Tennessee NeuroBlate Probe Lawyer
Brain surgery is one of the most complex medical procedures a person can undergo. Given the inherent risk for permanent brain damage or death, surgeons must exercise great care in selecting and using instruments designed to treat brain tumors. And if there is any reason to believe these tools are dangerous or defective in design, they need to be pulled from the market without delay.
This is exactly what the U.S. Food and Drug Administration (FDA) recently did with respect to the NeuroBalte probe produced by Monteris Medical. NeuroBlate is part of a larger surgical system produced by Monteris to remove, thicken or solidify, or destroy cells in brain tissue such as tumors. The NeuroBlate probate itself is a set of small, carbon dioxide-cooled catheters that allow the surgeon minimally invasive access to the patient’s brain tissue.
Unfortunately, the FDA issued a Class I recall for the NeuroBlate probe in March 2018. This is the strictest form of regulatory recall available under federal law. The FDA said it was compelled to act after Monteris Medical’s previous efforts at a voluntary recall failed to “significantly mitigate” the safety hazard posed by the NeuroBalte probe.
If you, or someone in your family, has sustained serious injury as the result of a defective NeuroBlate probe, you may be entitled to seek compensation from Monteris Medical and other parties. The qualified Tennessee NeuroBlate probe lawyers at Fox & Farley can review your case and help you decide what legal action may be appropriate.
Why Did the FDA Issue a Class I Recall?
The main problem with the NeuroBlate probe is easy to explain: the FDA received multiple reports where the devices overheated while inside a patient’s brain, causing “unintended damage” to the surrounding tissue. The FDA also found that when the probes overheated, some of the carbon dioxide gas used to cool the system also leaked into the patient’s brain. In at least one case, the FDA said a patient suffered “an intracranial hemorrhage and died” after a NeuroBlate probe overheated.
Given the risk of significant danger of death or serious injury, the FDA issued a Class I recall. This is the most urgent category of recall. In a letter to healthcare providers, the FDA said doctors “should strongly consider patients using alternative procedures” to the NeuroBlate probes. And if there are no “viable alternatives” for treatment, providers should still proceed “with extreme caution” in using the recalled devices.
Call Fox & Farley Today to Learn About Your Legal Options
If your healthcare provider has used the NeuroBlate probe following the recall–or you were injured by the devices beforehand–you should speak with an experienced Tennessee defective medical device lawyer as soon as possible. These types of personal injury claims are inherently complex. The mere fact the FDA issued a recall does not mean you are automatically entitled to damages. But it does put you on-notice that you need to seriously consider your legal options.
The attorneys at Fox & Farley can help. We serve clients in Knoxville and throughout Tennessee. Call us today at 866-862-4855 to schedule a free, no-obligation consultation.