The health risks posed by retrievable inferior vena cava (IVC) filters have long been the subject of much scrutiny. IVC filter lawsuits allege that companies like C. R. Bard and Cook Group released defectively designed IVC filters onto the market without adequately testing for dangerous side effects. In legal battles, IVC filter manufacturers have frequently stated that the devices’ health risks are outweighed by their potentially life-saving benefits. However, recent literature has questioned whether retrievable IVC filters confer any benefit at all. Many have started to wonder whether IVC filters from companies like Bard and Cook are all risk and no reward.
IVC filters have been around for many decades. The devices first came into use in the late 1960s as a way to prevent blood clots in patients with vascular conditions. However, it was not until the early 2000s that the U.S. Food and Drug Administration (FDA) created guidelines for the design and use of retrievable IVC filters. Retrievable IVC filters include levels of spoke-like struts that anchor the device in the inferior vena cava and act to catch blood clots before they reach major organs, such as the heart and lungs, where they can cause strokes and other life-threatening events.
The side effects of IVC filters are well documented. According to the FDA, between 2005 and 2010, when the agency issued a safety alert about the devices, 921 adverse event reports were submitted, “of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture.” The FDA expressed concern about long-term placement of IVC filters, and urged physicians and clinicians to consider removing filters as soon as possible.
IVC filters have received more and more use over the past decade, with an estimated 100,000 implanted annually. Despite the device’s popularity, however, little research has been done on the efficacy of retrievable IVC filters. To date, only one randomized controlled trial has been conducted with IVC filters. The study, published in July 2005, found that IVC filters decreased the occurrence of pulmonary embolism but increased the chance of deep-vein thrombosis. Furthermore, IVC filters had no observable effect on the survival rate of patients.
More recently, surgeons and patients have begun to question the overall efficacy of IVC filters, health risks aside. A study published in the Journal of the American Medical Association concluded that IVC filters confer “no benefit in terms of pulmonary embolism recurrence or mortality.” The study observed 400 patients suffering from acute, symptomatic pulmonary embolism. Half of the patients were given only anticoagulation treatment, while the other half received both anticoagulation treatment and an IVC filter. After six months, the researchers observed an insignificant difference in the risk of recurrent pulmonary embolism.
Patients who have already filed IVC filter lawsuits may be surprised to learn of evidence that suggests IVC filters offer no protection beyond what anticoagulation treatment can provide. Companies like Bard and Cook have touted retrievable IVC filters as a safe and effective way to combat fatal blood clots. If it were revealed that their products granted no medical benefit, plaintiffs in Bard and Cook IVC filter lawsuits would no doubt feel further wronged.
Check with your doctor or physician before making any changes to your treatment plan. If you or a loved one was injured by a failed Bard or Cook IVC filter, contact the IVC filter attorneys at Lopez McHugh right away to schedule a free legal consultation. You may be eligible to receive compensation through a Bard or Cook IVC filter lawsuit.