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

Catalog Number	468-350
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reason for reoperation: capsular contracture baker grade unknown.The event of "capsular contracture baker grade unknown" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.A review of the device history record has been completed.No deviations or non-conformances noted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.
Event or Problem Description
Healthcare professional reported "severe capsular contracture baker grade unknown and exchange from textured to smooth devices due to the patients concern with the product".This record is for left side.The device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: the device related to the reported events anxiety - product/ procedure and capsular contracture was received on (b)(6) 2026, with catalog number mcghan350cc.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: ¿ anxiety - product/ procedure : unable to observe through visual inspection as it is a physiological phenomenon.¿ capsular contracture : unable to observe through visual inspection as it is a physiological phenomenon.None of the other observations performed during the device analysis (crease, openings and wear abrasion) are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.Additional, changed, and/or corrected data: d.9., h.2., h.3., h.6.
Event or Problem Description
Healthcare professional reported "severe capsular contracture baker grade unknown and exchange from textured to smooth devices due to the patients concern with the product".This record is for left side.The device has been explanted and replaced.

• 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): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 23758208
• Report Number: 9617229-2025-21351
• Device Sequence Number: 21355101
• Product Code: FWM
• UDI-Device Identifier: 10888628001121
• UDI-Public: 10888628001121
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1996
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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 Expiration Date: 02/01/2000
• Device Catalogue Number: 468-350
• Device Lot Number: 2-521911
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/1996
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 56 KG