FDA Issues Warning on Dangers of Libation Therapy
The U.S. Food and Drug Administration is warning about injuries and death associated with the use of an experimental procedure often called “libation therapy” or “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).
Some researchers believe that CCSVI may cause multiple sclerosis (MS). They also speculate that it may contribute to the progression of the disease by impairing blood drainage from the brain and upper spinal cord. Studies that searched for a link between MS and CCSVI are inconclusive and the criteria used to diagnose CCSVI have not been adequately established.
Libation Therapy uses balloon angioplasty devices or stents to widen narrowed veins in the neck and chest. The FDA has learned of stroke, death, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the experimental procedure.
Balloon angioplasty devices and stents have not been approved by the FDA to be used as treatments for CCSVI.
If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you. Call us today at (800)-561-7154.