Product Liability

IVC Filter FDA Warning

In 2010, the U.S. Food and Drug Administration (FDA) issued an initial warning about inferior vena cava (IVC) filters.1 As more studies are published about the risks of the long-term use of the device, the more likely that lawsuits will be successful.

IVC filters

IVC filters are used to prevent blood clots from reaching the heart and lungs. Though there are types of permanent IVC filters, most are considered for temporary use. But leaving these devices in for too long is known to cause problems. Between 2005 and 2010, the FDA received more than 900 adverse event reports for the use of IVC filters.2,3

Problems reported with IVC filters

The adverse events reported to the FDA about IVC filters have included:1

  • Migration of the device
  • Deep vein thrombosis and embolization
  • Perforation of the vena cava
  • Fracture of the filter

The problems seen with IVC filters are likely due to a retrievable IVC filter, one that is not meant to be used permanently, not being removed.

IVC filter warning

In 2010, the FDA issued a warning about the need to review the benefits and risks for each patient regarding the retrieval of IVC filters. The warning was released at the same time as a study in the Archives of Internal Medicine about the experiences of one hospital with Bard Recovery Filter — they found that 16 percent of the filters they implanted between April 2004 and January 2009 had fractured.4 In 2011, a Japanese group found an even higher rate of fracture over a longer follow-up.5 These problems indicate a potentially life-threatening risk of using IVC filters.

Legal implications

Because of the chance for life-threatening injury by the IVC filters, a number of lawsuits are likely to be filed on behalf of patients or their loved ones seeking compensation. The first step to determining if you have a case is to contact a personal injury lawyer.

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