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

Catalog Number	SSX-545
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546); Migration (4003)
Health Effect - Clinical Codes	Capsular Contracture (1761); Failure of Implant (1924)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported left side ¿rupture¿ diagnosed via ultrasound and ¿silicone in axillary lymph node¿.Device remains implanted.
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, silicone migration.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5.
Event or Problem Description
Patient reported ¿rupture¿ diagnosed via ultrasound and ¿silicone in axillary lymph node¿.This record is for the left side.Device remains implanted.
Additional Manufacturer Narrative
Additional, corrected and/or changed data: b.5, b.6, h.6.
Event or Problem Description
Patient reported ¿rupture¿ diagnosed via ultrasound and ¿silicone in axillary lymph node¿.Later healthcare professional reported "no complaint against the device".Later patient reported "capsular contracture baker grade unknown".This record is for the left side.Device remains implanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, b6, d6b, h6.
Event or Problem Description
Patient reported ¿rupture¿ diagnosed via ultrasound and ¿silicone in axillary lymph node¿.Later healthcare professional reported "no complaint against the device".Later patient reported "capsular contracture baker grade unknown".Later healthcare professional reported "implant intact" and "capsular contracture baker grade iv".Capsulectomy was performed.This record is for the left side.Device was explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a6, d4.
Event or Problem Description
Patient reported ¿rupture¿ diagnosed via ultrasound and ¿silicone in axillary lymph node¿.Later healthcare professional reported "no complaint against the device".Later patient reported "capsular contracture baker grade unknown".Later healthcare professional reported "implant intact" and "capsular contracture baker grade iv".Capsulectomy was performed.This record is for the left side.Device was explanted.
Additional Manufacturer Narrative
Device evaluation: per the analysis performed, the assessments of the complaints and any potential manufacturing issue are displayed along with any further actions required: ¿ capsular contracture: unable to observe through visual inspection as it is a physiological phenomenon.None of the other observations performed during the device analysis deformation and creases are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.
Event or Problem Description
Patient reported ¿rupture¿ diagnosed via ultrasound and ¿silicone in axillary lymph node¿.Later healthcare professional reported "no complaint against the device".Later patient reported "capsular contracture baker grade unknown".Later healthcare professional reported "implant intact" and "capsular contracture baker grade iv".Capsulectomy was performed.This record is for the left side.Device was explanted.

• 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: 23187293
• Report Number: 9617229-2025-16648
• Device Sequence Number: 18419204
• Product Code: FTR
• UDI-Device Identifier: 10888628033399
• UDI-Public: (01)10888628033399(10)1197404(11)230712(17)280612
• 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: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/07/2026

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 Catalogue Number: SSX-545
• Device Lot Number: 1197404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2025
• Supplement Date Received by Manufacturer: 11/05/2025; 01/26/2026; 02/17/2026; 03/05/2026; 04/15/2026
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 11/20/2025; 02/06/2026; 03/03/2026; 03/26/2026; 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Hispanic