FDA Urges Caution with Robotically-Assisted Surgeries for Cancer

“The relative benefits and risks of surgery using robotically-assisted surgical devices compared to conventional surgical approaches in cancer treatment have not been established,” the safety communication said. The FDA noted that patients and physicians may not be aware that the safety and effectiveness of surgical robots has not yet been established for the prevention or treatment of cancer. The agency evaluates medical technology, but they do not regulate how it is used by medical professionals.

The FDA’s evaluation of surgical robots has generally focused on comparing complication rates 30 days after surgeries. However, to evaluate surgical robots for cancer prevention and treatment, the FDA would need to evaluate specific clinical outcomes, such as local cancer recurrence, disease-free survival rates, and overall survival at time periods significantly longer than 30 days.

In a New York Times article on March 11, 2019, Roni Caryn Rabin wrote, “Robotic surgery was never approved for mastectomy or any other cancer-related treatment, but that has hardly deterred doctors in the operating suite. The equipment is widely used to operate on patients with various malignancies, from breast cancer to prostate cancer…. Now the Food and Drug Administration has warned that there is no evidence cancer patients receiving robotic procedures live longer than those who have traditional procedures. And some research shows that patients with cervical cancer fare worse.”

“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.”

– Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health

The FDA noted two studies that showed robotic-assisted surgeries led to worse long-term survival for patients with breast or cervical cancers who had mastectomies or hysterectomies using surgical robots. One of the trials was stopped early because women with cervical cancer who had minimallyinvasive hysterectomies were four times more likely to have recurrence and six times as likely to die, compared to patients who had underwent traditional hysterectomy.*

Dr. Pedro T. Ramirez, the lead author of this cervical cancer study, told the New York Times the trial’s findings were especially noteworthy because radical hysterectomies usually cure cervical cancer. It is unclear why the minimally-invasive procedures led to worse outcomes for cervical cancer patients. Dr. Ramirez suggested it could be that the instruments used in the robotic surgery could cause cancer cells to spread, or that carbon dioxide pumped into the abdomen during robotic and minimally invasive surgery could increase the possibility of cancer cells implanting.

The other study cited by the FDA in their statement found that 9% of women died four years after having minimally invasive surgery for cervical cancer, compared to 5% after traditional open hysterectomy.*

Proponents of robotic surgery say that patients could have less pain, less blood loss, and shorter hospitals stays with the procedures. But Dr. Ramirez said in the New York Times, “If you tell a patient you may stay in the hospital one or two days longer versus going home the same day, but there is a higher likelihood your cancer is going to come back, what are you going to choose as a patient? Of course, you’ll stay in the hospital.”

Despite this evidence, many physicians and hospitals continue to recommend robotic surgery. However, as reported in Barron’s and CBS News, some hospitals, including Dr. Ramirez’s department at the University of Texas MD Anderson Cancer Center and Johns Hopkins Medicine in Maryland have stopped performing minimally-invasive surgery (including robot-assisted surgery) for cervical cancer, and instead have switched back to traditional open hysterectomies.

Dr. Catalona’s Opinion: For prostate cancer, we don’t have long-term comparative data between open and robotic-assisted radical prostatectomies. With robotic prostatectomy, the surgeon has no sense of touch, and suturing is more difficult. This leads to more use of electrocautery, risking thermal damage to the nerves responsible for erections and to other structures, and I question whether the cancer is consistently completely removed as well.