MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	FX-410495
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clarification d4: healthcare professional reported serial numbers (b)(6) and it was unknown which side was left or right.Until clarification can be provided, abbvie will report device catalog number.Clarification d6(a): patient reported devices were implanted in 2015; partial implant date of (b)(6) 2015 will be reported to align with device manufacturing date.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: rupture and capsular contracture, baker grade iv.
Event or Problem Description
Patient reported right side tumors (3) three.Healthcare professional reported rupture and capsular contracture, baker grade iv.The device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d3, d6b, d9, h3, h6.Device evaluation:.Based on the device analysis grid, the assessments of the complaint are: rupture: not observed.Lump/nodule: unable to observe as it is not related to the manufacturing process.Capsular contracture: unable to observe as it is not related to the manufacturing process.Calcification: not observed.Anxiety-product/ procedure: unable to observe as it is not related to the manufacturing process.As per the investigation procedure, deformation, cloudy wear abrasion and creases were completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.
Event or Problem Description
Patient reported "three tumors found on a mammogram" and "exchange of textured devices due to product concern".Later healthcare professional reported "suspected rupture" and "capsular contracture baker grade iv".Later healthcare professional reported "less calcification".This is for the right side.Device was explanted and replaced.

• Brand Name: STYLE 410 COHESIVE 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: 22172696
• Report Number: 9617229-2025-09528
• Device Sequence Number: 9401600
• Product Code: FTR
• UDI-Device Identifier: 10888628003002
• UDI-Public: (01)10888628003002(10)2707357(11)150217(17)200117
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: FX-410495
• Device Lot Number: 2707357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Female
• Patient Weight: 54 KG