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-410410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Lymphoma (3263)
Date of Event	06/01/2024
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.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: "late seroma" and suspicion of "breast implant- associated anaplastic large cell lymphoma".The reported events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Clarification to d6a implant date: 2010 (year only received.) e1 cont.Additional phone number: (b)(6).Fi summary: 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 events are classified as medical and they are unable to observe, therefore they are unable to be confirmed.A review of the current risk documents rmf-chl-bi family (v15.0) was performed, and the event of lymphoma ¿ alcl - suspected is a known event, for which current process controls and inspections are established to reduce the incidence of this defect.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.
Event or Problem Description
Healthcare professional reported "late seroma, ultrasound guided biopsy, pathology reported as breast implant- associated anaplastic large cell lymphoma", later reported capsular contracture baker grade ii confirmed via us.Histopathological markers are not reported, therefore, alcl cannot be confirmed.This record is for a left side.The device has been removed without replacement and a total capsulectomy was performed.

• 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: 21759490
• Report Number: 9617229-2025-05419
• Device Sequence Number: 18265224
• Product Code: FTR
• UDI-Device Identifier: 10888628002982
• UDI-Public: 10888628002982
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P040046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2015
• Device Catalogue Number: FX-410410
• Device Lot Number: 1819750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 04/03/2025
• Date Device Manufactured: 03/20/2010
• 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; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White