The US Food and Drug Administration (FDA) recently issued an alert, warning health care professionals and patients about injuries and death linked to the use of an experimental procedure, occasionally referred to as “liberation therapy” or the “liberation procedure.” The procedure is designed to treat chronic cerebrospinal venous insufficiency (CCSVI), which some researchers report may cause multiple sclerosis (MS) or may facilitate the diseases’ progression.
However, William Maisel, MD, MPH, chief deputy director for science in the FDA’s Center for Devices and Radiological Health, cautions that, “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.” He adds that patients should discuss the procedure’s risks and benefits with a neurologist or other physician who is familiar with MS, CCSVI, and CCSVI procedures and their outcomes.
According to an FDA news release, the experimental procedure uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. The FDA reports that is has learned of various risks associated with the procedure, which include death, stroke, detachment, migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding.
The release also notes that the FDA is notifying physicians and clinical investigators who plan to or are conducting clinical trials encompassing the use of medical devices to treat CCSVI that the investigational devices must comply with FDA regulations. The FDA emphasizes that it will continue to monitor reports of risks linked to “liberation therapy” or the “liberation procedure.”