthcare professional reported "grossly rupture", "capsular contracture" baker grade iii, "malposition" and "superomedial displacement of implant".This record is for the left side.The device has been explanted.

• Brand Name: STYLE 10 SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 23278927
• Report Number: 9617229-2025-17408
• Device Sequence Number: 12964079
• Product Code: FTR
• UDI-Device Identifier: 10888628001220
• UDI-Public: 10888628001220
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2019
• Device Catalogue Number: 10-240
• Device Lot Number: 2553618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 02/09/2026; 02/20/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/02/2025; 02/18/2026; 02/23/2026
• Date Device Manufactured: 02/07/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White