Use of IVC filters for preventing blood clots and pulmonary embolism in patients has increased dramatically in recent years, which has raised concerns about the risk-benefit profile of the medical devices, due to a potential risk for serious complications caused by faulty devices. Since 2005, the U.S. Food and Drug Administration (FDA) has received thousands of adverse event reports involving injuries from IVC filters, including migration of the device to other parts of the body, perforation of nearby organs or blood vessels, and pieces of the filters breaking off and embolizing to the heart. If you believe you have been harmed by alleged side effects of IVC filters, contact a reputable product liability lawyer today for legal help. You may have grounds to file an IVC filter lawsuit against the device manufacturing company, in order to pursue financial compensation for your injuries and medical bills.
There are two types of IVC filters – temporary (retrievable) and permanent (irretrievable) – and both have been linked to an increased risk of devastating side effects. For patients facing a risk of pulmonary embolism who are unable to take a blood thinner drug, some possible alternative treatment options to an IVC filter for preventing blood clots include the following:
In August 2010, the FDA issued a drug safety communication to consumers and the medical community, after receiving reports of more than 900 adverse events associated with IVC filters. At the time of the FDA’s IVC filter warning, the agency had received 921 adverse event reports from patients who received an IVC filter to prevent pulmonary embolism. Of the 921 reports, 328 involved migration of the device to other parts of the body, 146 involved broken pieces of the IVC filter traveling in the bloodstream, 70 involved the filter perforating the inferior vena cava, and 56 involved fractures of the IVC filter. In 2014, the FDA issued another drug safety communication recommending that IVC filters be retrieved within 29-54 days, as long as the patient’s risk of pulmonary embolism has subsided at that time. According to a media report in 2015, C.R. Bard continued to market and sell its IVC filters despite knowing that the devices were failing and causing serious injuries and even death.
In light of the potential for IVC filters to cause devastating side effects in patients, a growing number of studies are being conducted in order to examine the alleged safety risks of IVC filters for implant recipients. The following are some recent IVC filter side effect studies published by credible medical journals:
November 8, 2010 – The Archives of Internal Medicine publishes research indicating that the Bard Recovery and Bard G2 IVC filters are associated with high rates of fracture and embolization, with potentially life-threatening complications.
August 28, 2012 – A study published in the American Journal of Medicine indicates that IVC filters don’t actually reduce mortality rates for stable patients experiencing pulmonary embolism. In fact, the researchers concluded that only a small percentage of pulmonary embolism patients actually benefited from the IVC filter, and the rest were exposed to an unnecessary risk of possible side effects.
March 21, 2013 – The Journal of the American Medical Association publishes an editorial and two studies questioning the safety and efficacy of IVC filters. One study details the various ways in which IVC filters are used, and the other advises against using IVC filters, due to the high risk of blood clots and low retrieval rates.
April 2013 – JAMA Internal Medicine publishes a study indicating that only roughly 8.5% of retrievable IVC filters are successfully removed.
March 2, 2014 – A study published in the Journal of the American College of Cardiology establishes a potential connection between the use of IVC filters and a lower risk of pulmonary embolism, but ties the medical device to a higher risk of recurrent venous thromboembolism (VTE).
April 30, 2015 – According to research published in the Journal of the American Medical Association, IVC filters may not benefit patients who can use blood thinner medications instead, to reduce their risk of blood clots.
June 2017 – JAMA Internal Medicine publishes a study indicating that FDA warnings, reports of complications and lawsuits over injuries from IVC filters led to a significant decline in the use of the medical devices.
Estimates suggest that, in the last 30 years, approximately 30,000 IVC filters have been implanted. Patients who receive an IVC filter expect the medical device to capture blood clots before they enter the lungs, in order to reduce their risk of suffering pulmonary embolism. However, allegedly defective IVC filters have punctured veins, fractured, and migrated to other parts of the body in some patients, causing serious medical issues, and critics of the medical devices believe C.R. Bard and other IVC filter manufacturing companies should be held liable for side effects allegedly caused by their devices. Lawsuits filed against the makers of IVC filters allege the following:
Since the FDA issued its first IVC filter warning in 2010, consumers nationwide have come forward with claims of injuries allegedly caused by the medical devices, including filter fracture, organ perforation and device migration. Many of these implant recipients have suffered complications like chronic chest or abdominal pain, pulmonary embolism, or constant worry over the fact that their IVC filter may fracture and cause severe injury to their internal organs. If you or a loved one received an IVC filter to prevent blood clots in the past, and you have since suffered one or more devastating side effects, consult a knowledgeable IVC filter attorney to discuss your legal options. You may be entitled to financial compensation for your injuries, which you can pursue by filing an IVC filter complaint against the device manufacturing company.
