IVC Filters: Manufacturers Ignored Reports of These Dangerous Medical Devices

As a defective product lawyer in Portland, I seek to inform individuals of potentially injurious (and even deadly) medical devices. IVC filters are one of those products and have caused dozens of deaths and hundreds of serious injuries in patients who have had them implanted.

Illustration of a blood clot

IVC filters are designted to prevent the damage caused by blood clots

An inferior vena cava filter (or IVC filter) is a metal device designed to entrap blood clots before they reach the lungs or the heart. It is implanted in the inferior vena cava, a large vein that runs vertically through the torso and returns circulated blood to the heart for oxygen. The filter device has a number of thin wire legs that serve to catch the clots. IVC filters are used in patients who are at risk for developing blood clots such as individuals with deep vein thrombosis. Whenever possible, these patients receive anticoagulant therapy. Some patients, however, cannot use anticoagulants and require an IVC filter. These filters have been implanted in millions of Americans and many are marketed as retrievable. If you have experienced complications from your IVC filter, you must call an experienced medical device lawyer.

Many of these devices are meant to be removed after the threat of a blood clot is over. These defective medical devices have harmed a number of patients. In 2010, the US Food and Drug Administration (FDA) issued a safety alert regarding IVC filters. They issued this alert as a result of the 921 reports they received about IVC filter events in the previous years. Adverse events involving IVC filters include:

  • Filter perforation – The IVC filter can cut through the inferior vena cava and possibly puncture internal organs.
  • Filter tilt – The IVC filter can tilt inside the patient’s vein and greatly diminish the filter’s retrievability.
  • Filter migration – The device can become displaced or move into another part of the body. This can prevent the filter from working properly and can damage organs.
  • Filter fracture – The thin metal legs of the device can break off.
  • Detached device components (device embolization) – The components can travel to the heart and lungs.
  • Difficulty removing the device - Devices that have fractured, shifted, or migrated may be difficult or even impossible to remove.

Medical devices frequently come with some inherent risks, however in the case of IVC filters, major manufacturer Bard neglected to notify physicians or the public after they discovered ongoing risks associated with their devices. Reports indicate that Bard was aware of the malfunctions as far back as 2002 but failed to take action. In addition, the FDA found that Bard had a number of quality system violations at their facilities. A June, 2015 letter from the FDA to Bard reported ongoing quality system violations as well as medical device reporting violations. Bard now faces hundreds of IVC filter lawsuits from individuals injured by the filters.

If you have had an IVC device inserted, please be aware of the potential side effects that may occur if your filter malfunctions. Side effects after perforation, fracture, or migration include severe chest pain, internal bleeding, blood clots, pulmonary embolism, and even death. If you experience any of these side effects, see a physician immediately.

Have you experienced an IVC filter malfunction? Our team of compassionate, experienced attorneys are ready and willing to stand by your side and represent you so that you can receive the compensation you deserve. Contact a medical device lawyer at Angel Law, P.C. online or call us at (503) 862-8666.

Categories: Defective Products