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

Catalog Number	MX-410685
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swollen Lymph Nodes/Glands (4432)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "exchange with no complaint against the device".Later, healthcare professional reported "history of dcis breast cancer and exchange with no complaint against the device".Patient later reported "slimy and everything else, was told explant could have caused a real issue, and was told something really bad going on with explant".Later reported, "left breast showed abnormal enlarged level 1 left axillary lymph node" and "silicone lymphadenopathy".This record is for the left side.The device has been explanted.
Additional Manufacturer Narrative
The event of seroma 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: seroma-late.A review of the device history record has been completed.No deviations or non-conformances noted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b6, h6.
Event or Problem Description
Patient reported "exchange with no complaint against the device".Later, healthcare professional reported "history of dcis breast cancer and exchange with no complaint against the device".Patient later reported "slimy and everything else, was told explant could have caused a real issue, and was told something really bad going on with explant".Later reported, "left breast showed abnormal enlarged level 1 left axillary lymph node" and "silicone lymphadenopathy".This record is for the left side.The device has been explanted.

• 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: 24649821
• Report Number: 9617229-2026-04975
• Device Sequence Number: 9842679
• Product Code: FTR
• UDI-Device Identifier: 10888628003798
• UDI-Public: (01)10888628003798(10)2978645(11)161027(17)210927
• 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: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2021
• Device Catalogue Number: MX-410685
• Device Lot Number: 2978645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2016
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White