MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) Style 68 Saline Filled Breast Implant; prosthesis, breast, inflatable, internal, saline

Catalog Number	68-480
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
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.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.The reason for reoperation: capsular contracture baker grade unknown.
Event or Problem Description
Patient reported ¿capsular contracture baker grade unknown¿.Later healthcare professional reported ¿exchange with no complaint against device¿.No confirmation of capsular contracture by healthcare professional, which will remain in the record at this time.This record is for the left side.Device remains implanted.
Event or Problem Description
Patient reported ¿capsular contracture baker grade unknown¿.Later healthcare professional reported ¿exchange with no complaint against device¿.Later healthcare professional reported ¿capsular contracture baker grade iii¿.This record is for the left side.Device was explanted.
Additional Manufacturer Narrative
The reason for reoperation: capsular contracture baker grade iii.Additional, changed, and/or corrected data: b.5., d.6b., h.6., h.11.

• Brand Name: Style 68 Saline Filled Breast Implant
• Common Device Name: prosthesis, breast, inflatable, internal, saline
• 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: 25333950
• Report Number: 9617229-2026-10036
• Device Sequence Number: 9861556
• Product Code: FWM
• UDI-Device Identifier: 10888628000278
• UDI-Public: (01)10888628000278(17)271001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 68-480
• Device Lot Number: 1213938
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Supplement Date Received by Manufacturer: 08/17/2026; 09/16/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 09/01/2026; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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 Sex: Female
• Patient Weight: 180 LB
• Patient Race: White