What is a Stent?

A stent is a tiny lattice-shaped in the form of metal or plastic tube inserted permanently into the artery or blood vessel. The stent is applied to open the affected artery that became thin due to atherosclerosis, a condition where plaque accumulates on the inner walls of the artery that result to a blood clot. Stents are usually inserted in a coronary or heart artery after a balloon angioplasty procedure to stop “restenosis”, a condition where there is re-closing or re-blocking of the artery.

What is a Drug-Coated Stent?

Also known as “drug-eluting” stent, the drug-coated stent gradually releases the drugs that stop arterial scarring and lower the possibility of restenosis.

US Food and Drug Administration approved two brands of drug-coated stents:

1. The Cypher Sirolimus-Eluting Coronary Stent which is manufactured by the Cortis Corporation, a division of Johnson & Johnson
2. The Taxus Express Paclitaxel-Eluting Coronary Stent System which is manufactured by Boston Scientific Corporation

Press here for the list for the latest approved medical devices from the FDA, with links to consumer information.

Drug-Coated Stents Recent News

In an official statement made by the US Food and Drug Administration in September 14, 2006, it said that they are monitoring closely the drug-coating stents ever since they arrived in the US market in 2003 and 2004 until now. The new data claims that there is a tiny but significant risk of stent thrombosis or the blood clotting in the stent. Nevertheless, the FDA does not have sufficient information to draw a conclusion about the risk and reasons for stent thrombosis.

The US FDA also claims that coronary drug-coated stents are still safe and effective for the FDA-approved indications. There will be a public panel meeting of outside scientific experts to review all the data and to make recommendations on what steps must be taken.

Press here to read the official statement of FDA regarding the coronary drug-coated stents.

Drug-Coated Stents’ Risks

The following are identified as risks of stents and stent placement including

• Blood clot
• Bleeding
• Ruptured duct or vessel  when the stent is injected
• Infections
• Stent migration or the stent moving out of its place
• Allergic reactions to stent materials
• Allergic reactions to the drugs used in a drug-coated stent
• In-stent restenosis or a condition where the interior of the stent becomes clogged; the risks are greater compared to those with non-drug-coated stents

Other uncommon complications of coronary stents are as follows:

• Heart attack
• Chest pain
• Tearing of the blood vessel

Drug-coated stents may have developed other risks. Discuss with your healthcare provider about the risks related to the stents and drug-coated stents.

When should drug-coated stents not be used?

The drug-coated stents should not be recommended to patients, who went through a heart surgery, or women who are nursing their babies, or pregnant women.  The patients who have received the drug-coated stents may need anti-platelet drugs for several months.

Stents should not be recommended to patients who cannot stand angioplastic, or those who have allergic reactions to stent materials, and patients who cannot be placed on the blood thinning or anti-platelet treatments.

Studies of the safety and effectiveness of the drug-coated stent were not yet done to patients who underwent heart bypass, having a heart attack, or who have intravascular radiation procedure.

The drug-coated stents have other restrictions. These details will be discussed by your healthcare provider and will give you advice whether you can or cannot have this drug-coated stent method.

Drug-Coated Stents – Getting Legal Help

The medical equipment manufacturer has the obligation to produce products that are reasonably safe and inform the medical community, as well as the general public of any potential risks known to associate with their products. When the manufacturer fails in this duty, they can be held legally liable when the patients are injured as a consequence of insufficient warnings or for the unreasonably producing harmful device, under the legal theory known as product liability.

If you or any of your family members went through the drug-coated stent procedure and are suffering from any adverse side effects, contact your doctor right away. Then, you can look for a reliable and experienced lawyer in product liability who can guide you to your legal options and safeguard your rights to a legal remedy for injuries sustained as a result of the drug-coated stent.