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

Catalog Number	SSM-485
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "capsular contracture baker grade iii and maybe a rupture".This record is for the left side.The device remains implanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Trend summary confirmed: the review of historical complaints on the complaint management handling indicates that there were no other records related to this event for units manufactured on lot number 3453356.The search criteria of these queries are mentioned on qpp07-01-004-her1- g02 rev: 7.0.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 a0412 material rupture.The event of "capsular contracture, baker grade iii" 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 iii and device rupture.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b1, b5, d6b, h6.
Event or Problem Description
Device has been explanted and replaced.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d9, h3, h6.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.Rupture: not observed through visual inspection.None of the other observations performed during the device analysis (creases, wear abrasion and deformation) are found to be potentially related to the manufacturing process, and, therefore, no further actions are required for these observations.
Event or Problem Description
Healthcare professional reported "capsular contracture baker grade iii" and "maybe a rupture".Later, healthcare professional reported "breast hypoplasia", "implant folded on itself" and "thickened capsule".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: 23033717
• Report Number: 9617229-2025-15483
• Device Sequence Number: 9701498
• Product Code: FTR
• UDI-Device Identifier: 10888628032989
• UDI-Public: (01)10888628032989(10)3453356(11)200729(17)250629
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2026

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 Expiration Date: 06/29/2025
• Device Catalogue Number: SSM-485
• Device Lot Number: 3453356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 12/15/2025; 02/07/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 01/02/2026; 02/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2020
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White