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-400
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported ¿rupture¿, ¿pain¿ and ¿draining¿.This record is for the left side.Device remains implanted.
Event or Problem Description
Healthcare professional reported ¿rupture¿, ¿pain¿ and ¿draining¿.Later healthcare professional reported capsular contracture baker grade unknown and ¿possible intracapsular rupture¿.This record is for the left side.Device remains implanted.
Event or Problem Description
Healthcare professional reported ¿rupture¿, ¿pain¿ and ¿draining¿.Later healthcare professional reported capsular contracture baker grade unknown and ¿possible intracapsular rupture¿.Later healthcare professional reported ¿capsular contracture baker grade iv¿.This record is for the left side.Device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.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: rupture.
Additional Manufacturer Narrative
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.Reason for reoperation: capsular contracture, baker grade unknown additional, changed, and/or corrected data: a.2., b.3., b.5., b.6., h.6., h.11.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5.Reason for reoperation: rupture, capsular contracture baker grade iv.

• 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 ; +1(847)936-6324
• MDR Report Key: 50304225
• Report Number: 9617229-2026-15623
• Device Sequence Number: 10635184
• Product Code: FTR
• UDI-Device Identifier: 10888628030299
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

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 Catalogue Number: SCX-400
• Device Lot Number: 1232369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/27/2026
• Supplement Date Received by Manufacturer: 08/25/2026; 09/10/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/09/2026; 09/24/2026
• Date Device Manufactured: 03/11/2024
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 122 LB
• Patient Race: White