IVC Filters

The IVC filter attorneys at the law firm of Alley, Clark & Greiwe are investigating claims for patients seriously injured after having inferior vena cava (IVC) filters surgically implanted. IVC filters are implanted in patients who have a history of or are at risk of developing blood clots and are frequently used when patients cannot be successfully treated by other methods (i.e. blood thinning agents like Coumadin).

What Exactly is an IVC Filter?

The inferior vena cava is the main vessel that transports blood to the heart from the lower portion of the body. IVC filters are small, cage-like devices that are implanted into the inferior vena cava to capture blood clots and prevent them from reaching the lungs. IVC filters are specifically utilized in patients who are at high risk for blood clots and for whom anticoagulant therapy has either been ineffective or is contraindicated. In other words, when blood thinnners are not an option, a patient may have an IVC filter implanted (permanently or temporarily) in order to stop blood clots from traveling to the lungs.

Complications with IVC Filters

Certain IVC filters have been associated with serious complications. In fact, recent studies have shown that 1 out of 4 filters fracture or break inside the body, which could be life threatening. IVC filter complications include:

IVC device migration
Breakage of the IVC filter
IVC perforations
IVC filter fractures

These complications can also lead to internal bleeding, penetration into the spine, protrusion of internal organs, additional surgery to remove the filter, and even death.

By 2010, the U.S. Food and Drug Administration (FDA) had received more than 900 reports of patients suffering adverse effects from IVC filters. 328 were associated with the migration of the device, 146 involved embolization or detachment of device components, 70 patients reported that their inferior vena cava had been punctured due to displacement of the filter and 56 patients experienced filter fractures.

IVC Warning Letter Issued to Bard by FDA in July 2015

On July 13, 2015, the FDA issued a warning letter to C.R. Bard, Inc. and Bard Peripheral Vascular, Inc.(hereinafter referred to as “Bard”). The letter cited eight violations of federal law regarding the safety of Bard’s Inferior Vena Cava (IVC) filter product line. The IVC filter product line includes the following products: Recovery Filter, G2 Filter, G2X Filter, G2 Express Filter, Eclipse, Meridian and Denali. The violations included but were not limited to the following: Bard illegally sold adulterated and misbranded IVC Filters, Bard failed to report complications and adverse events, and Bard withheld critical information from the FDA and the public.

Cook IVC Filters

Cook Medical is another manufacturer of IVC devices which have been associated with complications such as the ones associated with the Bard IVC filters. Cook and its subsidiaries manufacture and sell the Celect Platinum and Tulip IVC filters.

Tampa IVC Filter Lawyers

Several studies and articles in medical journals question the safety and efficacy of the IVC filter products (see Helpful Consumer Information below). Both Bard and Cook have hundreds of lawsuits filed against them alleging injuries and death associated with their IVC filter products due to failure to warn, design defect, and manufacturing defect.

If you or a loved one experienced complications after having an IVC filter implanted contact the defective medical device attorneys at Alley, Clark & Greiwe for a free legal consultation.

Helpful Consumer Information

NBC Nightly News Segment on IVC Filters (Broadcast Date: 9/2/15)

Click here to read the 2015 warning letter from the FDA to Bard

Click here to read an excerpt from a medical study published in April 2013 in JAMA Internal Medicine

Click here to read an abstract of a medical study published in January 2006 in J. Trauma