MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) Style 115 Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	115-378
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546); Migration (4003)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a follow up to emdr 9617229-2020-06493.A review of the device history record has been completed.No deviations or non-conformance's noted.The events of silicone migration and capsular contracture are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.The reason for reoperation: rupture, capsular contracture baker grade iii, silicone migration.
Event or Problem Description
Patient reported right side "lump under her right arm pit", "plastic surgeon said it was like seepage", "they have a leakage or something", "silicone was gathering in the right armpit", and "concern with the product".Then healthcare professional reported "pain", "leaking", "capsular contracture baker grade iii" and "exchange from textured to smooth device due to the patients concern with the product".Device remains implanted.Device will be returned.
Event or Problem Description
Patient reported right side "lump under her right arm pit", "plastic surgeon said it was like seepage", "they have a leakage or something", "silicone was gathering in the right armpit", and "concern with the product".Then healthcare professional reported "pain", "leaking", "capsular contracture baker grade iii" and "exchange from textured to smooth device due to the patients concern with the product".Device has been explanted.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d6b, h6.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, h6 (explant date not provided).

• 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 ; +1(847)936-6324
• MDR Report Key: 23759557
• Report Number: 9617229-2025-21388
• Device Sequence Number: 10105298
• Product Code: FTR
• 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: 2011
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 115-378
• Device Lot Number: 2005274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 06/09/2026; 07/28/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 07/06/2026; 08/17/2026
• Date Device Manufactured: 08/31/2010
• 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 Race: White