Does the IVC Filter Produce More Harm Than Benefit?

April 21, 2016, 10:30AM. By Gordon Gibb

Washington, DCIt’s little wonder that IVC filter plaintiffs are ticked about the possibility that the spider-like filter placed into the inferior vena cava, intended to entrap blood clots and prevent them from reaching the lungs, may cause more harm than benefit. It’s also somewhat ironic that the specific placement for the inferior vena cava filter contains a word that many use to describe the reliability and value of the device itself...

A study released last year appears to bear that out.

The IVC filter is a device with spider-like appendages designed to ward against blood clot migration in patients at risk for blood clots, and for whom treatment with blood thinners would prove inappropriate. The IVC filter, such as the Bard IVC filter manufactured by C.R. Bard, is placed into the inferior vena cava (IVC) and is intended to retain its original placement in the IVC while doing its work filtering out blood clots. Most IVC filters are retrievable, and are meant only as a temporary measure until the highest risk for blood clot has passed.

But for many disgruntled patients and plaintiffs, it hasn’t worked out that way. IVC filters - the Bard G2 IVC filter among them - have been known to migrate away from the original insertion point and travel along the inferior vena cava toward the heart, becoming embedded into the tissue of internal organs. Once this happens, it makes it extremely difficult to retrieve safely.

For its part, the US Food and Drug Administration (FDA), following the receipt of hundreds of adverse reaction reports concerning IVC filter side effects, has gone on record as expressing concern that IVC filters may, indeed, remain implanted in the patient for too long, and should be retrieved as soon as the danger for pulmonary embolism (blood clot) has passed - ideally between 29 and 54 days following initial implantation.

And yet, this may not be possible in some patients, and appears to be an unrealistic expectation that fails to align with current statistics suggesting fewer than 10 percent of IVC filters have been successfully retrieved.

The longer an IVC filter remains in the patient, the greater the potential for IVC filter migration, the sheering away of filter struts and other related IVC filter side effects. It doesn’t help when studies, such as that published in 2015 in the Annals of Surgery (10/15, Volume 262, Issue 4), suggests that use of IVC filters in trauma patients fails to significantly improve rates of survivability, while at the same time increasing the potential for deep-vein thrombosis by a staggering 83 percent.

“High rates of prophylactic IVC filter placement have no effect on reducing trauma patient mortality and are associated with an increase in DVT events,” the study concluded.

Thus, IVC filter patients - reflective of this study - enjoy little of the benefit while facing substantial risk of IVC filter pulmonary embolism.

Not necessarily high praise for an oft-used medical device, but important fodder nonetheless for anyone fighting or considering an IVC filter side effects lawsuit.

There are many lawsuits out there, and various investigative reports carried through the media paint an alarming picture of the potential for health-related catastrophe. CTV News (2/23/16) in Canada aired a report earlier this year, and last year NBC News (9/3/15) revealed that executives at C.R. Bard knew of dangers associated with their C.R. Bard Recovery IVC filter. Rather than issue a Bard IVC filter recall, the company released the Bard G2. Critics say the G2 proved to be little improvement over the original, and C.R. Bard did not issue a recall of the G2.

Hence the IVC filter lawsuits, in C.R. Bard’s case consolidated in multidistrict litigation (In Re: Bard IVC Filters Products Liability Litigation - MDL No. 2641).