Prescribing Information for IVC Filters

What Potential Patients Should Know About IVC Filters

First approved by the U.S. Food and Drug Administration in the 1970s, IVC filters are implantable medical devices used to prevent complications caused by various types of blood clots. Inserted into the inferior vena cava—the longest vein in the body—IVC filters are an extremely popular anti-clotting treatment in the United States, with doctors implanting as many as 250,000 IVC filters each year.

However, IVC filters aren’t for everyone. In fact, for some patients, the risks associated with IVC filters outweigh the risks. If your doctor recently recommended an IVC filter, here’s what you should know before scheduling your surgery.

IVC Filter Patients

IVC filters aren’t suitable for everyone. For most patients, anticoagulants are still the first line of defense against blood clots and their complications, including strokes, pulmonary embolism (blood clots in the lungs), and deep vein thrombosis (blood clots in the legs).

However, for trauma patients and extremely overweight patients who are preparing to undergo surgery, IVC filters may help. The implantable devices are also used by patients who are unable to take traditional blood-thinning medications or for whom anticoagulants proved ineffective.

How Does an IVC Filter Work?

An IVC filter is a small metal device that looks a bit like a cage made of wiry spider’s legs. The purpose of an IVC filter is to catch blood clots before they make their way to the brain, causing a stroke; or the lungs, where they can cause a pulmonary embolism. Doctors laparoscopically insert the IVC filter into a small incision in the neck or groin, and thread it into the inferior vena cava. The longest vein in the body, the inferior vena cava carries de-oxygenated blood from the lower body and lower torso to the right side of the heart. Once the IVC filter is placed in the inferior vena cava, the wiry pieces catch any blood clots that flow by.

Permanent vs. Retrievable IVC Filters

There are two types of IVC filters available in the United States, and which type your doctor chooses can be a deciding factor in whether you’ll experience serious side effects and complications.

Permanent IVC filters, approved by the U.S. Food and Drug Administration (FDA) in the 1970s, have a sturdy design befitting a device that’s intended to be left in the body indefinitely. The FDA also approved retrievable IVC filters in the 1990s, and these temporary devices are the most widely used. However, permanent IVC filters offer real benefits over their newer and more popular retrievable counterparts. For example, the most serious side effects associated with IVC filters—breakage and particle migration—are problems that are primarily reported by people with retrievable versions of the device.

IVC Filter Side Effects and Complications

Patients can experience IVC filter side effects while the device is being implanted; while the device is in place; or during a removal procedure. Breakage and migration are the most serious side effects associated with retrievable IVC filters. When the wire “legs” break free of the device, they can travel to other parts of the body, puncturing organs and causing infections along the way. A fractured or poorly positioned IVC filter can also promote the formation of blood clots.

Additional side effects and complications include:

  • Bleeding or bruising at the laparoscopic site
  • Punctured blood vessels
  • Incorrect placement of the device
  • Deep vein thrombosis
  • Swollen extremities
  • Insertion site infection
  • Narrowing or obstruction of the inferior vena cava, resulting in slower blood flow
  • Air embolisms
  • Hemorrhagic pericardial effusion, or excess fluid around the heart

According to the FDA, many of these side effects can be avoided or mitigated by having the retrievable IVC filter removed no later than 54 days after implantation.

Are You Considering an IVC Filter Lawsuit?

Did you experience serious side effects and complications due to an IVC filter that broke apart or migrated? If so, you may be able to seek compensation from the device’s manufacturer. Contact McGartland Law today to set up an appointment for a free initial consultation to discuss your IVC filter case.