Health Canada Issues Safety Warning for IVC Blood-Clot FiltersAug 16, 2016
Health Canada, Canada's federal health regulatory agency, has issued a safety warning for inferior vena cava filters, noting the serious complications associated with the blood clot filters.
The agency joins the US Food and Drug Administration (FDA) in warning of IVC filter danger. Health Canada issued its warning on July 25, 2016. Canadian patients have filed lawsuits over serious complications they say were caused by IVC filters, Lawyers and Settlements reports.
In the announcement, Health Canada said that as of June 6, 2016, it had received 121 reports of serious complications linked to the IVC filters. The complications included "caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, cardiac tamponade, and death." Many of these complications occurred when the filter had been in place for more than 30 days. Health Canada noted that these types of complications had been reported internationally as well as in Canada.
Inferior vena cava filters are small, cage-like devices that are implanted in the patient's vena cava to prevent blood clots from reaching the heart and lungs. The IVC filters are intended to trap the clots.
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 taking blood-thinning drugs or when the risk of pulmonary embolism has subsided. In some cases, however, the surgeon is not able to remove the filter, putting the patient at risk for further injury.
Canada's CTV News reported on a patient whose doctor attempted to remove an IVC filter removed eight months after insertion. But the filter had become lodged in the wall of the vein and one of the legs of the filter almost punctured his pancreas. Because the filter cannot safely be removed, the man says he is constantly concerned about how the device will affect his health in the future. Another filter recipient told CTV News that one leg of her IVC filter perforated her internal jugular vein and the rest of the filter had moved into her small intestines. The filter cannot be removed. She told CTV News she will be on blood thinners for the rest of her life and she worries about the risk of the filter killing her.
Health Canada's announcement cited six makers of permanent and retrievable IVC filters: 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 blood-thinning drugs or for whom the drugs do not work well enough or quickly enough.
Lawsuits have been filed in the U.S. and Canada, alleging IVC filters have caused serious harm to patients. Plaintiffs allege that the filter makers knew about the risks but hid them from medical professionals and patients. In the U.S., IVC filter lawsuits involving Cook Medical and C.R. Bard have been consolidated into multidistrict litigations and cases are being scheduled for trial in early 2017.