What the FDA Says about IVC Filters
Legally Reviewed and Edited by: Terry Cochran
An IVC Filter is a device implanted in the Inferior Vena Cava to intercept blood clots and to prevent them from flowing to the heart and lungs. This apparatus has been used extensively since 1969 when it was invented by Kazi Modin-Udin, MD and later perfected by Lazar Greenfiled. However, since its inception, there have always been complications in patients where it was used. A qualified IVC filter lawyer will have this information if you have a claim due to the use of one of these filters.
Since 2001, the use of IVC filters has increased substantially with numbers growing from 2,000 implants in 1970 to 250,000 implants in 2012. With this vast increase in use the instances of patient injuries also increased and the U.S. Food and Drug Administration (FDA) began looking at the reasons why this was occurring. In Michigan, the law firm of Cochran, Kroll & Associates, P.C. have followed the development and use of this medical implant, and our law firm is prepared to assist you if you have been a patient who has suffered injury.
Safety Warning by the FDA
The FDA issued the first of two safety warnings in 2010 after it had received 921 cases where there were complications with patients who had received the implant. The recommendation at that time was that the IVC filters should be removed as quickly as possible once the patient can use blood thinners or other anticoagulants to control the blood clots in the veins. The report further suggested that many physicians who use the implants do not attempt to remove them with the long-term effect being patient injuries when the devices fracture and break apart.
The second safety warning was in 2014 when the FDA reported on the length of time the IVC filter had been in place. This report and warning was again directed at the need to remove the filters as soon as possible and updated the recommendation that this removal procedure take place within 29 to 54 days of implant. They further indicated that if the IVC filter is left in longer than that the risks of the device could outweigh the benefits. Most patient injuries and fatalities occur when the pieces of the IVC filter break off and migrate to other parts of the blood stream. This can cause permanent damage to the blood vessel, to other organs and the heart and lungs. Many times there is not a problem for 2-3 years, but it is after that amount of time has passed that there are problems.
Results of the FDA Warnings
When the FDA issued the first warning in 2010, there was a 29% decrease in the use of IVC Filters for stopping the flow of blood clots. The JAMA Internal Medicine Review suggested that one of the reasons that the use of the IVC filter decreased was that the reimbursement for the procedure was no longer available once the FDA findings were announced. It further noted that the numbers of patients with the condition of venous thromboembolism, a blood clot in a vein, usually in the leg, did not decline during that period. That is an indication that doctors were finding other treatments for the patients they cared for.
Final Thoughts
The FDA has issued two strong warnings regarding the use of IVC filter implants to treat the movement of clots in the body. As a result of these warnings the use of IVC filters by physicians has decreased. However, since these implants have been widely used from 1999 to present day, there is still the risk of patient injury if these devices break down and pieces move through the veins and arteries.
Eileen Kroll, a registered nurse and trial attorney at Cochran, Kroll & Associates, P.C. has a great deal of knowledge and experience working with patients who have had complications with the IVC filter, and she is available to answer your questions. Contact her, or any other member of our law firm us at 866-MICH-LAW for a free consultation. We never charge a fee unless we win your case.
Disclaimer : The information provided is general and not for legal advice. The blogs are not intended to provide legal counsel and no attorney-client relationship is created nor intended.
