What Is An IVC Filter?
An IVC filter (inferior vena cava filter) is a small metal device resembling a cage that is intended to prevent blood clots from travelling to the lungs. These blood clots could potentially result in a life-threatening pulmonary embolism. Under ideal circumstances, the cage-like design holds the blood clot in place in the vena cava, the largest vein in the body, until it dissolves naturally. A pulmonary embolism is a potentially fatal blockage with an artery that carries blood from the heart to the lungs.
IVC filters are commonly placed in people who are at risk for pulmonary embolism when anticoagulants (blood thinners) are determined to be ineffective or an undafe option for that individual. Patients with recurrent DVTs (deep vein thrombosis) while on anticoagulation (blood thinning) therapy and/or patients who can’t tolerate or consume anticoagulation therapy due to adverse bleeding reactions are generally good candidates for IVC filters. IVC filters are also recommended in patients who have suffered serious trauma or undergo surgery, both of which would increase the risk of blood clots.
IVC Filter Manufacturers
There are two major companies who manufacture IVC filters and these include C.R. Bard and Cook Medical. Some popular brands of filters include Bard G2 Express, Bard G2, Bard Recovery, Cook Celect, Cook Gunther Tulip, and Boston Scientific Greenfield.
IVC filters may be permanent or retrievable. Permanent IVC filters are designed for long-term use and retrievable filters are intended for short-term use. However, retrievable IVC filters provide the options of either long-term use or removal once a patient is no longer at risk for pulmonary embolism. While the IVC filters are designed and intended to trap clots, they can potentially migrate within the body, causing serious complications.
According to a 2014 study published in the Journal of Vascular Surgery, retrievable IVC filters that were left in place were associated with significantly higher complication rates than permanent filters. Patients with retrievable filters left in place were at a higher risk for both thrombotic (blood clot) and device-related complications.
IVC Filter Medical Concerns
IVC filters were approved by the U.S. Food and Drug Administration in 1979. By 2012, approximately 259,000 IVC filters had been placed in patients. A 2016 American College of Cardiology analysis concluded that IVC filters were likely being over-used. In 2010 and 2014, the FDA released safety communications warning of adverse events and problems associated with IVC filters which included device migration, filter fracture, embolization in which the filter or fragments thereof move to the heart or lungs, perforation of the IVC, difficulty in removal of the device, lower limb deep vein thrombosis and occlusion of the device. In these safety communications, the FDA expressed concern “that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.”
IVC filters are linked to a wide variety of side effects, some of which are life-threatening. The U.S. Food and Drug Administration generally recommends that the filters be removed as soon as they are no longer needed (between the 29th and 54th day after implantation when the risk of pulmonary embolism subsided), due to the high chance of complications that increase with the length of time that the IVC is left in the body.
Typically, complications from IVC filters fall into three categories: procedural, delayed and retrieval.
Procedural complications occur at the time of insertion and can include access site bleeding or bruising, blood vessel puncture, incorrect placement (malposition) of the filter and defective filter deployment.
Retrieval complications occur during removal of the filter and can include blood vessel perforation, clots in the filter that prevent removal, long surgery times due to difficult retrieval of the filter and scars in the vein that can prevent removal of the filter.
Delayed complications occur while the filter is in place within the body and can include migration (either to another part of the vena cava, the heart, or other organs), deep vein thrombosis (blood clots in the legs), fracture or breakage of the filter, perforation of the organs, infection of the device, blockage that can cause swelling in the legs and embolization (detachment of device components).
Other serious complications may include internal bleeding, cardiac or pericardial tamponade, ventricle tachycardia, constant and severe chest pain, respiratory distress and shortness of breath.
IVC Filter Lawsuits
IVC filter lawsuits allege that manufacturers such as Bard and Cook Medical designed a defective medical device and the design of IVC filter devices increase the likelihood of fracture, migration, tilting, and perforation of the inferior vena cava, which can cause severe injury or death. Compensable injuries include, but are not limited to, organ damage, blood clots, device migration, device fracture, and impossible filter removal.
More than 6000 federal lawsuits contend that these complications suffered by patients are the result of the manufacturers’ and their subsidiaries’ negligence, failure to warn, design defects, manufacturing defects, breach of implied warranty and negligent misrepresentation. There are currently two IVC filter multidistrict litigations, or MDLs – one in Indiana for lawsuits filed against Cook and the other in Arizona for lawsuits filed against Bard.
There are a variety of factors that can influence or determine the amount of compensation available to plaintiffs involved in an IVC filter lawsuit. If a case goes to trial, a jury may consider whether any lost wages were incurred by the patient. The jury could consider the past and future medical expenses, as well as the amount of pain and mental anguish was caused by an IVC filter injury (dependent upon the severity of the IVC filter complication and whether it resulted in hospitalization, surgery and/or death).
Legal Help Available Regarding IVC Filters
If you or a loved one has experienced any medical problems following placement or removal of an IVC filter you need to speak with an experienced attorney as soon as possible. Please contact us online or call us directly at 318.541.8188 to schedule your free consultation.