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

Catalog Number	N-TSX545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Lymphoma (3263)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient representative reported for an unknown side, "in a television program report it was reported that the patient affected by the disease noticed only a difference in the size of the breast, did not present changes in the routine exams, after the removal of the prostheses, with which patient had been 13 years old, noticed that one of the prostheses it had its normal color, and another yellowish color, that is, the textured part of the prosthesis released the carcinogenic substance, called pigment" which a physician indicated is "lymphoma associated with breast prosthesis." pathological markers confirming alcl have not been received.The device has been explanted.The patient underwent chemotherapy treatment.
Additional Manufacturer Narrative
The event of lymphoma-alcl-suspected is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.No contact information was provided for the initial reporter, therefore additional event, product, and/or patient details are not attainable.Reason for reoperation: no specific reason was cited other than, "the patient affected by the disease noticed only a difference in the size of the breast, did not present changes in the routine exams".

• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 13598392
• Report Number: 9617229-2022-02249
• Device Sequence Number: 1883345
• Product Code: FTR
• UDI-Device Identifier: 05060191607360
• UDI-Public: 5060191607360
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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: N-TSX545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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