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

Catalog Number	20-550
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported "rupture".Later healthcare professional reported "rupture".Healthcare professional reported "breast pain and rupture after a motor vehicle accident".Later healthcare professional reported "complete rupture", "thickened anterior capsule", and "capsule grade 2".Patient had a capsulorrhaphy and a partial capsulectomy.This record is for the right side.Device has been explanted.
Event or Problem Description
Patient reported "rupture".This record is for an unknown side.Device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Additional, changed, and/or corrected data: a2, a4, b3, b5, b6, b7, d1, d3, d4, d6a, d6b, g1, g2, h4, h6.
Additional Manufacturer Narrative
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.

• 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: 50508280
• Report Number: 9617229-2026-16422
• Device Sequence Number: 18506530
• Product Code: FTR
• UDI-Device Identifier: 10888628001756
• UDI-Public: (01)10888628001756(17)130721
• 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: 2009
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: 07/21/2013
• Device Catalogue Number: 20-550
• Device Lot Number: 1639647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/12/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 08/28/2008
• 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: 47 YR
• Patient Sex: Female
• Patient Weight: 158 LB