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

Catalog Number	115-547
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/05/2024
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.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.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: "ruptured" and "capsular contracture".
Event or Problem Description
Healthcare professional reported "ruptured".Healthcare professional reported "capsular contracture".This record is for the left side.Device was explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d1, d4, h4.
Event or Problem Description
Healthcare professional reported "ruptured".Healthcare professional reported "capsular contracture and recalled implant".This record is for the left side.Device was explanted and replaced.
Event or Problem Description
Healthcare professional reported left side rupture and capsular contracture, baker grade unknown.The device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d9, h3, h6.Device evaluation: 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 opening through microscopic inspection assessed as an unidentified tear.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.Anxiety - product/ procedure: unable to observe through visual inspection as it is a physiological phenomenon.Additional observations noted during the device analysis was creases.None of these are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.

• 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: 22545725
• Report Number: 9617229-2025-12117
• Device Sequence Number: 8614817
• Product Code: FTR
• UDI-Device Identifier: 10888628030190
• UDI-Public: (01)10888628030190(10)1275092(11)241128(17)291028
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2013
• Device Catalogue Number: 115-547
• Device Lot Number: 1649776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 09/08/2025; 11/19/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 10/01/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2008
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White