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FDA issues warning about unsafe, ineffective vein procedure

Medical errors can occur during even the most routine surgical procedures, ones that are safely performed thousands of other times. There are other situations, however, when the procedure itself is dangerous, unproven and not worth the risk.

The Food and Drug Administration issued a warning this month about one of these procedures. The FDA warns doctors and patients to avoid an experimental procedure called transvascular autonomic modulation (TVAM), stating there is no evidence that it is safe or effective.

TVAM involves inflating a tiny balloon in narrow veins to widen them and improve blood flow. The procedure has been promoted as a treatment for nervous system disorders, such as Parkinson's disease, multiple sclerosis and fibromyalgia. Trails and studies of TVAM have occurred throughout the United States, in Italy and in Canada.

According to the FDA, balloon angioplasty devices have not been approved for use in veins - and that might be for good reason. The FDA received one report of a balloon rupturing in a patient's jugular vein and moving into the lung. Other reports have included abdominal bleeding, blood clots, nerve damage to the brain and at least one death.

The FDA first issued a warning about TVAM in 2012. Since then many surgeons have stopped using the procedure, but some still persist. The FDA has taken action against one physician in California who was "performing the experimental procedure on patients without approval to conduct a trial." The case is still pending.

If you suffered injury due to the complications of a surgical procedure - experimental or routine - you could be entitled to monetary damages. Contact an attorney to discuss your legal options.

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