What is a Drug-Eluting Stent?
Drug-eluting stents were introduced to the United States market in 2003 when they were approved by the Food and Drug Administration. They were introduced to replace the bare-metal stent. The advantages of the bare-metal stent were it would eliminate abrupt artery closure, but over the course of time scar tissue would grow around the stent, causing a future clot in the artery.
The drug-eluting stent was designed to combat the formation of this scar tissue, and attempt to prevent future blockage. It works by utilizing time-release medication and hypothetically reduces the risk of a future clotting but preventing the formation of scar tissue that the bare-metal stent allowed to develop. Patients who have drug-eluting stents inserted also may have to take anti-clotting or anti-platelet medication for 6 months or longer following the procedure. The drugs eluted by the stents help prevent against stent thrombosis, which is a reaction to the stent that causes a thickening of the blood in a newly stented artery.
A main reason for the dangers presented by drug-eluting stents is that they are being used in ways not approved by the FDA. When the FDA approved of the drug-eluting variation of the stent, it was approved only for use in treating simple blockages in one artery, and where the patient has not had any significant damage to the heart. The FDA did not approve their use in patients with a history of heart damage or complex multiple blockages. It is estimated that up to 60% of doctors still use drug-eluting stents in patients regardless of this fact, in a practice referred to as “off-labeling”.
“Off-label” simply means the drug is not being used in the manner it has been approved, and may increase the risks facing each patient. Some experts feel this type of “off-label” use is putting the public at greater risk unbeknownst to them. In complex blockages, there is a large amount of uncertainty as to whether the benefits of the drug-eluting stents outweigh the risks they present.
Side Effects of Drug-Eluting Stents
Potential side effects of drug-eluting stents include;
- Future Risk of Major Artery Clog in Area of the Stent
Drug-Eluting Stent Litigation
At Sheff Law, we are the Massachusetts law firm with the resources, experience, and national reputation to investigate injuries resulting from exposure to drug-eluting stents. Patients across Massachusetts and America are starting to realize some of the potential harmful consequences of using drug-eluting stents to treat major artery blocks. If you or a loved one has been injured as a result of drug-eluting stents, contact an attorney at Sheff Law today by filling out a FREE consultation form, or call at (888) 423-4477 or 617-227-7000.
February 23rd, 2016 | Posted in Blog