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

Catalog Number	TCX-560
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported left side "breast pain and hardness".Additionally, patient reported "platelet level has dropped to 116 when it used to be 325, a pap smear 6 months ago was abnormal and indicated lesions, and the patient has shingles on their knee" which is not device related.Later, patient reported "this is the 3rd time implants have flipped and hardened", "pain in breast", "diagnostic testing due to the pain" and the following event that is not device related: "platelets have been low for two years".Additionally, patient reported "shingles, low count platelets, pain, and having lots of blood work having been performed." healthcare professional reported "rupture and pain." the device remains implanted.
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
Device has been explanted.

• Brand Name: INSPIRA TEXTURE 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
• 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: 17575058
• Report Number: 9617229-2019-14601
• Device Sequence Number: 15692634
• Product Code: FTR
• UDI-Device Identifier: 10888628031364
• UDI-Public: 10888628031364
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 08/19/2021
• Device Catalogue Number: TCX-560
• Device Lot Number: 2961228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2016
• 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: 54 KG