In a recent study published in Circulation, an online journal, researchers at UC Davis Health System have found that the use of inferior vena cava (IVC) filters may benefit a small portion of the patients who receive them, but can also increase the risk of more blood clots.
“If a filter is used, I recommend removing it as soon as possible to help reduce the possibility of additional clots forming,” said Richard White, lead author and chief of general medicine and medical director of the anticoagulation service at UC Davis. “Decisions about the use of IVC filters have so far not been driven by good science, primarily because there have been only two very small clinical trials that studied them.” White added, “Our results will help physicians know when a filter may be helpful and when it should not be considered.”
The high failure rate of IVC filters has resulted in hundreds of lawsuits against medical device manufacturers such as Rex Medical and Argon Medical Devices, the makers of the Option filter.
The Option filter gained its FDA approval through a 510(k) application. This process allows a medical device to be sold on the market without clinical trials as long as the device is equivalent to a device that has been previously approved by the U.S. Food and Drug Administration (FDA).
Unfortunately, the comparable device is the Recovery filter and the G2, both made by C.R. Bard. The Recovery filter has been linked to at least 27 deaths and hundreds of non-fatal injuries, and was removed from the market in 2005. The G2 was intended to be the Recovery’s replacement, but has proven to be just as flawed. Both filters have shown significantly high failure rates, with more than 900 lawsuits currently pending against C.R. Bard as a result.