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

Catalog Number	SSX-800
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Capsular Contracture (1761)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "capsular contracture baker grade unknown" and "the patient had a previous left side capsular contracture and the capsule was removed in (b)(6) 2025 and the same device was implanted back on the same day".This record is for the left side.The device remains implanted.The device will be returned.
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/will be requested.No additional information is available at this time.The reason(s) for reoperation is/are: "capsular contracture baker grade unknown".The reported event is a physiological complication, and device analysis typically does not help allergan determine the cause.
Additional Manufacturer Narrative
Correction to h6 adverse event problem in the initial medwatch: un-reporting a2303 improper or incorrect procedure or method.This event was determined to be not reportable to the fda as there was no allegation of patient injury or harm associated with the reuse of the patient's implant to treat capsular contracture.
Event or Problem Description
Healthcare professional reported "capsular contracture baker grade unknown" and "the patient had a previous left side capsular contracture and the capsule was removed (.) and the same device was implanted back on the same day".Later healthcare professional reported "no contracture" since patient's last visit.This record is for the left side.The device remains implanted.
Additional Manufacturer Narrative
Reason for reoperation: capsular contracture baker grade iii.
Event or Problem Description
Healthcare professional reported "capsular contracture baker grade unknown" and "the patient had a previous left side capsular contracture and the capsule was removed (.) and the same device was implanted back on the same day".Later healthcare professional reported "no contracture" since patient's last visit.Later healthcare professional reported "per patient description, capsular contracture baker grade iii".This record is for the left side.The device remains implanted.

• 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: 23993801
• Report Number: 9617229-2026-00442
• Device Sequence Number: 13317558
• Product Code: FTR
• UDI-Device Identifier: 10888628033467
• UDI-Public: (01)10888628033467(10)1261320(11)240830(17)290730
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SSX-800
• Device Lot Number: 1261320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 02/04/2026; 03/18/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/10/2026; 04/09/2026
• Date Device Manufactured: 08/30/2024
• 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 Ethnicity: Non Hispanic
• Patient Race: White