Heart stents can save lives by opening up clogged arteries, but they also have severe side effects. A number of recalls and safety warnings have been issued for stents that increase the risk of blood clots, heart attack, cardiac arrest, and death.
Heart Attack & Deaths Linked to Absorb GT1 Stent
In March 2017, the FDA warned doctors that the 2-year data from a 5-year study of the Absorb GT1 BVS absorbable heart stent found an 11% risk of major cardiovascular events vs. a 7.9% risk from the XIENCE metallic drug-eluting stent. The BVS stent also had a 1.8% risk of developing blood clots vs. a 0.9% risk for the XIENCE stent.
Absorbable Stent Side Effects
The Absorb GT1 BVS absorbable stent is linked to the following risks:
- Blood clots
- Heart attack
- Cardiac arrest
- Cardiac death
- Surgery to re-open arteries
Drug-Eluting Heart Stents
Stents are medical devices that open up clogged arteries in the heart. One of the most common problems with un-coated stents is the development of scar-tissue that re-clogs the blood vessel. This complication is called “re-stentosis.”
Drug-eluting stents are coated in medications that prevent the growth of scar-tissue. About 90% of the stents on the market are drug-eluting stents. They reduce the risk of re-stentosis, but increase the risk of blood clots on the exposed metallic surface.
Problems With Heart Stents
Drug-eluting heart stents have been linked to severe side effects like perforated arteries, allergic reactions, blood clots (thrombosis), and more. Patients must take blood-thinning medications, such as Plavix and aspirin, for the rest of their life to prevent deadly blood clots.
Long-term side effects of these medications include gastrointestinal bleeding, stomach ulcers, heart attacks, strokes, and death. Lawsuits over stent injuries accuse manufacturers of downplaying the risk.
Studies have shown a skyrocketing number of people who were injured by heart stents since 2008. At least 773 deaths and 4,125 non-fatal injuries were reported in 2012 alone, according to a Bloomberg investigation in 2013.
$37 Million Heart Stent Class Action Settlement
Hundreds of patients at St. Joseph Medical Center were awarded a $37 million class action lawsuit settlement after receiving unnecessary heart stents. Patients say Dr. Mark Midei told them their arteries were more blocked than they actually were to justify implanting a stent.
Cordis Cypher Stent Recall
Lawsuits were filed against Cordis Corporation, a Johnson & Johnson subsidiary, after the Cypher drug-eluting stent was linked to 290 reports of blood clots (thrombosis) and 60 deaths. The FDA issued a Safety Warning in 2003 after receiving 50 reports of severe allergic reactions to sirolimus, the drug coating the stainless steel Cypher coronary stent.
Taxus Express2 Stent Recall
Boston Scientific recalled Taxus drug-eluting stents in March 2004. Six months later, the company recalled Taxus stents after doctors said they were having problems removing the balloon used to inflate the stent. At least 3 deaths and 47 injuries were linked to the problem. The recall eventually grew to include over 100,000 Taxus heart stents.