Drug-Coated Stents FAQ
Q: What is a stent?
A: A stent is a small, lattice-shaped, metal or plastic tubeinserted permanently into an artery or blood vessel. A stent is used toopen an artery that has become too narrow due to atherosclerosis, a condition inwhich 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-coatedstent?
A: A drug-coated stent (also called "drug-eluting") stentslowly releases drugs that potentially prevent arterial scarring and reduce thepossibility of restenosis.
Q: Has there been anyrecent news about drug-coated stents?
A: In a recentstatement (updated September 14, 2006), the FDA said that it has been closelymonitoring 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 butsignificant risk of stent thrombosis (blood clottingin the stent). However, the FDA does not yet have enough information to draw anyconclusions regarding the risk and causes of stentthrombosis. Click here to read the FDA'sstatement on coronary drug-coated stents.
Q: Are drug-coated stents safe?
A: The FDAbelieves that coronary drug-coated stents remain safeand effective when used for the FDA-approved indications. A public panelmeeting of outside scientific experts is scheduled to review all recent dataand to make recommendations about what steps should be taken.
Q: Are there anyrisks associated with drug-coated stent placement?
A: Risks of stents and stent placementinclude infection; blood clot; bleeding; rupture of the duct or vessel when thestent is inserted; stentmigration (moving out of place); allergic reaction to stentmaterial; allergic reaction to the drug used in a drug-coated stent; and in-stent restenosis (the inside of the stentbecomes clogged). Other rarecomplications of coronary stents include chest pain,heart attack, or tearing of the blood vessel.
Q: Who should notundergo procedures involving drug-coated stentplacement?
A: Drug-coated stents may not be advised for patients who have had recentheart surgery, or women who are nursing or pregnant. Stents should notbe used in patients who cannot tolerate angioplasty, or who are sensitive(allergic) to the stent materials. They should not beused in patients who cannot be placed on blood-thinning (anti-platelet)medication. The safety and effectivenessof a drug-coated stent have not been studied inpatients who have a blockage in a heart bypass graft, who are actually having aheart attack, or who had previous intravascular radiation treatment.
Q: What should I doif I think I have been injured by a drug-coated stent?
A: If you or aloved one have been implanted with a drug-coated stentand are experiencing any unusual health problems or medical conditions, youshould contact your doctor immediately. You may also wish to meet with anexperienced attorney to discuss your options and to protect your right to alegal 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.