IVC Filter Overview
Inferior vena cava filters are small, cage-like metal devices that catch blood clots within the patient’s bloodstream. This helps reduce pulmonary embolism and stroke risks. A doctor surgically implants the IVC filter into a patient’s inferior vena cava, which carries blood to the heart and lungs. These blood clots then dissolve instead of traveling to the lungs (pulmonary embolism) or legs (deep vein thrombosis). Research shows that one American dies every five minutes from either a blood clot or deep vein thrombosis. Many of the 100-180,000 blood clot-related deaths can be prevented either by IVC filters or blood thinners. So what makes a doctor choose one treatment method over another? Find out in our IVC filter overview below.
IVC Filter Overview: IVC Filters vs. Anticoagulants
Surgeons usually recommend IVC filters instead of prescription anticoagulants for patients who:
- Have already had at least one pulmonary embolism (PE)
- Are at risk of having another PE, such as after a hip surgery
- Cannot take anticoagulants
Initially approved by the Food and Drug Administration in 2003, retrievable IVC filters quickly became popular. By 2012, doctors surgically implanted between 200,000 and 259,000 IVC filters each year. In Canada alone, the device market was worth $190 million in 2013. However, a 2015 JAMA study showed that IVC filters offered acute pulmonary embolism patients no benefit over anticoagulant medication. Surgeons should therefore carefully evaluate a patient’s medical history and health status before implanting a retrievable IVC filter.
IVC Filter Overview: Studies Show Adverse Reactions Increase Over Time
Despite the devices’ popularity, IVC filter studies show a distressing number of adverse effects from devices left in long-term. Since IVC filters are comprised of thin metal wire “struts,” pieces can easily break off and travel through the bloodstream. In fact, a 2013 retrospective patient review study published in JAMA Internal Medicine showed that 25% of patients given IVC filters also received anticoagulant therapy. In addition, 48% of IVC filter patients experienced venous thrombotic events (VTE) post-implantation, and DVT recurrence increased significantly after two years. “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 rates of venous thromboembolism,” the study concludes.
IVC Filter Overview: FDA Warning Recommends Device Retrieval Within 29-54 Days
Years of clinical studies showed little to no empirical data supporting IVC filter efficacy in improving patient outcomes. Then in 2014, the FDA issued an IVC filter warning recommending device retrieval within 29 to 54 days after implantation. To minimize any chance of injury, a surgeon should remove the IVC filter as soon as the risk of pulmonary embolism passes. A 2014 study published in Applied Radiology found device migration in up to 69% of IVC filter patients. In addition, up to 24% of patients eventually had an IVC filter’s strut puncture the interior vena cava. In order to minimize IVC filter injury risks, timely and complete device removal is key.
IVC Filter Overview: Lawsuits Filed; First Bellwether Trials Selected
After Kevin Phillips filed the first IVC filter lawsuit in June 2012, hundreds of similar claims against C.R. Bard and other manufacturers soon followed. Many plaintiffs suffered device fracture and migration complications similar to Phillips’ perforation injury, which was repaired with emergency heart surgery. Just 10 days into his trial in February 2015, Phillips settled with C.R. Bard for an undisclosed sum. About one month earlier, another plaintiff reached a confidential C.R. Bard settlement 11 days into an IVC filter trial. Then in 2016, a judge consolidated hundreds of Cook Medical IVC filter claims into a multidistrict litigation in Indiana. Judge Richard Young, hoping to quickly resolve many similar cases, scheduled settlement talks throughout 2015. However, plaintiffs and device manufacturers couldn’t reach any satisfactory agreements. As a result, those cases will now go to trial.
Judge Young chose three IVC filter bellwether trials for late 2017. Two cases include Celect IVC filters, and a third case is over a Günther Tulip IVC filter. Study data published between 2012 and 2015 may provide supporting evidence for plaintiffs during these bellwether trials. Researchers say “some degree” of perforation within 71 days is expected with either a Günther Tulip or Celect IVC. A 2015 University of Colorado study asserts that 43% of Celect IVC filter patients suffer perforation injuries within 14 months. No courts have yet ruled in individual IVC filter lawsuits. However, the outcome of these bellwether trials will likely influence any future large-scale settlements made by IVC filter manufacturers.
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