Inferior vena cava filters, also known as IVC filters, are implantable devices that look like tiny cages made of metal spider legs. Inserted laparoscopically through a small incision in the neck or groin area, IVC filters are then guided into the inferior vena cava—the body's longest vein—where they're tasked with catching passing blood clots and holding them until they dissipate. IVC filters are a go-to treatment for trauma patients, as well as for extremely obese patients who either can't take anticoagulant medications or haven't had success with them.
When trauma patients are brought into the emergency room and doctors are concerned about the possibility of an adverse thrombosis event, such as a pulmonary embolism or deep vein thrombosis (DVT), traditional medical thinking calls for the implantation of an IVC filter—and stat! However, a recent study conducted by researchers at the Boston Medical Center sheds new light on whether this process is necessary.
Boston Medical Center Study
The study was conducted by Boston Medical Center researchers and published in the September 28, 2016 issue of the JAMA Surgical medical journal. It analyzed data from 451 trauma patients who had an IVC filter implanted at Boston Medical Center between August 1, 2003 and December 31, 2012; and 1,343 controls without IVC filters to determine if having them improved the patients' chances of survival.
Patient checkups at six months, one year, and four years after discharge revealed no substantial difference in mortality between patients who had IVC filters and those who didn't, leading researchers to conclude that the IVC filters offered no significant survival benefits for trauma patients. As a result, the researchers recommended doctors rethink the routine use of IVC filters in trauma patients, citing a low IVC filter removal rate and an increased risk of morbidity in patients whose filters are not removed. During the nearly four-year study, researchers reported that only 8 percent of patients had their IVC filters removed.
Additionally, the researchers stated that while IVC filters may have their applications, they're no replacement for traditional anti-clotting treatment with anticoagulant medications, and encouraged doctors to begin or resume pharmacologic treatments as soon as possible.
IVC Filter Complications
There are two types of IVC filters on the market: permanent and retrievable. Most of the IVC filters used today are retrievable, which are only designed for temporary use. When left in place for too long, retrievable IVC filters can cause a wide variety of serious and even life-threatening complications.
- Break apart
- Puncture veins or organs
- Become infected
- Cause reoccurring blood clots in the insertion site, legs, lungs or vena cava
- Migrate to other parts of the body
- Cause filter embolization in the lungs, heart, kidneys or liver
In the most serious cases, IVC filters can even cause death.
FDA IVC Filter Warnings and Recommendations
In 2014, after numerous reports of IVC filter complications, including death, the U.S. Food and Drug Administration (FDA) issued a recommendation for the removal of retrievable IVC filters. According to the FDA, IVC filters should be removed as soon as the threat of a thrombosis-related event has passed, ideally between 29 and 54 days after implantation. After just four weeks, the IVC filter can become a health hazard and after 54 days, the risks associated with the device are said to outweigh the benefits.
Are You Considering an IVC Filter Lawsuit?
Thousands of IVC filter patients and their families have filed lawsuits against manufacturers C.R. Bard and Cook Medical, alleging they marketed defective products and failed to warn patients of the potential risks associated with the devices. Federal IVC filter lawsuits have been consolidated into multidistrict legislation, with C.R. Bard lawsuits being heard in the District of Arizona and Cook Medical Lawsuits being heard in the Southern District of Indiana.
If your IVC filter caused serious side effects and complications, McGartland Law Firm can help you explore your legal options. Contact us today to make an appointment for a no-cost, no-obligation initial consultation.