IVC filters have been commonly placed in patients (deemed to be at high risk) for the primary prevention of pulmonary emboli. Thus, IVC filter use by physicians has been rising over the past two decades, in particular due to the retrievable nature of the devices.
Since 2005, the FDA has received over 920 reports on adverse events regarding IVC filters including device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device. In 2010, the FDA published a Safety Communication about the risk of leaving a retrievable IVC filter in a patient for too long, and recommended that physicians remove the filter as soon as “protection from the [pulmonary embolism] is no longer needed.”
A particular retrievable IVC filter, the Recovery manufactured by C.R. Bard, has been at the center of controversy due to its link to increase risk of serious medical complications after implantation. Furthermore, according to a NBC News investigation, a former Bard insider claims that she never signed the FDA application for the device after becoming aware of some defects. Allegedly, Bard forged the application and knew about the problems with IVC filters, but did not disclose this fact to the FDA.
In early 2004, Bard began receiving complaints of IVC filter malfunctions with allegations that pieces of the device were prone to break off, and thus travel to other parts of the body potentially causing serious injury. Bard, worried about the complaints, contracted with litigation consultant Dr. John Lehmann, who prepared a report regarding the fracture and migration rate of the filters to previous models. The “Lehmann Report” provided legal advice to Bard about its vena cava filters and copies were distributed to a small number of employees with instructions that the report was confidential. In 2005, Bard stopped producing the Recovery filter, but never officially recalled it. Since then Bard has manufactured other IVC filters that have been approved but are associated with medical complications as well. Bard is one of many manufacturers of IVC filters, with 11 companies selling IVC filters in the U.S.