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Heart Valve Injury Lawsuit
Our law firm is currently evaluating claims for injuries associated with the Abbott Trifecta Heart Valve. In a recent development, the U.S. Food and Drug Administration (FDA) has issued an important warning letter on February 27, 2023. The concern lies with the potential risk of early structural valve deterioration (SVD) associated with Abbott Trifecta Heart Valves, specifically the standard Trifecta valves and Trifecta valves with Glide Technology (GT). It has been reported that Trifecta heart valves exhibit a higher incidence of early SVD when compared to other surgical bioprosthetic valves. If you or a loved one has suffered injury due to a defective Abbott Trifecta Valve, please contact our law firm as you may be entitled to financial compensation.
Abbott Trifecta Valve Recall
Abbott Laboratories is finally taking action to address the serious issue of early deterioration in their Trifecta heart valves, which has tragically resulted in nearly 200 patient deaths since 2011. In response to an FDA warning earlier this year, the company is removing these controversial valves from the market and recalling any remaining devices still held by medical providers. As of July 31, Abbott has officially stopped production of the Trifecta family of heart valves, which includes the Abbott Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT). Furthermore, they will be retrieving unused devices currently in the field. This total recall demonstrates patient safety concerns raised by the FDA.
Please contact our law firm today as you may be entitled to financial compensation.
Trifecta Heart Valve Early Deterioration Problems
The first generation model of the Trifecta valve was approved by the FDA in 2011, and the Trifecta GT valve was introduced in 2016. These heart valve prosthetics are specifically designed to treat individuals suffering from aortic valve diseases, such as aortic stenosis or aortic regurgitation.
Aortic valve dysfunction can have serious consequences for the circulatory system, hindering the vital flow of oxygen-rich blood throughout the body. In such cases, doctors may recommend the removal of the patient’s original aortic valve, replacing it with a Trifecta valve to restore normal functioning.
While marketed as safe and effective, the Trifecta valves have unfortunately been associated with potential risk of early structural valve deterioration (SVD) resulting in nearly 3,000 adverse events since 2011, including over 2,100 reported injuries and nearly 200 deaths.