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

Catalog Number	45-800
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's 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 requested.No additional information is available at this time.Reason for reoperation: capsular contracture baker grade iv, malposition, nipple sensation changes, visibility/palpability, decreased sensitivity, pain, neck pain-ndr, pain-ndr, varied injuries-ndr.
Event or Problem Description
Healthcare professional reported left side "capsular contracture baker grade iv".Healthcare professional later reported ¿inferior pole of the left breast is less full and the implant does have some superior malposition¿, ¿nipple sensation", "inferior pole of the left breast is less full¿, ¿tingling or numbness in entire hand", and ¿shoulder pain".Healthcare professional also reported "neck pain", "back pain", "unhappy with appearance", "breathing problems" are all not device related.Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: capsular contracture: unable to observe as it is not related to the device.Malposition: unable to observe as it is not related to the device.Nipple sensation increase/decrease: unable to observe as it is not related to the device.Visibility/palpability: unable to observe as it is not related to the device.Decreased sensitivity: unable to observe as it is not related to the device.Pain: unable to observe as it is not related to the device.Neck pain: unable to observe as it is not related to the device.Varied injuries: unable to observe as it is not related to the device.As per the investigation procedures observed an opening, creases and wear abrasion were completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.Additional, changed, and/or corrected data: b5, d9, e1, h3, h6.
Event or Problem Description
Healthcare professional reported left side "capsular contracture baker grade iv".Healthcare professional later reported ¿inferior pole of the left breast is less full and the implant does have some superior malposition¿, ¿nipple sensation", "inferior pole of the left breast is less full¿, ¿tingling or numbness in entire hand", and ¿shoulder pain".Healthcare professional also reported "neck pain", "back pain", "unhappy with appearance", "breathing problems" are all not device related.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: 21210833
• Report Number: 9617229-2025-01246
• Device Sequence Number: 3916409
• Product Code: FTR
• UDI-Device Identifier: 10888628002142
• UDI-Public: 10888628002142
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: 11/10/2014
• Device Catalogue Number: 45-800
• Device Lot Number: 1790692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2009
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White