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

Catalog Number	115-290
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Company representative reported on behalf of patient "dull aching near the breast".Healthcare professional later reported "rupture".Patient later reported through company representative "intracapsular rupture of breast implant", "textured implant included in the recall", "enlarged axillary lymph nodes are likely secondary to systemic process" and "few breast cysts".This record is for the left side.Device was explanted.
Additional Manufacturer Narrative
This is a follow-up report to a medwatch submitted under manufacture report number 9617229-2024-11085.A review of the device history record has been completed.No deviations or non-conformances noted.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.Device evaluation: based on the device analysis grid, the assessments of the complaint are: rupture: observed, broken device assessed as unidentified (tear) opening (shell thickness within specification).Pain: unable to observe since it is not related to the device.As per the investigation procedure particles and creases were completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.

• 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: 50675121
• Report Number: 9617229-2026-17116
• Device Sequence Number: 20153332
• Product Code: FTR
• UDI-Device Identifier: 10888628002371
• UDI-Public: (01)10888628002371(17)200227
• 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: 2015
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 02/27/2020
• Device Catalogue Number: 115-290
• Device Lot Number: 2718973
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2024
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2015
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 123 LB