Inferior vena cava (IVC) filters are small medical devices used for patients who are at a high risk of experiencing an arterial blockage in the lungs or a pulmonary embolism. These filters are designed to catch fragments of blood clots formed in a patient’s legs or pelvis before they can get to the heart or lungs and cause potentially deadly health conditions.
While these devices are necessary and helpful for many patients, they have recently been known to fracture or fail in other ways. When they malfunction, severe complications can occur, and some patients may even need corrective surgeries. If you had an IVC filter implanted and believe you have suffered due to a malfunction, an IVC filters lawyer may be able to assist you. Contact a well-versed mass torts attorney right away to discuss your case.
Who Receives IVC Filters?
Patients who meet certain criteria may be candidates to receive an IVC filter. In particular, the most common criterion is a past history or higher risk of developing blood clots in the legs or pelvis. Other potential candidates include those who:
- Have deep vein thrombosis (DVT)
- Have decreased mobility
- Were recently a victim of trauma
- Are post-surgical
- Were diagnosed with a pulmonary embolism or determined to be at risk for one
Defining IVC Safety Risks
The United States Food and Drug Administration (FDA) issued a safety alert for the long-term use of IVC filters in 2010. This alert was updated in 2014 and warns of a link between the long-term use of retrievable filters and their fracture or failure.
Other risks of IVC filters include filter embolization—when pieces of the filter break away and travel to other areas of the body—and IVC perforation that happens after embolization and can damage internal organs.
What is the FDA 510(k) Program?
Most Americans trust that any medical device approved by the FDA is safe. Unfortunately, as a lawyer who specializes in IVC filters can attest, this is not always the case. According to 21 CFR 807, manufacturers of medical devices such as IVC filters can apply for the 510(k) premarket program. Under this FDA program, manufacturers can put their products on the market with little to no testing if a similar product has already been tested and approved.
As a IVC filters lawyer knows, the purpose of this program is to allow companies to get their products into the hands of physicians sooner, therefore helping patients and potentially increasing their profits. However, this program comes with a lot of risk to manufacturers and patients alike.
Get Help from a Skilled IVC Filter Attorney
Learning that your IVC filter has failed or is at risk of malfunctioning can be frightening. The security and trust that this piece of equipment once provided may be replaced with feelings of disbelief and fear, and you may have even experienced complications and needed further surgery.
Fortunately, there are legal options available if you experience an IVC failure. An IVC filters lawyer could assess your medical records and speak with you regarding your situation to ascertain if you have a valid case. If so, you may be able to join a mass tort lawsuit with the help of a seasoned attorney. Call today to learn more.