Drug-Eluting Stent Risks of Defective Medical Devices

Lawyer for Drug-Eluting Stent (DES) Injuries

What Is a Drug Coated Stent?

A stent is a tube made of metal or plastic that is inserted into an artery during an angioplasty procedure to hold apart the walls of the artery. These stents remain implanted after a balloon angioplasty to prevent the arterial walls that have been cleared from closing in again. Since their introduction in the nineties, however, the stents have been found to be unable to prevent the growth of cells over the stents, leading to a clog in the artery again.

To solve this problem and prevent arterial reclogging through cell growth, surgeons began implanting drug coated stents in place of the plain tubes that were used earlier. Drug-eluting or drug coated stents have a special polymer coating and contain drugs in the coating that are released over time to reduce the chance of the artery becoming blocked again. These devices received approval in 2003 and were expected to prevent new cell growth and scarring.

The belief is that these stents reduce the need for a second surgery more than bare-metal stents. The companies that manufactured these stents, including Cordis Corporation with its Cypher Sirolimus Eluting Coronary Stent and Boston Scientific Corporation with its Taxus Express Paclitaxel Eluting Coronary Stent System saw billions of dollars in sales.

Have You Suffered from Drug Coated Stents?

Drug-eluting stents (also drug coated stents) are marketed as more effective than bare-metal stents in reducing the risk of restenosis or reclotting of the artery. However, in November 2006, The American Journal of Medicine published a study that found that patients with drug-eluting stents were four or five times more likely to suffer from a stent thrombosis, or late forming blood clots, which can lead to heart attack or death.

The stents were able to eliminate the cell growth problems that plagued the earlier stents, but new complications began to emerge. The presence of the stents contributed to a blood clot formation in the artery that could potentially lead to blockage. It appeared that patients might have traded the risk of restenosis with another risk of thrombosis.

One estimate published on the website of the American College of Cardiology estimated that the number of deaths caused due to stent related thrombosis or blood clotting in the artery was greater than 2,000.

About the Increased Rate of Death & Heart Attack

On September 14, 2006, the FDA released a statement on coronary drug-eluting stents in response to inquiries asking for the FDA’s position on adverse events related to drug coated stents. The FDA stated it had received scientific data that suggested an increased risk of thrombosis leading to a cardiac arrest and death in patients implanted with the medicated stents. In 2007, the chairman of the House Oversight and Government Reform Committee asked the two medical device companies for documents as part of an investigation.

Have You Been Injured by a Drug-Eluting Stent?

If you or a loved one has been injured following the implantation of a drug-eluting stent, you may be entitled to compensation from those responsible for your injury. If a loved one has died, the surviving spouse or other family members may be entitled to bring a wrongful death action against the responsible parties. At Arnold & Itkin LLP, our attorneys have the knowledge and experience to take on large medical device manufacturers and hold them accountable for their actions. You can trust that we will do everything possible to protect you.

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