FDA Issues Safety Warning for Robotic Surgeries

The U.S. Food and Drug Administration (FDA) is cautioning patients and healthcare providers about using robotic surgery 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 Dr. Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health.

Robotic surgery enables the surgeon to perform a variety of surgical procedures through small incisions in a patient’s body. The surgeon controls the surgical instruments attached to mechanical arms from a console while viewing the surgical site in three-dimension high definition. It can help reduce pain, blood loss, scarring, infection and recovery time in comparison to traditional open surgery.

While robotic technology has been employed at Moffitt Cancer Center for more than a decade, the cancer center is not performing any breast cancer-related procedures utilizing the robotic platform. Dr. Wade Sexton, director of Robotics at Moffitt, says surgeons should have a balanced, evidence-based discussion with potential robotic surgical candidates about the pros and cons of the technology.

Dr. Wade Sexton, director of robotics, Moffitt Cancer Center.

"A minimally invasive surgery is not the best nor the correct approach for every cancer patient that requires surgery as a component of their cancer management paradigm," said Sexton. "However, there is no doubt that when appropriate, surgeon use of the robotic platform affords patients a minimally invasive recovery profile and a smaller surgical ‘footprint’ that we cannot duplicate with open techniques. Our patients trust us to make the best decisions on their behalves, to manage them as if they were members of our immediate family."

There are also situations where an open surgery is usually the best option, like in the case with cervical cancer procedures. Evidence has shown that cervical cancer patients who opt for minimally invasive surgery, including robotic surgery, die sooner and are more likely to have their tumors reappear than those who have a conventional hysterectomy.

"While the verdict is not out for cervical cancer and more information is forthcoming, there is evidence that minimally-invasive surgery is excellent when treating endometrial cancer," gynecologic oncologist Mitchel Hoffman said. “It has equivalent oncologic outcome to open surgery.”

Moffitt has 13 surgeons who use the robotic platform.