FDA Concern Over Experimental Uses of Balloon Angioplasty
On March 8, 2017 the U.S. Food and Drug Administration (FDA) issued a safety communication, alerting health care providers and patients considering treatment options for conditions causing autonomic dysfunction (such as Parkinson’s disease, multiple sclerosis, fibromyalgia, multiple system atrophy, postural tachycardia syndrome peripheral neuropathies, primary dysautonomia, and familial dysautonomia), of the risks associated with the experimental procedure called Transvascular Autonomic Modulation (TVAM). The FDA notes that even though this procedure is being promoted as a treatment for numerous conditions, it has not been formally studied in clinical trials and that the TVAM procedure uses balloon angioplasty devices outside their FDA-approved use.
The TVAM procedure involves inserting a catheter with an attached balloon into a patient’s venous system. The balloon is then inflated to widen the vein walls. The FDA states,
“There is no clear scientific evidence to support that the treatment of internal jugular venous stenosis: is safe in any patients, including those with autonomic dysfunction; impacts the symptoms of autonomic dysfunction; changes the overall course of health conditions derived from autonomic dysfunction; or improves the quality of life for patients with autonomic dysfunction.”
The FDA has received reports associating TVAM and other similar experimental procedures with serious complications, including a balloon migrating to a patient’s lungs after rupturing during placement in the patient’s jugular vein. The FDA is also aware of other serious complications associated with these procedures including at least one death, blood clots in a vein in the brain, cranial nerve damage, and abdominal bleeding.
The FDA recommends that health care providers and patients discuss the benefits and risks of all available treatments for autonomic dysfunction. Patients should be informed that TVAM is experimental and the FDA has not been presented with any evidence that balloon angioplasty devices are safe and effective when used in this procedure. Doctors should monitor patients who have undergone this procedure for potential complications such as excessive pain, discomfort, bruising, excessive bleeding from the puncture site, and stroke or stroke-like complications. Patients should immediately inform their health care provider if they suffer from any complications. For a full list of the FDA’s recommendations please see the full safety communication found on the FDA’s website.
If you or a loved one suffered injuries that you believe were caused by a Transvascular Autonomic Modulation or related procedure contact one of the experienced medical malpractice or medical device attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.