MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	115-401
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported left side fluid buildup, rupture and implant removal from textured to smooth due to the concerns of the product confirmed with mri and ultrasound.Later healthcare professional reported rupture confirmed via mri.The device remains implanted.
Additional Manufacturer Narrative
Clarification to b3: partial date of 2019 provided.A review of the device history record has been completed.No deviations or non-conformances noted.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/will be requested.No additional information is available at this time.Reason for reoperation: rupture; fluid buildup.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h6.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b6.
Event or Problem Description
Patient reported "fluid buildup, rupture and implant removal from textured to smooth due to the concerns of the product".Later healthcare professional reported "rupture".Later healthcare professional reported "single prominent elongated lymph node".This record is for the left side.Device was explanted.

• Brand Name: STYLE 115 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: 23144554
• Report Number: 9617229-2025-16286
• Device Sequence Number: 8842692
• Product Code: FTR
• UDI-Device Identifier: 10888628002418
• UDI-Public: (01)10888628002418(10)2799212(11)150903(17)200803
• 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: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2026

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: 08/03/2020
• Device Catalogue Number: 115-401
• Device Lot Number: 2799212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 02/26/2026
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/27/2025; 03/16/2026
• Date Device Manufactured: 09/03/2015
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian