Deep vein thrombosis (DVT) is a serious and potentially life-threatening medical condition that can cause blood clots from other parts of your body to enter your lungs. The most common place for blood clots to develop is in the legs.
Once a blood clot forms, it can break off from its point of origin and travel through your bloodstream to your lungs or sometimes your heart. You could have a pulmonary embolism if the blood clot travels to the lungs and interferes with blood vessels. Shortness of breath and chest pain are the most common symptoms of a pulmonary embolism. It can also cause sudden death. If a blood clot reaches your heart, you could experience a serious cardiovascular event such as heart failure or a heart attack.
Inferior Vena Cava Filter and the Treatment of Blood Clots
One of the leading ways to treat DVT and other health conditions that cause dangerous blood clots is with inferior vena cava filter placement. Commonly known as an IVC filter, surgeons insert the medical device in your body’s large vein using a minimally invasive technique and creating a small incision. The name of this vein is inferior vena cava. The IVC filter is a small medical device constructed from metal that traps large blood clots before they can travel to your heart or lungs. Your large vein runs through your stomach and delivers blood from the lower portion of your body to your heart.
Healthcare professionals typically require patients to try blood thinners called anticoagulants before they become a serious candidate for an IVC filter. Anticoagulants come in the form of oral tablets or injections. However, not everyone can tolerate anticoagulation drugs. The inability to take anticoagulants is especially common in people with certain medical conditions that can worsen due to anticoagulant medication. Here are the most typical health conditions in addition to DVT for which doctors recommend IVC filter placement:
- Brain bleed from an accident or fall
- Digestive tract bleeding caused by inflammatory bowel disease, tumors, ulcers, or one of several other causes
- Hemodynamic instability, also known as poor circulation
- Hemorrhagic stroke
- Malignant hypertension, another term for extremely high blood pressure
- Mobile thrombosis, which describes the process of blood clots that move from one location to another in your body
- Pregnancy complications
- Recent injury to the brain, eye, or spinal cord
- Serious injury of the spinal cord or other organs since this can increase the risk of pulmonary embolism due to blood clots
Your doctor will not recommend IVC filter placement if you can tolerate anticoagulant medication to prevent blood clots. You also should not receive an IVC filter if you have any of these issues:
- Abnormal or excessive blood clotting issues
- Bacteria in your blood that causes sepsis, a dangerous medical condition that develops due to the way your body responds to an infection
- Current or previous blood clot that blocks the entirety of your vena cava vein
- Your inferior vena cava vein is too small to insert an IVC filter
The surgical procedure for IVC filter placement takes approximately one hour in an outpatient setting. Like any surgery, IVC filter placement comes with some risks. The most common ones include:
- Blockage of normal blood flow: IVC filter placement can prevent or slow blood flow within the inferior vena cava and cause significant leg swelling.
- Excessive bleeding in the large vein where a surgeon places the IVC filter.
- Increased risk of DVT even if the IVC filter prevents a pulmonary embolism.
- IVC filter breaks or moves to your heart or lungs, causing injury or increasing the risk of death. This also requires a second surgery to remove the IVC filter.
- IVC filter pierces the walls of the inferior vena cava and causes damage to nearby organs.
- Placing the IVC filter in the wrong vein or inserting it from an awkward angle could mean a repeat surgery.
- Risk of infection.
It is important to weigh your potential benefits against the potential risks of IVC filter placement with your healthcare provider before agreeing to this surgery.
Information Released by the FDA About IVC Filters
The Food and Drug Administration (FDA) approved the IVC filter in 1979. Most surgeons implanted permanent IVC filters originally, but their use dropped off in favor of retrievable IVC filters. Although surgeons place a retrievable or removable IVC filter with the intention of eventually taking it out, that does not always happen due to lack of patient follow-up. Even retrievable IVC filters can be difficult to remove when they become imbedded in the body’s large vein.
The FDA issued warnings about IVC filter placement and IVC filter removal in 2010 and 2014 stating that IVC filters placed for the short-term treatment of pulmonary embolism prevention often remain inside of patients’ bodies for years. After its two warnings, the FDA began to recommend that surgeons remove retrievable IVC filters once the risk of the patient developing a pulmonary embolism passes. The typical timeframe is 29 to 54 days. When retrievable IVC filters remain implanted past that time, their risk likely outweighs any benefit.
By 2016, the Seminars in Interventional Radiology estimated that surgeons had completed nearly 260,000 IVC filter placements since the FDA approved the medical device. The same year, the American College of Cardiology published a study stating that doctors were over-using IVC filters and not completing retrieval and patient follow-up as expected. The American College of Cardiology study also stated that doctors in the United States opt for IVC filter placement at a rate 25 times higher than doctors in Europe.
Lawsuits Against IVC Filter Manufacturers
According to the Consumer Safety Division, more than 17,000 people had filed a lawsuit against C.R. Bard, Boston Scientific, and other makers of this medical device for failing to warn them about these potentially serious consequences of IVC filter implantation or removal:
- Blood vessel perforation
- Deep vein thrombosis of the lower limbs
- Difficulty removing the medical device
- Device migration
- Inferior vena cava occlusion
- IVC filter fracture