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High Usage Rates of IVC Filters Continue Despite FDA Safety Warning


JAMA Internal Medicine recently published an editorial regarding IVC filters and their continued use despite warnings indicating their defects and risks.

The U.S. Food and Drug Administration issued a Class II safety warning of Bard Recovery IVC filters in 2010, when the device's high fracture rate contributed to 921 adverse events being reported in less than five years.

Despite the FDA warning doctors to remove these retrievable IVC filters, more filters are never retrieved.  This increases the risk for patients as studies have suggested that the longer the filter is in the inferior vena cava, the higher it's chance of fracturing.

The editorial also explained the lack of evidence of the benefits of IVC filter usage. Studies indicate that many IVC filters are placed in patients who are able to take anticoagulants, which should be the first treatment for prevention of pulmonary embolism.

These defective IVC filters have also been used in other groups of patients for whom there is no evidence of benefit, such as prophylactic use prior to bariatric surgery.

The United States has a much higher rate of IVC filter usage than any other country, despite its definite harms. Experts suggest that the use of IVC filters should be prohibited until and unless there is evidence showing, "efficacy greater than risk."

To contact us about a potential defective medical device claim, call or text us at (888) 997-4110 or click here to complete an online intake form for a free consultation.

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