FDA Reports Dangerous Risks of Adverse Events with Bard Inferior Vena Cava Blood (IVC) Filters

September 7, 2010

Every year hundreds of thousands of Americans suffer from venous thromboembolism (VTE), deep-vein thrombosis (DVTs) and/or pulmonary embolism (PEs), commonly referred to as "blood clots." For certain patients, an intervenous vena cava filter (IVC filter) is implanted in the vein leading to a patient's heart in an effort to prevent these blood clots. According to the FDA, nearly 167,000 vena cava blood filters were implanted in patients in 2007, and that number continues to rise rapidly.[1]

The FDA has received 921 device adverse event reports involving IVC filters.[2] Reported adverse events include device migration (movement from the site where it was originally implanted, such as to the heart or lungs), embolizations (detachment of device components), perforation of the inferior vena cava vein itself and fracture of the device.[3] Patients with IVC filter failures can require immediate surgery to remove the broken filter, and are at risk for grave injury or death.

Bard Peripheral Vascular sold two IVC filters. The first, the Bard Recovery filter, was used from April of 2003 through October of 2005.[4] In September of 2005, the second filter - the Bard G2 - was released.[5] On August 9, 2010, the Archives of Internal Medicine published a study that concluded that Bard Recovery IVC and Bard G2 filters have a "high prevalence of fracture and embolization, with potentially life-threatening consequences."[6]

Last month, the FDA issued a communication to emergency medicine physicians, surgeons, and any other implanting physicians and clinicians responsible for the ongoing care of patients with IVC filters. The FDA recommended the removal of IVC filters as soon as protection from pulmonary embolism (PE) is no longer needed.[7]

Robins, Kaplan, Miller & Ciresi L.L.P. is investigating potential claims on behalf of patients implanted with or injured by the Bard Recovery Filter and Bard G2 Filter. If you wish to speak to us about a potential claim or an injury caused by a Bard IVC blood filter, please call Kathy Neuman, R.N., B.S.N., at 1-800-553-9910, or contact her via email by clicking on this link: contact us.

[1] U.S. Food and Drug Administration, Removing Retrievable Interior Vena Cava Filters: Initial Communication (August 9, 2010), available at http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm221676.htm.
[2] Id.
[3] Id.
[4] William Nicholson, M.D., et.al., Prevalence of Fracture and Fragment Embolization of Bard Retrievable Vena Cava Filters and Clinical Implications Including Cardiac Perforation and Tamponade, Archives of Internal Medicine, available at http://archinte.ama-assn.org/cgi/content/full/2010.316 (last visited August 27, 2010).
[5] Id.
[6] Id.
[7] U.S. Food and Drug Administration, Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use (August 9, 2010), available at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm221707.html.

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