Trifecta Heart Valves
On July 31, 2023, Abbott, the manufacturer of the Trifecta heart valves issued a voluntary recall after the the Food and Drug Administration (FDA) issued a warning that the Trifecta valves were associated with reports of higher instances of early structural valve deterioration (SVD). The FDA communicated these concerns with Abbott in February 2023, following reports from consumers and scientific research. Abbott evaluated over 20 scientific studies before eventually issuing the recall. The outcome of this research consistently showed that the Trifecta heart valves failed earlier than different brands, often can lead to the need for revision surgeries, traumatic heart damage, or even death.What Are Heart Valves?
People with diseased or damaged hearts will often need operations to repair these damaged areas. Prosthetic heart valves are designed to mimic the actions of a functional heart valve. The majority of heart valves are placed internally, or inside of the valve. The Trifecta valves were approved for use in 2011, and their updated model the Trifecta with Glide Technology. Both models were designed to be mounted on the outside of the heart valve in order to prevent the need for open heart surgery and to allow for faster recovery. These Trifecta valves are made from the tissue of a cow heart as many other models are.Structural Valve Deterioration
Heart valves can be thought of as the “doors of the heart”. These valves open and close when necessary to pump blood to different parts of the body at the right time and in the right direction. When someone’s heart is significantly damaged or diseased to the point where their valves are not opening properly, they will often need to have prosthetic valves placed. When these implants fail or begin to deteriorate, it interferes with the structure and mechanics of the prosthetic and can cause more damage to the person’s heart.
Research has found that the Trifecta heart valves fail at a higher rate due to being externally mounted. The valves are found to create structural valve deterioration and fail at a much faster rate than alternatives. Prosthetic heart valves are meant to last approximately 10 years. The FDA has found that the Trifecta heart valves fail mainly due to ripping off of the valve itself (dehiscence) and often fail within 3-4 years. It is worth noting that SVD is based on the state of the implanted valve, not the patient’s medical state.Do You Have a Trifecta Heart Valve?
The FDA and Abbott, the manufacturer of Trifecta heart valves, are working together to create a plan for patients who have received implants of Trifecta valves. According to Abbott’s statement to their Cardiac Team on February 27, 2023, the following measures should be taken post-implant:
- Seek medical attention with new onset of symptoms such as shortness of breath or fatigue.
- Transthoracic echocardiogram (TTE) study within 1 to 3 months after the implant procedure to evaluate valve function.
- Annual follow-up visits clinical evaluation, including TTE.
- Patients presenting with changes in symptoms (e.g., shortness of breath or fatigue on exertion) or signs (e.g., murmur) indicative of potential SVD should undergo a TTE.
- Patients with evidence of SVD should see a cardiac team, for a possible valve intervention with either surgical aortic valve replacement or a transcatheter valve-in-valve intervention.
- Report any adverse reactions to the FDA immediately.
Neumann Law Group is evaluating claims involving those who have received an Abbott Trifecta heart valve implant and have been diagnosed with structural valve deterioration. It takes a significant amount of skill and expertise to bring claims against pharmaceutical companies. To receive the most compensation for your injuries, medical expenses, lost wages, pain and suffering, and other damages you should be represented by strong and aggressive attorneys.
If you or someone you love has been injured by Trifecta heart valves, the Detroit, Grand Rapids, and Traverse City defective medical device lawyers at Neumann Law Group may be able to help you recover the compensation you deserve. We represent injured patients in Petoskey, Warren, Holland, Midland, Muskegon, Saginaw, Wyoming, Kalamazoo, Lansing, Flint, Ann Arbor, and communities throughout the Upper Peninsula, as well as in New York, California, and Massachusetts. Contact us at 800-525-NEUMANN to discuss your potential case or contact us online.