MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 120 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	120-300
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
Patient, through other company representative, reported "pain" and "textured implant".Healthcare professional later reported "recalled", "capsular contraction", baker grade unknown and "capsular calcification".Later healthcare professional reported "grade 4 capsular contracture".This record is for the left side.The device remains implanted.It is unknown if the device will be returned.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of capsular contraction 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: "recalled", "capsular contraction", baker grade unknown and "capsular calcification".
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5, d.6b, h.6.
Event or Problem Description
The device was explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d9, h3, h6 device evaluation: 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.¿ calcification: observed calcification on device through visual inspection.No further actions are required as it is not related to the manufacturing process.None of the other observations performed during the device analysis (creases, wear abrasion and deformation) are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.
Event or Problem Description
Patient, through other company representative, reported "pain" and "textured implant".Healthcare professional later reported "recalled", "capsular contraction", baker grade unknown and "capsular calcification".Later healthcare professional reported "grade 4 capsular contracture".This record is for the left side.The device was explanted.

• Brand Name: STYLE 120 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 ; 8479366324
• MDR Report Key: 23979257
• Report Number: 9617229-2026-00330
• Device Sequence Number: 14597007
• Product Code: FTR
• UDI-Device Identifier: 10888628002531
• UDI-Public: 10888628002531
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2026

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: 01/09/2013
• Device Catalogue Number: 120-300
• Device Lot Number: 1552339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 02/11/2026; 04/21/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/17/2026; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2008
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 70 KG