FDA Warns of Risks With “Liberation Procedure”
This morning, the FDA has finally stepped in and is warning healthcare professionals and MS patients alike about death and other injuries associated with the so-called “liberation procedure” (ugh), which amounts to either angioplasty or stenting of (typically) jugular veins. The procedure, which is ostensibly designed to promote the egress of blood flow from the brain, has no basis for use, because there is no confirmed link between chronic cerebrospinal venous insufficiency (CCSVI) and multiple sclerosis. For background on this ever-vexing issue, start here.
The FDA has received reports of associated adverse events, which include “death,
stroke, detachment and migration of the stents, damage to the treated
vein, blood clots, cranial nerve damage and abdominal bleeding.” In February, the agency sent a letter to a NY vascular surgeon, warning of “objectionable conditions” and the lack of regulatory protocol and oversight for what amounts to an investigational (ie, non-FDA-approved) procedure.