MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 468 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	468-620
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported left side ¿exchange from textured to smooth implants due to the patient's concerns with the product¿, "capsular contracture baker grade iv" and "discomfort and hardness".Device remains implanted.
Additional Manufacturer Narrative
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 iv.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a5, a6, b5, d6b, e1, h3, h6.
Event or Problem Description
Healthcare professional reported left side ¿exchange from textured to smooth implant due to the patient's concerns with the product¿, "capsular contracture baker grade iv" and "discomfort and hardness".Device was explanted and it is unknown if it will be returned.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d.9, h.3, h.6.Device evaluation: per the investigation procedure, the device is analyzed through visual inspection microscopic inspection if openings are observed and a weight verification (if applicable).Per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: capsular contracture: unable to observe through visual inspection as it is a physiological phenomenon.Anxiety - product/ procedure: unable to observe through visual inspection as it is a physiological phenomenon.Visibility/palpability: unable to observe through visual inspection as it is a physiological phenomenon.None of the other observations performed during the device analysis (opening, creases, wear abrasion) are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.
Event or Problem Description
Healthcare professional reported left side ¿exchange from textured to smooth implants due to the patient's concerns with the product¿, "capsular contracture baker grade iv" and "discomfort and hardness".Device was explanted.

• Brand Name: STYLE 468 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): SANTA BARBARA; 900 parkway global park zona f; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 23388009
• Report Number: 9617229-2025-18319
• Device Sequence Number: 4916116
• Product Code: FWM
• UDI-Device Identifier: 10888628001176
• UDI-Public: 10888628001176
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1997
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2026

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: 468-620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 11/21/2025; 01/08/2026
• Initial Report FDA Received Date: 10/26/2025
• Supplement Report FDA Received Date: 12/10/2025; 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 78 KG