For years, Inferior Vena Cava filters (IVC filters) were used to help mitigate the risk of blood clots in patients who cannot take traditional blood thinners. An increasing number of lawsuits claim IVC filters are defective, cause serious side effects, and have incredibly high rates of fracture. A new study published in the Journal of The American Medical Association (JAMA) found IVC filters did not provide any benefits to trauma patients.
IVC Filter Usage
Patients who have experienced some type of trauma, like an accident or surgery, cannot take blood thinners to reduce their risk of blood clots because it could cause dangerous bleeding. Instead, surgeons often utilize IVC filters to catch blood clots before they travel into the heart or lungs and cause a life-threatening condition called pulmonary embolism (PE).
The newly published JAMA study advises doctors to rethink the use of IVC filters in trauma patients. The study looked at both patients who had received IVC filters and those who had not received IVC filters and found no difference in mortality rates regardless of whether a filter was used. Doctors also discovered only 8% of IVC filter patients had their device removed within 3.8 years of implantation. The FDA recommends filters removal between 29 and 54 days after implantation to decrease the risk of suffering complications.
The study recommends IVC filter use “should be reexamined because filter removal rates are low and there is increased risk of morbidity in patients with filters that remain in place.”
The seven most dangerous IVC filters most commonly named in lawsuits include:
1. Cook Günther Tulip Filter – Approved by the FDA in 2003, the Günther Tulip was one of Cook Medical’s first IVC filters. However, a study in 2012 in Cardiovascular and Interventional Radiology found 86% of patients with Günther Tulip IVC filters experienced device perforation of the inferior vena cava wall.
2. Cook Celect Filter – Released onto the market in 2008, it did not take long for reports of Celect filter device failure to come in. The Celect proved to be no better than its predecessor, the Günther Tulip, at resisting failure.
3. Bard Recovery Filter – The Recovery filter was C.R. Bard’s first IVC filter to hit the market in the U.S. when it received approval in 2002. However, as early as 2004, the company received reports that the devices were causing serious complications. In 2005, Bard voluntarily removed the Recovery filter from the market.
4. Bard G2 Filter – While the Recovery filter was being recalled, Bard released the G2 filter onto the market. Although the G2 was supposed to have enhanced fracture resistance, the FDA continued to receive reports of device failure.
5. Bard G2 Express – Released shortly after the G2, the G2 Express proved to be just as dangerous. The G2 Express has a fracture rate of 12%, and only half of fractured devices can be successfully removed.
6. Cordis OptEase – Not only was the OptEase by Cordis dangerous for its failure rate, a labeling error printed an arrow pointing the wrong direction, causing devices to be implanted upside down. Only when the device is in the upright position can it be anchored in place by the struts. The printing error led to many patients having the device migrate through the body, causing severe complications.
7. Cordis TrapEase – Although the Cordis TrapEase filter contained better labeling and instructions, a 2011 study found the TrapEase had a higher risk of fracture compared to other IVC filters.
IVC Filter Litigation
Patients in the various IVC filter litigations believe manufacturers like C.R. Bard, Cook Medical, and Cordis Corporation failed to adequately warn them of the risks associated with the defective medical devices. Thousands of IVC filter lawsuits now seek justice from more than a dozen manufacturers. The first Cook Medical IVC filter lawsuits will go to trial in early 2017.