FDA sounds warning on robot-assisted mastectomy, other surgeries

  • Miriam Davis, PhD
  • Oncology drug update
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  • The FDA issued a safety communication to patients and providers that robotically assisted surgical devices have not been cleared by the agency for use in mastectomy for breast cancer or for treating or preventing cancer of any type.
  • Although robotically assisted surgical devices may reduce pain, blood loss, and scarring; enable quicker recovery; and increase surgical precision, the FDA is concerned about use because limited evidence suggests these devices may decrease long-term survival.

Why this matters

  • Healthcare providers need to know that robotically assisted devices are subject to FDA review and clearance before marketing.
  • Although robotically assisted devices have been cleared by the FDA for use in certain types of surgical procedures, they have not been cleared for mastectomy and other types of cancer.
  • Healthcare providers should report any adverse events or complications with robotically assisted surgical devices to the FDA's MedWatch.

Key points

  • The potential harm of robotically assisted surgical devices was reported in the New England Journal of Medicine by researchers who compared the device with open surgery for hysterectomy related to cervical cancer. The nonrandomized trial found that the robotically assisted surgery group had lower DFS than open surgery.
  • No research on potential harm of mastectomy exists, but the FDA recommends that healthcare providers who advise patients on the need for mastectomy should warn patients about potential harms of robotically assisted surgical devices.

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