A lengthy NBC News investigation reported on deaths and injuries associated with Bard IVC (inferior vena cava) filters starting soon after the devices came to market.
IVC filters implanted in the body’s largest vein to prevent blood clots from traveling from the lower body to the heart or lungs. IVC filters are used for patients who are unable to take blood-thinning drugs or for whom the drugs do not work well enough.
Hundreds of individuals have filed injury lawsuits against IVC filter makers, saying the devices are defective and the manufacturers were negligent in not warning doctors and consumers about potential problems.
Some of the lawsuits claim that the IVC filter moved from the original implantation site and became deeply lodged in another area of the body, making it impossible for the filter to be safely removed, or the filter tilted and then could not effectively trap clots. In other instances, part of the IVC filter broke off and either became embedded in the vein or an organ or formed a clot that endangered the patient. When an IVC filter breaks and pieces migrate, the patient can experience severe pain, bleeding, further clots, and other life-threatening complications.
While some IVC filters are implanted permanently, most of the filters are intended to be removed when the patient is no longer at risk for blood clots. The Food and Drug Administration (FDA) recently recommended that IVC filters should be removed between 29 and 54 days after implantation to avoid the risk of the device breaking or traveling elsewhere within the body.
The NBC News report highlighted experiences of patients who had IVC filters. A 45-year-old woman had an IVC filter implanted after a 2004 car accident that put her at risk for blood clots. Four months after the filter was implanted, the woman developed a severe headache and passed out. She said she flat-lined in the ambulance on the way to the hospital. Doctors discovered that a piece of the IVC filter had broken off and pierced her heart. She needed emergency open-heart surgery, but doctors were able to successfully remove the filter fragment.
According to NBC News, reports of injuries and deaths began soon after the Recovery filter came to market in 2002, but Bard did not recall the Recovery. The filter remained on the market until 2005, when it was replaced with the similar G2 filter series. Bard’s own records and hundreds of reports to the Food and Drug Administration (FDA) indicate that the G2 filter series did not solve the problems. G2 filters stayed on the market until 2010.
In 2002, C.R. Bard recruited regulatory specialist Kay Fuller to help the device maker with the FDA clearance process. The agency had turned down a previous Bard application. But Fuller told NBC News that the company failed to provide her with important test results and that a clinical trial raised concerns. Fuller said when she expressed her concerns she was told she would be removed from the team if she continued to pursue the matter.