IVC Filter Removal Complications Can Be Reduced By Doctors Actively Monitoring Patients, Study Indicates
Over the past decade, there have been concerns about problems with IVC filter complications, after the small struts on many retrievable designs have been found to fracture or break off, or become embedded in the vena cava. However, new research suggests that if patients are closely monitored by their implanting physician, there is a greater likelihood of successful IVC filter removal.
In a new study, published on March 15 in JAMA Network Open, researchers from the University of Colorado found that when doctors maintained active surveillance over patients with inferior vena cava (IVC) filters, it increased the chances of successful removal from less than 50% to more than 60%.
IVC filters have been widely used among individuals at risk of experiencing a pulmonary embolism, who are unable to take anticoagulants or after those medications have failed.
The filters are small spider-like devices inserted into the vein to “catch” blood clots that may break free in the body. However, a number of designs have been plagued with problems, where the struts have punctured the vena cava, migrated out of position, or even fractured, sending small pieces into the lungs and heart, where they can cause life-threatening injuries.
Thousands of Bard IVC filter lawsuits and Cook IVC filter lawsuits have been filed in recent years, and the manufacturers of certain retrievable designs have agreed to pay millions in settlements to resolve claims involving alleged design defects.
Although many IVC filters were designed to be removable after the blood clot risk is reduced, many patients have been told the small filters are irretrievable, usually because they have migrated out of position or fractured. The researchers in this latest study warn this is a large contributor to future IVC filter problems, as the devices are left in over long periods of time. In addition, the filters were often left implanted because moving them posed a potential health risk to the patient.
As a result of the complications experienced by patients, the FDA and other health organizations have called for improved surveillance of patients with the filters, and this latest study sought to determine how effective such surveillance could be. In 2016 it became routine for the implanting physician to take responsibility for active surveillance, and IVC filter retrieval was assessed periodically.
Surveillance Effects on Successful IVC Filter Removal
The researchers conducted a retrospective cohort study involving 699 patients who received IVC filters between June 2011 and September 2019 at an academic care center. They looked at patients who did not receive active surveillance from 2011 to 2016, and patients who did receive active surveillance as per FDA recommendations, starting in 2016.
According to their findings, before active surveillance, only 48.7% of the patients were able to have their IVC filters successfully removed. After the new surveillance guidelines, successful IVC filter retrieval rates increased to 61.3%, the researchers determined.
Only 1.6% of the IVC filters in patients who received active surveillance needed to be left in permanently, the researchers found. That compared to 12.2% among patients who did not receive active surveillance.
“The findings of this cohort study suggest that active surveillance by implanting physicians is associated with improved inferior vena cava filter retrieval,” the researchers concluded. “These findings support encouraging physicians who implant the filter to take primary responsibility for tracking and retrieval.”
Increasing IVC Filter Problems
The findings come just a couple months after a study posted in JAMA Internal Medicine found that reported IVC filter problems are increasing annually.
According to the findings, there were 9,311 adverse events linked to IVC filters from 2016 to 2020. However, during that time, the number of reports went from 1,020 reports in 2016, to 2,842 adverse events in 2020; representing an increase of more than 25% every year.
The researchers determined that 64% of the reports were due to patient injuries, nearly 32% were due to device malfunctions, and four percent, or 377 reports, involved patient deaths.
Their findings suggested the increases are coming as the devices age, fracture and migrate over time, increasing the importance of removing the IVC filters successfully when they are no longer needed or pose a risk to the patient.
2023 Bard IVC Filter Lawsuit Update
At the litigation’s peak, C.R. Bard faced more than 8,000 product liability lawsuits over retrievable IVC filters fracturing or breaking, each involving similar allegations that plaintiffs suffered painful and potentially complications when the small devices moved out of position, punctured internal organs or fractured, causing small pieces to travel throughout the body.
Given common questions of fact and law involved in the litigation, claims filed throughout the federal court system had been centralized in the District of Arizona since 2015, where U.S. District Judge David G. Campbell presided over coordinated discovery and pretrial proceedings as part of an MDL, or multidistrict litigation.
Following a series of early “bellwether” trials before Judge Campbell, which were designed to help parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the claims, including one trial which resulted in a $3.6 million verdict and two other claims that resulted in defense verdicts, individual IVC filter settlements were reached to resolve the vast majority of the claims.
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