MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 15 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	15-616
Medical Device Problem Codes	Gel Leak (1267); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
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: gel leak.
Event or Problem Description
Patient reported "leak".This record is for unknown side.The device was explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.2., b.5., h.2., h.6.
Event or Problem Description
Patient reported "leak".Healthcare professional later reported no complaint against the device.This record is for left side.The device was explanted.

• Brand Name: STYLE 15 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: 24160569
• Report Number: 9617229-2026-01445
• Device Sequence Number: 9001128
• Product Code: FTR
• UDI-Device Identifier: 10888628001541
• UDI-Public: 10888628001541
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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: 02/13/2017
• Device Catalogue Number: 15-616
• Device Lot Number: 2254953
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/16/2026
• Date Device Manufactured: 03/13/2012
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White