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.
“... We are warning patients and providers that the use of robotically-assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency, and therefore the survival benefits to patients, when compared to traditional surgery, have not been established,” said Terri Cornelison, MD, PhD, assistant director for the health of women in FDA’s Center for Devices and Radiological Health.
Cornelison said the agency is aware of scientific literature reporting that surgeons have been using robotically-assisted surgical devices for off-label uses.
"We want doctors and patients to be aware of the lack of evidence of safety and effectiveness for these uses so they can make better-informed decisions about their cancer treatment and care," he said.
The agency also noted that there have been reports of poor outcomes for patients, including one limited report that describes a potentially lower rate of long-term survival of long-term survival when surgeons and hospital systems use robotically-assisted surgical devices instead of traditional surgery for a hysterectomy in cases of cervical cancer.
FDA also said physicians should complete the appropriate training for the specific robotically-assisted surgical procedures performed. Doctors also should discuss the benefits, risks, and alternative procedure options with their patients to make informed treatment decisions, the agency said. Patients should ask their doctors about training, experience, and outcomes related to the use of robotically-assisted surgery, FDA said.