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Idea: Keep better track of IVC filter injuries

Inferior vena cava filters are cage-like devices that stop blood clots, or deep venous thrombosis (DVT), from reaching the lungs and thus becoming a pulmonary embolism (PE). Unfortunately, the device itself is known to migrate or break apart, causing serious injury elsewhere in the body. If you are a victim, you may want to talk to an attorney about your legal options. You are not alone; for IVC lawsuits are being filed across the country.

In the meantime, medical science and the U.S. Food and Drug Administration are trying to figure out how to minimize adverse events. Researchers from the U.S. and Turkey suggest that perhaps it is time for the U.S. to implement a "device registry," which the British already have, to track filter complications and thus to raise safety concerns. The Portuguese Journal of Cardiology released their article Aug. 19.

"IVC filter placement," the authors wrote, "has emerged as a break-through endovascular technique which has gained increased acceptance and has probably saved thousands of lives by preventing fatal thromboembolic events. However, in the absence of a national IVC filter registry an accurate estimate of device complications is currently unavailable. Increasing reports of adverse events have raised the concern that too many permanent IVC filters may be currently placed in the U.S. and the FDA has recommended (in 2010 and in 2014) the retrieval of filters when they are no longer needed."

If an IVC filter registry had been in place in recent years, perhaps it would have gauged how common adverse events reported to the FDA in recent years really were. The agency's recommendations followed reports of serious injury.

"The FDA has received reports of adverse events and product problems associated with IVC filters," the agency wrote May 6, 2014. "Types of reports include device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. Some of these events led to adverse clinical outcomes. These types of events may be related to how long the filter has been implanted. Other known long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides."

Many victims of IVC fracture, embolization, migration and perforation are holding the manufacturers accountable by asserting their right to compensation for their injuries.

In a court document concerning a lawsuit against the IVC filter maker C.R. Bard Inc., the alleged victims write through their attorneys, "Plaintiffs all allege that Defendants' IVC filters were widely advertised and promoted by them as a safe and effective treatment for prevention of recurrent pulmonary embolism via placement in the vena cava when, in fact, Defendants knew or should have known their IVC filters were defective due to, inter alia [among other things], the filters' inability to withstand normal and expected anatomical and physiological loading cycles exerted in vivo. Defendants knew or should have known that their IVC filters were likely to fracture, tilt, perforate the vena cava wall, and/or migrate, and thus cause injury."

The plaintiffs' bottom line is this: "Despite their knowledge, Defendants failed to disclose to physicians, patients or to the Plaintiffs that their IVC filters were subject to fracture, tilt, perforation and migration. Defendants then continued to promote their IVC filters as safe and effective, despite the absence of adequate clinical trials to support long or short term efficacy and even after studies have shown them to lack such efficacy."

No one injured by a defective IVC filter should have to suffer in silence. Requesting a free consultation from one of the product liability attorneys at Reich & Binstock is one step worth considering.

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