It was recently decided by an FDA administration panel that the agency is in support of a brain stimulating device being used to lessen the rate of seizures in epileptics. The panel voted on Friday, February 23, 2013, with the vote resulting in a unanimous 11-0 recommendation for the approval of the system. Two of the panelists abstained in voting during the panel meeting, the results of which were published in MedPage Today.
The device that was being voted upon is smaller and thinner than a defibrillator implant, and is battery-powered and programmable. The device, called an RNS System, is implanted just beneath the skull during surgery. The device works by triggering a short circuiting nerve cells in the part of the brain that causes seizures. One of the main benefits linked to the device is that it can be programmed differently in accordance with the patient’s changing medical needs over time.
“This is the first responsive neuro-stimulation system ever designed,” said Frank Fischer, president and CEO of Mountain View Calif.-based NeuroPace Inc., which developed the device. “Our long-term results show that patients have a reduction of 50 percent or more in their seizure frequency, compared to baseline, and a lessening of seizure severity.”
Epilepsy is a condition that affects millions of people worldwide. The condition is often treated with prescription drugs like Topamax, which is used to prevent seizures. However, the pills have been linked to serious side effects for babies whose mothers take them while pregnant, including PPHN, oral clefts, spina bifida and neural tube defects. The risks in taking Topamax are increased when doctors have to guess which dosage to use on patients in order to find the right one.
If your baby has suffered from birth defects after being exposed to Topamax in-utero, contact attorney Greg Jones today for a free consultation. I am experienced at fighting Topamax lawsuits and may be able to help you recover money for your child’s injury.