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-310
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Clinical Signs, Symptoms or Conditions (4582)
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: capsular contracture, baker grade iv.
Event or Problem Description
Patient reported right side "fold/indented/capsular contracture, baker grade iv".The device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d6b, h6.
Event or Problem Description
Patient reported right side "fold/indented/capsular contracture, baker grade iv".The device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5, h.6.
Event or Problem Description
Previous medwatch submission noted capsular contracture.Upon further information, allergan has determined that the event of capsular contracture did not occur.Healthcare professional later reported "implant migration is related to the poor skin quality of the patient"; this event is not device related.

• 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: 22687575
• Report Number: 9617229-2025-12998
• Device Sequence Number: 15740616
• Product Code: FTR
• UDI-Device Identifier: 10888628030268
• UDI-Public: (01)10888628030268(10)3405482(11)200116(17)241216
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2025

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: 12/16/2024
• Device Catalogue Number: SCX-310
• Device Lot Number: 3405482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 10/09/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/18/2025; 10/31/2025
• Date Device Manufactured: 01/16/2020
• 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 Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Hispanic