An inferior vena cava filter, also known as an IVC filter, is a small, metal device designed to stop a blood clot from traveling to the lungs and causing a pulmonary embolism. A pulmonary embolism is a potentially fatal blockage in an artery that carries blood from the heart to the lungs. Doctors surgically implant the cage-like device into the largest vein in the body, known as the inferior vena cava. IVC filters are designed to trap clots, but they have the potential to move in the body and cause serious complications.
If you've suffered from a fractured filter, device migration, perforation or other complication, you may be eligible for compensation.
IVC filters help people recovering from accidents and surgeries by preventing potentially fatal lung clots. Doctors insert the temporary or permanent device into a patient’s inferior vena cava, the main vein in the body that returns blood from the lower body back to the heart. The device resembles a metal cage, and when blood clots form in the legs, known as deep vein thrombosis, the filters catch the clots when they break away and travel towards the heart. IVC filters are commonly placed in people who are at risk for pulmonary embolism when anticoagulants (blood thinners) are ineffective or not an option. The filters are designed to be permanent implants but some can be removed.
The U.S. Food and Drug Administration (FDA) approved the device in 1979, and its use has increased continuously through the years. By 2012, doctors inserted about 259,000 filters in patients, according to a 2016 study in Seminars in Interventional Radiology.
A 2016 analysis published by the American College of Cardiology found IVC filters were likely being over-used. The author concluded that “retrieval rates are low and information regarding appropriate use and surveillance are lacking.”
In 2010 and again in 2014, the FDA released safety communications in which the agency warned of adverse events and product problems associated with IVC filters, including device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, difficulty removing the device, lower limb deep vein thrombosis and IVC occlusion.
“The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.”
The agency recommends doctors consider removing retrievable IVC filters as soon as protection from pulmonary embolism is no longer needed. “For patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided,” the agency said. The FDA recommends retrievable devices be removed between the 29th and 54th days after implantation in patients in which the risk of pulmonary embolism subsided.
The inferior vena cava is the largest vein in the body. It moves de-oxygenated blood from the lower legs to the heart and then to the lungs. Doctors implant an IVC filter in the vein to prevent blood clots from traveling through the vein into the lungs.
Using a catheter, or a thin tube, a doctor inserts the device into a patient’s inferior vena cava through a small incision in the neck or groin. The device’s metal wires capture and trap blood clots before they can reach the lungs.
It usually takes a couple of days for a patient to recover from IVC filter placement.
Some filters are permanent, and some are retrievable or temporary. Doctors remove retrievable filters in a similar way that they implant them. Health care providers inject contrast or X-ray dye around the device to make sure it is safe to proceed with the removal. A catheter-like snare goes into the vein and grabs the hook located at the end of the filter. A sheath covers the filter, and the doctor pulls the device out of the vein.
There are two types of IVC filters: permanent and optional (retrievable). Retrievable filters are intended for short-term use but provide the option either for long-term use or for removal when there is no longer a risk for pulmonary embolism. Permanent IVC filters, on the other hand, are designed only for long-term use.
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. The study’s authors identified 383 patients in whom retrievable filters were left in place and compared them with patients with permanent filters. Both thrombotic (blood clot-related) and device-related complications were more common with retrievable filters.
Blood clots that develop deep inside the pelvis and the lower and upper extremities are referred to as deep vein thrombosis, or DVTs.
DVTs are not typically life-threatening, but they can cause death when they travel to the lungs and produce pulmonary embolisms, or clots that block normal blood flow in the lungs. These embolisms cause about 300,000 deaths every year. It is the third-most-common cause of death in hospital patients.
People who had recurrent DVTs while on anticoagulation (blood-thinning) medication and/or people who can’t tolerate or consume anticoagulation because of an adverse reaction or bleeding make good candidates for IVC filters. Doctors may also recommend IVC filters in patients who suffer serious trauma or undergo surgery because the risk of blood clots is elevated.
IVC filters have the potential to migrate away from their surgically positioned location, rendering them ineffective. Sometimes the device itself punctures a vein, causing bleeding and other complications. Broken pieces of filters can travel through the blood and lodge in other organs, such as the heart. Retrievable filters in particular are associated with potential risks, like damaging veins and failing to stop blood clots from bypassing the device.
Between 2005 and 2010, the FDA received 921 device adverse event reports involving IVC filters. About 328 reports involved device migration, 146 involved embolizations, 70 involved perforation of the IVC, and 56 involved filter fracture. Some of the reported events resulted in adverse clinical outcomes in patients. The agency concluded the adverse events could have been related to a retrievable filter remaining in the body after the risk for pulmonary embolism had subsided. It recommended removing retrievable devices within 54 days after implantation if the risk has diminished.
The FDA has also required the collection of additional for currently marketed IVC filters in the U.S. The studies address safety questions that remain unanswered for both permanent and retrievable filters, according to the agency. Manufacturers were given two options for collecting the data: the PRESERVE study or postmarket surveillance. PRESERVE stands for PREdicting the Safety and Effectiveness of InferioR VEna Cava Filters and is an independent national clinical study that will examine the use of IVC filters in the prevention of pulmonary embolism. Postmarket surveillance will involve 522 studies.
“The data gathered from the PRESERVE study and the 522 studies will help the FDA, manufacturers and health care professionals assess the use and safety profile of these devices, understand evolving patterns of clinical use of IVC filters, with the goal of ultimately improving IVC filter utilization and patient care,” the FDA said, according to a 2016 study in Seminars in Interventional Radiology.
Manufacturers issued six major IVC filter recalls between 2005 and 2015. The recalls affected more than 81,000 units. Most were for packaging and labeling issues.
There have been no major IVC filter recalls since 2015. Thousands of people have reported IVC filter complications. But companies have not recalled some of the most problematic devices.
A 2015 NBC News investigation linked Bard Recovery and G2 IVC filters to 39 deaths. The company never recalled either device. Instead, it replaced them with similar models.
Cook Medical IVC filters also face blame for injuries and deaths. The FDA has received hundreds of reports on Cook Celect and Gunther Tulip problems. But the company never issued recalls for either.
Thousands of people who suffered injuries have filed IVC filter lawsuits.
Research studies have confirmed problems with retrievable IVC filters. A 2013 study in the Journal of the American Medical Association (JAMA) looked at the filter’s failure rate. Researchers discovered doctors only removed 58 out of 679 retrievable IVC filters. When the filters remained in patients longer than medically necessary, 18.3 percent of attempts to remove the filters failed, 7.8 percent of patients had venous thrombotic events and 25 patients suffered pulmonary embolisms.
The Recovery filter was C. R. Bard’s first-generation product introduced in 2003. A second-generation device, the Bard G2, arrived in 2005 as a replacement for the Recovery. But before Bard replaced the Recovery, the FDA received 300 reports of adverse events linked to the device. Results from one study showed about 25 percent of the Recovery filters failed, causing the device to fracture or break apart. One patient died at home, although the study did not explain the reason. An investigation by NBC News linked the device to at least 27 deaths.
The Bard G2 had a 12 percent failure rate and remained on the market a shorter amount of time than its predecessor. Bard stopped selling the Recovery when the G2 arrived on the market in 2005. The G2’s successor, the G2 Express, entered the market in 2008. One study found all of Bard’s devices experienced a combined 12 percent fracture rate.
Another study found both of Cook Medical’s filters, the Gunther Tulip and the Celect, had histories of perforating patients’ vena cava wall. The perforation often occurred within 71 days of implantation, and the filters migrated out of place in 40 percent of patients.
A 2017 study found that use of IVC filters experienced a “significant decline” after the FDA’s 2010 safety warning.
Researchers at Washington University School of Medicine in St. Louis looked at more than 1 million patient records covering a 10 year period. They saw IVC filter use rising by more than 22 percent between 2005 and 2010. But use dropped dramatically after the FDA advisory, falling more than 25 percent by 2014.
At their peak, nearly 130,000 IVC filters were placed in patients in 2010. By 2014, the number had dropped to around 96,000.
A 2018 study found an association between IVC filters and increased death risk. The study looked at 126,000 patients’ medical records. It found the risk of dying within 30 days of getting an IVC filter shot up 18 percent for certain patients. Those at risk had two specific conditions. They had venous thromboembolic (VTE) disease and they could not take blood thinners. VTE includes deep vein thrombosis, pulmonary embolism or both.
The researchers called for randomized clinical trials to better test the filters’ safety and effectiveness. Their work appeared in JAMA Network Open.
IVC Filters should only be used in patients with acute blood clots who can’t take anticoagulants (blood thinners). If these filters are implanted for other indications it should be after much consideration and accompanied by appropriate documentation, experts say. For patients who are not good candidates for IVC filters, doctors may instead recommend blood thinners or lifestyle changes.
The most widely used blood thinner is warfarin, followed by novel oral anticoagulants like Xarelto, Pradaxa and Eliquis. Blood thinners carry risks for side effects like uncontrollable bleeding, and in most cases, patients who begin blood thinners must take them for the rest of their lives.
Changes in lifestyle may also prevent a person’s likelihood of developing blood clots. People should avoid smoking, high-sodium diets and things that cause high amounts of stress. Treating conditions like high blood pressure, high cholesterol or an overactive thyroid can also decrease blood clot risks.
Please seek the advice of a medical professional before making health care decisions.
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