September 9, 2015 — An investigation by NBC News has linked C.R. Bard’s Recovery IVC filter with 27 deaths in the last decade, raising safety concerns and questions about its approval.
IVC filters are 1.5-inch spider-shaped wire devices that are implanted in the inferior vena cava (IVC), the largest vein in the body, to catch blood clots before they reach the lungs.
NBC News also obtained a confidential study (PDF) that linked the Recovery IVC filter with higher rates of death, filter fracture, and movement than all its competitors.
Interviews with a company insider suggest that Bard dismissed early warning signs of potentially deadly side flaws with the Recovery and possibly forged her signature on an approval application.
In 2002, Bard recruited Kim Fuller, a veteran regulatory specialist, to get clearance for the Recovery after its first application was rejected. However, Bard refused to give her important safety performance data. She says a small clinical trial also raised red flags.
With serious concerns about the Recovery, Fuller refused to sign the application — yet her name (markedly different from her normal signature) appeared on the document. Bard denies the signature was forged.
After gaining FDA-approval for the Recovery, Bard sold about 34,000 filters. Hundreds of non-fatal adverse events and dozens of deaths have been reported. Just three years after introducing the Recovery, Bard replaced it with a modified version called the G2.
Unfortunately, a study published in 2010 warned that both the Recovery and G2 had high rates of fracture and embolization, with potentially life-threatening consequences.
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