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

Catalog Number	TRM-295
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/16/2025
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.The review of historical complaints on the complaint management handling system identified that there were other records for units manufactured on lot number 2857580: 1752650: device migration.Device returned to device analysis.1764768: rupture, crease folding of implant.Device returned to device analysis.1767438: capsular contracture, double capsule.Device returned to device analysis.1767439: capsular contracture, double capsule.Device returned to device analysis.1949453: pain, varied injuries-ndr.Device not returned to device analysis.1968646: anxiety - product/procedure, pain.Device returned to device analysis.2116314: visibility/palpability, pain, anxiety - product/procedure, seroma late.Device not returned to device analysis.2116317: anxiety - product/procedure.Device not returned to device analysis.Even though there was 1 additional complaints of rupture for this lot number, the device was returned, and after inspection no workmanship was detected.The search criteria of these queries are mentioned on qpp07-01- 004-her1-g02 wording guidelines for complaint investigation closure revision 6.0 the review of all potential trend evaluations for breast implants closed during the past 12 months indicates that no confirmed complaint trends have been observed for the event a0412 material rupture.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: device rupture.
Event or Problem Description
Healthcare professional reported "rupture".This record is for the left side.The devices have 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: 22779048
• Report Number: 9617229-2025-13575
• Device Sequence Number: 9487833
• Product Code: FTR
• UDI-Device Identifier: 10888628008076
• UDI-Public: (01)10888628008076(10)2857580(11)160123(17)201223
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/11/2025

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: 12/23/2020
• Device Catalogue Number: TRM-295
• Device Lot Number: 2857580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/11/2025
• Date Device Manufactured: 01/23/2016
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 70 KG