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

Catalog Number	SRM-520
Medical Device Problem Codes	Gel Leak (1267); Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
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
Patient reported right side rupture with mri.Later healthcare professional confirmed rupture.Device remains implanted.
Additional Manufacturer Narrative
Unreporting the previously reported ruptured since device was not found ruptured upon explant.
Event or Problem Description
The device has been explanted and replaced.Healthcare professional reported upon explant "any creases", "oily, slimy film outer shell", "silicone bleed", "the implant had a film of silicone on the outside but there was no frank rupture of the prosthesis".Unreporting the previously reported ruptured since device was not found ruptured upon explant.
Additional Manufacturer Narrative
Device evaluation: per the investigation procedure, the device is analyzed through visual inspection microscopic inspection if openings are observed and a weight verification.Per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: ¿ gel bleed: not observed since no gel is out of the device and the weight is within specification.¿ crease / folding of implant: observed creases on device through visual inspection.No further actions are required as it is not related to the manufacturing process.None of the other observations performed during the device analysis ( deformation ) are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.Additional, changed, and/or corrected data: d9, h3, h6.
Event or Problem Description
Patient reported right side rupture with mri.Later healthcare professional confirmed rupture.Healthcare professional reported upon explant "any creases", "oily, slimy film outer shell", "silicone bleed", "the implant had a film of silicone on the outside but there was no frank rupture of the prosthesis".Unreporting the previously reported ruptured since device was not found ruptured upon explant.The device has been explanted and replaced.

• Brand Name: INSPIRA SMOOTH 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: 23125271
• Report Number: 9617229-2025-16106
• Device Sequence Number: 13099335
• Product Code: FTR
• UDI-Device Identifier: 10888628007161
• UDI-Public: (01)10888628007161(10)3208457(11)180522(17)230422
• 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: 2018
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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: 04/22/2023
• Device Catalogue Number: SRM-520
• Device Lot Number: 3208457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 09/25/2025; 11/19/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 10/17/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2018
• 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: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White