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New Studies Evaluate IVC Filter Complications

March 21, 2013 – Two studies and an editorial published this week in JAMA Internal Medicine raised questions about the placement of inferior vena cava (IVC) filters, devices used to prevent blood clots in patients who are unable to take anticoagulant drugs. The research indicates that not only is there a lack of evidence establishing the effectiveness of IVC filters, but that a lack of data has led to great uncertainty as to how to correctly use the implants. IVC filters were approved under the FDA’s controversial 510(k) fast-track clearance process, which allows devices that are ‘substantially equivalent’ to existing products to enter the market without undergoing clinical trials.

Free Confidential Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

What’s the Problem?

In one study, which examined IVC filter use from one hospital to another, researchers identified a large variation in how the devices were implanted based on where the recipient was treated. Another study published in the same issue of JAMA looked at nearly 1,000 patients implanted with IVC filters at the same hospital and found that less than 10% were successfully removed, and nearly 8% of recipients suffered a venous embolism despite the filters.

Vena cava filters are spider-like devices which contain a number of legs or ‘struts’ that extend out to catch errant blood clots that break free from other parts of the body. Unfortunately, IVC filter struts have recently been reported to fracture and become lodged in the heart, lungs, and other critical organs.

One study looked at 952 patients implanted with IVC filters at Boston Medical Center, and found that 7.8% of recipients suffered a venous thrombotic event, and nearly a quarter were prescribed anticoagulant medications. Of the 679 vena cava filters that were determined to be retrievable, only 58 (roughly 8.5%) were successfully removed. Efforts to remove the devices failed in 13 recipients, just over 18% of attempts.

“Our research suggests that the use of IVC filters for prophylaxis and treatment of venous thrombotic events, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in suboptimal outcomes due to high rate of venous thromboembolism,” the study’s authors concluded.

The other study examined the use of inferior vena cava filters in 263 California hospitals, and found that 15% of the 130,643 patients admitted for venous thromboembolism were implanted with the devices. The rate of IVC filter placement varied widely, with some hospitals never using them, and others implanting them in nearly 40% of patients. The researchers concluded that additional studies need to be conducted to determine whether the variations in IVC filter use are based on cultural differences between hospitals, or a lack of evidence about the effectiveness of the devices.

Medical technology giant C.R. Bard is currently facing a large number of lawsuits over its Recovery and G2 IVC filters. The complaints allege that Bard knew – or should have known – about their products’ potential to fracture, but that it failed to warn the public and medical communities about this risk.

Do I Have an IVC Filter Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in IVC filter lawsuits. We are handling individual litigation nationwide and currently accepting new heart, lung, and vena cava injury cases in all 50 states.
Free Confidential Lawsuit Evaluation: If you or a loved one has had an IVC filter implanted, you should contact our law firm immediately. Our lawyers are evaluating every individual case regardless of whether you have been injured or not. So, if you have received an IVC filter implant, we would like to speak with you. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

Free Confidential Case Evaluation

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