Health Canada Issues IVC Filter Warnings

Ottawa, Canada Health Canada has issued its own safety warning concerning inferior vena cava filters, following in the footsteps of the US Food and Drug Administration. The Canadian agency issued its warning on July 25, 2016, and noted there were serious complications associated with the IVC filters. As with the United States, IVC lawsuits have been filed in Canada alleging patients suffered serious complications as a result of the filters.

In making its announcement, Health Canada noted it had received 121 incident reports concerning serious complications linked to the IVC filters. Serious complications included caval perforation, caval thrombosis, filter fracture, fragment embolization, cardiac perforation, and death. Health Canada noted that many complications occurred in long-term filter implantation, meaning filters that were implanted for longer than 30 days.

Inferior vena cava filters are metal devices implanted in the patient's vena cava to prevent blood clots from reaching the heart. The IVC filters trap the clots in struts, which look similar to spider legs. But concerns about the filters include problems with struts breaking off and becoming trapped in the body, or the filters perforating the patient's heart or other tissues.

The filters are approved in Canada to prevent pulmonary embolism. Health Canada warns that retrievable filters should be removed either when the patient is able to start anticoagulation therapy or if the risk of pulmonary embolism has subsided. But in some cases, patients allege that retrievable filters became impossible to remove, putting them at risk of even further injury.

CTV News (8/8/16) reports the story of John Boehmer who attempted to have his filter removed eight months after implantation. The filter, however, had become lodged in the wall of his vein, while a leg almost punctured his pancreas. Boehmer is now stuck with a filter that doctor's can't remove and says he is constantly concerned about how the device will affect his health.

Meanwhile, Wendy Kopeck found out when she went to have the temporary filter removed that her filter was broken. One leg of the filter perforated her internal jugular vein and the rest of the filter had moved into her small intestines. She tells CTV News (2/23/16) that she cannot have the filter removed and will be on blood thinners for the rest of her life while she worries about the risk of the filter killing her.

Six makers of IVC filters were noted in Health Canada's announcement, which included both retrievable (sometimes called "optional") and permanent filters. Among the makers of the filters were A.L.N., Bard Peripheral Vascular, B. Braun Medical, Cordis Cashel, REX Medical, LP, and William Cook. The filters are still considered life-saving devices for patients who cannot tolerate anticoagulants.

Lawsuits have been filed in the US and Canada, alleging IVC filters have caused serious harm to patients. Plaintiffs claim the makers of the filters knew about the risks but hid them from medical professionals and patients. The FDA has also issued a warning about the risk of retrievable filters remaining in patients for too long.