IVC filters can be lifesavers for certain patients. These small, metal medical devices are used to prevent blood clots from getting into the lungs or heart, where they can cause fatal incidents, in patients who have been injured or had surgery. These types of patients are at a greater risk for developing life-threatening blood clots and blood thinners are not always the best defense. Sometimes an implanted filter is a better option.
The downside to these filters is that they can cause serious complications. Certain brands made by some medical device manufacturers have been found to fail more often than others. A filter that fails can come loose and migrate to another part of the body, perforate organs, pierce blood vessels, and cause serious injuries. If you have been hurt by an IVC filter, you may have a case for a successful lawsuit.
What Is an IVC Filter?
An IVC filter is a small device that can be implanted in the largest vein in the body to filter out and trap blood clots from blood flowing through the vein. IVC stands for inferior vena cava, the name of the vein in which the device is implanted. The first modern IVC filter was made in 1973 by Greenfield. It was a small cone-shaped device deigned to be implanted with the narrower end downstream of blood flow in the vein to catch and trap clots.
The first Greenfield filter was implanted in a patient in 1973 and since then the use of IVC filters has exploded. Hundreds of thousands of patients get these devices implanted each year. The design has evolved over the years, but essentially retained the same conical shape and size. Many different companies manufacture and sell filters.
When Are They Used?
IVC filters are used to trap blood clots and are implanted in patients who are vulnerable to forming these clots. Those most susceptible to clot formation are people who are having surgery or who have been injured in an accident. Blood thinners are used to prevent clot formation in these patients, but a filter may be used in someone who either can’t be given blood thinners or for whom the medication is not enough to prevent clots.
The Dangers of Blood Clots
Clotting of the blood is a natural process that protects us from bleeding to death. However, when clots form in the blood stream they can migrate to the lungs, heart, or brain and cause serious damage or death. Clot formation is especially likely and problematic after surgery and after an accident.
Blood clots typically form in the legs, arms, or in the pelvis, where they are harmless. This is called a deep vein thrombosis, or DVT. DVTs can move through the bloodstream and enter the lungs or heart and cause blockages. In the lungs a blood clot that causes a blockage is called a pulmonary embolism, which is often fatal. The Centers for Disease Control and Prevention states that between 60,000 and 100,000 people die from a pulmonary embolism every year. DVTs may also enter the heart and cause a blockage and a heart attack.
How IVC Filters Work
IVC filters are designed to be placed in the inferior vena cava, the largest vein in the body. This vein carries blood from the legs to the heart and lungs. Because most clots form in the legs or pelvis area, the filter is situated to trap and collect any that form there and move up towards the lungs or heart. The device is implanted in the IVC just below the kidneys.
The shape of the filter is conical. The narrow end points downstream of blood flow through the vein so that all blood must move through the filter at that narrow end. Most blood passes right through, but any clots are trapped in the device. There the clot will sit until natural components in the blood, anticoagulants, break it down.
Types of IVC Filters
There are two main types of IVC filters: those that are permanent and those that are retrievable. Early filters were designed to be permanent. They are implanted into the IVC and left there indefinitely. A retrievable filter can be removed later if it is not deemed necessary anymore.
Some retrievable filters may be used on a more permanent basis too, which gives doctors the option to decide to leave it in or remove it later, although this may carry certain risks. Retrievable filters are more commonly used prophylactically in patients who have no history of DVTs, but who are at risk for them because of surgery or an injury.
Complications and FDA Warnings
Having any type of surgery carries risks, such as excessive bleeding, infections, or a bad reaction to the anesthesia. With an IVC filter there are additional and specific risks. It is possible that a clot could bypass a filter and cause problems. A filter may cause damage to the vein, including perforating it. The filter could come loose or shift position after being inserted. If the filter comes loose and moves through the vein, it could cause damage to other parts of the body and organs.
The U.S. Food and Drug Administration (FDA) issued a safety warning in 2010 that stated the organization had received 921 reports of adverse events with filters since 2005. These included the filter coming loose and migrating, perforation of the inferior vena cava, and broken filters. The FDA also stated that some of these problems occurred with retrievable filters that were not removed when they should have been, that is after the risk of clot formation had passed. Currently the FDA recommends that filters be removed when the risk of clots is over, but is still reviewing the safety concerns.
In 2014, after further study and analysis, the FDA again issued the warning about risks and the continued recommendation that retrievable filters be removed as soon as is possible after the risk has passed. In addition to the risks stated in the 2010 warning, the FDA also concluded that long-term implantation of the device can actually cause DVT or blockage of the inferior vena cava.
In response to the FDA warnings, several manufacturers of IVC filters have voluntarily began a long-term and large-scale study of the safety and effectiveness of the devices. The study is called the PRESERVE study and is specifically looking at the possibility that the devices can break or migrate while implanted in the vein.
Filter Brands Prone to Fail
There are a couple of manufacturers of IVC filters that have seen specific problems with some of their devices. These include Cook Medical, whose Celect filters were found in a study to cause vein perforation at a greater rate than other filters. C.R. Bard is another company whose filters have caused issues. Bard received a warning letter from the FDA in 2015 stating that the company was marketing an unapproved product or a product that had been significantly altered since being approved. Reports also indicate that several of Bard’s IVC filter devices break more often than others.
Broken, shifting, or failed IVC filters, or those that have not been removed when the risk of clot formation had passed, can cause serious damage and long-term health consequences. If you have had a filter implanted that caused any kind of health problems, you may be able to join the many people who have already filed lawsuits against the manufacturers. Several of these have been found to have marketed and sold devices that were prone to fail. Surgeons who did not remove devices that should have been retrieved may also be susceptible to lawsuits when patients suffer the consequences of long-term implants.