While many medical products are safe, there are times when situations occur that present a high level of concern for medical professionals and government regulators. Such is the case with the United States Food and Drug Administration (FDA), which recently chose to issue a Class 1 recall regarding 50 NeuroBlate brain probes. Designed to be used with MRI-guided brain surgery, the purpose of the devices is to allow surgeons to burn away brain lesions and cancer cells associated with cancer or other serious conditions.
However, due to recent issues concerning patients on whom the device was used, including one death potentially linked to the device, the FDA chose to issue the Class 1 recall, which is the most serious recall the agency can issue, as it points to potentially serious problems or deaths linked to the device. But despite the concerns from the FDA, the agency is currently choosing to classify this as a voluntary recall, meaning there are no plans at this time to remove the products from the field.
Prior to the FDA NeuroBlate recall, the probe’s manufacturer, Monteris Medical, issued three product advisories to doctors regarding possible issues with the devices. However, as several additional problems arose after the advisories were sent out, the FDA issued the Class 1 recall as well as “Dear Health Care Provider” letters, which are intended to let health care professionals know the agency believes the manufacturer’s advisories did not sufficiently explain the potential risks associated with the product.
According to the FDA, since there are a number of concerns about the use of this product, surgeons are advised by the agency to consider using alternative treatment methods that are known to be safe and effective. Meanwhile, Monteris Medical is attempting to gather additional information about its product by conducting simulated-use testing, hoping this will identify any possible problems with the units and allow its engineers to make the necessary corrections.
Based on prior issues that have been linked to the product, the FDA has narrowed the problem to one that deals with overheating. According to data from the FDA, the probe can become overheated during the process of burning away brain lesions due to it being used in conjunction with the MRI unit. As a result of the potential overheating, unexpected tissue damage can occur within the patient’s brain, leading to severe complications or death.
Having been used in almost 1,800 various procedures, the NeuroBlate device has had 12 procedures in which problems with overheating led to issues with patients. For example, one patient had what was termed “limited thermal damage” to brain tissue located near the probe, while in a second case a patient died from a intracranial hemorrhage upon having the probe used on them. However, doctors were not able to independently confirm that the patient’s death was directly associated with the probe, stating there was insufficient medical evidence.
Even though there are concerns associated with the use of the probe, the FDA NeuroBlate recall has not stopped most doctors from using the probe to conduct various procedures dealing with the elimination of brain lesions. But for others who fear the possibility of medical malpractice lawsuits being levied against them for using the NeuroBlate, alternative medical treatments are being used instead. No matter which path doctors choose to pursue regarding the use of this probe, it’s clear the FDA as well as Monteris Medical are still in the early stages of gathering data that can be properly analyzed to reach a sound conclusion. In the meantime, common sense and good judgement on the part of doctors will need to prevail.
Learn more about Medical Device Recalls.