Coronary heart disease is responsible for approximately 370,000 deaths each year in the United States, according to the National Heart, Lung, and Blood Institute. The condition develops when deposits build up and narrow the coronary arteries, decreasing blood flow to the heart. Doctors often opt to treat the condition with a procedure called angioplasty to widen the artery using a metal stent.
A stent is a small tube made out of mesh that is used to treat narrow or weak arteries. Arteries are blood vessels that carry blood away from the heart and relocate the blood to other areas of the body. When an artery is narrowed by a buildup of plaque, blood flow is reduced which places extra stress on the heart. A stent is permanently placed within the body and is used to prop open an artery which allows blood to flow normally.
To open a narrowed or weak artery, a physician will likely perform a procedure called a percutaneous coronary intervention which means that a catheter is inserted into the artery and placed at or near the plaque blockage. A balloon is then inflated which serves to open the artery by compressing the plaque. A stent is placed over the balloon catheter and locks into place at the time the balloon is inflated.
History of Stent
The stent was believed to be first used by Jacques Puel and Ulrich Sigwart in France in 1986 as a scaffold to prevent the closure of the artery as well as to keep scar tissue from from interrupting vascular flow.
The first FDA approved stent was created by Cesar Gianturco and Gary Roubin.
Injuries that are associated with stent implants include, but are not limited to:
- Allergic reaction to medications or dyes used in the procedure
- Issues with breathing due to anesthesia or using a stent in the bronchi
- Continuous bleeding
- A blockage of the artery
- Blood clots
- Heart attack
- An infection of the vessel
- Kidney stones due to using a stent in the ureters
- Re-narrowing of the artery
There has been a rise in litigation related to the use of stents but not necessarily due to adverse side effects. Instead, lawsuits have been filed due to the overuse of stents in patients. Stent implants have been used in over 7 million patients over the past decade with over 700,000 per year being used on patients that are in stable condition where alternative treatments could have been utilized.
The reason for the overuse is tied to the system that rewards physicians monetarily for the quantity of procedures performed. Doctors are paid between approximately $10,000 and $30,000 per stent implant procedure and around an average of $250 for a mere consultation. When the numbers are viewed side-by-side, it is easy to see how the overuse problem can manifest. In fact, that New York Times analyzed the 2012 billing records for the 10 top-billing cardiologists in the United States and found that eight of the ten doctors made about half of their reimbursements from Medicare by performing stent procedures.
It is estimated that the overuse of stents has resulted in over 1 million people over the past ten years undergoing a stent procedure when it was deemed to be unnecessary while costing the health care system approximately $2.4 billion per year.
The FDA has reported that at least 773 deaths and 4,125 non-fatal injuries were associated with stent procedures in 2012.
While the negative effects of an unnecessary stent procedure are not yet known, it is clear that such a procedure unnecessarily places patients at risk for the side effects associated with receiving a stent implant.
Since 2010 over 1,500 patients have received letters sent by hospitals who became aware of the fact that unnecessary stent procedures were performed by their physicians.
The most notable overuse lawsuit was brought against Dr. Mark Midei who implanted at least 600 unnecessary stents in patients between 2007 and 2009. It is usually thought to be necessary for there to be at least a 70% artery blockage rate before a stent implant is considered to be a treatment option for a patient. However, some patients were being told they required the procedure when their blockage was much less significant.
The owner of St. Joseph Medical Center, which employed Dr. Midei, agreed to settle the claims for $37 million. At least 273 patients were to receive payments from the settlement which took over four years to reach. Dr. Midei left St. Joseph's after losing his medical license but now runs a medical consulting business.
The Future of the Stent
The FDA recently approved the first fully absorbable stent to treat coronary artery disease. The device is called the Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), which releases the drug everolimus to limit the growth of scar tissue. Rather than being permanent, the stent is gradually absorbed by the body in approximately three years.
The approval will allow new treatment options for individuals who are candidates for angioplasty but were not previously interested in a permanent implant.
If you have suffered adverse health effects as a result of a faulty or unnecessary stent implant, it is possible that you may be entitled to compensation. Consulting with an experienced and skilled medical device attorney is the first step to receiving the justice that you deserve. Since 2004, the law firm of Jeremy Rosenthal has focused exclusively on personal injury law and makes it their priority to put your best interest first while supplying you with first class legal representation. Call (303) 825-2223 today to schedule a consultation.