For the last 10 years, product liability lawyers have represented clients around the US who have suffered from IVC filter blood clot problems and other complications. Although these devices are implanted to the cut the risk of pulmonary embolism, there can be many problems with the devices that can lead to deadly complications.
Even though there are serious concerns about blood clot filter safety and also questions about how effective they are, the products continue to be used.
In the last few years, the majority of IVC filters that are implanted are supposed to be retrieved eventually; the device can be removed once the risk of blood clot has lessened. However, because of inadequate warnings that many device manufacturers provide, the devices may be kept in the body longer than medically necessary, which can boost the chances of injury.
The most common side effects of blood clot filters include these:
- Fracture or migration of the filter
- Perforation of the lung, heart, vena cava or other tissue of the body
- Cardiac or pericardial tamponade
- Ventrical tachycardia
- Shortness of breath
- Chest pain
Blot Clot Filter Warnings from FDA
FDA has issued several warnings over the years about IVC blood clot filters; the first safety recommendation about them was issued by FDA in 2010.
At the time, FDA warned from 2005-10, over 900 adverse event reports were sent to FDA about blood clot filters. There were 328 reports of migration of the filter; 145 reports of embolization or detachment; 70 reports where the vena cava was perforated; and 55 reports of device fracture.
FDA stated that IVC filter usage has increased dramatically in the last 30 years; in 1979, only 2000 of the devices were used. In 2007, that had increased to 167,000. Approximately 259,000 were used in 2012.
FDA added that it is concerned that retrievable IVC filters are not always being removed once the risk of pulmonary embolism has reduced.
Still, manufacturers are continuing to promote IVC devices without enough warnings and instructions, and more and more doctors are implanting blood clot filters.
In May 2014, FDA issued yet another safety warning to doctors. It stressed that blood clot filters should be removed as soon as they are not needed anymore.
FDA stated this time that it had received many adverse event reports that are associated with the devices, including device migration, filter fracture, embolization, perforation and difficulty removing the device.
It stated again that many of the complications can be avoided if the blood clot filter is taken out once there is little risk of PE. FDA stated that it is concerned that the devices are not always removed when they should be.
Blood Clot Filter Effectiveness Questioned
Some experts have questioned if retrievable IVC filters truly reduce the risk of PE. Some studies indicate the such devices are used too much, and that many patients are no better off with an IVC filter rather than a blood thinner.
According to a September 2010 study in the Archives of Internal Medicine, about half of all blood clot filter surgeries may not bee needed. After it went over data on 1500 who were at risk for a blood clot going to the lungs, researchers determined that about 50% of those who had a blood clot filter were actually in need of it.
In March 2013, two clinical studies were published in JAMA Internal Medicine that indicated that there was not enough evidence for the usefulness of blood clot filter. Also, the journal suggested that there was a lack of data to such a degree that there was not a consensus on how the devices should even be used.
Another study published in 2015 questioned if blood clot filters should usually be used over anticoagulants in the first place. French scientists found that people who got a blood clot filter could be twice as likely to have a pulmonary embolism as those who just got a blood thinner. Of 200 people who received the device, six had a PE within 90 days. And three patients had part of the filter break off and go into the lungs or heart.
About Blood Clot Filters Overall
The inferior vena cava is the biggest vein in your body. It is the path used for used, oxygen poor blood goes from the body to the heart’s right side, where it is pumped to the lungs to receive oxygen. After it goes to the lungs and gets oxygen, it goes back to the left side of your heart and it is pumped yet again to provide oxygen to the body.
People who have serious medical conditions including deep vein thrombosis (DVT) and other serious clotting problems could develop blood clots that can break up and go into the lungs. A blood clot that gets into the lungs can kill.
Many patients with this disorder use blood thinners, but some people cannot deal with the side effects. Blood clot filters are made to be put into the inferior vena cava and to catch blood clots that have formed and get loose in the blood.
More About Pulmonary Embolisms
Blood clots can form in the body for many reasons, including deep vein thrombosis as mentioned earlier. Some of the factors that can increase the risk of DVT are:
- History of embolisms in your family
- Leg or hip fractures
- Genetic blood clotting issues
- Heart attack or stroke history
- Major surgery
- Sedentary life
The symptoms that you will experience if you have a blood clot in the lungs depends upon where it is and its size. The most common symptom is being unable to breathe. This could happen either gradually or suddenly.
Some of the other symptoms of this problem are:
- Clammy and/or blue skin
- Chest pain that goes into the jaw, neck, arm and shoulder
- Heart arrhythmia
- Rapid breathing
- Rapid pulse
- Spitting up blood
Diagnosis of this problem can be difficult, which is especially true if you have another lung or heart problem, including high blood pressure or asthma.
Your doctor will likely do a chest X-ray and/or an ECG to see if you have suffered a PE. He also may do a CT scan or MRI in some cases.