It would not be the first time a medical device wound up causing the same problems it was designed to prevent. Case in point: inferior vena cava (IVC) filters, which are now causing deep vein thrombosis – a condition they were designed to prevent.
Patients who have undergone joint replacements face the danger of blood clots traveling up the major vein that carries deoxygenated blood from the lower extremities to the heart. If a clot blocks blood flow to the heart or lungs, the patient can suffer a debilitating stroke. The filter itself is a small, cage-like device, resembling a common cellar spider. It is inserted into the inferior vena cava in order to trap these clots and prevent them from entering the heart or pulmonary system.
This device was intended to be a temporary measure for patients who cannot tolerate anticoagulant medication (such as Xarelto). However, two problems have become apparent. First, IVC filters are prone to breakage, allowing small metal pieces to travel through the cardiovascular system and become lodged in tissues and puncture internal organs, with potentially fatal consequences. Secondly, the devices are very difficult to remove. One physician, Dr. William Kuo of Stanford University, has developed a procedure to successfully remove the device. However, it remains an extremely specialized skill, and very few surgeons are qualified to carry out this high-risk procedure. According to Kuo, “Every filter patient is unique, and thus the treatment must be meticulously planned and personalized to fit the patient.”
In the meantime, there has been an alarming increase in the number of patients who are suffering DVT because of defective IVC filters. Metal fragments, or even the device itself, can enter the heart muscle, causing an embolism.
IVC filters first came onto the market in 1979 – yet it took over 30 years for the FDA to issue its first warning about the device, only after lawsuits listing IVC filter-related injuries as a cause of action began emerging. During that time, the regulatory agency received over 900 reports of injuries and complications involving the device. At the end of 2015, NBC news released an investigative report exposing criminal fraud on the part of IVC manufacturer C.R. Bard. That report revealed that company executives were aware of the dangers of the product, and were willing to falsify documents in order to win FDA approval.