A new study suggests that the use of inferior vena cava (IVC) filters in certain patients could more than double the mortality risk compared with similar patients who do not receive the device, once again raising questions about whether IVC filters are safe for use. Among the concerns are a risk of IVC filter thrombosis. Patients who received the filters have filed lawsuits against the makers, alleging the filters are not safe to be used and were defectively designed.
Attorneys at Patterson Dahlberg understand how devastating and catastrophic a defective medical device can be, and we fight hard to hold medical device manufacturers accountable for the products they put on the market. Patients put their faith in pharmaceutical and medical companies and believe the products they ingest or have implanted will do more good than harm. Unfortunately, all too often we see healthcare products that do not work in the manner promised, putting patients’ health and safety at risk.
Older Patients May Have Higher Mortality Risk
According to the study, published online in Jama Internal Medicine, senior patients who received an IVC filter after a pulmonary embolism had an increased risk of death compared with seniors who were hospitalized for a pulmonary embolism but did not receive the filter. When researchers adjusted for bias, the mortality risk more than doubled.
The study used Medicare data from patients aged 65 and older who were discharged from the hospital following a pulmonary embolism diagnosis. Between 2011 and 2014—the period included in the study—there were more than 214,000 patients who fit in this group. Of those, 13.4 percent received an IVC filter to prevent subsequent pulmonary embolisms.
Researchers found an increase in mortality at 30 days, although the significance of the difference varied depending on the statistical method used. Mortality at a year, however, showed a statistically significant increased risk for IVC patients no matter what type of analysis was used.
The most recent study seems to confirm findings from another study conducted in 2018 that also examined 30-day mortality in patients who received IVC filters. A major difference with this previous study is that it included patients in whom anticoagulation was contraindicated (meaning they could not use an anticoagulant for any of a variety of reasons), whereas the more recent study did not. The previous study also included all adult patients, not only those who were seniors. Researchers found that patients with venous thromboembolic disease and a contraindication to anticoagulation who were treated with an IVC filter had an increased risk of mortality at 30 days compared with patients who did not receive the filter.
“The most significant finding of this study of IVC filter use in patients with VTE and a contraindication to anticoagulation is that treatment with an IVC filter was associated with a higher 30-day mortality than treatment without IVC filter placement after adjustment for demographics, comorbidities, immortal times bias, and the propensity to receive a filter,” researchers wrote.
IVC Filter FDA Warning
In 2010, the US Food and Drug Administration (FDA) issued a warning about IVC filters, noting that it received more than 900 reports regarding adverse events linked to the devices and recommending the filters be removed as soon as the risk of pulmonary embolism had passed.
A study published in the Journal of Vascular Surgery Venous and Lymphatic Disorders in 2013 suggested that for patients who had only a temporary risk of a pulmonary embolism the ideal time to remove the filter was between 29 and 54 days of implantation.
Some—though not all—IVC filters are retrievable. In a 2016 evaluation of IVC filter types, researchers noted they had identified 14 retrievable and 9 permanent IVC filters. Those filters are also made in different styles, including conical, spiral, and complex. Retrievable filters are those used in patients who have a temporary risk of pulmonary embolisms, such as those who have been in a traumatic car accident, and for whom the risk of PE will pass shortly but cannot be given an anticoagulant.
Patients who have had the IVC filters implanted have filed lawsuits against the makers, alleging they were not adequately warned about the risks associated with using the devices. The IVC filter lawsuits argue the devices are prone to fracture, migration and other issues that increase the risk of serious, life-threatening complications.
If you or a loved one received an IVC filter and suffered harm as a result, you need an attorney who specializes in personal injury and medical device litigation. Our highly skilled lawyers are available to answer your questions and advise you of your rights. We’re experienced in fighting against large medical device companies and will not back down, which is how we’ve obtained more than $120 million for our clients. Contact us today to find out how we can help you build a strong claim to maximize your recovery.