The FDA has doubled down on warnings regarding balloon angioplasty. Proposed as a treatment for multiple sclerosis, the surgical use of balloons in the jugular vein has been deemed risky at best. Keep reading or follow the original story here to learn more.
Also known as transvascular autonomic modulation, angioplasty of the jugular vein is an experimental treatment. In balloon angioplasties, an uninflated balloon is inserted into an obstructed vessel and expanded to increase blood flow or bypass an obstruction.
The FDA approved balloon angioplasty devices for use in arteries. Using the same devices in the venous system has, however, been marked unsafe. There is neither proof for patient safety or positive results according to the FDA. The only supported evidence points to the procedure’s risks.
FDA warnings about these procedures began in 2012. The agency issue cautions to multiple sclerosis patients. A similar treatment had been tested to treat what was being called chronic cerebrospinal venous insufficiency. The treatment carried significant risks with no provable benefits. Paolo Zamboni, MD, associated with the University of Ferrara in Italy, first submitted the vascular hypothesis for multiple sclerosis. This hypothesis has since been almost completely discredited by negative studies.
Certain supporters of the balloon angioplasty procedure have continued despite FDA warnings. The FDA noted Michael Arata, MD, of Synergy Health Concepts who continues to conduct studies despite being warned by letter in 2012. Arata’s research is, as a result, unauthorized. The FDA began steps to block his access to the questionable devices in September of 2016 after he conducted a research study without FDA review and approval.
As of the 2012 safety communication, the FDA received several notices of dangerous procedures. At least one report detailed a balloon rupturing while being placed in a patient’s jugular vein. After examination, doctors were able to locate the balloon. It migrated tot he patient’s lung. The device then required a surgical procedure to remove it.
That’s just the beginning of FDA reports. Other complications as a result of the unapproved devices include death, blood clots in the brain, abdominal bleeding, and cranial nerve damage.
For further information, you can also read the follow up article presented with the original story on Medpage Today.
To read more about multiple sclerosis, click here.