Drug-Eluting Stents Lawyers

On September 14, 2006 the U.S. Food and Drug Administration (FDA) issued a response to inquiries regarding the agency's position on coronary drug-eluting stents. The inquiries were prompted by concerns about the stents in light of studies that appeared to show a small increase in the rate of heart attacks and deaths in patients 18 months to 3 years after they had the stents implanted.

Stents are lattice-shaped, metal tubes that are inserted into arteries to keep them held open after angioplasty procedures. But soon after they were first implanted, the arteries' cells grew back over the wire mesh, once again clogging the vessels in 20 to 30 percent of cases.

To solve this problem, stents began being coated with drugs that release over time to discourage new cell growth and help keep the artery walls from closing again. In 2003 the FDA approved the use of these drug-eluting stents, also known as drug-coated or medicated stents, and they rapidly captured most of the market.

It is now suspected, however, that the drug coating on the stents are so effective at preventing new cell growth that a piece of the stent ends up protruding from the artery. This creates a perfect scenario for a blood clot to form and block the artery, often increasing the risk of a heart attack. Dr. George Diamond and Dr. Sanjay Kaul from the Cedars Sinai Medical Center in Los Angeles estimate that over 2,000 patients die each year as a result of these devices.

The FDA statement acknowledges that the agency does not have enough information to draw any conclusions. In an effort to understand what is causing the increase in the incidence of drug-eluting stent thrombosis, or blood clot, the FDA has met with the manufacturers of the devices and convened a Circulatory System Devices Advisory Panel.

While the FDA is continuing to appraise the data and expert opinions presented at the panel, its preliminary findings were that while there was a slight increase in the incidence of thrombosis in patients with drug-eluting stents compared with that of patients with bare metal stents, "this increased risk of stent thrombosis was not associated with an increased risk of death or myocardial infarction (MI)".

With more complex patients and off-label use of drug-eluting stents, however, there is an expected increased risk in adverse events, including stent thrombosis, death or MI. So the FDA recommended that drug-eluting stent labels state that when used off-label, patient outcomes may differ from those of the clinical trials the FDA relied on to approve the devices.

If you currently have a drug-eluting stent, the importance of taking the anticoagulant drugs as prescribed by your cardiologist cannot be overstated. If another physician or health care provider recommends changes in your medications, consult with your cardiologist before you do so. You may also wish to monitor the FDA website for any announcements regarding drug-eluting stents and contact your cardiologist if you have any questions.

If you are concerned about having a stent or stents implanted, discuss alternative treatments with your doctor.

Contact our Personal Injury Lawyers and Attorneys today to find an experienced Drug-Eluting Stent lawyer.