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By Jim Adler April 1, 2016

The U.S. Food and Drug Administration (FDA) has issued reports and warnings about IVC filters for years. During that time, FDA news about inferior vena cava filters has included alarming reports of defects, side effects and complications.

Why Did the FDA Approve IVC Filters?

 

All this may make you wonder why the FDA approved IVC filters in the first place.

Like many drugs and medical devices, IVC filters may have seemed beneficial during clinical trials or while their creators were seeking FDA approval, but only later were revealed to have potential for harm.

Over the years, the FDA has approved a number of different IVC filters for treatment of the risk of blood clots or pulmonary embolisms. Some of these filters have done the job for which they were approved — helping patients avoid blood clots — and without harmful side effects. But others have been found to cause IVC filter complications.

Among IVC filters the FDA has approved are:

 
  • The Titanium Greenfield, manufactured by Boston Scientific of Massachusetts. A permanent IVC filter, as opposed to a retrievable filter, it was approved by the FDA in 1989 and, given its lengthy time on the market, has become widely considered as the standard for IVC filters.
 
  • The Cook Celect, manufactured by Cook Medical Inc. of Indiana. In 2007, the FDA  approved the Cook Celect as a permanent IVC filter. Then the FDA approved a  retrievable Cook Celect in 2008.
 
  • The G2, manufactured by C.R. Bard Inc. of New Jersey. Bard’s G2 IVC filter was approved by the FDA in 2005 for permanent use. The FDA approved a retrievable G2 IVC filter in 2008.
 
  • The Stainless Steel Over-the-Wire Greenfield, manufactured by Boston Scientific. In 1995 the FDA approved this permanent IVC filter.
 
  • Gunther Tulip, manufactured by Cook Medical Inc. The FDA approved this device in 2000 for permanent use, then in 2003 approved a retrievable version.
 

FDA IVC Filter Warnings

Just because the FDA initially approves of a medical device doesn’t mean the device can’t be proven to be harmful at a later date, or after it has been placed in wide use. Some of the retrievable IVC filters that the FDA originally approved have since become the targets of FDA warnings and alerts.

On Aug. 9 of 2010, the FDA made its first “safety communication” concerning the potential danger of a retrievable IVC filter not being removed from a patient’s body after the risk of a blood clot had eased. The FDA’s warning was called “Removing Retrievable Inferior Vena Cava Filters: Initial Communication.”

With this IVC filter warning, the FDA told patients they shouldn’t let IVC filters stay in their bodies for lengthy times, because the retrievable filters might lead to serious if not life-threatening injuries, perhaps by eroding, facturing or perforating veins.

Between 2005 and 2010, the FDA received more than 900 complaints of IVC filter defects, including filter fracture, filter perforation, filter migration and detachment of filter elements. Another problem was that retrievable filters turned out not to be retrievable, but rather became  embedded in veins and impossible to remove.

Since 2010, the FDA has received over 1,600 adverse event reports related to IVC filter devices. These include 12 deaths and hundreds of serious injuries related to the G2 filter manufactured by Bard.

 

IVC Filter Lawsuits

After the FDA’s safety communication and concerns became public knowledge, victims or their families began filing IVC filter lawsuits against Cook and Bard.

If a member of your family was injured or killed by a defective IVC filter, notify the law firm of Jim Adler & Associates. We have over four decades of experience helping injured Americans get the payments they legally deserved when someone else’s negligence harmed them. Contact us today for a free legal review of your case.

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