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

Catalog Number	SRF-415
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "capsular contracture" baker grade unknown, "intracapsular and extracapsular rupture", "was completely ruptured, the shell was in two pieces, the silicone was free-floating within the breast" and "biopsy-proven benign enhancing mass".This record is for the right side.Device has been explanted.Patient underwent a inferior capsulotomy.
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 requested.No additional information is available at this time.Reason for reoperation: rupture and capsular contracture, baker grade unknown.
Event or Problem Description
Healthcare professional reported "capsular contracture" baker grade unknown, "intracapsular and extracapsular rupture", "was completely ruptured, the shell was in two pieces, the silicone was free-floating within the breast" and "biopsy-proven benign enhancing mass".This record is for the right side.Device has been explanted.Patient underwent a inferior capsulotomy.
Additional Manufacturer Narrative
Device evaluation: the device related to the reported events rupture and capsular contracture was received on august 20, 2026, with lot number 2897957.Per the investigation procedure, the device is analyzed through visual microscopic inspection if openings are observed and a weight verification.Per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: - rupture: observed broken device through microscopic inspection assessed as fold flaw opening and observed a missing piece of shell through microscopic inspection assessed as inconclusive.No further actions are required as it is not related to the manufacturing process.- capsular contracture: unable to observe through visual inspection as it is a physiological phenomenon.None of the other observations performed during the device analysis (non-penetrating nick) are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.Additional, changed, and/or corrected data: d.9., h.2., h.3., h.6.

• Brand Name: Inspira Smooth 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: 25634545
• Report Number: 9617229-2026-12271
• Device Sequence Number: 9679918
• Product Code: FTR
• UDI-Device Identifier: 10888628007338
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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 Expiration Date: 03/04/2021
• Device Catalogue Number: SRF-415
• Device Lot Number: 2897957
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2026
• Is the Reporter a Health Professional?: Yes
• 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: 09/02/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2016
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 108 LB
• Patient Race: White