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

Catalog Number	115-253
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Seroma (2069)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of "seroma-late" 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: rupture and rupture and seroma-late.
Event or Problem Description
Physician reported right side rupture and fluid collection.Physician later reported "high blood pressure and heart failure" which is not device related.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5 e1 e2 e3 g2 h6.
Event or Problem Description
Patient was the initial reporter who provided a physician diagnosis of rupture.Healthcare professional reported after surgery, the device was discarded according to hospital regulations.
Additional Manufacturer Narrative
Continued e1 phone number: (b)(6).Clarification to h6: disregard previously reported e0307 seroma.Previously reported "fluid collection" (seroma) was never diagnosed by a physician and will be unreported.
Event or Problem Description
Previously reported "fluid collection" (seroma) was never diagnosed by a physician and will be unreported.

• 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: 22520181
• Report Number: 9617229-2025-11909
• Device Sequence Number: 9231457
• Product Code: FTR
• UDI-Device Identifier: 10888628002357
• UDI-Public: (01)10888628002357(10)3122046(11)171030(17)220930
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• 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): 10/22/2025

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: 09/30/2022
• Device Catalogue Number: 115-253
• Device Lot Number: 3122046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 10/22/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 10/21/2025; 10/22/2025
• Date Device Manufactured: 10/30/2017
• 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: 41 YR
• Patient Sex: Female
• Patient Weight: 55 KG