The Food and Drug Administration (FDA) has issued a safety warning regarding the use of robotically assisted surgical devices for mastectomies and other cancer surgeries, asserting that “the safety and effectiveness of robotically-assisted surgical devices for use in mastectomy procedures or prevention or treatment of cancer has not been established.” The warning is included in the FDA Safety Communication issued to healthcare providers and prospective patients on February 28, 2019.

The warning followed publication of a study in the New England Journal of Medicine finding that use of the robotically assisted devices in radical hysterectomies in women with cervical cancer was associated with lower rates of disease-free survival and overall survival than traditional open abdominal radical hysterectomies. The publication also noted that other researchers have reported no significant difference in statistics concerning long-term survival when comparing these types of surgical procedures (Ramirez, Fumovitz, “Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer”, N Engl J Med 2018; 379:1895-1904).

For cancer-related robotic surgeries, risks may outweigh benefits

The use of robotically assisted surgical devices has grown in popularity. They allow surgeons to utilize mechanical arms to perform procedures with smaller incisions and in harder-to-reach places, ultimately resulting in greater precision; decreased pain, scarring and risk of infection; and faster healing. However, not all procedures are created equally. The FDA has emphasized that the warning is limited to use of robotically assisted devices for cancer-related surgeries.

The FDA’s prompt warning may be in part attributable to previous concerns about cancer risks posed by power morcellators, used to laparoscopically remove fibroids and benign tumors of the uterus for over 20 years before a black box warning was issued. Those non-invasive devices work by shredding benign fibroid tumors, posing the risk of spreading malignant cells throughout the abdomen in the event of a hidden uterine sarcoma. Despite the morcellator risks, the demand for non-invasive alternatives has continued to grow, as many open-surgery risks can be avoided.

The new concern for robotically assisted devices is based on their relatively recent use in the medical community. Additional research is underway to determine whether this robotic technology is sufficient to imitate or surpass traditional open surgery in the context of cancer-related procedures. According to the FDA, at present there is not enough scientific literature supported by specific clinical outcomes to properly evaluate use of robotically assisted devices for cancer-related surgeries. The FDA has not cleared or approved any robotically assisted surgical device based on cancer related outcomes such as overall survival, recurrence and disease-free survival.

“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,” said Dr. Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health. The agency’s warning also recommends that patients and doctors discuss the benefits, risks, and alternative procedure options before making treatment decisions; and advises patients to ask their doctors about training, experience, and outcomes related to the use of robotically assisted surgery.

Training guidelines and informed consent help minimize risk

As robotically assisted surgical devices continue to evolve and grow in popularity, instituting training guidelines and detailing the informed consent process will ultimately help to advance safety protocols and minimize risk.

Healthcare providers must be mindful of the necessity to complete appropriate training specific to procedures in which they intend to utilize robotically assisted surgical devices.

It is essential that individual healthcare organizations:

• Develop and implement training to protect against undue risk

• Enforce strict patient selection criteria based on comorbidities and other relevant factors

• Ensure that appropriate informed consent is obtained from patients contemplating robotically assisted procedures

• Implement standards based on maintaining patient safety

Of course, documentation of all patient risks and benefits, alternative options, selection criteria, information specific to the type of procedure performed, the surgeon’s training with robotic devices, outcomes associated therewith, and patient acknowledgement of same is crucial to support any decision making process.

This alert does not purport to be a substitute for advice of counsel on specific matters.

Harris Beach has offices throughout New York State, including Albany, Buffalo, Ithaca, Melville, New York City, Rochester, Saratoga Springs, Syracuse, Uniondale and White Plains, as well as New Haven, Connecticut and Newark, New Jersey.