MAUDE Adverse Event Report: Allergan (Costa Rica) Style 110 Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	110-390
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "rupture".Later healthcare professional reported "capsular contracture" baker grade unknown and "extracapsular rupture".This report is for the left side.The device was explanted.
Additional Manufacturer Narrative
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.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The event of capsular contracture baker grade unknown 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 and capsular contracture baker grade unknown.

• Brand Name: Style 110 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: 50898037
• Report Number: 9617229-2026-18225
• Device Sequence Number: 12225581
• Product Code: FTR
• UDI-Device Identifier: 10888628002258
• UDI-Public: (01)10888628002258(17)151019
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 10/19/2015
• Device Catalogue Number: 110-390
• Device Lot Number: 2047823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 11/19/2010
• 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
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 165 LB
• Patient Race: White