MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 115 SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	115-401
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069); Lymphoma (3263)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
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
Healthcare professional reported bilateral exchange from textured to smooth devices due to the patient's concern with the product.Later, healthcare professional reported left side capsular contracture, baker grade iii.Device remains implanted.
Event or Problem Description
Device has been explanted.
Event or Problem Description
Capsular contracture has now been confirmed as baker grade iv.Further reported was left breast seroma/hematoma and "fluid sent for alcl testing;" markers confirming this event have not been reported.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, b6, d6b, d9, g1, h3, h6 the events of seroma-late and lymphoma - alcl - suspected are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for this event.
Event or Problem Description
Capsular contracture has now been confirmed as baker grade iv.Further reported was left breast seroma/hematoma and "fluid sent for alcl testing;" markers confirming this event have not been reported.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: anxiety - product/ procedure: unable to observe since it is a medical event and is not related to the device.Capsular contracture : unable to observe since it is a medical event and is not related to the device.Seroma : unable to observe since it is a medical event and is not related to the device.Hematoma : unable to observe since it is a medical event and is not related to the device.Lymphoma-al cl-suspected : unable to observe since it is a medical event and is not related to the device.Additional observations: deformation observed on the device.No further actions are required as no issues with the manufacturing process are observed.

• 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
• 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: 18364509
• Report Number: 9617229-2023-19914
• Device Sequence Number: 7697060
• Product Code: FTR
• UDI-Device Identifier: 10888628002418
• UDI-Public: 10888628002418
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/14/2024

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: 03/23/2020
• Device Catalogue Number: 115-401
• Device Lot Number: 2731714
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 02/26/2024; Not provided; 04/22/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 03/05/2024; 04/19/2024; 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2015
• 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: 51 YR
• Patient Sex: Female