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March 4, 2019

FDA warns against using robots to assist with breast cancer surgeries

Daily Briefing

    FDA in a public safety notice published Thursday warned health care providers and patients that the agency has not approved the use of surgical robots for mastectomy procedures or the prevention and treatment of cancer.

    FDA: The benefits, risks of using surgical robots for cancer treatments are unclear

    FDA in the notice said noted that robotically-assisted surgical procedures have been "widely adopted" in the United States as they "may allow for quicker recovery and could improve surgical precision." However, FDA said patients and providers should be aware that research to date has not yet established the relative benefits and risks of using surgical robots instead of conventional surgical approaches to treat or prevent cancer.

    According to FDA, limited preliminary research has shown that patients who have been treated with robotically-assisted surgical devices for the treatment or prevention of cervical cancer might experience diminished long-term survival. However, FDA said separate research has found no difference in outcomes between patients who underwent robotically-assisted surgeries and those who underwent surgeries without robotic assistance for cervical cancer treatment or prevention.

    Further, FDA said it would need to evaluate measures such as local cancer recurrence, disease-free survival, or overall survival time in order to approve robotically-assisted surgeries for the prevention or treatment of cancer and mastectomies.

    As such, FDA said providers must "be aware that robotically-assisted surgical devices have been evaluated by the [agency] and cleared for use in certain types of surgical procedures, but not for mastectomy" (Baker, "Vitals," Axios, 3/1; Gever, MedPage Today, 2/28; FDA notice, 2/28).

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