MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	115-322
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
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 requested.No additional information is available at this time.Reason for reoperation: rupture.
Event or Problem Description
Healthcare professional reported no complaint against the device.Later healthcare professional reported "benign calcification" and "lymph nodes in the right axilla".Later healthcare professional reported "rupture" and "exchange of textured device due to patient's concern with product".Later healthcare professional reported "implant capsules sent to pathology", "capsular contracture baker grade i", "glandular ptosis", fibroglandular tissue" and benign calcification" confirmed with mammography.This record is for the right side.Device remains implanted and it will not be returned.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h.6.
Event or Problem Description
Healthcare professional reported no complaint against the device.Later healthcare professional reported "benign calcification" and "lymph nodes in the right axilla".Later healthcare professional reported "rupture" and "exchange of textured device due to patient's concern with product".Later healthcare professional reported "implant capsules sent to pathology", "capsular contracture baker grade i", "glandular ptosis", fibroglandular tissue" and benign calcification".Confirm whit mammography.This record is for the right side.Device was explanted and replaced.

• Brand Name: STYLE 115 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: 23686773
• Report Number: 9617229-2025-20716
• Device Sequence Number: 5854825
• Product Code: FTR
• UDI-Device Identifier: 10888628002388
• UDI-Public: 10888628002388
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 01/21/2026

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: 01/23/2019
• Device Catalogue Number: 115-322
• Device Lot Number: 2565374
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/21/2026
• Date Device Manufactured: 02/23/2014
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White