Heart stents are a life-saving device for people with blocked arteries. In recent years, a number of recalls have been issued for stents that significantly increase the risk of blood clots, heart attacks, and death.
Absorbable Heart Stent Linked to Heart Attack & Death
In March 2017, the FDA issued a letter to warn doctors about an increased risk of life-threatening side effects associated with the Absorb GT1 BVS absorbable coronary stent made by Abbott Laboratories.
that 2-year data from a 5-year safety study of the Absorb GT1 BVS found an overall 11% risk of major cardiovascular events vs. a 7.9% risk from the XIENCE metallic drug-eluting stent. BVS was also linked to a 1.9% risk of blood clots, double the risk of the metallic drug-eluting stent.
What is the Risk?
Safety risks of the BVS bio-absorbable coronary stent include:
- Blood clots
- Heart attack
- Cardiac arrest
- Cardiac death
- Surgery to re-open arteries
What is a Heart Stent?
A stent is a medical device that props open arteries that are clogged. The problem with bare stents is that they sometimes develop excessive scar-tissue growth in the stented artery, re-clogging the previously cleared blood vessel. This is called “re-stentosis.”
Drug-eluting stents solve the problem of re-stentosis by gradually releasing medications that inhibit scar-tissue growth. Today, drug-eluting stents make up 90% of all coronary stent sales in the United States. The problem is that the longer the metallic surface remains exposed, the higher the risk of developing blood clots in the heart.
Heart Stent Lawsuits
Drug-eluting stents can cause deadly side effects, such as perforated arteries, allergic reactions, and blood clots. To prevent blood clots, patients must take blood-thinning drugs (usually Plavix and aspirin) for the rest of their life.
In addition to the long-term risks of having a stent in the heart, the long-term risks of treatment with blood-thinning medications include severe internal bleeding, ulcers, heart attack, stroke, and death.
In 2013, Bloomberg reported at least 773 deaths and 4,125 non-fatal injuries were associated with coronary stents in 2012 alone. The data also shows a skyrocketing number of injuries and deaths since 2008. Heart stent lawsuits accuse manufacturers of downplaying these risks.
$37 Million Stent Lawsuit Settlement
In 2014, the former owners of St. Joseph Medical Center agree to pay a $37 million class action lawsuit settlement with hundreds of patients were given unnecessary coronary stents. Lawyers say Dr. Mark Midei lied to patients about how blocked their arteries were to justify implanting dangerous coronary heart stents.
Johnson & Johnson Cypher Drug Eluting Stent Recall
Cordis Corporation, a subsidiary of Johnson & Johnson, is facing lawsuits from people who were injured by the Cypher Stent, a stainless-steel drug-eluting coronary stent that is coated in sirolimus.
In 2003, the FDA issued a Safety Warning after receiving 290 reports of blood clots and at least 60 deaths were reported. The agency also received 50 reports of hypersensitivity reactions like pain, rash, respiratory problems, hives, itching, fever, and changes in blood pressure.
Taxus Express2 Stent Recall
In March 2004, Boston Scientific received FDA approval to sell Taxus drug-eluting heart stents. Less than 6 months later, the company announced a recall of Taxus heart stents due to safety concerns. The recall eventually grew to include over 100,000 heart stents. At least 3 deaths and dozens of injuries were linked to the recalled stent.