MAUDE Adverse Event Report: Allergan (Costa Rica) Style 410 Cohesive Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	FF-410255
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "rupture" diagnosed via mri and "textured silicone implants".Healthcare professional also indicated ¿breast implant-associated anaplastic large cell lymphoma¿ as the ¿contributing event for claim".Healthcare professional later reported "capsular contracture¿ baker grade iii, "hole, non-specific" observed during surgery, and confirmed that there is not a report of breast implant-associated anaplastic large cell lymphoma.This record is for the left side.Device was explanted.
Additional Manufacturer Narrative
Clarification to h6 adverse event problem: un-reporting e180102 breast implant associated anaplastic large cell lymphoma (bia alcl) and f1203 life threatening illness or injury as it was confirmed that there was no report or diagnosis of bia-alcl.The event of "capsular contracture" is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.Reason for reoperation: rupture; capsular contracture baker grade iii.Additional, changed, and/or corrected data: b2, b3, b5, b6, d6b, h6.
Event or Problem Description
Healthcare professional reported "rupture" diagnosed via mri and "textured silicone implants".Healthcare professional also indicated ¿breast implant-associated anaplastic large cell lymphoma¿ as the ¿contributing event for claim".Pathological markers cd30+ and alk- have not been confirmed.This record 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.The event of "lymphoma-alcl-suspected" is a physiological complication and analysis of the device generally does not assist abbvie 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: rupture; suspected bia-alcl, pathological markers cd30+ and alk- not 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: 50177255
• Report Number: 9617229-2026-14869
• Device Sequence Number: 9880272
• Product Code: FTR
• UDI-Device Identifier: 10888628002647
• UDI-Public: (01)10888628002647(17)180421
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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: 04/21/2018
• Device Catalogue Number: FF-410255
• Device Lot Number: 2461955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/03/2026
• Date Device Manufactured: 05/21/2013
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 130 LB
• Patient Race: White