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

Catalog Number	SCF-485
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Reason for reoperation: contamination.
Event or Problem Description
Healthcare professional reported "when opening a natrelle implant, the assisting np noticed something inside the implant".This device was not implanted and surgery was completed with a backup device.
Event or Problem Description
Healthcare professional reported "when opening a natrelle implant, the assisting np noticed something inside the implant".This device was not implanted.
Additional Manufacturer Narrative
Device evaluation: the device related to the reported event foreign material on implant was received on april 29, 2026, with lot number 1339109.Per the investigation procedure, the device is analyzed through visual inspection 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: ¿ foreign material on implant: observed a particle inside on the gel, through visual inspection assessed as workmanship.A further investigation is requested.None of the other observations performed during the device analysis deformation and creases are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.
Event or Problem Description
Healthcare professional reported "when opening a natrelle implant, the assisting np noticed something inside the implant".This device was not implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d9, h3, h6 device evaluation: per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: ¿ foreign material on implant: observed a particle inside on the gel, through visual inspection assessed as workmanship.A further investigation is requested.None of the other observations performed during the device analysis deformation and creases are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.

• 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: 24567793
• Report Number: 9617229-2026-04418
• Device Sequence Number: 8366208
• Product Code: FTR
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SCF-485
• Device Lot Number: 1339109
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/29/2026
• 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: 02/18/2026
• Supplement Date Received by Manufacturer: 05/06/2026; 06/05/2026; 07/09/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 06/01/2026; 07/01/2026; 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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: Unknown