“Minimally invasive” robotic surgery has been around since the early 1980s. A major breakthrough was achieved in 2006 when a robot with artificial intelligence successfully carried out heart surgery remotely on a patient in Italy.
Robotics have proven effective in many kinds of surgeries, but in one area, it has been shown to be a deadly failure. According to a pair of recent studies, women who undergo minimally invasive robotic radical hysterectomies for the removal of cervical cancer have much higher chances of recurrence and lower long-term survival rates.
Both studies were published in the New England Journal of Medicine in November 2018. One was a cohort study funded by the National Institutes for Health. Researchers compared outcomes for 2,461 cervical cancer patients who had radical hysterectomies between 2010 and 2013, just under half of whom underwent robotic surgery. Although the women in the robotic group were primarily white, privately insured and enjoyed higher socioeconomic status, their long-term mortality rate was more than 40 percent higher than those who underwent traditional open surgery.
The other, study was a clinical trial initially involving over 631 women suffering from cervical cancer. 319 of the women were assigned to minimally invasive robotic surgery, while the remaining 312 underwent traditional surgery. Only 3.5 percent of the latter group saw a recurrence of the disease within 54 months following the surgery. For those who had the robotic surgery, the recurrence rate was 14 percent.
Lead author Dr. Pedro T. Ramirez, a specialist in gynecological cancers at the M.D. Anderson Cancer Center, notes that radical hysterectomy usually results in a complete cure. Although it is not clear as to why robotic hysterectomies result in poorer outcomes, Ramirez believes that the equipment and the methods used may cause the cancer to spread. A similar problem arose a few years ago with a device known as a power morcellator, resulting in an investigation by the Department of Justice.
Despite its success in other types of surgery, the use of robotics for cancer surgery has never been approved by the Food and Drug Administration. Instead, the FDA has issued a warning against the use of robotics in cancer surgery. Dr. Terri Cornelison, assistant head of the FDA Center for Devices and Radiological Health, says “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.”
Nonetheless, the use of robotic surgery is growing in popularity. A recent market analysis by iData Research predicts that sales of surgical robots will total $7 billion within the next 6 years – an increase of 100 percent over current figures. Much of this is driven by patient demand, as minimally invasive robotic surgery boasts lower risks and faster recovery times. Doctors also continue to recommend it, despite the FDA warning.
Ramirez, whose department has stopped the use of robotics in radical hysterectomies, comments that a number of surgeons have told him his research is irrefutable, but they aren’t in a position to stop using robotics. To his colleagues, he says, “This is about patient care…not about how much time you devoted to your training or your ego. It’s an issue of cancer, and having a high likelihood of cancer coming back if you have surgery through this approach.”