MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 468 SALINE FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	468-270
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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/will be requested.No additional information is available at this time.Reason for reoperation: "rupture" of a saline device; capsular contracture, baker grade iii.
Event or Problem Description
Healthcare professional reported right side ¿change in size of breasts¿, ¿textured style 468 saline filled implants¿, ¿grade iii capsular contracture¿, and ¿intracapsular rupture¿ of a saline device.The device remains implanted.
Event or Problem Description
Healthcare professional reported right side ¿change in size of breasts¿, ¿textured saline filled implants¿, ¿grade iii capsular contracture¿, ¿intracapsular rupture¿ of a saline device per ct scan.Device was found to be intact at explant surgery.Additional report of "calcification and fibrosis of the capsule".The device has been explanted.
Additional Manufacturer Narrative
The device was found to be intact, the event of deflation will no longer be reported.
Event or Problem Description
Healthcare professional reported right side "rupture", capsular contracture, baker grade iii and texture to smooth exchange of a saline device.The has been explanted.
Additional Manufacturer Narrative
Photographic device evaluation: a review of the device through photographs noted an opening on the device, however the assessment of the opening cannot be confirmed as microscopic analysis is not possible.The event of capsular contracture could not be observed as it is a physiological complication.
Additional Manufacturer Narrative
Correction to g.3.Aware date of supplemental medwatch #2.Aware date should have been listed as 18jul2024.
Event or Problem Description
Healthcare professional reported right side "rupture", capsular contracture, baker grade iii and texture to smooth exchange of a saline device.The has been explanted.

• Brand Name: STYLE 468 SALINE FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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 ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 18837365
• Report Number: 9617229-2024-03712
• Device Sequence Number: 7132924
• Product Code: FWM
• UDI-Device Identifier: 10888628001107
• UDI-Public: 10888628001107
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/19/2025

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: 03/22/2007
• Device Catalogue Number: 468-270
• Device Lot Number: 561248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 03/12/2024; 02/13/2024; 09/09/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/03/2024; 08/09/2024; 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2003
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White