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The FDA Updates IVC Filter Health Risk Warning

The FDA Updates IVC Filter Health Risk Warning

Inferior vena cava (IVC) filters have drawn heavy criticism and numerous lawsuits by patients who claim to have incurred injuries due device failure, manufacturer negligence, defective design, and misrepresentation. The U.S. Food and Drug Administration (FDA) has updated its communication warning of these potential health risks and has stated that IVC filters should generally not be kept in use after the threat of a pulmonary embolism passes. These filters have been used by thousands of patients who have a high likelihood of blood clotting but are unable to take anticoagulant drugs or for which drugs are ineffective.

How Do IVC Filters Work?

The IVC filter is inserted into the inferior vena cava, the largest artery in the body, responsible for transporting de-oxygenated blood from the lower body through the heart and to the lungs. A pulmonary embolism occurs when this artery becomes blocked. Symptoms can include difficulty breathing, chest pains, or even death. Once inserted, the device “traps” blood clots and holds them until they dissipate.

The device is intended to stop clots before a blockage can reach the heart, however, in many cases, these filters have not been working as intended and have led to further complications. Although IVC filters meant for permanent use do exist, the risks outlined by the FDA and lawsuits from injured patients refer to newer devices which are manufactured for temporary use and retrieval.

Risks of IVC filters

The risks and potential complications presented by IVC filters have been recognized for several years. The FDA reported receiving 920 complaints between 2005 and 2010 detailing the adverse health effects experienced by patients using IVC filters. The FDA report also noted many cases of doctors leaving IVC devices in use for longer periods of time than recommended.

The types of events reported include:

  1. Device migration: Among the most numerous events reported, migration occurs when the device wrongly detaches itself from its position in the vein. Migration can cause serious complications if the device blocks flood flow or enters critical areas such as the heart.
  2. Perforation: The bodily functions such as blood flow can wear down and erode parts of an IVC filter, leading to the puncture, or perforation, of the patient’s inferior vena cava. The risk of perforation may increase over time.
  3. Filter fractures: IVC devices can break, fracturing into multiple pieces while still within the body. Small pieces of the device can then migrate to other parts of the circulatory system. Fractured IVC filters can also be extremely difficult to retrieve.

Lawyers Representing Victims of IVC Filters

More than 100 lawsuits have been filed against the makers of these medical devices since 2012, with additional litigation pending. If you have suffered an injury due to the insertion of a retrievable or defective medical device, do not hesitate to contact Kaiser Gornick, LLP. Our IVC Filter Lawyers have an in-depth knowledge of product liability litigation in the U.S and can help you to hold manufacturers responsible when defective products cause injury.

Call (855) 534-0061 to schedule a free consultation with our firm today.

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