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

Catalog Number	SCX-225
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	01/28/2025
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 iii/iv.
Event or Problem Description
Healthcare professional reported left side capsular contracture, baker grade iii/iv with pain.Additionally, patient experienced hematoma, decreased left nipple sensation and implant had flipped.Patient was treated with medication.The device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a5, a6, b5, d6b, e1, h6.
Event or Problem Description
Healthcare professional reported left side capsular contracture baker grade iii/iv with pain.Healthcare professional later reported patient experienced hematoma, decreased left nipple sensation and implant had flipped.Patient was treated with medication.Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaints are: nipple sensation increase/decrease: unable to observe as it is not related to the manufacturing process.Malposition: unable to observe as it is not related to the manufacturing process.Hematoma: unable to observe as it is not related to the manufacturing process.Capsular contracture: unable to observe as it is not related to the manufacturing process.As per the investigation procedure, crease, and deformation were observed 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: b3, d9, h3, h6.
Event or Problem Description
Healthcare professional reported left side capsular contracture baker grade iii/iv with pain.Healthcare professional later reported patient experienced hematoma, decreased left nipple sensation and implant had flipped.Patient was treated with medication.Device has been explanted and replaced.

• Brand Name: INSPIRA SMOOTH COHESIVE 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: 22011309
• Report Number: 9617229-2025-07801
• Device Sequence Number: 20140775
• Product Code: FTR
• UDI-Device Identifier: 10888628030237
• UDI-Public: (01)10888628030237(10)3638650(11)220901(17)270801
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SCX-225
• Device Lot Number: 3638650
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 08/26/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 08/06/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 50 KG