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Inferior vena cava filters help people recovering from accidents and surgeries by preventing potentially fatal lung clots. The temporary or permanent devices are inserted into the largest vein in the body and trap clots. Unfortunately the devices are linked to a number of complications like vein and organ perforation, migration and breakage that can injure patients.
A retrievable inferior vena cava filter (IVC filter) is a small, metal device designed to stop a blood clot from traveling to the lungs, known as a pulmonary embolism. When deep vein thrombosis — a blood clot in the legs — develops, the filters catch them. The device resembles a metal cage. Doctors insert the device into a patient’s inferior vena cava, the vein that takes blood back to the heart and lungs. People who cannot take anticoagulants are more likely to receive a filter.
The FDA approved the device in 1979, and its use increased continuously through the years. By 2012, doctors inserted approximately 259,000 filters in patients. The two major companies that manufacture these filters are C.R. Bard and Cook Medical.
Unfortunately studies and FDA reports link the devices to a number of complications such as vein and organ perforation, migration and breakage that can injure patients. These injuries led some patient to file lawsuits against device manufacturers.
The most popular brands of devices include
Blood clots that develop deep inside the pelvis, lower and upper extremities are referred to as deep vein thrombosis, or DVTs. DVTs do not usually threaten life. However, they can cause death when they travel to the lungs and cut off normal blood flow to a person’s lungs. Pulmonary embolisms (PE) are clots that block the lungs. These embolisms cause about 300,000 deaths every year. It is the third-most common cause of death in hospital patients.
Some IVC filters designed to stave off the traveling of blood clots work better than others. Some filters even migrate away from their surgically positioned location, rendering them ineffective. Sometimes the device itself punctures a vein, causing bleeding and other complications. IVC filter embolization occurs when the filter breaks and pieces travel in the blood and lodge in other organs, such as the heart.
Surgeons place the filters with the best intentions but keep an eye out for issues that can stem from filter procedures.
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 the lungs. To prevent blood clots from traveling through the vein into the lungs, doctors implant an IVC filter in the vein.
A doctor inserts the device using a catheter — a thin tube — 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.
Some filters are permanent, and some are retrievable or temporary. Doctors remove retrievable filters in a similar way that they implant them. Healthcare 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 , or retrievable.
Retrievable filters provide short-term protection. Manufacturers designed them for removal from a patient’s body when there is no longer a risk for PE. Unfortunately, retrievable filters can cause complications like blood vessel and organ perforation and filter migration.
Good candidates for filter implantation:
After people suffer serious injuries or undergo surgery, the risk of blood clots is elevated. Doctors use IVC filters to prevent blood clots in people who cannot take blood thinners. For instance, people who just had surgery or traumatic injury might not be candidates for these drugs because there is a risk of uncontrolled bleeds with these medications.
Here are some cases in which doctors might recommend using an IVC filter:
Retrievable filters are associated with potential risks, like damaging veins and failing to stop blood clots from bypassing the device. Serious complications can occur because of the implanted filters, like when a device breaks apart and travels to another area of the body.
In 2010, the U.S. Food and Drug Administration announced a safety alert regarding retrievable IVC filters. The FDA received 921 reports of adverse events from 2005-10. Events involved:
A majority of the adverse events (35 percent) involved device migration. Migration occurs when filters move away from their intended location. The FDA listed embolization as the second most frequently reported complication.
Retrievable IVC filters are only intended for short-term placement. However, the FDA reported concern about the devices staying in patients long after PE risks subsided. The FDA updated safety communication in 2014, recommending retrievable devices be removed between the 29th and 54th day after implantation in patients in which PE subsided.
Research studies 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:
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 NBC News investigation 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.
Patients should talk to their health care provider about the type of IVC filter they will be receiving or already received. They should discuss the benefits and risks of the different types and brands of filters.
IVC Filters should only be used in patients who can’t take anticoagulants (blood thinners) or other treatments. 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 life.
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.
IVC Filter implants can lead to serious complications including punctured veins and migrated devices. If you or your loved ones were harmed by an IVC filter, you may have legal options. Tell us about your experience and we will provide you with a free case review.