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

Catalog Number	TRM-345
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Swollen Lymph Nodes/Glands (4432)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Healthcare professional reported left side ¿rupture¿ diagnosed via mri and mammogram and exchange from textured to smooth due to the patients concerns with the product.Device was explanted and replaced.
Additional Manufacturer Narrative
The event of lymphadenopathy is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Additional, changed, and/or corrected data: a5, a6, b5, b6, b7, h6.
Event or Problem Description
Healthcare professional reported left side ¿rupture¿ diagnosed via mri and mammogram and "implant exchange from textured to smooth due to the patient's concerns with the product".Healthcare professional later reported "ruptured and very messy.We got them out with a suction instrument and they are now inside this instrument".Healthcare professional additionally reported "prominent axillary lymph nodes" diagnosed via mammogram, ultrasound, and mri.Device has been explanted and replaced.

• 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: 22889974
• Report Number: 9617229-2025-14485
• Device Sequence Number: 12975138
• Product Code: FTR
• UDI-Device Identifier: 10888628008106
• UDI-Public: (01)10888628008106(10)2766707(11)150706(17)200606
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 06/06/2020
• Device Catalogue Number: TRM-345
• Device Lot Number: 2766707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/11/2025
• Date Device Manufactured: 07/06/2015
• 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: 37 YR
• Patient Sex: Female
• Patient Weight: 63 KG