FDA warns that we are trusting surgeon-robots too much

Elena Riboldi

The US Food and Drug Administration issued a safety communication about robotically-assisted surgical procedures for cancer prevention or treatment, pointing out that their safety and effectiveness has not been established yet.
In the Unites States, the availability of robotically-assisted surgical devices has grown exponentially in the last few years. Surgeons are prone to offer the most recent procedures because robots improve precision and may allow for a faster recovery. “However, the FDA is concerned that health care providers and patients may not be aware that the safety and effectiveness of these devices has not been established for use in mastectomy procedures or the prevention or treatment of cancer” the FDA’s experts state.

The FDA has not granted marketing authorization for any robotically-assisted surgical device for use in the United States for the prevention or treatment of cancer. In fact, so far, the FDA’s evaluation of robotically-assisted devices in surgical oncology was confined to the complication rate at 30 days, whereas clinical outcomes, such as local cancer recurrence, disease-free survival, or long-term overall survival are still to be determined.

Limited evidence exists that the use of robotically-assisted surgical devices for the treatment of cervical cancer may be associated with diminished long-term survival, as was reported for instance in a recent trial published on the New England Journal of Medicine.

“Health care providers and patients should consider the benefits, risks, and alternatives to robotically-assisted surgical procedures and consider this information to make informed treatment decisions” the FDA advises, while urging surgeons to take training for the robotically-assisted surgical procedures and patients to choose an experienced surgeon.

Academic and research institutions, professional societies, and manufacturers should establish patient registries to gather data on the use of robotically-assisted surgical devices: patient registries may help characterize surgeon’s learning curves, assess long-term clinical outcomes, and identify safety problems. The collection of data is essential for legitimating the use of robots in surgical oncology.

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