9/16/06: Newer stents used since 2003 with a drug coating may increase the risk of blood clots when compared to cheaper bare-metal stents.
Recent reports indicate that newer types of heart stents, containing drug-coated mesh, may increase the risk of potentially fatal blood clots, known as stent thrombosis. These stents were introduced in 2003 and have grown to account for over 85% of the coronary stent market.
Studies have indicated that there is a statistically significant risk of clots when compared with less expensive bare-metal stents. The increased risk could extend for several years, requiring extended use of anti-clotting medications and continued monitoring. The blood clots can cause serious harm to patients and could result in death.
Stents are tiny wire mesh devices which are implanted to keep previously clogged arteries open. They may be used during heart bypass surgery and following less invasive angioplasty. It has been estimated that 6 million people worldwide have drug coated stents today.
DANGERS ASSOCIATED WITH DRUG COATED CARDIAC STENTS
Drug coated stents contain medicine intended to prevent scar tissue growth inside the stent. This helps prevent new blockages from forming after surgery. However, the drug lining also leaves the metal exposed which can act as a magnet for blood clots. Older bare metal stents allow the heart cells to grow over the metal, which creates a natural lining.
Although concerns over clotting with drug-coated stents have been expressed by cardiologists for about a year, the manufacturers previously denied that the devices increased any risk. The drug-coated stents are manufactured by Johnson and Johnson under the brand Cypher and by Boston Scientific under the brand Taxus.
Many believe that the manufacturers have failed to properly warn of this increased risk and have failed to fully investigated the risks associated with their product out of fear that it would impact sales. In recent years the drug-coated stents have generated approximately $5 billion in annual sales. While the cost of a bare-metal stent is approximately $800, the drug lined stents cost over $2,000 apiece.
In September 2006, Boston Scientific acknowledged that when their Taxus stent is compared with bare metal stents, there is a statistically significant risk of clots months after implantation. Studies have shown that the increased risk is also associated with Johnson and Johnson’s Cypher stent.
RISK OF BLOOD CLOTS (STENT THROMBOSIS)
The risk of stent related blood clots can continue for years after the stent is implanted. As a result, experts believe that there may be a need for anticlotting medication, such as Plavix, for much longer than the three months previously recommended on labels for the drug coated stents. The extended use of anti-clotting medications raises additional concerns, as it may lead to potential side effects, including serious bleeding.
Concerns have been expressed over the possible health issues which could be faced by patients who received these stents. With over one million people getting the stents every year, even a small increase in the risk of blood clots when compared with bare metal stents could cause complications for thousands. The risk of blood clots is serious, since estimates have indicated that stent thrombosis can be deadly approximately 30% of the time.
FURTHER INVESTIGATION OF DRUG COATED STENTS IS NEEDED
Cardiologists have called for immediate studies to further evaluate the risk of these potentially fatal clots compared to the benefits offered by the drug lined stents. In September 2006, the FDA indicated that they will convene a panel of experts by the end of the year to review the safety of these stents.
For those who have had a procedure resulting in stents over the past three years, they should review concerns over potential blood clots with their doctors. Continued monitoring may be necessary as evidence suggests the risk of clotting could continue for at least four years.
The product liability lawyers at Saiontz & Kirk are currently reviewing research and investigating whether the manufacturers may be responsible for bloot clots suffered by individuals with drug-coated stents. If you, a friend or family member have suffered a blood clot (or stent thrombosis) after having stents implanted since 2003, request a free consultation and claim evaluation.