Unapproved heart stent use increases risk of problems
Two studies published this week in the Journal of the American Medical Association (JAMA) raise additional concerns about the safety of heart stents. Although drug eluting stents (DES) are only approved to treat certain type of blockages, researchers found that over half of all stents implanted are off-label, or outside the FDA tested and approved profile. Further, the reports indicate that those heart stent patients who receive the devices “off-label”, have a higher rate of heart attacks and repeat stent procedures. The makers of these tiny devices face stent lawsuits nationwide from users who were injured.
>>INFORMATION: Heart stint lawsuits
Heart stents are used to open clogged arteries and restore blood flow. In 2003 and 2004, drug eluting heart stents were approved, containing a medication which coats the tiny scaffolds to prevent the artery from becoming reblocked as a result of scar tissue, known as restenosis. By 2006, DES stents accounted for 90% of all stent sales, generating $6 billion worldwide.
Late last year information was released about heart stent problems, which could result in an increased risk of potentially fatal blood clots that may form months or even years after the stent was implanted. The manufacturers failed to properly warn of this heart stent risk, and researchers have been working to obtain a better understanding of the extent of the danger.
The Journal of the American Medical Association (JAMA) published two studies and an editorial this week, discussing the widespread use of medicated heart stents in patients with conditions which have not been tested or determined to be safe for stent use. This “off-label” stent use involves people who are in the midst of a heart attack, have multiple blockages or other more complex and serious medical issues.
One of the stent studies involved 5,541 patients, and researchers found that the risk of death, heart attack or blood clots was doubled when used in patients with unapproved conditions or blockages. The other stent study involved 3,323 patients and found that over 50% had at least one of the characteristics which should have ruled the patient out for stent use if following FDA guidelines. Researchers found that those who did not meet the approved profile had higher rates of death, heart attacks and vessel revascularization (the need to retreat an artery which has been stented). The heart stent problems occurred in nearly 11% of the off-label group, compared with 5% for the on-label group.
HEART STENT LAWSUITS
The drug eluting heart stent lawyers at Saiontz & Kirk, P.A. represent individuals who have died, suffered a heart attack or reclogging of the artery after receiving one of these devices. If you, a friend or family member believe you may have a case, request a free claim evaluation to determine if compensation may be available.
1 Comment • Add Your Comments
scott kinsley says:
My mother had 2 Medtronic non drug coated stents implanted into her heart at the washington hospital center. Approximately 48 hrs later she had a massive heart attact and barely survived. Both of the stents had occluded. After a long recovery doctors at the univ of md. determinded that the heart attack had caused so much damage she was diagnosed with end stage heart failure. She died in oct 2007.
Posted on February 29, 2008 at 11:57 am