IVC Filter Use Declined in Wake of FDA Warnings, Still Excessive: Study

Published on July 11, 2017 by Sandy Liebhard

It appears that a U.S. Food & Drug Administration’s (FDA) warning on IVC filter complications did result in lower implantation rates. However, a study published this week in JAMA Internal Medicine suggests that the allegedly dangerous devices are still being implanted in too many people.

FDA IVC Filter Warning

IVC filters are placed in the inferior vena cava to prevent pulmonary embolism in patients at risk for deep vein thrombosis and who are unable to take standard blood-thinning medications. The small, wire, basket-like devices prevent pulmonary embolism by intercepting blood clots that have broken loose from the extremities. Retrievable varieties are intended to be removed once a patient is out of danger.

In 2010, the FDA warned that retrievable IVC filters had been linked to more than 900 adverse event reports, including incidents of migration, filter fracture and embolization. Other reports detailed cases in which filter pieces had perforated organs and blood vessels. The FDA reminded healthcare providers to remove the filters as soon as the blood clot risk subsided in order to reduce the potential for patient harm.

In May 2014, the FDA issued a second alert to remind doctors of the importance of IVC filter retrieval.

Study Conclusions

To determine exactly how much the FDA’s warning influenced IVC filter utilization in the U.S., the authors of the JAMA Internal Medicine study identified all individuals (1,131,274) from the National Inpatient Sample (NIS) who underwent filter implantation from January 2005 to December 2014.  Between 2005 and 2010, the rate of placement grew by more than 22%.  A 29% drop in usage was observed between the release of the FDA alert in 2010 and 2014. While hospitalizations related to venous thromboembolism rose between 2005 and 2010, they remained steady in the years following the FDA warning.

While the FDA’s communication proved effective in reducing IVC filter utilization, implantation rates in the U.S. remain excessive.

“In the United States, the IVC filter implantation rates are 25 fold higher than in Europe. The hospitals across this country collectively are spending close to a billion dollars on these devices every year without a known significant benefit,” Riyaz Bashir, MD, FACC, RVT, the study’s lead author. said in statement announcing the findings.

Dr. Bashir and his team recommend that IVC filters “be mostly reserved for those patients with an absolute indication like active bleeding,” given the potential for serious complications.

U.S. IVC Filter Litigation

Court documents indicate that more than 2,100 IVC filter lawsuits have been filed against Cook Medical, Inc. on behalf of patients who were allegedly injured due to malfunction of the company’s Celect and Gunther Tulip retrievable blood clot filters. Most of these claims have been centralized in the U.S. District Court, Southern District of Indiana, where bellwether trials are scheduled to begin in October. C.R. Bard, Inc. has been named a defendant in just over 2,000 product liability lawsuits involving its Recovery and G2 retrievable filters. Those cases have been centralized in a second multidistrict litigation that is now underway in the U.S. District Court, District of Arizona.

Plaintiffs involved in these two litigations allege that the companies’ retrievable IVC filters are defective, making them prone to fracture, migration and other problems that can result in life-threatening complications. They further claim that the device makers failed to provide doctors with appropriate safety warnings, including information regarding the importance of IVC filter removal.

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