A 2010 warning from the U.S. Food & Drug Administration (FDA) regarding the potential for IVC filter complications appears to have made an impact. According to a study presented earlier this month at the Society of Interventional Radiology meeting in Washington D.C., the popularity the blood clot filters began to trend downward in the wake of the alert.
The study looked at the rate of IVC filter placement from 1993 to 2014, and drew data from a 20% stratified sample from the National Inpatient Sample (NIS). Prior to the issuance of the FDA alert, IVC filter use was rising by more than 9% annually. Following the alert, rates fell an average of 7.36% per year.
“The absolute number and rate of IVC filters placed annually in the U.S. has declined each year since 2010, which correlates with the year in which the FDA advisory on the judicious usage of filters was released,” the study authors concluded. “This negative trend is statistically significant when compared with rates of filters placed previously from 1993-2010, a time period in which filter placements were steadily increasing.”
IVC filters are placed in the inferior vena cava in patients who are at risk for pulmonary embolism. Once in place, the tiny wire devices are able to intercept blood clots before they can travel to the heart and lungs. Retrievable IVC filters are designed to be removed once a patient is out of danger.
In August 2010, the FDA disclosed that it had received more than 900 adverse event reports related to retrievable IVC filters. The majority of these reports (328) involved device migration, while the remaining involved embolizations (detachment of device components), perforation of the inferior vena cava and filter fracture. Some of the adverse events resulted in serious patient injuries.
“The FDA is concerned that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient’s risk for PE subsides,” the alert stated.
Nearly four years later, the agency issued a second communication:
“The FDA encourages all physicians involved in the treatment and follow-up of patients receiving IVC filters to consider the risks and benefits of filter removal for each patient,” the May 2014 statement advised. “A patient should be referred for IVC filter removal when the risk/benefit profile favors removal and the procedure is feasible given the patient’s health status.”
According to RXInjuryHelp.com, C.R. Bard, Inc. and Cook Medical, Inc. have been named in hundreds of lawsuits, all of which were filed on behalf of patients who allegedly suffered the types of IVC filter complications noted in the FDA’s alerts. Plaintiffs charge that the device manufacturers were aware of problems with their retrievable IVC filters, but concealed these risks and failed to provide appropriate warnings to patients and doctors. Devices cited in these lawsuits include Bard’s Recovery and G2 series filters, as well as Cook Medical’s Celect and Gunther Tulip devices.
Bernstein Liebhard LLP represents those who have been harmed by allegedly defective medical devices. To learn more about filing an IVC filter lawsuit, please call (888) 674-0093.