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)
Date of Event	04/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "rupture", "leaking silicone" and "exchange of textured devices due to product concern" via mammogram.Later healthcare professional reported "capsular contracture baker grade iv".Later healthcare professional reported "early calcification".Additional report of "any creases".This is for the left side.Device was explanted and replaced.
Additional Manufacturer Narrative
Additional, corrected and/or changed data: a.2, b.5, d.6b, d.9, h.3, h.6.
Event or Problem Description
Patient reported "rupture", "leaking silicone", and "exchange of textured devices due to product concern" via mammogram.Later, healthcare professional reported "suspected rupture" and "capsular contracture baker grade iv".This is for the left side.Device remains implanted.
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/will be requested.No additional information is available at this time.The reason(s) for reoperation is/are: "rupture", "leaking silicone", "exchange of textured devices due to product concern", and "capsular contracture baker grade iv".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.
Additional Manufacturer Narrative
Device evaluation: the device related to the reported event of rupture, capsular contracture, calcification and anxiety-product/procedure was received on june 24, 2025, with lot number 2704701.Based on the product analysis performed, the assessments of the complaints are: rupture: observed an opening assessed as unidentified (tear) opening.Anxiety-product/procedure: 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.As per the investigation procedures, creases and wear abrasion 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 "rupture", "leaking silicone" and "exchange of textured devices due to product concern" via mammogram.Later healthcare professional reported "capsular contracture baker grade iv".Later healthcare professional reported "early calcification".Additional report of "any creases".This is for the left 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: 22146552
• Report Number: 9617229-2025-09247
• Device Sequence Number: 12671135
• Product Code: FTR
• UDI-Device Identifier: 10888628003002
• UDI-Public: (01)10888628003002(10)2704701(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
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2025

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 Expiration Date: 01/17/2020
• Device Catalogue Number: FX-410495
• Device Lot Number: 2704701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 07/12/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/07/2025; 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2015
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 54 KG