Drug-Coated Stents : FDA To Review Clot Risk

Heart stents were invented to alleviate the danger of clogged arteries. A catheter with a balloon function and a heart stent is inserted into an artery clogged with plaque. The balloon swells to expand the heart stent, which locks in place, keeping the artery open and the blood flowing freely – in theory. While this is surely a helpful, pain-relieving procedure, it has not yet been perfected. There may be a risk of blod clotting around the complicated structure of the stents with a drug coating, which would essentially undo the preventative procedure.

The drug coating was designed to reduce inflammation and prevent blockage in the arteries. A few months after drug-coated stents were introduced in April, 2003, the FDA issued a warning linking the drug coat to a significantly higher increase in blood clots than in stents without the drug coating. So while the drug-coated heart stents may have a higher likelihood of keeping arteries free from plaque buildup, they also hold a greater possibility for complications with blood clots.

To address the clotting issue, patients who have recieved drug-coated stents (approximately 4 million to date) are required to take a blood-thinning medication for three to six months after their operation. Yesterday, the FDA announced a two-day meeting scheduled for December 7 and 8 to discuss whether or not the medication should be continued beyond the previously determined three to six months. Daniel Schultz, the head of the center of medical devices at the FDA, claimed that “this is a public health issue of great importance.” Beyond determining the solution to problems in the development of drug-coated stents, he said the meeting was to “provide the American public with a coherent explanation of the risks and benefits associated with these products.”

While the drug-coated stents are in the process of being perfected, complications may still exist for many patients. If you have questions about drug-coated heart stents or other defective medical devices, please feel free to contact a personal injury attorney. Experts such as Jacoby and Meyers of San Diego, California have a great deal of information on product liability.

*Images taken from the Salinas Valley Medical Healthcare System website, found here: www.svmh.com.