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

Catalog Number	SRF-605
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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: capsular contracture baker grade iv, rupture.A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Patient reported "rippling".Later reported capsular contracture baker grade iv and rupture.This record is for the left side.Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b.5, b.7, d.6b, h.6.
Event or Problem Description
Later healthcare professional reported "capsular contracture baker grade iii/iv with a possible rupture and bilateral rippling".This record is for the left side.The device has been explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d9, h3, h6.
Event or Problem Description
Patient reported "rippling".Later patient reported "capsular contracture, baker grade iv".Later healthcare professional reported "capsular contracture baker grade iii/iv with a possible rupture and bilateral rippling".This record is for the left side.The device has been explanted and replaced.Device has been returned.

• 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: 23174472
• Report Number: 9617229-2025-16525
• Device Sequence Number: 9612452
• Product Code: FTR
• UDI-Device Identifier: 10888628007383
• UDI-Public: (01)10888628007383(10)3163313(11)180207(17)230107
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2025

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: 01/07/2023
• Device Catalogue Number: SRF-605
• Device Lot Number: 3163313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 10/03/2025; 11/12/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 10/28/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2018
• 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 Sex: Female
• Patient Weight: 54 KG