FDA warns of dangerous vein procedure

Posted On March 15, 2017 Medical Malpractice by John Allen Phebus

Arizona patients who suffer from nervous system disorders such as Parkinson’s disease should be aware of a dangerous experimental procedure that is being promoted as a treatment. This procedure, called transvascular autonomic modulation, has been associated with at least one death and has resulted in multiple severe injuries.

This particular procedure has been promoted to be a treatment for some conditions, such as fibromyalgia and multiple sclerosis. For this procedure, a balloon is injected into veins that have narrowed with the goal of improving blood flow by widening them. According to the Food and Drug Administration, there is no evidence that suggests that the procedure actually works. In a warning that was made in mid March, the FDA said that this procedure was similar to balloon angioplasty, which uses a similar balloon to open heart arteries that may be clogged. However, even this procedure was not approved for use in veins.

A number of complications associated with the procedure have been reported. For example, there was at least one incident when a balloon caused a patient’s jugular vein to rupture before the device became stuck in a lung. Other patients suffered abdominal bleeding, nerve damage to the brain and blood clots.

If a doctor recommends a risky procedure that results in injuries or a worsened medical condition, a patient could potentially seek compensation for any damages that were sustained. A medical malpractice attorney may determine if the patient has a legitimate claim against the doctor. The attorney may also gather evidence, which could include expert witness testimony, that proves that the doctor was aware that the procedure was dangerous and not FDA-approved. After the lawsuit is filed, the attorney may negotiate a settlement out of court so that the patient can focus on recovering instead of worrying about litigation.