The FDA reminded patients and providers that it has not yet approved any robotic system for cancer-related surgeries—specifically mastectomies—and has not established the survival benefits and risks compared to traditional surgical procedures.
The agency’s safety communication is in response to reports in the scientific literature and elsewhere, including in the media and promotional materials, that describe surgeons and hospital systems that use robotically assisted surgical devices for mastectomy.
In particular, the FDA said it was aware of some peer-reviewed publications reporting poor patient outcomes, including one limited report published in the New England Journal of Medicine last November describing lower long-term disease-free survival in robot-assisted hysterectomies for cervical cancer. The agency also said it has received a small number of medical device injury reports following cancer-related procedures.
“Our surveillance using multiple tools—medical device reports, patient registries, scientific literature—helps us monitor and identify potential problems with medical devices as they arise,” Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in an agency statement. “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.”
The NEJM study, funded by Medtronic and MD Anderson Cancer Center, compared the noninferiority of laparoscopic and robot-assisted hysterectomy to open surgery, tracking cervical cancer patients for four-and-a-half years. It found that the rate of disease-free survival was 86.0% with minimally invasive surgery, compared to 96.5% with open surgery.
So far, the FDA's product evaluations have mostly focused on tracking complication rates in the 30 days following a robotic procedure and comparing them to other surgical techniques. A fuller assessment of robotic surgery devices for the prevention or treatment of cancer would have to include analyses of clinical outcomes such as local tumor recurrence, disease-free survival or overall survival across a much longer time frame, the agency said.