Product Liability:
Drug-Eluting Stents
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Drug-eluting heart stents were approved by the Food and Drug Administration (FDA) in 2003 as an innovative solution to the problem of clogged arteries. They were considered to be a cut above their predecessors - bare metal stents made of wire mesh - which weren't as effective in keeping vessels open. Since their introduction, drug-eluting stents have been implanted into the hearts of more than 3 million American patients.

Unfortunately, the same drug-eluting stents that fuel a $5 billion-a-year market are now being blamed for potentially deadly side effects. Recent studies of patients who have had the devices for 6 months or longer report a 3 to 5% occurrence of severe blood clots which may lead to sudden heart attack. The American College of Cardiology website estimates that fatalities from drug-eluting stents may exceed 2,000 a year. This begs the question: Are these “medical marvels” doing far more harm than good?

What is a Drug-Eluting Stent?

A drug-eluting stent (DES), sometimes called a drug-coated stent, is a small, lattice-shaped metal tube that is used to treat a condition called atherosclerosis. Atherosclerosis is a progressive disease involving the build-up of plaque and waste on the inner walls of coronary vessels. This obstruction narrows the pathway for oxygen-rich blood, causing a slow or blocked blood flow that can lead to stroke, heart attack and even death. A drug-eluting stent is permanently implanted during an angioplasty, a medical procedure performed to restore blood flow to blocked vessels. The purpose of a heart stent is to hold open the vessel to help promote the movement of blood through it.

Unlike older stents which were made of bare metal, a drug-eluting stent is a more sophisticated form of the device. A disadvantage of bare metal heart stents is that although they eliminated abrupt artery closure, the body in time would grow scar tissue over the stent which would cause the artery to become clogged again. In contrast, drug-eluting stents are designed to inhibit growth of this tissue by releasing a special time-release medication, thereby reducing the chances that the artery will re-close. Patients with drug-eluting stents must also take anti-clotting or anti-platelet medication for 6 months or longer after stenting. These drugs help prevent stent thrombosis, a reaction to the device which causes a thickening of the blood in the newly expanded artery. For more information, see What is a Drug-Coated Stent?.

Drug-Eluting Stents: Unapproved Use

When the FDA approved drug-eluting stents, their use was intended primarily for simple blockages involving just one artery, where the patient has no significant damage to their heart. The devices were not approved for patients with a history of complex multiple blockages or severe heart attacks, although many doctors – an estimated 60% - still use them in such patients. Some experts feel that this type of “off-label” use may further increase the adverse risks to stent patients. In these more complicated cases, there is uncertainty that the benefits of the devices outweigh the hazards.

As the medical community explores alternatives to drug-eluting stents, the question remains: What is to become of the millions of patients who already have a DES implanted? The devices are neither safe nor easy to remove. To help minimize the risk of dangerous clotting, some patients are being advised to remain on their blood-clotting medication indefinitely. However, these drugs, including Plavix, carry their own worrisome side effects - as well as a prohibitively high price tag.
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