In a recent story on Bard inferior vena cava (IVC) filters, NBC News released a previously confidential report comparing the relative safety of Bard’s Recovery IVC filter with that of competing products. The report found that the Recovery filter posed a greater risk of filter fracture, device migration, and death than other retrievable and permanent IVC filters.
But what’s most surprising about this report is the date—December 2004. That’s a full ten months before Bard finally pulled the Recovery filter from shelves and introduced its new G2 filter, during which time an estimated 34,000 more Recovery filters were sold. It took a further five years before the U.S. Food and Drug Administration (FDA) released a safety communication warning about the risks of long-term IVC filter placement. The agency cited 921 adverse event reports it had received between 2005 and 2010, including instances of device migration, filter fracture, embolization, and vena caval perforation. The FDA followed up four years later with a communication urging doctors to remove retrievable IVC filters between 29 and 54 days after implantation.
This newly publicized report confirms that Bard knew of the Recovery filter’s flaws well before the product was withdrawn from the market. Plaintiffs who have filed Bard IVC filter lawsuits will no doubt want to know why, after finding evidence that “urgently warranted” further investigation, Bard waited nearly a year before recalling its Recovery IVC filter.