Fewer Than Ten Percent of Retrievable IVC Filters Are Successfully Harvested

Washington, DCIt was a year ago this month that the influential Wall Street Journal (WSJ 3/23/15) articulated what has been on the minds of pundits and advocates alike in recent years: the 510(k) Clearance loophole observed by the US Food and Drug Administration (FDA), and the role the fast-tracked approval process may have played in various injuries sustained by patients and plaintiffs alike when medical devices fail. The IVC filter is one such device that was referenced in the discussion.

The IVC filter is a device designed to be inserted into the inferior vena cava, an integral part of the cardiovascular system. When a blood clot or clots pose risks for stroke or pulmonary embolism, an inferior vena cava filter is often inserted in order to entrap a migrating blood clot and prevent it from reaching the lung.

However, many patients have experienced migration of the IVC filter itself, when the spider-like appendages designed to entrap a blood clot and hold the filter in place, invariably fail and the filter is left to slip through the inferior vena cava to points beyond.

Sometimes the resting place is the heart itself. At other times, the IVC filter has become imbedded so intricately into organ tissue that it becomes virtually impossible for doctors to retrieve an IVC filter once it has become so imbedded.

The FDA recently released an edict recommending to surgeons a specific timeline for removal of the retrievable IVC filter once the danger for blood clot has passed. For the vast majority, this has not been possible and they must live with the IVC filter permanently.

Some have not survived. Others have come dangerously close to a serious health event that might have proved fatal.

Various IVC filters have been the target of an IVC filter lawsuit, including the C.R. Bard IVC filter and the Bard G2 IVC filter. Other IVC filters from other manufacturers have been targeted in dangerous medical device lawsuits, including those under the Cook Medical banner.

Two IVC filter lawsuits have in fact recently been filed in Canada against Cook Medical Inc. Both are class actions, and both allege that Cook Medical failed to properly warn consumers and patients of the potential for fracture and migration of the device.

The two Canadian lawsuits, akin to US-based lawsuits, involve Celect and Gunther Tulip filters manufactured by Cook Medical and the aforementioned Bard Recovery and G2 filters.

A study appearing in April 2013 in JAMA: Internal Medicine suggested that actual retrieval of devices designed to be retrieved occurs in fewer than 10 percent of IVC filter patients.

IVC filters are among a plethora of medical devices that have been fast-tracked to market via the FDA’s 510(k) Clearance. In fact, the Wall Street Journal reported last year that the vast majority of medical devices that have come into the market since the 510(k) Clearance were implemented to have been fast-tracked without thorough pre-market testing.

In fact, according to the The Wall Street Journal, the only requirement is for a manufacturer to demonstrate that a device is substantially the same as one already on the market.

The Wall Street Journal convened a roundtable discussion last March with various members of the medical community to talk about the FDA 510(k) Clearance - its value, limitations and risks. One of those participating in the discussion was Dr. Rita Redberg, cardiology professor at UC San Francisco.

“Yet another example of a high-risk implanted device entering the market without clinical studies is the inferior vena cava filter,” Dr. Redberg said, “which for some models, studies have shown that one in four fracture after implantation in the major blood vessel entering the heart and are risky to remove.”