You may have seen reports of IVC filters in the news. Maybe you have have read about them on our website or others. IVC filters, or inferior vena cava filters, are put in the body to prevent deep venous thrombosis from reaching the lungs and heart. Should one of these reach the lungs, the person could suffer a primary embolism.
Currently, there are about 50,000 patients with IVC filters in the United States. They are widely used in patients who have suffered a pulmonary embolism. IVC filters are used as a preventive measure. They are typically used in this manner with anticoagulation therapy. Despite their popular use, the effectiveness of these filters has been called to question.
When IVC filters work properly they are helpful. The issues begin when the filter migrates. Filters are held in place by a hook that is placed in a vein. In some instances, this hook has failed, and the filter has tipped or strayed from its place of implantation. The filter causes damage as it moves, puncturing veins and organs along its route.
As if this wasn’t dangerous enough, some of these filters have been known to fracture. When they do, the small pieces they turn into travel throughout the body. Much like a blood clot, if one of these pieces enters the brain, heart or lungs, they can cause serious damage and may prove fatal.
Surgeons know that these filters can cause problems, and removable filters have been created. While these may seem safer, and often are, the removal process itself can be difficult. In some instances, the removal process may fail, leaving behind a filter that is no longer supposed to be in the body. Doctors are also aware of these problems and may opt to leave a filter behind. The numbers say that only about 1/3 of implanted removable filters are actually taken from the patient’s body. After five years of implantation, the risk of a removable filter fracturing rises to 40 percent.
The complications of IVC filters are grouped into three categories: Procedural, retrieval and delayed.
In 2016, the FDA issued an official communication to medical practitioners who implant IVC filters. The safety communication was also released to patients with the filters. The agency advised that the filter should be considered for removal as soon as the patient was no longer at risk for pulmonary embolism. The agency went so far as to say that removal should be considered between 29 and 54 days after implantation to minimize risk.
The FDA made a determination that reported complications such as filter fracture, blood clot filter migration and difficulty removing the filter may have been eliminated if the filters involved had been removed sooner. Device manufacturers were ordered to collect more data regarding the use of these filters in patients.
IVC filters were recalled as early as 2005. A Class 2 device recall was issued this year. Boston Scientific, creators of the Greenfield Vena Cava Filter, issued an urgent recall notice advising customers to discontinue use of the product immediately. They specifically warned of the possible adverse health conditions.
Another recall was issued in 2013 by the FDA. This recall named a model manufactured by the Cordis Corporation and covered approximately 33,000 units. The FDA states that the reason for the recall was due to a labeling correction.
Patients whose doctors recommend IVC filters should inquire about alternative options. In some cases, prescription medications can prevent blood clots. A change in lifestyle can also help. Those changes include low-sodium diets, smoking cessation and lowered stress. While these options may not benefit all patients, they are certainly worth exploring.
When an IVC filter is deemed to be the only option, speak to your medical provider at length about complications and what to watch for. Make a plan for the removal of your filter, and be honest about your concerns. You are your own healthcare advocate, and you deserve to have all the information available in order to make an informed decision.
Contact an IVC Filter Class Action Attorney Today
If you have had an IVC filter implanted and have suffered with complications, our experienced team of personal injury attorneys is here for you. Reach out to our team at our Fort Lauderdale office today for more information on taking part in a class action lawsuit or filing suit on your own. We can provide you with your legal options and help you make the best decisions for your unique situation.