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-410775
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Granuloma (1876); Swollen Lymph Nodes/Glands (4432)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of granuloma and lymphadenopathy are 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: granuloma, lymphadenopathy, rupture.
Event or Problem Description
Patient reported rupture on unknown side via mri and ultrasound as well as exchange from textured to smooth due to concern with the product.Patient representative confirmed left side rupture.Healthcare professional confirmed left-side rupture confirmed via mri and ct scan, needle biopsy of -silicone granuloma.The device has been explanted and replaced.
Event or Problem Description
Patient reported rupture on unknown side via mri and ultrasound as well as exchange from textured to smooth due to concern with the product.Patient representative confirmed left side rupture.Healthcare professional confirmed left-side rupture confirmed via mri and ct scan, needle biopsy of -silicone granuloma.The device has been explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d9, h3, h6 device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ rupture and silicone migration: observed broken device assessed as fold flaw opening and a missing piece of shell assessed as inconclusive.¿ anxiety-product/procedure: unable to observe as it is not related to the manufacturing process.¿ lymphadenopathy: unable to observe as it is not related to the manufacturing process.¿ granuloma: unable to observe as it is not related to the manufacturing process.As per the investigation procedure, 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.

• 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: 21853384
• Report Number: 9617229-2025-06334
• Device Sequence Number: 8699176
• Product Code: FTR
• UDI-Device Identifier: 10888628003040
• UDI-Public: (01)10888628003040(10)2802226(11)150927(17)200827
• 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: 2016
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 08/27/2020
• Device Catalogue Number: FX-410775
• Device Lot Number: 2802226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2015
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White