FDA Cautions Against the Off Label Use of Surgical Robotics for Cancers
Off-label use medical device use is a tricky subject and one that has been at the center of many heated debates. It is strictly against the law for manufacturers to promote their products for off-label use, however, physicians have the discretion to use a device in an off-label manner if such use might be beneficial to the patient.
One area where this practice has become particularly touchy is robotically-assisted surgery. FDA issued a safety note Thursday to doctors and patients urging caution when using robotically-assisted surgical devices for mastectomy and other cancer-related surgeries.