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FDA issues safety communication about use of robotically assisted devices for cancer surgeries
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The FDA today issued a safety communication urging health care providers and patients to be cautious about use of robotically assisted surgical devices for cancer-related surgeries.
Robotically assisted surgical devices allow surgeons to perform procedures through smaller incisions.
Proponents suggest this can reduce pain, infection risk and blood loss compared with traditional surgeries, helping to shorten recovery time.
However, the FDA warns that the effectiveness and safety of robotically assisted surgical devices for mastectomy or other cancer-related surgeries has not been established.
“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 [compared with] traditional surgery have not been established,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in an FDA-issued statement. “In the case of robotically assisted surgical devices and cancer-related uses such as mastectomy, we are aware of scientific literature reporting that surgeons have been using the device for uses not granted marketing authorization by the FDA.”
The FDA urged patients and providers to discuss the risks and benefits of robotically assisted surgery, as well as alternative options, so they can make informed decisions.
The agency also advised patients to ask providers about their training and experience with robotically assisted surgery, as well as the outcomes associated with those types of procedures.
As HemOnc Today previously reported, two studies published last fall in The New England Journal of Medicine showed women with early-stage cervical cancer who underwent minimally invasive radical hysterectomy had increased risk for recurrence and poorer survival outcomes than women who had open surgery.
“The FDA is aware of scientific literature and media publications reporting poor outcomes for patients, including one limited report that describes a potentially lower rate of long-term survival when surgeons and hospital systems use robotically-assisted surgical devices instead of traditional surgery for hysterectomy in cases of cervical cancer,” the safety communication states.
The agency also has received “a small number” of reports about patient injuries when these devices are used as part of cancer-related procedures, according to its safety communication.
“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,” Cornelison said.