The indications for IVC filters placement, the selection of filter type, and the management after filter insertion are still controversial. Over 400 injured patients, some of whom will live permanently with broken medical devices inside their own bodies, have chosen to pursue legal action, suing the manufacturers of IVC filters – small implants that act as a net for blood clots inside one of the body’s largest veins. In 2014, the FDA issued a safety communication update, specifying that most IVC filters need to be withdrawn between the 29th and 54th day after they have been implanted. Unfortunately, this update was too late for some patients. Lawsuits were being filed across America with claims that the retrievable filters caused harm and even death in some cases.
IVC Filters have been used by patients to reduce the risk of blood clots, along the Bard IVC filter and those made by other manufacturers is designed to be used in patients who can’t tolerate blood thinners, and for whom blood clots are a continuing risk. When that risk expands, a filter is often implanted in the inferior vena cava in an effort to prevent a blood clot from reaching the lung and causing an IVC filter pulmonary embolism. The devices have been utilized since 1979, where initially 2,000 people utilized IVC filters to combat the risk of pulmonary embolism. In 2007, about 167,000 IVC filters were being used to trap clots, and data suggests that the number of users has continued to increase in recent years.
IVC Filter Complications
Recent reviews of vena cava filters have demonstrated a wide variety of complications, both short and long term, mortality attributed directly to placement or presence of a vena cava filter is extremely rare. One study, which included a markedly high rate of filter related complications, did not have a single mortality attributed solely to filter presence. Adverse events during filter placement or as a result of filter migration have presented in a variety of emergent conditions. Despite the gravity of these complications most of the patients survived after proper resuscitation and surgical intervention. As of June 6, 2016, Health Canada has received 121 incident reports of serious complications associated with IVC filters. Serious complications such as caval perforation, caval thrombosis, filter fracture and fragment embolization, intracardiac migration, cardiac perforation, cardiac tamponade, and death have been reported in patients who have been implanted with IVC filters. Many of these complications occurred with long-term (greater than 30 days) filter implantation. These complications have also been reported internationally.
IVC filter manufacturer C.R. Bard has found itself under considerable scrutiny from the media is in a similar position. Bard is facing several hundred lawsuits by patients who have had the Recovery and G2 IVC filters implanted, resulting in injury. Plaintiffs claim that the company marketed poorly designed devices and failed to warn the medical community and public about potential risks. Over 210 lawsuits have been filed against Bard, manufacturer of the wildly-popular Recovery (before its withdrawal from the market in 2005) and G2 series IVC filters. All of the lawsuits accuse Bard of selling a dangerous device that has an unreasonable risk of fracture, migration, tilt, perforation of the vena cava, and permanent health problems.