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FDA Safety Communication: Robotically-Assisted Surgical Devices

March 1, 2019

The Food and Drug Administration (FDA) has released a safety communication discouraging the use of robotically-assisted surgical devices for mastectomy or for the prevention or treatment of cancer in women.  

Robotically-assisted surgical devices provide a minimally invasive surgical approach through small incisions, and may reduce pain, bleeding, scarring, and infection, as well as facilitate quicker recovery. The FDA notes that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer has not been established. Additionally, the FDA has not granted marketing authorization for the use of robotically-assisted surgical devices for mastectomy or for the prevention or treatment of cancer.

Key FDA recommendations for healthcare providers include the following:

  • Understand that the FDA has not cleared or approved any robotically-assisted surgical device based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.
  • Be aware that robotically-assisted surgical devices have been evaluated by the FDA and cleared for use in certain types of surgical procedures, but not for mastectomy.
  • The FDA recommends that surgeons receive training for the specific robotically-assisted surgical device procedures performed.
  • Surgeons should talk with patients about their experience and training, and about the clinical outcomes expected with the use of robotically-assisted surgical devices.
  • Discuss the benefits, risks, and alternatives of all available treatment options with patients to help them make informed treatment decisions.
  • Report adverse events or complications with a robotically-assisted surgical device through MedWatch.


Food and Drug Administration (FDA). Caution When Using Robotically-Assisted Surgical Devices in Women’s Health Including Mastectomy and Other Cancer-Related Surgeries: FDA Safety Communication. February 28, 2019. Available at: click here. Accessed March 1, 2019.