MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	TRLP-190
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported right side intracapsular rupture and capsular contracture baker grade iv, with device perspiration, folds, waves, rotation, and deformity.The device has been explanted.
Additional Manufacturer Narrative
E1.Phone number continued: +(b)(6).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: rupture, crease/folding of implant, malposition of device, capsular contracture baker grade iv, deformation-breast.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d4.
Event or Problem Description
Healthcare professional reported right side intracapsular rupture with silicon perspiration and capsular contracture, baker grade iv, with folds, waves and rotation.The device has been explanted.

• Brand Name: INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer (Section G): UNKNOWN ALLERGAN; 900 parkway global park zona f; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 20351710
• Report Number: 9617229-2024-21863
• Device Sequence Number: 12812376
• Product Code: FTR
• UDI-Device Identifier: 10888628007833
• UDI-Public: 10888628007833
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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: TRLP-190
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/09/2024
• 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