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

Catalog Number	FM-410270
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Malposition of Device (2616)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported ¿flipped and upside down¿.Later, healthcare professional reported "capsule".This record is for the left side.Device was explanted.
Event or Problem Description
Patient reported ¿exchange from textured to smooth¿.Later healthcare professional reported "capsule".This record is for the right side.Device was explanted.
Additional Manufacturer Narrative
Reason for reoperation: malposition additional, changed, and/or corrected data: a2, b1, b3, b5, b6, d9, e1, h3, h6 clarification for b1, b5 and h6: the events of e2303 - capsular contracture and a010102 - device appears to trigger rejection, captured on previous medwatch 9617229-2026-14535-00, are being un-reported.That event only relates to the right side record.This record relates now to the left side and will only capture serious event malposition of device.A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The event of "malposition" is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.Device evaluation: per the investigation procedure, the device is analyzed through visual inspection microscopic inspection if openings are observed and a weight verification.Per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: -malposition: unable to observe through visual inspection as it is a physiological phenomenon.None of the other observations performed during the device analysis (deformation, wear abrasion and crease) are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of "capsular contracture" 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: capsular contracture, baker grade unknown.

• 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: 50115333
• Report Number: 9617229-2026-14535
• Device Sequence Number: 5305591
• Product Code: FTR
• UDI-Device Identifier: 10888628002838
• UDI-Public: (01)10888628002838(17)140825
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: 08/25/2014
• Device Catalogue Number: FM-410270
• Device Lot Number: 1765719
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/08/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 08/03/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2009
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 125 LB
• Patient Race: White