FDA Issues Safety Warning on “IVC Filter” Medical Devices

Amidst growing concern over safety issues with IVC filters, the Food and Drug Administration (FDA) has issued a warning recommending caution medical devices. IVC filters are surgically implanted into a patient’s inferior vena cava vein, which brings blood from the lower part of the body back to the heart. The small, cage-like filters are designed to stop blood clots before they enter the patient’s lungs, causing a pulmonary embolism.

For patients unable to successfully use blood-thinning medication, IVC filters were designed to be an alternative therapy. Patients may have either temporary retrievable (removable) filters or more permanent ones, depending on their personal health and risk factors.

Why Did The FDA Issues A Warning on IFC Devices?

The FDA has received many adverse reports associated with the filters, such as device migration, filter fracturing, punctured vena cava, difficult removal of retrievable filters, and even movement of the filter (in part or in whole) to the patient’s heart or lungs. In the five years between 2005 and 2010, the FDA received 921 such reports. IVC filters also increase risk of long-term effects including deep vein thrombosis and IVC blockage.

Due to these complications, the FDA first issued a safety warning in August 2010, and an updated communication in May 2014. The FDA experts recommended that medical professionals remove IVC filters “as soon as protection from is no longer needed.” Although each patient faces different risk factors with an IVC filter, the FDA advises all treating physicians to evaluate the risks and benefits of removing the filter when feasible.

Although hundreds of thousands of IVC filters have been implanted since the 1970s, questions still remain regarding their risk-to-benefit ratio.. The FDA is still researching, reviewing medical literature, and in the process of developing a final position on IVC filters. Although the FDA has not issued a recall on the devices, they still can pose very serious risks to patients at risk of pulmonary embolism.

Consult With An Ohio Defective Device Lawyer

If you or a loved one received an IVC filter and have experienced adverse effects, contact a medical professional as soon as possible. Once a physician has examined the situation, it would be wise to contact an experienced lawyer to decide your best course of action.