MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) Style 20 Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	20-350
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Inflammation (1932); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "post-traumatic capsular contracture release following fall.History of capsular contracture.", "fall approximately one month ago from a counter, landing flat on the chest.Reports immediate swelling and heat, unable to touch breasts for weeks.Experienced a sensation of the capsule "peeling off' with certain movements" and "baker i".Later healthcare professional reported "reports a constant grabbing sensation in the arms since the fall".Healthcare professional reported "silicone implants without rupture, minimal fluid collection".This record is for the right side.Device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The reported events are physiological complication 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.Reason for reoperation: capsular contracture, baker grade iii, inflammation and visibility/palpability.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d4, d6b, h.6.
Event or Problem Description
Healthcare professional reported "post-traumatic capsular contracture release following fall.History of capsular contracture.", "fall approximately one month ago from a counter, landing flat on the chest.Reports immediate swelling and heat, unable to touch breasts for weeks.Experienced a sensation of the capsule "peeling off' with certain movements" and "baker i".Later healthcare professional reported "reports a constant grabbing sensation in the arms since the fall".Healthcare professional reported "silicone implants without rupture, minimal fluid collection".This record is for the right side.Device has been explanted.

• Brand Name: Style 20 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: 24685676
• Report Number: 9617229-2026-05275
• Device Sequence Number: 9653395
• Product Code: FTR
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Report Date (Section B): 08/24/2026

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: 09/03/2018
• Device Catalogue Number: 20-350
• Device Lot Number: 2509746
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 05/21/2026; Not provided
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 06/17/2026; 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2013
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 130 LB