Deep-vein thrombosis (DVT) is a condition that affects nearly one million Americans each year. It begins when blood clots develop within the body’s deeper veins (like your legs). But if these blood clots break loose and travel to your lungs, they can trigger a life-threatening pulmonary embolism (PE). Each year, thousands of DVT patients get inferior vena cava (IVC) filters to help prevent PE. Surgeons implant these cage-like blood clot filter devices directly into your biggest blood vessel, the inferior vena cava. Once in place, that filter should catch and help break up any blood clots before they can do any harm.
Due to High Blood Clot Filter Injury Reports, FDA Issues Warning
Despite the risks involved with leaving in any retrievable blood clot filter long-term, their usage rose steadily until 2010. In fact, from 2005 to 2010, IVC blood clot filter placement procedures within the United States increased 22.2%. In 2010, the U.S. Food and Drug Administration reviewed 921 IVC blood clot filter adverse event reports submitted since 2005. IVC blood clot filter injuries may include:
- Device migration
- Internal tissue or organ perforation
- Fractured fragments that surgeons cannot retrieve or remove
The agency issued an August 2010 safety communication reminding physicians to remove IVC filters once the patient’s PE risk subsides. Within months, an investigative study found that 16% of Bard Recovery and G2 filters fractured within three years. These alarming numbers made consumers and medical experts alike take notice, and many injured patients filed product liability lawsuits.
FDA Warning Significantly Drives Down Blood Clot Filter Use In U.S. Patients
According to a recent Temple University study, blood clot filter use fell 29% after the FDA’s 2010 warning. Researchers from the School of Medicine at Temple University measured the FDA warning’s impact on subsequent IVC filter placement rates. Study lead Dr. Riyaz Bashir stated, “The significant decrease in IVC filter implantations after the FDA communication reflects that such communications are a very powerful means of affecting contemporary practice patterns around the country.”
IVC Filter Use Still Rampant In U.S., Despite Few Proven Benefits
Unfortunately, the U.S. IVC filter placement rate is still 25x higher than those found in European countries. “The hospitals across this country collectively are spending close to a billion dollars on these devices every year without a known significant benefit,” asserts Dr. Bashir. Next, Dr. Bashir’s team looked for any benefits to explain rampant IVC filter use in DVT patients. From 2005 to 2010, venous thromboembolism (VTE) hospitalization rates rose from ~160 per 100,000 to 211.6 per 100,000 patients.
The study found no real change in VTE hospitalization rates after 2010, either. In other words, the main diagnosis leading to IVC filter placement didn’t change, so that couldn’t explain the 29% decline. Researchers concluded the current U.S. IVC blood clot filter implantation rate of 39.1/100,000 is still inappropriately high. Instead, Dr. Bashir suggests American doctors aim to stay at or below the current European rate of 3/100,000.
Ultimately, the study proved U.S. physicians do pay attention to FDA warnings. That, in turn, can trigger rapid changes in standard treatment protocols. “Such communications are a very powerful means of affecting contemporary practice patterns around the country,” concludes Dr. Bashir.
Inappropriate Blood Clot Filter Use Remains High, Study Shows
Another March 2017 population-based study found prophylactic filter placement in 5% of patients, despite 2012 ACCP guidelines against such uses. These guidelines say if a patient responds well to blood thinner medication, there’s no need for an IVC blood clot filter. But in 2013, 66% of patients inappropriately received filters without any clear indication — and only 7% were later removed. FDA guidelines suggest removing filters 29-54 days after implantation to minimize any risks. So why are many hospitals discharging DVT patients with temporary IVC filters left in, especially if the danger’s already passed?
Researchers speculate that “increased reimbursement rates when filters are retrieved in an outpatient setting and an under appreciation of the potential harms of leaving filters in place for extended periods” could be why. The March study also found an 8.7% mortality rate among U.S. blood clot filter patients from 2005-2013.
What IVC Blood Clot Filter Victims Can Do
While IVC filter use recently fell, many doctors recommend them for off-label use. Despite research showing IVC filters grow more dangerous the longer they’re left in, their use remains rampant. As a result, injured patients are suing device manufacturers to get the justice and compensation they deserve. To see in just minutes if you may qualify for a cash settlement, get your IVC filter claim evaluation today. Once you’ve submitted your contact information, an attorney will call to discuss your compensation options.
Mandy Voisin is a freelance writer, blogger, and author of Girls of the Ocean and Star of Deliverance. As an accomplished content marketing consultant, mom of four and doctor's wife, Mandy has written hundreds of articles about dangerous drugs and medical devices, medical issues that impact disabled Americans, veterans' healthcare and workers' compensation issues since 2016.