Inferior vena cava filters, or IVC filters as they’re more commonly known, are used to treat patients with blood-clotting disorders who don’t tolerate more traditional treatments, such as blood thinners. In these special cases, IVC filters can be a life-saving alternative. However, in recent months, IVC filters have been at the center of numerous lawsuits. Concerns about device migration, where the filter moves to other areas of the body, and partial migration, where a piece breaks off and migrates, have resulted in new warnings by the Food and Drug Administration (FDA). So, if you have an IVC filter, should you have it removed? Contact a Boston Defective Medical Products Lawyer Today.
Filters Should Be Removed as Soon as Possible
In response to numerous adverse event reports by patients claiming they were injured by the defective filters, the FDA updated its guidelines for device monitoring and removal. According to the agency, patients with an IVC blood filter should be closely monitored by their physician while the filter remains implanted. Furthermore, filters should be removed as soon as possible, based on the patient’s individual circumstances. In layman’s terms, this means that IVC filters should be removed the moment they are no longer medically necessary. More specifically, the FDA warns that IVC filters should be removed between the 29th and 54th day following implantation.
The Risk of Embolism
The FDA gave special attention to a problem called embolization, in which parts of the filter migrate to the patient’s lungs or heart. This potentially life-threatening condition is of great concern. In addition to the risk of puncturing vital organs and blood vessels, broken and fractured filters are also extremely difficult to remove. When migration and fracture occur, the removal process itself can be risky.
The main culprits in the IVC filter lawsuits are manufacturers Cook Medical and C.R. Bard.
The lawsuits claim defective design, failure to warn, negligence, and breach of implied warranty. In 2010, the FDA received more than 900 adverse event reports related to IVC filters. Included in those reports were 328 device migrations, 146 embolisms, 70 filter perforations, and 56 filter migrations.
Talk to Your Doctor
Long story short, the longer an IVC filter remains in a patient’s body, the higher the patient’s chance of experiencing an adverse event. Every patient’s circumstances are unique, but if you currently have an IVC filter implant, or are getting one, it is in your best interest to discuss the risks with your doctor. Continue reading