MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) Style 168 Saline Filled Breast Implant; prosthesis, breast, inflatable, internal, saline

Catalog Number	168-360
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Later, a healthcare professional reported "capsular contracture baker grade iv", "pain", "possible rupture", an mri showed devices were intact, "flipped or misplaced implant", "20ccs of dark brown fluid surrounding implant", and "fluid surrounding the implant".
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5 b6 d4 g2 h6.Additional reason for removal: capsular contracture grade iv.The reported event is a physiological complication (capsular contracture grade iv), and device analysis typically does not help allergan determine the cause.
Event or Problem Description
Patient reported "pain", "fluid" and "wrinkle", "textured to smooth" and "fluid was dark red" later patient reported "i have a huge capsule with a large amount of complex fluid around the implant inside the capsule" and "breast is high up under my hard, hard and swollen".This record is for left side.The device remains implanted.
Additional Manufacturer Narrative
The event of seroma 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.A review of the device history record has been completed.No deviations or non-conformances noted.Reason for reoperation: seroma-late.
Event or Problem Description
Patient reported "pain", "fluid" and "wrinkle", "textured to smooth" and "fluid was dark red" later patient reported "i have a huge capsule with a large amount of complex fluid around the implant inside the capsule" and "breast is high up under my hard, hard and swollen".This record is for left side.The device remains implanted.
Additional Manufacturer Narrative
Additional, corrected and/or changed data: b.5, d.6b, h.6.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b6.
Event or Problem Description
Patient reported "pain", "fluid" and "wrinkle", "textured to smooth" and "fluid was dark red".Later patient reported "i have a huge capsule with a large amount of complex fluid around the implant inside the capsule" and "breast is high up under my hard, hard and swollen".Later healthcare professional reported "capsular contracture baker grade iv", "pain", "possible rupture", "flipped or misplaced implant", "20ccs of dark brown fluid surrounding implant", "fluid surrounding the implant", "pathology results were negative for atypia or malignancy".This record is for left side.The device was explanted.

• Brand Name: Style 168 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: 25220086
• Report Number: 9617229-2026-09293
• Device Sequence Number: 15945934
• Product Code: FWM
• UDI-Device Identifier: 10888628000834
• UDI-Public: (01)10888628000834(17)030918
• 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: 2000
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/14/2026

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: 09/18/2003
• Device Catalogue Number: 168-360
• Device Lot Number: 546621
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2026
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 05/21/2026; 06/10/2026; 07/10/2026; 09/01/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/10/2026; 06/29/2026; 08/03/2026; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/1999
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 200 LB
• Patient Race: White