Society of Interventional Radiology Reveals IVC Filter Clinical Practice Guidelines
Inferior vena cava (IVC) filters are used to treat venous thromboembolism (VTE). In recent years, numerous IVC filter manufacturers have been facing thousands of lawsuits for allegedly designing, manufacturing, and selling defective medical devices. IVC filters have been linked to injuries and death, giving rise to a massive nationwide litigation.
In September of 2020 (perhaps in response to the onslaught of IVC filter lawsuits), the Society of Interventional Radiology (SIR) issued guidelines governing the implantation of IVC filters. The practice guidelines are “evidence-based recommendations on the use of” IVC filters to treat VTE following a “gold-standard methodology.”
The IVC filter guidelines “advise against the routine placement” of IVC filters in most cases where patients are taking anticoagulants (blood thinners) without difficulty. If anticoagulation therapy does not prevent the development of deep vein thrombosis (DVT) or pulmonary embolism (PE), IVC filters may be considered.
However, all clinical risk factors must be weighed, including “bleeding, vascular injury, device migration and increased risk of recurrent” DVT. If the benefits of implanting an IVC filter outweigh the risks, and a patient is implanted with the device, the new SIR guidelines “recommend a follow-up program to increase retrieval and detect complications.”
IVC filters may be permanent, with no intention of ever removing the device, or they may be retrievable, meaning they can be removed if they are no longer needed. The new SIR guidelines recommend that retrievable IVC filters be removed unless a patient is still at risk of developing a pulmonary embolism.
Complications Associated with IVC Filter Placement
When anticoagulation therapy fails, patients may be left with few options for preventing life-threatening blood clots. Retrievable IVC filters, which are placed in the abdomen’s largest vein, the vena cava, are intended to prevent blood clots that form in the leg (DVT) from traveling into the lungs. Once a patient is no longer at risk of developing a PE, the filter is removed.
However, far too often, retrievable IVC filters remain in a patient’s body permanently. The longer the filter remains in a patient’s body, the more difficult it becomes to retrieve the device. Examples of IVC filter complications many patients experience include, but may not be limited to, the following:
- Filter fracture;
- Filter migration;
- Vein perforation;
- Failure to open completely;
- Infection; and
Fracture and migration are two of the most serious complications associated with IVC filter placement. In many cases, a piece of the filter breaks off and migrates to the heart or lungs, a complication that can be fatal.
Some patients may have complications and not even know if they do not feel any symptoms. Only imaging can determine whether an IVC filter is posing a risk to a patient in terms of the filter’s placement.
Moreover, even if a patient is not currently experiencing a complication, he or she may experience complications in the future given that the risk of complications increases the longer the IVC filter is in a patient’s body.
Did IVC Filter Manufacturers Know About Serious Complications?
Whether manufacturers of IVC filters knew about the serious complications associated with their medical devices is the subject of thousands of lawsuits pending across the country. The United States Food and Drug Administration (FDA) has received a significant number of adverse reports citing IVC filter migration, filter fracture/detachment, and perforation of the inferior vena cava, among others.
Because of numerous adverse event reports pertaining to IVC filters (especially retrievable filters), the FDA issued two public health safety notifications to patients. The first safety notification was in 2010, which noted the following:
- The frequency of IVC filter placement procedures increased significantly;
- Numerous adverse event reports had been filed following the increase in frequency of placement of the IVC filter; and
- Many of the adverse events (such as fracture/breakage, migration, and perforation, etc.) may be the result of the filter being left in patients for too long.
The 2010 FDA public health safety notification advised doctors to remove retrievable IVC filters once a patient is no longer at risk of developing a pulmonary embolism.
In 2014, the FDA issued a second public health safety notification that emphasized the risks associated with leaving a retrievable IVC filter inside a patient for too long. The notification cited a study that concluded the risks of implanting IVC filters outweighs the benefits once the filter has been inside a patient’s body for between 29 and 54 days.
In response to the FDA’s 2014 public health safety notification regarding IVC filters, many manufacturers of IVC filters conducted post-market clinical trials to test the safety and efficacy of the device for its intended use.
Additionally, the FDA sent C.R. Bard, Inc. a “warning letter” alleging that the IVC filter manufacturer was selling two products that were not approved or cleared for use by the FDA. The letter also alleged that Bard failed to report to the FDA malfunctions/complications associated with injuries and death that the company knew about.
By failing to report adverse events, Bard continued to manufacture and sell the IVC filters as if they were free from dangers, covering up complications that were injuring and killing patients. Bard is just one of many IVC filter manufacturers facing lawsuits.
Will the New SIR Guidelines Help to Prevent Future IVC Filter Injuries?
The SIR guidelines concerning implantation of IVC filters may very well be the result of more than a decade’s worth of serious and sometimes fatal complications. While recognition of IVC filter injuries and complications is helpful, new guidelines do not undo the pain and suffering so many IVC filter patients have experienced over the past two decades.
Speak to an IVC Filter Lawyer Right Away
If you have experienced complications following implantation of an IVC filter, you may qualify to receive compensation from the manufacturer(s) of the IVC filter implanted in you. IVC filter injuries can be catastrophic and even fatal. To find out whether you have a potential legal claim, seek the advice of an IVC filter lawyer.
At Searcy Denney, each IVC filter lawyer has substantial experience fighting large medical device manufacturers, and the IVC filter litigation is no exception. Receive a free case evaluation today by calling (800) 780-8607 or by completing a case inquiry form on our website.