Arie Kuiper has filed a class action lawsuit in Canadian court against Cook Medical over health problems allegedly caused by the company’s retrievable IVC filter, a device temporarily implanted in the largest vein in the body to capture blood clots before they travel to the heart or lungs.
Retrievable IVC filters are cage-like devices implanted in the inferior vena cava, the largest vein in the body, which runs along the spine. They are used in patients at risk for blood clots who cannot be treated with blood thinners. The devices are often implanted in patients undergoing bariatric, trauma or orthopedic surgeries.
Permanent IVC filters are been on the market since the 1960s. In 2003, medical device manufacturers introduced retrievable IVC filters for patients with only temporary blood clot risk. These devices are intended to be removed within 29 to 54 days.
Kuiper says doctors had made two unsuccessful attempts to remove his IVC filter, and he is scheduled for a third attempt. He claims he has started experiencing dizzy spells, which doctors say may be a sign that his device has become clogged and is blocking his blood flow.
Kuiper is suing because he says he was never warned that the device could become stuck inside his body and cause complications. IVC filters can migrate and fracture inside the body, and perforate organs and tissue, leading to embolism, organ damage and death.
Canadian drug and medical device regulator Health Canada says it has received 12 incident reports related to IVC filters by C.R. Bard and Cook from Jan. 1, 2008, to Feb. 1, 2016, including six reports of perforation or penetration; five reports of device migration; and three reports of inability to remove the device.
A 2014 University of Ottawa and Ottawa Hospital Research Institute study found that IVC filters were “associated with a substantial rate of complications,” with about 20 percent of individuals implanted with the device having at least one “filter-related complication.”
In December, the U.S. Food and Drug Administration (FDA) organized a five-year, 2,100-patient study in partnership with the Society of Interventional Radiologists, the Society for Vascular Surgery and blood clot filter manufacturers, to look at the safety and effectiveness of IVC filters.
Source: CTV News