Results of a recent NBC News Investigation indicate that C.R. Bard, Inc. might have prioritized profits over patients in its handling of the G2 IVC Filter. Among other things, the network revealed that officials at Bard were well aware of the G2’s safety issues within months of its approval by the U.S. Food & Drug Administration (FDA), but did nothing to warn the public or recall the potentially dangerous blood clot filters.
Instead, Bard kept the G2 series filters on the market until 2010, the same year that Chris Svedise had a Bard G2 Express filter implanted in his inferior vena cava. In October 2013, his doctor discovered that the filter had moved out of position.
“He said, ‘It is dangerously close to your heart,'” Svedise told NBC News.
During emergency surgery to remove the device, it was discovered that the filter had also fractured, and that pieces had traveled to his lungs. During the procedure, two partially fractured legs broke away completely, leaving the surgical team to watch as the components floated to the heart – first into the right atrium and then into the right ventricle.
IVC Filters like Bard’s G2 devices are implanted into the inferior vena cava, where the small, spider-like devices catch blood clots before they can travel to the heart and lungs and become a pulmonary embolism. The G2 IVC filter series was introduced by Bard in 2005, and was intended to replace the company’s Recovery IVC filters. Among other things, the company maintained that devices included in the G2 series would be more resistant to fracture and migration than their predecessor.
But according to NBC News, an internal memo written by a Bard VP in December 2005 expressed concerns about the performance of the G2 filters. Another document that included data through 2010 indicated that G2 series filters were associated with more fractures, migrations and reported problems than any of its competitors. The broadcast also cited 12 deaths among G2 IVC filter recipients that have been linked to these types of complications.
This isn’t the first time NBC News has revealed disturbing findings about Bard’s IVC filters. This past September, the network reported in another broadcast that the Recovery filter had been associated with more than 300 non-fatal injuries and 27 deaths before it was replaced with the G2 series. That report also disclosed a confidential study commissioned by Bard in 2004 which linked the Recovery IVC filter to higher rates of death, fracture and movement compared to its competitors.
During the NBC News segment on the G2, Dr. William Kuo, an interventional radiologist who specializes in removing failed blood clot filters, maintained that both the G2 series and the Recovery IVC filter should have been pulled from the market.
“Whether it’s an ethical reason, a moral obligation, in the interest of public safety and patient safety, absolutely these devices should have been recalled,” he said.