FDA Recommends IVC Filter Removal When Embolism Protection No Longer Needed

On August 9, 2010, the U.S. Food and Drug Administration (“FDA”) issued a safety communication about the risks of adverse events concerning retrievable IVC filters. In the communication, FDA recommended physicians consider removing the IVC filter “as soon as protection from [pulmonary embolism] is no longer needed.” The FDA further recommended ongoing followup and referral for IVC filter removal when “feasible” and “clinically indicated.”

The FDA issued a second safety communication on May 6, 2014, repeating the prior guidance and updating studies and market research on retrievable IVC filters. The second safety communication stated:

The mathematical model suggested that if the patient’s transient risk for pulmonary embolism has passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation.

Although the results of the decision analysis provide important insight for retrievable IVC filters, the FDA is requiring collection of additional clinical data for currently marketed IVC filters in the United States. The studies will address safety questions that remain unanswered for both permanent and retrievable filters.

IVC Lawsuit Filter FAQ

As explained in our IVC Lawsuit Filter FAQ patients allege retrievable IVC filters migrate, meaning they move within the body. Patients further allege IVC filters may tilt or shift, causing the IVC filter to fracture or explode in the body, preventing removal and causing filter pieces to migrate within the body, including traveling to the heart and lungs.

Plaintiffs also allege defective IVC filters have punctured adjacent organs and blood vessels. Hundreds of lawsuits have been filed against IVC filter manufacturers. ‎

Join an IVC filter lawsuit

Our firm currently is investigating injuries resulting from IVC filters. If you, or someone you know, was injured by an IVC filter, please contact us for a free consultation by filling out the confidential form below or call us toll-free at 1-800-736-9085, as you may have a valuable legal claim.