Abbott Pulls Trifecta Heart Valves from U.S. Market
Following an FDA warning issued earlier this year, Abbott Labs announced it was removing its controversial Trifecta heart valves from the market and recalling any valves that medical providers may still have on hand.
The replacement heart valves are a “bioprosthetic” device made from bovine pericardial tissue (a membrane that surrounds the heart of a cow). Tissue valves can serve as an alternative to mechanical valves – which may be last longer, but require you take blood thinners the rest of your life. Given that a cow’s life span may be 15 years or so, those who get a bovine tissue valve can expect a 10-to-15-year use.
Earlier this year, the FDA announced that adverse event reports and medical literature regarding the safety and effectiveness of the Trifecta valve revealed that it was significantly more prone to early deterioration (3 to 4 years after implant) than other commercially available tissue valves (10 to 15 years). Outcomes of the failures included deaths.
Abbott responded by announcing it was withdrawing and discontinuing Trifecta valves. Our firm is currently representing numerous individuals with Trifecta valves who have been advised that they need valve replacement due to deterioration.
