CCSVI Treatment On FDA Alert List As Potentially Deadly

FDA Alert on Liberation Therapy For CCSVI

does ccsvi cause ms/ recalled drugs/fda alertsExperimental procedure referred to as “liberation therapy” or “liberation procedure” used in the treatment of chronic cerebrospinal venous insufficiency (CCSVI) is on the U.S. Food and Drug Administration alert list.  Health care professionals and patients are being warned about injuries and deaths linked to the use of the procedure.

CCSVI, which causes the veins in the neck and chest to narrow, some researchers believe, may cause multiple sclerosis (MS) or add to the increase chance of getting MS by adversely influencing the blood drainage from the brain and the spinal cord.  Studies investigating the connection between CCSVI and MS have been obscure and even the criteria used in diagnosing CCSVI have been questionable and not clearly established.

MS is an immune-mediated disorder of  the spinal cord and brain and progresses over time.  With MS nerve fibers are damaged in the brain and spinal cord which result in significant disabling neurological symptoms, however the cause of this is unknown.

 “Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously-conducted, properly-targeted research to evaluate the relationship between CCSVI and MS,” said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health. “Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist or other physician who is familiar with MS and CCSVI, including the CCSVI procedures and their outcomes.”
Liberation therapy  is an experimental procedure that uses balloon angioplasty devices and stents to try to widen the narrowed veins of the neck and chest.  This procedure has been found by the FDA to cause death, stroke blood clots, abdominal bleeding, damage to the treated veins and cranial nerve damage.  Also, the FDA has never even approved balloon angioplasty devices and stents as treatment for CCSVI.
The FDA alert notifies investigators and doctors who are planning on running clinical trials on the use of medical devices and stents to treat CCSVI that they must first have FDA approval and comply with all FDA regulations.

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