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 Codes	Failure of Implant (1924); Breast Mass (2439)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Patient reported "rupture" through company representative.This record is for the left side.The device remains implanted.It is unknown if explant surgery is scheduled or if the device will be returned.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a2, b3, b6, d1, d2, d4, d6a, g4, h4, h6.
Event or Problem Description
Patient reported "rupture" through company representative.This record is for the left side.The device remains implanted.It is unknown if explant surgery is scheduled or if the device will be returned.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
The device was explanted.
Event or Problem Description
Later, healthcare professional reported "lump on / next to the implant", "fibroadenoma but biopsy showed non-refractile material in keeping with silicone and fibrosis/scaring".
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5, h.6.
Event or Problem Description
Patient reported "rupture" through company representative.Later, healthcare professional reported "lump on / next to the implant", "fibroadenoma but biopsy showed non-refractile material in keeping with silicone and fibrosis/scaring".The rupture event was reported by the patient and was not confirmed by the healthcare professional.This record is for the left side.The device was explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b1, b5, d4, g2, h4, h6.

• 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 ; +1(847)936-6324
• MDR Report Key: 23525893
• Report Number: 9617229-2025-19477
• Device Sequence Number: 15738348
• Product Code: FTR
• 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: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/26/2026

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 Expiration Date: 09/12/2021
• Device Catalogue Number: N-TSM310
• Device Lot Number: 2958397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 12/17/2025; 01/19/2026; 08/04/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/11/2025; 01/12/2026; 01/27/2026; 08/26/2026
• Date Device Manufactured: 09/12/2016
• 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: 40 YR
• Patient Sex: Female