MAUDE Adverse Event Report: Allergan (Costa Rica) Style 15 Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	15-397
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "rupture".The rupture was reported to be discovered during surgery.Later, healthcare professional reported "unhappy with the shape", "too big", "scar tissue", "shape deformation", "contour irregularity", "radial folds", "lymph node", "malpositioning", "discomfort" and "free gel in the capsule".This record is for the right side.Device was explanted.Patient underwent popcorn capsulorrhaphy and capsulotomy.
Additional Manufacturer Narrative
Additional, changed, and/or corrected: b5, b6, d9, h3 and h6.Reason for reoperation: unknown.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: ¿ rupture: observed an opening through microscopic inspection assessed as fold flaw opening.No further actions are required as it is not related to the manufacturing process.¿ unsatisfactory result: unable to observe through visual inspection as it is a physiological phenomenon.None of the other observations performed during the device analysis creases and non penetration nicks are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.

• Brand Name: Style 15 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: 50652288
• Report Number: 9617229-2026-16990
• Device Sequence Number: 15882324
• Product Code: FTR
• UDI-Device Identifier: 10888628001480
• UDI-Public: (01)10888628001480(17)200103
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2026

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: 01/03/2020
• Device Catalogue Number: 15-397
• Device Lot Number: 2702070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/07/2026
• Date Device Manufactured: 02/03/2015
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 140 LB
• Patient Race: White