MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 45 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	45-600
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Seroma (2069)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "rupture and exchange".Healthcare professional later reported "intracapsular rupture and ruptured with floating shell" and "edema and enhancement involving the sternum and ribs may be secondary to known fracture from trauma" confirmed via mri.This record is for the left side.Device has been explanted and replaced.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.The event of seroma 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: rupture and seroma.
Additional Manufacturer Narrative
Clarification to h6/h11 of initial medwatch: disregard e0307 seroma, as this event was never reported.Seroma will be unreported.Laboratory analysis summary the device related to the reported events rupture was received on sep 24, 2025, with lot number 2846221.Based on the product analysis performed, the assessments of the complaint codes are: ¿ rupture: observed broken device assessed as surgical damage and observed a missing piece of shell assessed as inconclusive.As per the investigation procedure, creases were observed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.
Event or Problem Description
Healthcare professional reported "rupture and exchange".Healthcare professional later reported "intracapsular rupture and ruptured with floating shell" and "edema and enhancement involving the sternum and ribs may be secondary to known fracture from trauma" confirmed via mri.This record is for the left side.Device has been explanted and replaced.

• Brand Name: STYLE 45 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 ; 8479366324
• MDR Report Key: 22889297
• Report Number: 9617229-2025-14482
• Device Sequence Number: 21062541
• Product Code: FTR
• UDI-Device Identifier: 10888628002111
• UDI-Public: (01)10888628002111(10)2846221(11)151219(17)201119
• 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: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 11/19/2020
• Device Catalogue Number: 45-600
• Device Lot Number: 2846221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2015
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White