The U.S. Food and Drug Administration (FDA) has warned against the use of robotic devices for mastectomy (breast cancer surgery) and other cancer surgeries. The agency has said that robotic surgeries are not approved for the prevention or treatment of cancer.
Dr. Terri Cornlison, the assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said, “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. The survival benefits to patients when compared to traditional surgery have not been established.”
Robotic devices allow surgeons to execute procedures through small incisions in the patient’s body. The surgeon is then able to visualize the surgical site in three-dimensional high definition, controlling surgical instruments that are attached to mechanical arms with the help of computer and software technology.
Typically, robotically assisted surgeries are minimally invasive, which help reduce pain, blood loss, scarring, infection, and recovery time after surgery, when compared with traditional surgical interventions.
Robotic devices have been widely used by surgeons for non-cancer-related surgical interventions, which is why they have become so popular that they are putting a foot in the cancer surgery world.
The FDA has analyzed, evaluated and approved robotic surgical devices for certain procedures, but not for mastectomy, mentioning that their safety and efficacy have not been established yet.
When it comes to cancer-related surgeries, the FDA has limited data on the use of robotically assisted surgical devices, which is not encouraging.
According to a study published in the New England Journal of Medicine, minimally invasive surgical interventions, including robotic surgery, had a lower rate of long-term survival when compared with traditional abdominal surgery.
The FDA has been continuing to review the safety and effectiveness of data as it becomes available. Meanwhile, it has urged patients to discuss all the risks, benefits and alternatives treatment options with their medical providers. The drug regulatory body has also suggested that patients should ask their surgeons about their knowledge, training, experience, and outcomes with robotic-assisted surgeries. For medical providers, the FDA has urged to undergo appropriate training for the specific robotically assisted surgical devices procedures. The agency has also urged them to perform and openly discuss their level of experience as well as clinical outcomes with their patients.
