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Concerning the Dangers of Transvascular Autonomic Modulation

In recent years, a controversial medical procedure has been touted for the treatment of multiple sclerosis, Parkinson's disease, and other nervous system disorders. Called transvascular autonomic modulation (TVAM), the treatment involves the insertion of a balloon catheter into a vein. Proponents of the procedure claim beneficial effects from increased blood flow and stimulation of the nerves in the area around the balloon catheter.

However, the U.S. Food and Drug Administration (FDA) has issued a warning about the dangers of TVAM, and it notes that there is "no clear scientific evidence" to show that the procedure is effective.

Why Did the FDA Issue Its Warning?

Balloon catheters have been used to treat arteriosclerosis (hardening of the arteries) for many years. In this procedure, a tiny balloon is inserted into an artery and then inflated, stretching the artery and increasing blood flow. TVAM employs a balloon catheter that is inserted into a vein, not an artery. The FDA has approved the use of balloon catheters in arteries, but not in veins.

The FDA first issued a warning about TVAM in 2012 and re-issued a warning earlier this year. The agency notes that it has received a report of a balloon rupturing in a vein and eventually lodging in the patient's lung.

But is TVAM effective? Patients suffering from diseases such as multiple sclerosis, Parkinson's disease, fibromyalgia, multiple system atrophy, and other autonomic dysfunctions, certainly hope it is. But as regards TVAM, they are likely to be disappointed. A study conducted by researchers at the University of British Columbia and Vancouver Coastal Health showed that 104 multiple sclerosis patients who underwent TVAM procedures fared no better than a control group that received a placebo treatment.

The Risks of TVAM

Patients who undergo a TVAM treatment face a number of very serious and potentially fatal risks, including:

  • Blood clots
  • Abdominal bleeding
  • Migration of the balloon device
  • Cranial nerve damage
  • Stroke

Less serious complications include pain, bruising and excessive bleeding at the puncture site. Any person who has undergone TVAM treatment should be closely monitored.

If you or a loved one has been harmed after undergoing a TVAM procedure, you may be eligible for compensation. You should speak with an experienced medical malpractice attorney to learn about your legal options.

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