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

Catalog Number	N-TSM310
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "breach of implant integrity (rupture)", "gel leakage detected" and "silicone touched the patient".Later healthcare professional reported "mastodynia".This record is for the left side.Device was explanted.
Additional Manufacturer Narrative
Visual analysis: it is not possible to determine the lot number or catalog through the photos provided.* rupture: observed, opening on the device but cannot perform an assessment of the opening as no microscopic analysis can be performed.No additional observations are performed.No further actions are required since no issue in the manufacturing of the device is observed.A review of the device history record has been completed.No deviations or non-conformances noted.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.

• 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 ; 8479366324
• MDR Report Key: 25414653
• Report Number: 9617229-2026-10639
• Device Sequence Number: 12194333
• Product Code: FTR
• UDI-Device Identifier: 10888628033917
• UDI-Public: (01)10888628033917(17)230601
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

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: 06/01/2023
• Device Catalogue Number: N-TSM310
• Device Lot Number: 3210582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2026
• Initial Report FDA Received Date: 06/05/2026
• Date Device Manufactured: 06/01/2018
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 64 KG