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

Catalog Number	TRM-755
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
Event or Problem Description
Patient reported right side "lumps all over her breast that are extremely painful." patient later reported rupture.Patient later reported capsular contracture, baker grade iv.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 iv and rupture.
Additional Manufacturer Narrative
Clarification h6: device photos have been received, and pending investigation.
Event or Problem Description
Patient reported for right side "product recall" and "the recall is because the implants can cause anaplastic large cell lymphoma (bia-alcl)".Device has been explanted and replaced.
Additional Manufacturer Narrative
Visual analysis: visual analysis of the photographs identified: lump/nodule: unable to observe as it is not related to the device.Pain: unable to observe as it is not related to the device lump/nodule: unable to observe as it is not related to the device.Product/procedure: unable to observe as it is not related to the device.Skin rash/dermatitis: unable to observe as it is not related to the device.Anxiety- product/procedure: unable to observe as it is not related to the device.No additional observations are performed.No further actions are required as no manufacturing issues are observed.Device evaluation: based on the device analysis grid, the assessments of the complaint are: capsular contracture: unable to confirm as it is a medical event not related to the device.Additional observations: crease fold observed.Observed crease sharp assessed as fold flaw opening.Wear abrasion observed.No further actions are required as no manufacturing issues are observed.
Event or Problem Description
Patient reported right side "lumps all over her breast that are extremely painful." patient later reported rupture.Patient additionally reported capsular contracture baker grade iv.Patient also reported "product recall" and "the recall is because the implants can cause anaplastic large cell lymphoma (bia-alcl)." patient additionally reported "rash under breast and on stomach for approximately one year." healthcare professional later reported rupture is on the contralateral side.Device has been explanted and replaced.

• 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 ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17550674
• Report Number: 9617229-2023-13445
• Device Sequence Number: 6863180
• Product Code: FTR
• UDI-Device Identifier: 10888628008212
• UDI-Public: 10888628008212
• Combination Product (Y/N): N
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2023

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: 03/16/2021
• Device Catalogue Number: TRM-755
• Device Lot Number: 2901009
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 10/03/2023; 11/10/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 11/02/2023; 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2016
• 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 Sex: Female
• Patient Weight: 57 KG