FDA issues warning that the use of robots for breast cancer surgery may not be safe.
The U.S. Food and Drug Administration (FDA) has issued a new safety communication about the use of robots to assist with mastectomy surgery, warning patients and physicians that the safety and effectiveness of such devices have not been established in the prevention or treatment of breast cancer. The agency also called out robotically assisted surgical (RAS) device use in the United States that lacks proper federal oversight.
“The FDA is aware of allegations that clinical studies are being conducted” with RAS devices in breast cancer “without the FDA oversight required for such significant risk studies,” the agency said. The news comes after a set of clinical trials underway using RAS devices for nipple-sparing mastectomy, both prophylactically and as a breast cancer treatment. A published report found that investigators are either not collecting cancer outcomes or not doing so as a primary measure.
“Congratulations to the press on doing its job well and informing government. I think this [safety communication] is a direct result of Medscape following up on this issue,” said Hooman Noorchashm, MD, PhD, a patient advocate from Philadelphia. Noorchasm added, “The agency also stated unequivocally – after previously hinting – that any study of robotic mastectomy must include monitoring of long-term clinical outcomes such as cancer recurrence, disease-free survival, and overall survival.”
The FDA cleared the first surgical robot, da Vinci Surgical System, for minimally invasive surgeries in July 2000. Then, in 2001, the FDA cleared the robot for prostate removal in prostate cancer treatment. In 2005, the robots were cleared for use in gynecologic cancer surgeries. In 2017, a robot called the Senhance System received FDA approval. Studies show that patient demand for robotic surgeries has helped encourage widespread use. In 2019, the FDA, however, warned that the agency is not clear whether using a robot provides cancer patients with better outcomes than more traditional treatments.
In 2011, a group of surgeons launched a randomized clinical trial to compare robotic laparoscopic surgery to conventional laparoscopic surgery. The study, published in JAMA in 2017, included 471 patients. “Anecdotally, we had felt there was a big role for robotic surgery, so we wanted to see if it was better,” said study co-author Alessio Pigazzi, a colorectal surgeon at the University of California, Irvine. “But it was not the silver bullet we thought it might be.”
Forty surgeons took part in the study. “Surgical studies are hard to do,” Pigazzi explains. “When you are comparing a technique or tool, there are other factors that come into play. It’s not like comparing drug A to a placebo or drug A to drug B. You have to take into account the surgeon’s skills, and that can make a big difference. What our study showed is that the robot is a really good tool, but if you are a very good surgeon, you will get good results whether or not you use it.”
These mixed responses when it comes to the use of robots in the medical field complicate the assertion that use of robots is both necessary and effective. The latest communication suggests that they are not a foolproof option.