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

Catalog Number	TSX-340
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Capsular Contracture (1761); Seroma (2069)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported events of "capsular contracture, baker grade iv" and "seroma- late" are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.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 seroma- late.
Event or Problem Description
Patient representative reports "patient's left breast swelled, it was 3 times larger than it was".Patient "drained the fluid and took anti inflammatory." third party lawyer later reported "the patient was surprised by the news of a worldwide recall of allergan breast implants due to the high risk of developing a rare type of cancer - anaplastic lymphoma, directly associated with the textured surface of the implants" "the situation caused immense anguish, fear and emotional instability for the patient, who was forced to seek immediate physician assistance." ¿it evolved with baker iv capsular contracture and distortion of the shape of the breasts¿."the patient developed baker iv capsular contracture and distortion of the shape of her breasts." this is for the left side device.The device remains implanted.

• 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; la aurora de heredia ; CS
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; la aurora de heredia ; CS
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 22444124
• Report Number: 9617229-2025-11383
• Device Sequence Number: 8383746
• Product Code: FTR
• UDI-Device Identifier: 10888628034310
• UDI-Public: (01)10888628034310
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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 Catalogue Number: TSX-340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/08/2025
• 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 Ethnicity: Hispanic