A new report by NBC News shows that C.R. Bard, manufacturers of the G2 series of IVC filters, may have known about the device’s potential risk. Yet, they did not take action to have the filters removed from the market.
The inferior vena cava (IVC) is one of the largest veins in the body, carrying deoxygenated blood to the heart. The IVC filter was created to prevent blood clots from reaching the lungs or the heart. The device resembles a small spider with metal prongs sticking out of it. On average, 250,000 filters are sold and used in the United States each year. One of the leading manufacturers of the device is C.R. Bard, who released the Recovery filters and the G2 series filters. Unfortunately, these devices have been linked to extensive injuries and even death.
NBC News recently found confidential records from the Bard company that documented the manufacturer’s concern over their device. Bard released the G2 series of IVC filters to replace their Recovery model. Records show that the company received reports of device failure and injury four months after it was approved by the Food and Drug Administration (FDA). Rather than recall the filters, Bard kept it on the market for another 5 years, selling over 160,000.
According to Bard and FDA reports, the G2 series of filters are connected to at least 12 deaths and hundreds of other injuries and defects. The major defect of the product lies in the prongs detaching and floating through the veins. If not caught in time, the filter part can reach vital organs like the lungs and heart.
More reports come in about patients who have suffered from the IVC filters. Dr. William Kuo, an interventional radiologist who operates the Stanford Health Care’s IVC Filter Clinic, has operated to remove broken filters in at least 1,000 patients in the last 10 years. In his experience, Bard’s medical devices have caused the majority of the problems. He states,
All of the data that we've seen in our own studies, as well as other clinician researchers', is that this device consistently fractures, consistently causes major complications… What we've learned the hard way is that we can no longer rely on medical device companies to do what's in the best interest of the patient. And we can no longer rely on the FDA to properly regulate these device.
Iowa Senator Charles Grassley recently sent the FDA a letter highlighting his concerns over the IVC filter. The FDA declined to answer.
At Bailey Cowan Heckaman PLLC, we believe that manufacturers should be held accountable for the products they release on the market. If you or a loved one has suffered serious injuries because of your IVC filter, contact our Houston office. We help clients nationwide fight suits against IVC filter injuries. Contact our medical device attorneys today for a free consultation!