FDA warns about robotic devices for mastectomy, other surgeries
The US Food and Drug Administration has issued a warning to patients and doctors considering the use of robotic surgery for mastectomy and other cancer-related surgeries, saying that robotic surgeries are not approved for the treatment or prevention of cancer.
“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,” Dr. Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in a news release. “The survival benefits to patients when compared to traditional surgery have not been established.”
Robotically assisted surgical devices allow surgeons to perform procedures through small cuts in a patient’s body. The surgeon can then visualize the surgical site in three-dimensional high definition and control surgical instruments attached to mechanical arms via computer and software technology. Because it is minimally invasive, this approach may in turn reduce pain, blood loss, scarring, infection and recovery time after surgery, compared with traditional surgical procedures.
Robotic surgery has been widely adopted by surgeons for non-cancer-related surgeries, with their popularity crossing into the cancer surgery world, according to the report. The FDA has evaluated and approved robotically assisted surgical devices for use in certain types of procedures but not for mastectomy, saying that their safety and effectiveness have not been established.
The limited data available on the use of robotically assisted surgical devices in cancer surgery is not encouraging. One study published in the New England Journal of Medicine found that minimally invasive surgery, including robotic surgery, appeared to be associated with a lower rate of long-term survival compared with traditional abdominal surgery. Yet other researchers have reported no difference in long-term survival when these types of surgical procedures are compared.
While the FDA continues to review safety and efficacy data as it becomes available, it urges patients to discuss the risks, benefits and alternatives of all available treatment options with health-care providers. The agency also suggests that patients ask surgeons about their training, experience and outcomes with robotic surgeries.
As for physicians, the FDA urges them to take training for the specific robotically assisted surgical devices procedures they perform and openly discuss their level of experience and clinical outcomes with their patients.