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 Codes	Capsular Contracture (1761); Failure of Implant (1924)
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.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.
Event or Problem Description
The patient reported "extremely painful lumps all over breast".Patient later reported "rupture".Device remains implanted.This record is for left side.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: b6.
Event or Problem Description
The patient reported "extremely painful lumps all over breast".Patient later reported "rupture".Device remains implanted.This record is for left side.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: pain: unable to observe, since it is not related to the device.Lump/nodule: unable to observe, since it is not related to the device.Capsular contracture: unable to observe, since it is not related to the device.Skin rash/dermatitis: unable to observe, since it is not related to the device.Rupture: observed, a broken device on posterior assessed, as an unidentified (tear) opening (shell thickness within spec).Additional observations: black particles observed, on the device and in the gel.Yellow encapsulation observed, on the device.
Event or Problem Description
The patient reported, "extremely painful lumps all over breast".Patient later reported, "rupture".This record is for left side.Healthcare professional, later reported, capsular contracture, baker grade iv.Device has been explanted.
Additional Manufacturer Narrative
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.Reason for reoperation: capsular contracture, baker grade iv.
Event or Problem Description
Healthcare professional, later reported, capsular contracture, baker grade iv.

• 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: 17552162
• Report Number: 9617229-2023-13281
• Device Sequence Number: 17841832
• Product Code: FTR
• UDI-Device Identifier: 10888628008212
• UDI-Public: 10888628008212
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/11/2023

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: 03/20/2021
• Device Catalogue Number: TRM-755
• Device Lot Number: 2903433
• 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: 09/06/2023; 10/03/2023; 10/30/2023; 11/16/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/29/2023; 10/24/2023; 11/16/2023; 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2016
• 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