Did Bard Know About Recovery IVC Filter Risks?

September 15, 2015 — C.R. Bard may have known about the risks of its Recovery IVC filter before it was approved by the FDA, according to a NBC News.

NBC News obtained a confidential study (PDF) conducted by Dr. John Lehmann, a private consultant who was hired to study the Recovery’s risks in 2004.

Dr. Lehmann discovered that the Recovery had higher rates of complications than other IVC filters on the market, and wrote:

“Further investigation of the Recovery VCF filter performance in relation to migration and fracture is urgently warranted.”

But instead of telling the FDA or recalling the Recovery, Bard continued selling it. As the number of deaths and injuries grew, Bard hired a public relations firm to develop a crisis management plan (PDF).

After selling about 34,000 Recovery IVC filters for nearly three years, Bard launched a modified version with a new name — the G2. According to NBC, Bard’s own confidential records in 2006 estimated that more than 20,000 people still had the filter implanted inside their body.

The findings are concerning because both the Recovery and G2 have been linked to higher rates of filter fracture, migration, organ perforation, and other side effects. When pieces of the filter break off, they can travel to parts of the body where they are impossible to remove — leaving patients with a lifelong risk of deadly complications.

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