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FDA warning for TVAM

Mar 15, 2017 | Surgical Errors

New York patients who have certain disorders of the nervous system should know that the Food and Drug Administration has issued a warning to avoid an experimental procedure that has been advertised as a treatment. The procedure entails using a tiny balloon to widen and improve the flow of blood in narrowed veins. It has been touted as a treatment for conditions like Parkinson’s disease and multiple sclerosis.

According to the FDA, there is no evidence that the procedure, transvascular autonomic modulation, is effective or safe. The method is similar to balloon angioplasty, which is typically used to unclog heart arteries. However, the FDA states in its warning that balloon angioplasty devices have not been approved for use in veins.

The FDA first issued a warning about the procedure in 2012 and said it has received one report of a balloon bursting in the jugular vein of a patient and getting stuck in a lung. There have also been reports of other complications, including nerve damage in the brain, abdominal bleeding, blood clots and at least one fatality.

The procedure has been promoted and tried in the United States, Italy and other countries as a remedy for multiple sclerosis, a disease that results in complicating with speech, memory and walking. Researchers in Canada reported that the results of a study that assessed the effectiveness of the procedure on 104 patients indicate that the treatment was no better than that of a mock one.

Patients who have been injured in a surgical procedure have been victims of medical malpractice. A medical malpractice attorney may pursue damages against any liable parties for surgical errors, such as forgotten equipment left inside of a patient, improper organ transplant, bowel perforations, wrong site surgery or pre-operative care errors.