The Monteris Medical, Inc. NeuroBlate System Brain Ablation Device – What You Should Know
A variety of medical conditions may require the use of an intracranial ablation device, such as tumors and lesions that may need to be removed from a person’s brain. An intracranial ablation device is one that utilizes a laser probe, MRI imagining, and a heating system to remove tissue from the brain. For example, a doctor may recommend a patient with a brain tumor undergo a procedure with the use of an intracranial ablation device to perform laser thermotherapy as opposed to traditional invasive brain surgery. The procedure is guided by MRI, so patients not only must be good candidates for the device itself but also must be able to handle MRI imaging.
In the past year, some medical device manufacturers have been under fire for patient injuries sustained because of defective intracranial brain ablation devices. For example, Monteris Medical, Inc., the manufacturer of the NeuroBlate System, a brain ablation device, faced a Class I recall by the FDA, effectively telling patients and doctors that the device may cause injuries or death to patients. In particular, one patient suffered a fatal intracranial hemorrhage following a procedure involving the use of the NeuroBlate System. This patient’s story was included in the FDA’s Class I recall notice.
What is the Monteris Medical NeuroBlate System?
According to the Monteris website, Monteris’ Medical NeuroBlate System is a minimally invasive medical device used to remove lesions in the brain, including tumors that may be cancerous. The NeuroBlate System is unlike a standard brain surgery that requires a large opening in a patient’s skull. Rather, the NeuroBlate System only requires that a small opening in the brain be made so that a laser probe has enough room to make contact with brain tissue. The laser, through an adequate amount of heat, removes the affected brain tissue that is thought to be malignant or dangerous in some way. The probe of the NeuroBlate System is intended to deliver just the right amount of heat to destroy the affected tissue. Additionally, the NeuroBlate System requires the use of MRI so that the surgeon can specifically visualize what he or she is doing.
While the NeuroBlate System is minimally invasive, it is not without dangers. The probe of the device has been linked to unintended overheating that raised concerns not only with Monteris, the manufacturer of the medical device, but also with the United States Food and Drug Administration (FDA). After the FDA issued a Class I recall specific to the NeuroBlate System’s probe, Monteris designed a new component that is non-metallic to avoid unintended overheating. However, this new component is not yet available, and it is unclear whether the new component will prevent unintended overheating in the future.
Injuries Associated with the Monteris Medical NeuroBlate System
The FDA’s recall of the NeuroBlate System in early 2018 demonstrates that there are serious risks associated with the medical device. Because of unintended overheating, patients are at risk for suffering the following injuries:
- Damage to healthy brain tissue;
- Intracranial hemorrhaging (bleeding in the brain);
- Permanent brain damage;
- Substantial physical and mental pain;
- Failure of the device to remove the affected or damaged brain tissue; and Death
While all medical devices carry risks, Monteris Medical did not predict that the probe would overheat unintentionally and thereby cause serious and potentially fatal injuries. The death of one patient resulted in significant concerns both within Monteris and with the FDA. The patient suffered intracranial hemorrhaging (bleeding) which subsequently resulted in the patient’s untimely death.
Have You Been Injured by the Monteris Medical NeuroBlate System?
If you believe you have suffered an injury related to the use of the Monteris Medical NeuroBlate System, you should consider speaking with a Defective Medical Device Lawyer. While injuries can happen whether a medical device is defective or not, because the FDA has alerted patients and physicians about the risk of injury or death associated with the NeuroBlate System, it is well worth your time to discuss your situation with a lawyer. By speaking with a lawyer, you will have a better understanding of what legal options are available to you.
For example, if your injuries can be linked to the use of the Monteris NeuroBlate System, you may have a viable lawsuit against Monteris Medical, and potentially against the surgeon who performed the operation using the NeuroBlate System (i.e., if the surgeon used the device after the FDA issued a Class I recall and did not inform the patient about the FDA recall). Depending on where you were injured and where you live, a lawyer may recommend that you file a lawsuit against Monteris. Some lawsuits often settle out of court, and in some situations, some potential legal claims can be settled before filing a lawsuit. However, given that all situations are different, it is best to follow the advice of a highly qualified Defective Medical Device Lawyer who handles complicated product liability cases on a regular basis.
Contact Parker Waichman LLP Today to Schedule a Free Consultation
If you underwent a procedure involving the Monteris Medical NeuroBlate System and subsequently sustained injuries, such as soft tissue damage to the brain, you may have a potential lawsuit and could be eligible for compensation. At Parker Waichman LLP, we employ highly skilled Defective Medical Device Lawyers who routinely help injured victims obtain compensation for their injuries. To find out if you have a potential NeuroBlate System Lawsuit, contact Parker Waichman LLP today by calling 1-800-YOUR-LAWYER (1-800-968-7529) to receive your free consultation.
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