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

Catalog Number	45-650
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported, left side "capsular contracture, baker grade iii".Device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.The event of capsular contracture 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: capsular contracture, baker grade iii.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Healthcare professional is now reporting left side exchange with no complaint against the device as reason for removal.This record is no longer reportable to the fda and will be un-reported.Additional, changed, and/or corrected data: b2, b5, d6a, h1, h6, h11.
Event or Problem Description
Patient and healthcare professional previously reported left side capsular contracture baker grade iii.Healthcare professional is now reporting left side exchange with no complaint against the device as reason for removal.Rupture and capsular contracture were only on the contralateral side.

• 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 2525 dupont drive; building 3; irvine, CA 92612 ; 8479366324
• MDR Report Key: 18168014
• Report Number: 9617229-2023-19253
• Device Sequence Number: 17795384
• Product Code: FTR
• UDI-Device Identifier: 10888628002128
• UDI-Public: 10888628002128
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2019
• Device Catalogue Number: 45-650
• Device Lot Number: 2662033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 01/17/2024; 03/07/2025
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/20/2024; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2014
• 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: 29 YR
• Patient Sex: Female
• Patient Weight: 61 KG