Inferior Vena Cava filters (IVC filters) have been the subject of hundreds of lawsuits in the United States and two safety communications from the Food and Drug Administration (FDA). Now the devices are being scrutinized in Canada.
Health Canada recently announced a warning to physicians advising them to consider the risks associated with IVC filters before implantation. Health Canada received more than 100 reports of serious and life threatening adverse events caused by IVC filters. Adverse events included caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, cardiac tamponade, and death. Many of these complications occurred with long-term use of the filter for longer than 30 days.
Health Canada urged doctors and patients to have the device removed as soon as the risk of blood clots had subsided or as soon as the patient could take anticoagulants to reduce their risk of blood clots. Several lawsuits have been filed against C.R. Bard and Cook Medical in Canada over the dangerous side effects posed by these defective medical devices.
IVC filters are used to catch blood clots before they travel into the heart and lungs, but several studies have now confirmed that IVC filters are susceptible to fracture, migration, perforation, and embolization.
The first warning against IVC filters in North America came in 2010 after the FDA received nearly 1,000 reports of adverse events related to IVC filters. Of these reports, 328 involved device migration, 146 involved embolization, 70 involved perforation, and 56 involved device fracture. In 2015, the FDA reiterated the dangers of IVC filters and recommended doctors remove the devices between 29 and 54 days after implantation.
IVC filter manufacturers, C.R. Bard and Cook Medical, have trials scheduled to begin in early 2017 in the U.S. These trials could set an important precedent for other IVC filter lawsuits and predict how Canadian lawsuits against IVC filter manufacturers will resolve.