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FDA warns about dangers of experimental procedure

Oklahoma residents may be interested to learn that, on March 8, the Food and Drug Administration warned that an experimental procedure that was being promoted as a potential treatment showed no evidence that it was safe or effective. The procedure, called transvascular autonomic modulation, involves inflating a small balloon into narrowed veins to try and improve blood flow.

The FDA had initially warned doctors and patients of the procedure in 2012. This warning occurred after there was a report that a balloon caused an injury to a patient’s jugular vein. The balloon also reportedly became lodged in the patient’s lung. There were also other reports of injuries that included nerve damage in the brain, blood clots and abdominal bleeding. One death was also attributed to the experimental procedure.

Although the procedure has been promoted to help treat certain disorders, like multiple sclerosis and Parkinson’s disease, a study showed that patients who were given the treatment fared no better than patients who were given a sham treatment. The FDA did note that it was taking action against the researcher for performing the experimental treatment on patients without prior approval due to the risks associated with it.

When people are diagnosed with a condition that requires treatment, they trust their doctor to provide them with appropriate options that may give them the best outcome. If a doctor does not disclose all of the risks of a procedure and this leads to a worsened medical condition, a medical malpractice attorney may file a lawsuit against both the doctor and the hospital where the procedure took place. The attorney may provide evidence that the risks of the procedure were well known.