MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) Inspira Textured Silicone Gel Filled Breast Implant; prosthesis, breast, noninflatable, internal, silicone gel-filled

Catalog Number	N-TSX340
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Pain (1994); Anxiety (2328); Swelling/ Edema (4577)
Date of Event	02/01/2026
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 events of edema, pain and anxiety are 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: edema, pain and anxiety.
Event or Problem Description
Patient reported "persistent pain", "breast swelling", "physical discomfort" and "anxiety attacks" against the left side.The device remains implanted.
Event or Problem Description
Patient professional reported "persistent pain", "breast swelling", "physical discomfort", "worry and insecurity", "emotional suffering", and "panic and anxiety attacks".Later healthcare professional reported capsular contracture baker grade iii, "mixed anxiety and depressive disorder" and "panic episodes".Patient was prescribed assert, alprazolam, and paroxetine.This record is for the left side.The device remains implanted.
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 iii.Additional, changed, and/or corrected data: a.5., a.6., b.3., b.5., b.6., d.4., g.2., h.6., h.11.

• Brand Name: Inspira Textured 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: 25620173
• Report Number: 9617229-2026-12141
• Device Sequence Number: 18696418
• Product Code: FTR
• UDI-Device Identifier: 10888628034310
• UDI-Public: (01)10888628034310(17)201125
• 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 Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2020
• Device Catalogue Number: N-TSX340
• Device Lot Number: 2833707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 06/25/2026
• Supplement Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 11/25/2015
• 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 Sex: Female
• Patient Race: White