For consumers with multiple sclerosis (MS), the so-called “liberation therapy” seemed like a magic bullet. Not so fast, says the U.S. Food and Drug Administration (FDA). The FDA recently issued an alert warning about injuries and deaths associated with the use of the liberation procedure to treat MS.
Liberation therapy was developed to treat chronic cerebrospinal venous insufficiency (CCSVI). Some physicians think CCSVI, which is characterized by narrowing of blood vessels in the neck and chest, can cause or contribute to MS. However, no medical study has conclusively linked the two conditions.
Since the procedure is considered experimental, health care providers who perform it must carefully and thoroughly explain its experimental nature, the lack of data supporting clear benefits and the significant risks. For consumers considering this procedure, full disclosure is critical to informed consent.
Risks of the procedure include death, stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the procedure. The treating physician should also disclose that the balloon angioplasty devices and stents used in the procedure have not been approved by the FDA for use in treating CCSVI. Only one clinic in Ohio currently performs the procedure, so its use has not become widespread locally. But like many lucrative procedures, it is probably only a matter of time before more physicians offer the treatment to their desperate patients.