FDA caution on using robotically-assisted devices in women’s health

Noting that it “takes women’s health issues very seriously,” the U.S. Food and Drug Administration issued a safety communication stating that, “Since robotically-assisted surgical devices became available in the U.S., robotically-assisted surgical procedures were widely adopted because they may allow for quicker recovery and could improve surgical precision. 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. Patients and health care providers should also be aware that the FDA encourages health care providers who use robotically-assisted surgical devices to have specialized training and practice in their use. To date, 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, including breast cancer. The labeling for robotically-assisted surgical devices that are legally marketed in the United States includes statements that cancer treatment outcomes using the device have not been evaluated by the FDA.”
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