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

Catalog Number	SRX-615
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
Date of Event	05/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is a follow-up report to a medwatch submitted under manufacture report number 9617229-2021-46350.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 ¿rupture¿.This record is for the left side.Device was explanted and replaced.
Event or Problem Description
Patient reported left side rupture.Healthcare professional reported capsular contracture, baker grade iv.A total capsulectomy was performed.The device was observed to be intact upon explant.The device has been explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, g2, h6.The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: capsular contracture, baker grade iv.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d9, h3, h6.Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ capsular contracture : unable to observe as it is not related to the manufacturing process.¿ rupture: not observed.As per the investigation procedure, creases, wear abrasion and deformation were completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.
Event or Problem Description
Patient reported left side rupture.Healthcare professional reported capsular contracture, baker grade iv.A total capsulectomy was performed.The device was observed to be intact 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: 22086713
• Report Number: 9617229-2025-08662
• Device Sequence Number: 20848037
• Product Code: FTR
• UDI-Device Identifier: 10888628007598
• UDI-Public: (01)10888628007598(10)3104272(11)170909(17)220809
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2025

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: 08/09/2022
• Device Catalogue Number: SRX-615
• Device Lot Number: 3104272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 05/23/2025; 07/05/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/19/2025; 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2017
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 59 KG