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

Catalog Number	TRF-485
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	03/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported a left side "rupture, and textured implant" confirmed via ct and mri.Healthcare professional later reported "hole, non-specific," and "hole on patch side." healthcare professional additionally reported "trace amount of simple fluid noted within the capsule." patient undergone partial capsulectomy.Device has been explanted and replaced.
Additional Manufacturer Narrative
The event of seroma-late is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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, anxiety-product/procedure, seroma-late.
Event or Problem Description
Healthcare professional reported a left side "rupture, and textured implant" confirmed via ct and mri.Healthcare professional later reported "hole, non-specific," and "hole on patch side." healthcare professional additionally reported "trace amount of simple fluid noted within the capsule." patient undergone partial capsulectomy.Device has been explanted and replaced.
Additional Manufacturer Narrative
Device evaluation: based on the product analysis performed, the assessments of the complaint codes are: ¿ seroma-late: unable to observe as it is not related to the manufacturing process.¿ anxiety-product/procedure: unable to observe as it is not related to the manufacturing process.¿ rupture: observed broken device assessed as surgical damage and unidentified (tear) opening and observed a missing piece of shell assessed as inconclusive.No additional observations performed on the device.No further actions are required.A review of the device history record has been completed.No deviations or non-conformances noted.Additional, changed, and/or corrected data: a2, b6, d4, d6a, d9, e1, h3, 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 ; 8479366324
• MDR Report Key: 22035075
• Report Number: 9617229-2025-08074
• Device Sequence Number: 9484649
• Product Code: FTR
• UDI-Device Identifier: 10888628008359
• UDI-Public: (01)10888628008359(10)3042807(11)170417(17)220317
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 03/17/2022
• Device Catalogue Number: TRF-485
• Device Lot Number: 3042807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2017
• 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: 36 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic