Liberation Therapy Procedure for MS Linked to Death, Injuries: FDA

Federal health officials are warning about the unproven and sometimes deadly side effect of liberation therapy, which is an experimental procedure used to treat multiple sclerosis (MS).

According to an FDA safety communication issued on May 10, individuals with MS, their families and medical providers are being warned that liberation procedures have been associated with a risk of serious injury or death.

At least one person has died and another has been left permanently paralyzed after undergoing liberation therapy, which uses stents to open up veins that may be constricted.

The treatment is based off of the belief that MS could be caused by a condition known as chronic cerebrospinal venous insufficiency (CCSVI), which is described as a narrowing of neck and chest veins. To treat CCSVI, stents or balloon angioplasty devices are inserted in the internal jugular or azygos veins to widen them.

The FDA warns that not only are the links between MS and CCSVI inconclusive, but there is not even clear evidence that CCSVI is a real condition. The narrowing of veins seen on imaging tests are seen in normal, healthy people, according to the FDA, and could just be normal variations.

Liberation therapy, which is also referred to as a liberation procedure, has no proven record of helping MS patients, alleviating their symptoms or improving their quality of life, the FDA warns, and stent placement in some cases can worsen vein narrowing due to the body’s reaction to the placement of foreign objects in the veins.

“The benefits of these experimental procedures have not been proven,” the FDA warned,” and their promotion as a treatment for MS may lead people with the disease to make treatment decisions without being aware of the serious risks involved.”

The one known death associated with the procedure was caused by a patient who died from bleeding in the brain. Another was permanently paralyzed by a stroke. Other complications linked to liberation therapy include stents migrating from where they were implanted to other parts of the body, including the heart, blood clots, venous injury, cranial nerve damage and abdominal bleeding.

The FDA has issued a warning letter to Dr. Manish Mehta of Vascular Group PLLC of Albany, New York. Vascular Group, according to the FDA, is sponsoring a clinical study of CCSVI without approval from the FDA’s Investigational Device Exemption (IDE) program, which ensures the safety of patients taking part in the testing of potentially risky medical devices and procedures. As a result, the study has been voluntarily shut down.