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 Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	03/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "rupture".Later healthcare professional reported "complete rupture", "free silicone", "silicone extending superiorly and up into the old transaxillary passageway and toward the anterior shoulder" and capsular contracture baker grade unknown.This record is for the right side.Device was explanted and replaced.Device will be returned.Patient underwent capsulectomy.
Additional Manufacturer Narrative
This is a follow-up report to a medwatch submitted under manufacture report number 9617229-2022-07013 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: "complete rupture", "free silicone", "silicone extending superiorly and up into the old transaxillary passageway and toward the anterior shoulder" and capsular contracture baker grade unknown.
Additional Manufacturer Narrative
Device evaluation: per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: ¿ rupture: observed broken device through microscopic inspection assessed as surgical damage.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.No additional observations performed on the device.No further actions are required.
Event or Problem Description
Healthcare professional reported "rupture".Later healthcare professional reported "complete rupture", "free silicone", "silicone extending superiorly and up into the old transaxillary passageway and toward the anterior shoulder" and capsular contracture baker grade unknown.Later healthcare professional reported "complete rupture".This record is for the right side.Device was explanted and replaced.Device was returned.Patient underwent capsulectomy.

• 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: 23716985
• Report Number: 9617229-2025-20997
• Device Sequence Number: 18368004
• Product Code: FTR
• UDI-Device Identifier: 10888628002104
• UDI-Public: 10888628002104
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/13/2026

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: 12/10/2018
• Device Catalogue Number: 45-550
• Device Lot Number: 2546694
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2014
• 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: 40 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: American Indian Or Alaskan Native