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

Catalog Number	SRF-520
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Necrosis (1971)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "breast implant replacement due to trauma induced rupture in the contralateral breast".Later healthcare professional reported "breast wound dehiscence with skin/soft tissue necrosis and exposed implant".This record is for the left side.The device has been explanted.
Event or Problem Description
Healthcare professional reported "breast implant replacement due to trauma induced rupture in the contralateral breast".Later healthcare professional reported "breast wound dehiscence with skin/soft tissue necrosis and exposed implant".This record is for the left side.The device has been explanted.
Additional Manufacturer Narrative
Continued e1: alternate email address: (b)(6).Reason for reoperation: "breast wound dehiscence with skin/soft tissue necrosis and exposed implant".The event of "breast wound dehiscence with skin/soft tissue necrosis and exposed implant" is a physiological complication and analysis of the device generally does not assist abbvie in determining a probable cause for this event.A review of the device history record has been completed.No deviations or non-conformances noted.Further information regarding event, product, or patient details has been requested.No additional information is available at this time.
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: - exposure: unable to observe through visual inspection as it is a physiological phenomenon.- necrosis: unable to observe through visual inspection as it is a physiological phenomenon.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 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: 50240816
• Report Number: 9617229-2026-15296
• Device Sequence Number: 18733225
• Product Code: FTR
• UDI-Device Identifier: 10888628007369
• UDI-Public: (01)10888628007369(17)301108
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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 Catalogue Number: SRF-520
• Device Lot Number: 1356491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/13/2026
• Date Device Manufactured: 12/08/2025
• 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: Female
• Patient Weight: 110 LB
• Patient Race: Asian