Amid recent questions over the safety of Inferior Vena Cava blood clot filters, two new reports warn of their immanent dangers and a federal judicial panel has disclosed a surge in lawsuits filed by injured patients.
Inferior Vena Cava (IVC) filters are tiny, metal vein implants that catch blood clots before they reach the heart or lungs. They are generally used in emergencies or for those who can’t take blood thinners. Each year, they are used in around 250,000 patients.
FDA Warns IVC Dangers
In 2010 and 2015, the FDA warned of higher-than-normal side effects from IVC filters, as well as reports that top manufacturers were misrepresenting the dangers. Studies have also suggested that as many as 43% of these IVC filters may fail.
If the metal arms of an IVC filter fail, they can tear through the wall of the vein, they can move through the vein, or, most dangerous, they can break off and be swept into the heart or lungs.
AMA Study Shows IVC Filters No Better At Preventing Death
Last month, the Journal of the American Medical Association published a study conducted over nearly ten years at the Boston University School of Medicine that found the use of IVC filters may not be worth the risk to patients.
The study, which noted the use of IVC filters in hospital ERs has been on the rise, tracked their use at the level 1 trauma center at Boston Medical Center from August 2003 through December of 2012.
Among nearly 1,800 trauma patients, the findings showed there was no difference in the rate of death among those who had received IVC filters to prevent blood clots versus those who had been given blood-thinning drugs.
Radiologists recommend removal of IVC filters
Although IVC filters are designed for short-term use in place of blood thinner medications, studies show many patients leave them in place for longer periods of time, increasing the risk of failure.
Last month, the Illinois Herald-News also published a report from radiologists who feared many patients had IVC implants in place for up to a decade, and urging them to have them removed.
Dr. Noah Schwind at Presence Saint Joseph Medical Center noted that, as time passed, the risk that the metal legs of the IVC filters would fail increased. This would heighten the chances of vein wall tearing, filter movement, or device breakage and heart/lung damage.
IVC Filter Lawsuits on the Rise
In the midst of the recent warnings, more and more patients who received IVC filters have suffered serious injury without proper warning from the companies that make the devices. In fact, the FDA warned Bard in 2015 of misrepresenting the safety of IVC filters.
In 2014, a federal judicial panel consolidated a growing number of IVC filter lawsuits against Cook Medical into a special multidistrict court in Indiana. Likewise, as cases grew against the other largest IVC maker C.R. Bard, they were combined into a special court in Arizona.
At that time, there were only about 200 total cases. Now, however, the number of IVC filter lawsuits against Cook Medical or Bard has grown to nearly 1,800. And, experts believe this only represents about one-third of those injured.
With the first trial over IVC injuries approaching, lawyers believe the manufacturers may try to reach an IVC filter settlement instead of face negative publicity.
Lawyers are still helping those who have received IVC filters or suffered injury investigate their cases and file claims. For more information or to speak with a lawyer today at no cost, contact DrugNews.
Sarosiek, S., et al. Association Between Inferior Vena Cava Filter Insertion in Trauma Patients and In-Hospital and Overall Mortality. JAMA Network. (September 28, 2016). Retrieved from http://archsurg.jamanetwork.com/article.aspx?articleid=2556171
Mallory, M. Saint Joseph radiologists recommend removal of filters designed to stop blood clots. Herald-News. (September 27, 2016). Retrieved from http://www.theherald-news.com/2016/09/27/saint-joseph-radiologists-recommend-removal-of-filters-designed-to-stop-blood-clots/aljyozw/
The FDA enacted tough new regulations this week aimed at making sure all women who are considering implantation of the Essure birth control device fully understand all the risks and benefits before moving forward.
Cerebral Palsy is the most common form of childhood disability in America, affecting nearly 1 out of every 500 births and as many as a million young people at any given time.