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Canadian Government Issues Safety Warning for IVC Filters
We’ve known for a while in the U.S. that IVC filters have been linked to severe complications, and even deaths. The Canadian government recently issued a safety warning due to the dangers associated with the device.
What is an IVC Filter?
The “IVC” in IVC filter stands for the inferior vena cava, the largest vein in the body. Doctors will typically implant an IVC filter in the vein near the groin. The main reason is to trap any blood clots originating in the legs before they can reach the lungs, resulting in a potentially deadly pulmonary embolism.
The problem with the device, which has metal legs that make it look somewhat like a spider, is that one or more legs have been known to break off and travel through the body. Those struts that break off can pierce vital organs such as the liver, heart and others, which can be fatal. Doctors have sometimes had to leave a portion of an IVC filter embedded in an organ because removing it would be life-threatening to the patient.
NBC News reported last year that the Recovery filter manufactured by C.R. Bard had been linked to 27 deaths and about 300 injuries alone. NBC also reported that a regulatory specialist hired by Bard said that someone with Bard forged her name on an application sent to the FDA to gain approval for the device. The regulatory specialist stated she had refused to sign it because she had several concerns regarding the Bard Recovery filter.
Canada Steps Up
In the safety warning it issued on July 25, Health Canada reported that it had received 121 reports of incidents involving IVC filters. These incidents include device migration into other areas of the body, perforations of the heart and other organs by broken pieces of the filter, and other serious filter complications.
The agency is recommending that doctors take a close look at the risks associated with IVC filters, and to make sure they remove retrievable filters in a timely fashion. Health Canada advises patients who have a retrievable IVC filter to talk to their surgeon about when is the best time to remove it.