MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 45 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	45-550
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "possible rupture".This record is for "the" right side.Device remains implanted.Device 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 requested.No additional information is available at this time.The reason for reoperation: rupture.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h.6.
Event or Problem Description
Healthcare professional reported "possible rupture".Later, healthcare professional reported "asymmetric and ptotic hypomastia" and "intracapsular rupture".This record is for the right side.Device was explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, b6, h6 clarification h6: e2402 utilized to capture the reported event of ptosis and asymmetry the events of ptosis and asymmetry are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Event or Problem Description
Healthcare professional reported right side rupture, asymmetry and ptosis.The device has been explanted.

• Brand Name: STYLE 45 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: 23733461
• Report Number: 9617229-2025-21165
• Device Sequence Number: 13199225
• Product Code: FTR
• UDI-Device Identifier: 10888628002104
• UDI-Public: 10888628002104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 01/22/2026

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: 07/30/2012
• Device Catalogue Number: 45-550
• Device Lot Number: 1478535
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 01/09/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/08/2026; 01/22/2026
• Date Device Manufactured: 09/03/2007
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 86 KG