Retrievable IVC Filter Risks to be Evaluated in First Large-Scale Study
New clinical trials will begin next year, which are designed to look at the potential risks with retrievable inferior vena cava (IVC) filters, which federal regulators have warned can break and send pieces into the heart and other organs.
In spring 2015, the first patients will begin enrollment in a multispecialty prospective clinical research trial sponsored by the Society of Interventional Radiology (SIR) and the Society for Vascular Surgery (SVS). Known as the “Predicting the Safety and Effectiveness of Inferior Vena Cava Filters” (PRESERVE) study, the research comes in response to the prior FDA warning over the risk of IVC filter problems.
The study will look at the safety and effectiveness of the retrievable filters, which are implanted in the inferior vena cava to “catch” blood clots that may break free inside the deep veins of the body and travel toward the lungs. Researchers will also look at the effectiveness and practicality removing the filters after the blood clot risk has passed, as many of the complications have been reported with newer designs that are designed to be retrievable.
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The study is designed to last for five years, and researchers hope to enroll about 2,100 patients at 60 sites across the United States.
A number of medical device manufacturers make IVC filters, including C.R. Bard and Cook Medical, and the researchers are planning to enroll 300 patients for each type of filter on the market.
FDA Warns of IVC Filter Risks
In August 2010, the FDA issued a warning to doctors, alerting them about potential retrievable IVC filter risks, indicating that retrievable devices should be removed once the danger of a pulmonary embolism has passed.
At that time, at least 900 adverse event reports had been received by the FDA involving complications from IVC filters. One of the most common complaints involved IVC filters fracturing or breaking, allowing small pieces to migrating through the patient’s body and pose a potentially life-threatening risk.
In May 2014, the FDA issued an updated safety statement indicating that patients may face an increased risk of problems with IVC filters the longer they remain in place, advising doctors that the ideal time for removal appears to be between 29 days and 54 days after implantation.
A study published in the medical journal JAMA Internal Medicine in March 2013 raised questions about the effectiveness of IVC filters, indicating that less than 10% of filters evaluated in the study were successfully removed from patients and 8% of recipients of IVC filters suffered a pulmonary embolism despite the device’s presence.
IVC Filter Injury Lawsuits
In recent years, a number of IVC filter lawsuits have been filed against manufacturers of devices that have failed, including C.R. Bard and Cook Medical.
According to allegations raised in Cook IVC filter lawsuits, a study was published in the medical journal Cardiovascular Interventional Radiology in April 2012, which found that 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal caval wall within 71 days of being implanted. The study also found that 40% of the filters became tilted and out of position.
In addition to lawsuits against Cook Medical, a number of similar lawsuits over Bard Recovery IVC Filter and Bard G2 IVC Filters have been filed in recent years, alleging that the manufacturer has known for years that their filters are prone to fracture, which can cause severe complications, including death, but failed to warn doctors and patients.
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