Inferior vena cava filters have been around since the late 1960s, and the first FDA approved removable IVC filters were approved in 2003 and 2004. Permanent filters had already been FDA approved at that time. On average 250,000 people each year have an IVC filter implanted.

According to an article in the Journal of American College of Cardiology from 2013, 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.

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.

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.”

In a 2014 Safety Communication Update, the FDA again recommended that physicians who used retrievable IVC filters consider removing the filter as soon as the risk of pulmonary embolism had abated. They cited to a 2013 decision in the Journal of Vascular Surgery: Venous and Lymphatic Disorder, which suggested that once a patient’s risk for pulmonary embolism had passed, “the risk/benefit profile begin to favor removal of the IVC filter between 29 and 54 days after implantation.”

Furthermore, a study from the Journal of Vascular and Interventional Radiology, published in February 2012, found that 40% of Bard Recovery IVC filters fractured after 5.5 years. Additionally, of the 363 people who were implanted with the device, only 97 had it removed. The study evaluated cases involving filter migration into the pulmonary arteries, iliac/femoral veins, on in the right ventricle of heart, and the renal vein.

One 2013 study in the Journal of American Medical Association, notes that no empirical studies have been conducted to validate the effectiveness of IVC filters capturing a blood clot. Another study published that same year in the Journal noted that unretrieved removable IVC filters may carry significant long-term risks. It reviewed medical records of a level 1 trauma center in Boston for any complications with the use of IVC filters. The study found some serious filter-related complications including death, fractured filter lodged in pulmonary artery, IVC perforation, and filter prongs lodged in lumbar vessels and overlying the aorta.