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Drug-Coated Stents FAQ

Q: What is a stent?
A: A stent is a small, lattice-shaped, metal or plastic tube inserted permanently into an artery or blood vessel. A stent is used to open an artery that has become too narrow due to atherosclerosis, a condition in which plaque builds up on the artery's inner walls blocking blood flow. Stents are typically placed inside a coronary (heart)artery after a balloon angioplasty procedure, in order to prevent restenosis (re-closing or re-blocking of the artery).

Q: What is a drug-coated stent?
A: A drug-coated stent (also called "drug-eluting") stent slowly releases drugs that potentially prevent arterial scarring and reduce the possibility of restenosis.

Q: Has there been any recent news about drug-coated stents?
A: In September 14, 2006, the FDA said that it has been closely monitoring drug-coated stents since they entered the U.S. market in 2003 and 2004, and will continue to do so. New data suggests that there is a small but significant risk of stent thrombosis (blood clotting in the stent). However, the FDA does not yet have enough information to draw any conclusions regarding the risk and causes of stent thrombosis.

Q: Are drug-coated stents safe?
A: The FDA believes that coronary drug-coated stents remain safe and effective when used for the FDA-approved indications. A public panel meeting of outside scientific experts is scheduled to review all recent data and to make recommendations about what steps should be taken.

Q: Are there any risks associated with drug-coated stent placement?
A: Risks of stents and stent placement include infection; blood clot; bleeding; rupture of the duct or vessel when the stent is inserted; stent migration (moving out of place); allergic reaction to stent material; allergic reaction to the drug used in a drug-coated stent; and in-stent restenosis (the inside of the stent becomes clogged). Other rare complications of coronary stents include chest pain, heart attack, or tearing of the blood vessel.

Q: Who should not undergo procedures involving drug-coated stent placement?
A: Drug-coated stents may not be advised for patients who have had recent heart surgery, or women who are nursing or pregnant. Stents should not be used in patients who cannot tolerate angioplasty, or who are sensitive (allergic) to the stent materials. They should not be used in patients who cannot be placed on blood-thinning (anti-platelet) medication. The safety and effectiveness of a drug-coated stent have not been studied in patients who have a blockage in a heart bypass graft, who are actually having a heart attack, or who had previous intravascular radiation treatment.

Q: What should I do if I think I have been injured by a drug-coated stent?
A: If you or a loved one have been implanted with a drug-coated stent and are experiencing any unusual health problems or medical conditions, you should contact your doctor immediately.  You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by a drug-coated stent. To find an experienced attorney, use the "Find a Lawyer" tool on this page, or click here.

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