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Health Canada Warns of IVC Filter Complications

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In 2010, the FDA warned that inferior vena cava (IVC) filters—small, cage-like devices implanted to capture blood clots and prevent them from reaching the lungs—had been associated with 921 adverse event reports. Over 300 of these involved device migration, where the filter actually moved from its initial position to other body organs and tissues. The FDA advised doctors to remove the devices as soon as the risk of pulmonary embolism (blood clot in the lung) had passed.

A few years later, in May 2014, the FDA again warned about these devices, and their potential for migration, fracture, and perforation of other organs. They recommended again that doctors remove them as soon as possible, and this time gave an optimal time period for removal—between 29 and 54 days after implantation.

Then, in July 2016, Health Canada followed suit, warning doctors that serious complications had been reported in patients implanted with IVC filters, including perforation, blood clots, filter fracture, and even heart perforation and death. They encouraged each hospital to “identify all patients who have a retrievable IVC filter placed and to develop a formal strategy to assess these patients for filter removal.”

Health Canada Encourages Doctors to Remove IVC Filters As Soon as Possible

According to Health Canada’s report, as of June 6, 2016, they had received 121 reports of serious complications associated with IVC filters. Many of these occurred after the device had been inside the patient’s body for more than 30 days. Among the products listed on these reports was the Bard G2 filter system, which has been the subject of many personal injury lawsuits here in the United States.

Health Canada notes two randomized controlled trials (RCTs) of IVC filter use. They conclude that the results from these two studies “do not support the use of IVC filters in patients who can be treated with anticoagulation.” They add that the devices have not been shown to reduce the risk of blood clots or death.

Though patients who are at risk of certain types of blood clots who cannot take blood-thinning drugs are still considered good candidates for IVC filters, doctors are warned to schedule patients for “retrieval assessment” at the time of implantation. In other words, doctors should be thinking of removal even when they first put an IVC filter into a patient. That way, they’ll be more likely to follow up and remove the devices at the earliest possible time.

The hope is that if patients are monitored more closely and the IVC filters are removed more quickly, the risks of side effects will be reduced.

Over 1,000 IVC Filter Lawsuits Pending in United States

In addition to warning doctors and patients about the risks associated with IVC filters, Health Canada states that it’s also working with filter manufacturers to monitor post-market safety and effectiveness of these devices. They are requiring companies to put into place post-market evaluations, so they can further narrow down those patient populations that may truly benefit from implantation.

Meanwhile, the number of IVC filter lawsuits continues to increase here in the United States. More than 700 cases concerning Bard IVC filters in the District of Arizona, and more than 650 cases concerning IVC filters are pending in centralized litigation in the Southern District of Indiana.