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

Catalog Number	SCL-125
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
A review of the device history record has been completed.No deviations or non-conformances noted.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.The reason for reoperation: rupture, capsular contracture baker grade unknown.
Event or Problem Description
Healthcare professional reported "rupture" and "capsular contracture baker unknown".This record is for the left-side.Device remains implanted and will be returned.
Additional Manufacturer Narrative
Clarification to h6 adverse event problem: un-reporting a0412 material rupture as the explanting physician confirmed the device was found intact during explant surgery.Correction to h6 adverse event problem and h11 additional mfg narrative in the initial medwatch: b12 trend review and b14 analysis of production records should not have been submitted.The device history record was not performed at the time of initial medwatch submission as device information was not available.A review of the device history record has been completed.No deviations or non-conformances noted.Reason for reoperation: capsular contracture baker grade iii; suspected rupture (found intact) device evaluation: based on the product analysis performed, the assessments of the complaints are: ¿ capsular contracture: unable to observe as it is not related to the manufacturing process.As per the investigation procedure, deformation, wear abrasion and crease were observed and none of the observations are found to be potentially related to the manufacturing process.No further actions are required.
Event or Problem Description
Healthcare professional reported "rupture" and "capsular contracture baker unknown".Physician further reported baker grade iii for the capsular contracture and noted the implant was "intact" upon removal.This record is for the left-side.Device was explanted and replaced.

• Brand Name: INSPIRA SMOOTH COHESIVE 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: 23294857
• Report Number: 9617229-2025-17543
• Device Sequence Number: 20055998
• Product Code: FTR
• UDI-Device Identifier: 10888628029446
• UDI-Public: (01)10888628029446(10)3059285(11)170526(17)220426
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 04/26/2022
• Device Catalogue Number: SCL-125
• Device Lot Number: 3059285
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2017
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White