January 5, 2016 — Confidential documents reviewed by NBC News show that C.R. Bard was concerned about the safety of the G2 IVC filter within four months of its approval, but continued to sell 160,000 of the devices over the next five years.
The G2 was created to replace the Recovery, a retrievable filter that was pulled off the market in 2005 after a study found higher rates of filter fracture, migration, and death compared to its competitors.
In December 2005, just months after the G2 was approved by the FDA, the vice president of Bard wrote a memo (PDF) expressing concern about problems with migration, tilting, and perforation — the same problems as the Recovery.
Another memo with data through 2010 showed that the G2 had more problems with fracture and migration than any of its competitors.
NBC News talked to Dr. William Kuo of Stanford Health Care’s IVC Filter Clinic, who said the G2 “consistently fractures, consistently causes major complications.” Dr. Kuo has removed about 1,000 Bard filters over the last decade, 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.”
Instead of recalling the devices, Bard kept the G2 on the market until 2010. Today, hundreds of adverse events and at least 12 deaths have been blamed on the G2, according to NBC News. Bard is now facing 72 lawsuits in a centralized federal Multi-District Litigation (MDL No. 2641) in Arizona.
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