MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	SRL-110
Medical Device Problem Codes	Material Rupture (1546); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
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.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: rupture.
Event or Problem Description
Patient reported ¿rupture".This record is for the left side.Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5, d.6b, h.6.
Event or Problem Description
Device was explanted and replaced.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Additional, changed, and/or corrected data: b5, d6b, h6.
Event or Problem Description
Patient reported ¿rupture".Later the healthcare professional reported "no rupture found".This record is for the left side.Device was explanted.

• 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 ; 8479366324
• MDR Report Key: 24021781
• Report Number: 9617229-2026-00665
• Device Sequence Number: 13045556
• Product Code: FTR
• UDI-Device Identifier: 10888628006645
• UDI-Public: (01)10888628006645(10)3397286(11)191212(17)241112
• 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: 2021
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2026

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: 11/12/2024
• Device Catalogue Number: SRL-110
• Device Lot Number: 3397286
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 01/12/2026; 02/03/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/27/2026; 02/20/2026
• Date Device Manufactured: 12/12/2019
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic
• Patient Race: White