September 30, 2013 — Bloomberg reports that cardiac stents were linked to at least 773 deaths last year, according to a review of FDA adverse event reports — a 71% increase in the number of reports since 2008. Last year, over 4,135 non-fatal injuries were reported, including perforated arteries, blood clots, and other incidents — a 33% increase from 2008.
The use of cardiac stents began in the 1980s, but didn’t take off until the 2000s. Today, about 700,000 stent procedures are performed in the U.S. every year. The devices are implanted with a catheter, typically inserted through an incision in the groin and guided into the heart. Once in place, a doctor inflates the balloon-like stent to prop open arteries.
Although the benefits of cardiac stents in patients who have just had a heart attack is well-established, there is controversy over the benefits of stents in stable patients with pre-existing heart conditions.
In the last few years, unnecessary stents have sparked increasing concern, federal investigations, criminal charges, and a number of personal injury lawsuits. Last year, Dr. Mehmood Patel began a 10-year prison sentence after he was convicted on federal charges stemming from a multi-million scheme to implant thousands of unnecessary cardiac stents.
Unnecessary Stent Lawsuits
Many unnecessary stent lawsuits involve people who were seriously injured or killed during the implant procedure, bleeding, blood clots, or other long-term complications of heart stents. Bloomberg cites lawsuits filed by Gary Crabtree, the husband of a 64 year-old woman who died after one of her arteries was torn in a stent procedure that led to an infection. He was awarded $240,000 from a 2011 settlement against her doctor.
Since 2010, over 1,500 people have received letters from hospitals warning that their stent may be unnecessary, including 700 people who received letters in April from the University of Pennsylvania Health System. Hundreds of patients have filed lawsuits.
St. Joseph Medical Center in Towson, Maryland, is facing lawsuits from 361 patients. One patient, Rhonda McClure, had her arteries catheterized 18 times, and now suffers from chest pain and shortness of breath.
Studies of Unnecessary Cardiac Stents
- In July 2011, JAMA Internal Medicine published a study finding that 49% of cardiac stent procedures were unnecessary or uncertain. Out of 500,000 patients who received cardiac stents in the last decade, 12% were “inappropriate” and 38% were “uncertain.”
- In May 2011, the Journal of the American Medical Association published a study of over 467,000 stent patients. They found that just 44% tried medication and/or lifestyle changes before undergoing the stent procedure.
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