January 5, 2016 — NBC News has reviewed confidential documents showing that C.R. Bard executives had concerns with the G2 IVC filter soon after its approval, but kept it on the market and sold 160,000 devices over the next five years.
Bard created the G2 to replace the Recovery, which was withdrawn in 2005 after only three years on the market. Studies linked the Recovery to higher rates of fracture and migration than its competitors.
Unfortunately, the G2 may have similar problems as the Recovery. Just four months after the G2 was approved, an executive at Bard issued a memo (PDF) asking for more information about adverse events involving migration, tilting, and perforation.
NBC News reviewed another document that includes data through 2010 showing that the G2 filters had more fractures, migrations, and reported problems than any of its competitors.
Investigators also talked to Dr. William Kuo, a surgeon at Stanford who estimates he has removed 1,000 Bard filters in the last ten years. He warned that the G2 “consistently fractures, consistently causes major complications” and said:
“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.”
Bard has not recalled the G2 or Recovery IVC filters, despite hundreds of adverse events. At least 12 deaths have been linked to the G2, according to data from the FDA and Bard. The company is now facing over 70 federal lawsuits in Arizona (MDL No. 2641).
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