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

Catalog Number	115-435
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "capsular contracture, baker grade unknown", "pain" and "exchange from a textured to smooth".Later the healthcare professional confirmed "rupture", "pain", "asymmetry", "different", "capsular contracture - baker grade iii/iv" and an "exchange of textured device" via mammogram.This record is for the right side.Device remains implanted.The device will be returned.
Additional Manufacturer Narrative
This is a follow-up report to a medwatch submitted under manufacture report number 9617229-2020-05422.A review of the device history record has been completed.No deviations or non-conformances noted.The event of "capsular contracture" 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: capsular contracture, baker grade iii/iv.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h.6.
Event or Problem Description
Healthcare professional reported "capsular contracture, baker grade unknown", "pain" and "exchange from a textured to smooth".Later the healthcare professional confirmed "rupture", "pain", "asymmetry", "different", "capsular contracture - baker grade iii/iv" and an "exchange of textured device" via mammogram.This record is for the right side.Device remains implanted.
Event or Problem Description
Healthcare professional reported "capsular contracture, baker grade unknown", "pain" and "exchange from a textured to smooth".Later the healthcare professional confirmed "rupture", "pain", "asymmetry", "different", "capsular contracture - baker grade iii/iv" and an "exchange of textured device" via mammogram.This record is for the right side.Device was explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5.
Additional Manufacturer Narrative
Device evaluation: per the investigation procedure, the device is analyzed through visual inspection microscopic inspection if openings are observed and a weight verification.Per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: ¿ capsular contracture: unable to observe through visual inspection as it is a physiological phenomenon.¿ anxiety - product/ procedure: unable to observe through visual inspection as it is a physiological phenomenon.¿ pain: unable to observe through visual inspection as it is a physiological phenomenon.None of the other observations performed during the device analysis (deformation, creases, wear abrasion) are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.
Event or Problem Description
Healthcare professional reported "capsular contracture, baker grade unknown", "pain" and "exchange from a textured to smooth".Later the healthcare professional confirmed "rupture", "pain", "asymmetry", "different", "capsular contracture - baker grade iii/iv" and an "exchange of textured device" via mammogram.This record is for the right side.Device was explanted.
Event or Problem Description
Healthcare professional reported "capsular contracture, baker grade unknown", "pain" and "exchange from a textured to smooth".Later the healthcare professional confirmed "rupture", "pain", "asymmetry", "different", "capsular contracture - baker grade iii/iv" and an "exchange of textured device" via mammogram.This record is for the right side.Device was explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: h.6.

• 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: 23935224
• Report Number: 9617229-2025-22778
• Device Sequence Number: 17545716
• Product Code: FTR
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2016
• Device Catalogue Number: 115-435
• Device Lot Number: 2219407
• Date Returned to Manufacturer: 06/01/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 04/06/2026; 05/05/2026; 06/04/2026; 07/22/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 05/01/2026; 05/29/2026; 06/26/2026; 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2012
• 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: 57 YR
• Patient Sex: Female