Has there been an FDA recall of IVC Filters?

What is the FDA’s Position on these Potentially Dangerous Medical Devices?

If you have been implanted with a retrievable IVC filter and have heard many of the safety concerns regarding these filters, you may wonder about the FDA stance on IVC filters. Retrievable IVC filters are small metal devices which are used to prevent blood clots from traveling from the legs or pelvic region to the heart or lungs. Although prescription blood-thinners are generally the first line of defense in these situations, for some patients, prescription blood thinners are not effective, or are contraindicated.

In other situations, a patient may be in an emergency situation in which the use of prescription blood thinners is not realistic, therefore a retrievable IVC filter could be implanted. One of the primary problems with these filters is that they were never meant to be permanent. In fact, the FDA recommends removing the filter within 26-59 days, or as soon as the doctor believes the risk of blood clot has passed.

Hundreds of Thousands of IVC Filters Implanted

Although the design of IVC filters has evolved somewhat over the 45 years since its inception, it is essentially the same, with many manufacturers selling these retrievable IVC filters. There are currently more than 6,500 IVC filter injury lawsuits against C.R. Bard and Cook, and a recent bellwether trial in Phoenix resulted in a $3.6 million settlement in favor of the plaintiff. Despite this, there has been no FDA recall of retrievable IVC filters.

IVC Filter Injuries

A retrievable IVC filter can loosen, moving through the inferior vena cava, and even perforating the blood vessel and/or other surrounding organs. In a recent Bard case, the plaintiff’s IVC filter caused her to have emergency open heart surgery, and there is still a piece of the filter in her body which the doctors were unable to retrieve. Jurors in this case found Bard guilty of IVC filter failure to warn. An IVC filter can cause a stroke, or even death, when left in the body longer than it should be.

FDA Stance on IVC Filters

As of this date, only an IVC filter FDA safety communication has been issued (in 2010) following more than 900 adverse event reports from patients who had IVC filters implanted and had problems associated with those filters. IVC filter FDA warnings have been issued, regarding retrievable IVC filters which are not removed after the threat of blood clots has passed. The IVC filter FDA safety concerns also mentioned that when retrievable IVC filters are not removed in a timely manner, these filters may be responsible for inferior vena cava blockage, or deep vein thrombosis.

IVC Filter Clinical Studies

These IVC filter FDA warnings have resulted in a number of IVC filter manufacturers engaging voluntarily in large-scale, long-term studies to determine the safety and efficacy of the devices. Once such IVC filter clinical study is called the PRESERVE study and specifically looks at the likelihood that the IVC filters can experience breakage or migration when implanted in the inferior vena cava. Regarding IVC filter FDA safety concerns, Bard’s IVC filters appear to be even more prone to breaking than other brands. If you have experienced problems associated with an IVC filter, it could be beneficial for you to speak to your physician, as well as an experienced IVC filter injury attorney.

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Author: Andrew Sullo
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Andrew Sullo

Andrew SulloAndrew Sullo

Andrew Sullo is a National Trial Lawyer's Top 100 Selection for 2013-2018. He is also a member of the American Association of Justice.

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