Minimally invasive procedures are designed to reduce surgical risks for patients. Unfortunately, in one type of surgery used to treat epilepsy, defective medical devices used during the operations are harming patients and causing permanent damage. In April 2018, the U.S. Food and Drug Administration (FDA) warned patients and doctors that a device used in minimally invasive epilepsy surgery was subject to a Class I recall, the most serious type of recall issued by the FDA. The situation is even more tragic, because minimally invasive epilepsy surgeries are often performed on children.
MRI Guided Laser Surgery For Epilepsy
Epilepsy is a disorder in which an individual suffers repeated seizures. Epilepsy has a wide variety of causes, but in some patients, lesions on the brain cause the seizures. Until recently, operating on the brain has been extremely dangerous, but advances in technology have allowed for the removal of these lesions through minimally invasive procedures. In 2010, Texas Children’s Hospital became the first hospital in the world to use magnetic resonance imaging (MRI) in real time to guide the insertion of catheters into the brain to remove lesions. The operation works by inserting catheter probes into the brain, which are positioned with the help of real-time MRI data. The probes then deliver controlled thermal energy to the lesions to destroy them. The real-time MRI data also reports temperatures inside the brain via the probe.
The NeuroBlate System and Laser Delivery Probes
The NeuroBlate System and Laser Delivery Probes is a medical devices manufactured by Monteris Medical to perform minimally invasive epilepsy surgeries. The NeuroBlate System is designed to remove, thicken or solidify, or destroy cells in the brain tissue. The system relies on real-time MRI scans to guide probes and map out brain lesions, and the FDA has received reports that MRI systems can negatively interact with the Laser Delivery Probes.
In some instances, interaction between MRI systems and the Laser Delivery Probes has caused unexpected heating and damage to the probes. This can heat the surrounding brain tissue, causing injury, or allow the carbon dioxide cooling gas inside the probe to leak into the brain. According to the FDA, Medical Device Reports (MDRs), and other literature, adverse events follow, including “neurological deficits (e.g., focal motor deficits, aphasia, cognitive changes), increased intracerebral edema or pressure, intracranial bleeding, and/or visual changes (e.g., visual field deficits, blurry vision), when these devices were used to treat intra-cranial lesions.” The FDA goes on to warn, “Several of these reports note events which required urgent medical and/or surgical intervention, and may have been associated with patient deaths.”
Manufacturer Duty To Produce A Safe Device
Medical device manufactures have a huge responsibility to make sure their products are safe for use. While many manufactures meet this responsibility, others do not. Monteris Medical created a defective product; and, unfortunately, patients had to discover the defect and suffer its harmful consequences. Patients harmed by the NeuroBlate System suffered serious injuries, including permanent physical damages and even death. Monteris Medical needs to be held accountable for the injuries they have caused.
Get Help Today
If your child underwent minimally invasive epilepsy surgery and suffered an injury or complication, don’t wait to call Blizzard Law today. Our lawyers have a long track record of holding negligent medical device companies accountable, and we can explain your legal rights. Contact us today to schedule an appointment with one of our dedicated trial attorneys. Our consultations are free, and we work on a contingency fee basis, meaning there is no upfront cost for working with us, and you won’t owe us anything unless we help you obtain compensation.