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 Codes	Capsular Contracture (1761); Seroma (2069); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "possible rupture", "fluid" and "possible alcl".Histopathological markers cd30+ and alk- have not been received, hence the report of alcl has not been confirmed.Healthcare professional later confirmed "rupture; peri prosthetic fluid collection" and reported "capsular contracture" baker grade unknown.This record is for the right side.Device remains implanted.
Additional Manufacturer Narrative
Explanting physician information: name: (b)(6).A review of the device history record has been completed.No deviations or non-conformances noted.Further investigation: the review of the documentation associated to the manufacturing process indicates that all devices involved in this work order were released in accordance with abbvie¿s procedures and were no defects/problems/issues found in the documents or in the personnel training related to the reported event.Additionally, no er/ ncr(s) were identified during the investigation associated with this lot and the complaint.According to the complaint review the device will not be returned for analysis in the device analysis laboratory.However, the reported event lymphoma ¿ alcl - suspected is classified as medical and it is unable to observe, therefore it is unable to be confirmed.A review of the current risk documents was performed in pfmea-silicone filled bi and sizer assembly, smooth (v3.0), and the event of bia-alcl is a known hazard for breast implants.Considering that there is no adverse trend for this type of event, no additional actions are deemed required at this time.The issue with lymphoma ¿ alcl - suspected will continue to be monitored and corrective actions will be taken in the future if deemed appropriate.The events of "lymphoma-alcl-suspected", "seroma-late", and "capsular contracture" are physiological complications and analysis of the device generally does not assist abbvie in determining a probable cause for these events.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;."peri prosthetic fluid collection"; capsular contracture, baker grade unknown; "possible alcl", pathological markers cd30+ and alk- have not been confirmed.

• 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 ; +1(847)936-6324
• MDR Report Key: 50947852
• Report Number: 9617229-2026-18550
• Device Sequence Number: 10348738
• Product Code: FTR
• UDI-Device Identifier: 10888628003002
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 02/04/2020
• Device Catalogue Number: FX-410495
• Device Lot Number: 2713012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 03/04/2015
• 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: Other; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 129 LB
• Patient Race: White