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

Catalog Number	TRM-375
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Rupture (1546)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported right side "exchange from textured to smooth breast implants due to the patient¿s concern with the product".Patient later also reported a right side capsular contracture baker grade unknown, hard as rock, and exchange.Device remains implanted.
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.Reason for reoperation: capsular contracture baker grade unknown.
Event or Problem Description
Device has been explanted.Patient reported rupture.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b5, d6b, h6.
Event or Problem Description
Patient reported right side "exchange from textured to smooth breast implants due to the patient¿s concern with the product".Patient later also reported a right side capsular contracture baker grade unknown, hard as rock, exchange, and a rupture.Device has been explanted.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: a2, b5, d9, h3, h6.Device evaluation: based on the product analysis performed, the assessments of the complaints are: rupture: observed an opening assessed as an unidentified (tear) opening (shell thickness within spec).¿ capsular contracture: unable to observe as it is not related to the manufacturing process.¿ anxiety-product/procedure: unable to observe as it is not related to the manufacturing process.As per the investigation procedure, observed an opening assessed as an unidentified (tear) opening (shell thickness within spec) were completed and none of the observations are found to be potentially related to the manufacturing process, no further actions are required.

• Brand Name: INSPIRA TEXTURED 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: terry ingram ; 2525 dupont drive; building 3; irvine, CA 92612 ; 8479366324
• MDR Report Key: 18395602
• Report Number: 9617229-2023-19942
• Device Sequence Number: 2646278
• Product Code: FTR
• UDI-Device Identifier: 10888628008120
• UDI-Public: 10888628008120
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2021
• Device Catalogue Number: TRM-375
• Device Lot Number: 2970561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/10/2024; 02/19/2025
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 12/27/2024; 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2016
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 53 KG