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Over the years, professionals in the medical field have been working to improve the current models of IVC filters available to patients to decrease health risks associated with the procedure. Since their introduction in 1973 and their FDA approval in 2003, the IVC filter has undergone several adaptations according to reported problems with IVC filter placements, resulting in a handful of different models to choose from today.
Understanding the risks and benefits associated with each type of filter can help patients make an informed decision with their doctors before having an IVC filter placed. The type of IVC filter your doctor chooses will depend on if the patient requires a permanent or temporary solution, determined by the patient’s level of risk for pulmonary embolism (PE), caused by blood clots in the lungs or heart.
There are currently six different manufacturers of IVC filters in the United States that have been approved by the FDA, but C.R. Bard Inc. (Covington, GA) and Cook Inc. (Bloomington, IN) filters are those most commonly used.
Bard filters are all made out of Nitinol, a nickel titanium alloy. Bard removable filters are the main models of temporary IVC filters used in patients today. Over 260,000 people are fitted with IVC filters annually, with tens of thousands using Bard filters. Removable Bard filters have been related to filter fracture (70%), perforation (69%), device migration (64%), and other adverse affects (50%), from 2004-2008.
The FDA issued a warning letter to Bard in 2015, indicating that certain IVC filter systems were not FDA approved, that complaints against their G2, G2x, and Eclipse filters were not property evaluated, and that Bard had not reported information regarding instances of device malfunction or potential cause of injury or death.
Researchers have also questioned the safety of Cook Inc. IVC filters, and the manufacturers were held liable for injuries and failures, including perforation and migration – leading to serious injury and even death.
Other IVC filter manufacturers, such as Cordis Corp. and Boston Scientific, have only created a couple of different filter models, and do not have enough significant evidence to either support or disprove cases of negative effects and adverse reactions.
Each manufacturer has created multiple models of IVC filters in an effort to steadily improve the technology involved. Bard Inc. and Cook Inc. have the widest variety of model types currently available, with Bard being the leading IVC filter brand. Each type of IVC filter comes with its own placement and removal procedures, as well as its own set of risks.
Bard IVC filters have one permanent model, the Simon Nitinol, which has been FDA approved, and six removable filter models:
The most recent Bard model is the Denali, which boasts advanced filter technology to help prevent movement, tilt, and penetration. The Denali filter has been part of the largest and longest filter study, with relatively positive results compared to previous Bard models. However, it has been in use for a lesser amount of time than its counterparts and has not yet been approved by the FDA.
Understanding the risks and benefits associated with each model of IVC filter can grant patients a more educated decision on which, if any, filter is right for them. IVC filters have taken great strides toward reducing PE and PE-related deaths, but there are still serious health risks associated with each IVC filter model to date. At Sweeney Merrigan Law, we know how scary an IVC filter-related health issue can be. Let our attorneys use their years of experience caring for clients suffering from health effects to help you with your case.
