What is a Stent?
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).
What is a Drug-Coated Stent?
A drug-coated (also called "drug-eluting") stent slowly releases drugs that potentially prevent arterial scarring, and reduce the possibility of restenosis.
The U.S. Food and Drug Administration has approved two brands of drug-coated stents, among others: the Cypher Sirolimus-Eluting CoronaryStent manufactured by Cortis Corporation (a division of Johnson & Johnson), and the Taxus Express Paclitaxel-Eluting Coronary Stent System manufactured by Boston Scientific Corporation. Click here for a list of recently-approved medical devices from the FDA, with links to consumer information.
Drug-Coated Stents News
In 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.
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 the data and to make recommendations about what steps should be taken. Click here to read the FDA statement on coronary drug-coated stents.
Drug-Coated Stents Risks
Risks of stents and stent placement may include:
- Blood clot
- Rupture of the duct or vessel when the stent is inserted
- Stent migration (stent moving out of place)
- Allergic reaction to stent material
- Allergic reaction to the drug used in a drug-coated stent
- In-stent restenosis (the inside of the stent becomes clogged) -- the risk is higher in those with non-drug-coated stents
Other rare complications of coronary stents include chest pain, heart attack, or tearing of the blood vessel.
Drug-coated stents may have additional risks. Ask your health care professional about the risks associated with stents and drug-coated stents.
When Should Drug-Coated Stents Not Be Used?
Drug-coated stents may not be advised for patients who have had recent heart surgery, or women who are nursing or pregnant. Patients who receive a drug-coated stentmay need anti-platelet drugs for at least several months.
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.
Drug-coated stents have additional restrictions. Your health care professional can tell you more about whether or not you are an appropriate candidate for this technology.
Drug-Coated Stents - Getting Legal Help
A medical device manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of any known risks associated with its products. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the medical device, under the "product liability" legal theory.
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.