FDA Safety Communication – Caution When Using Robotically-Assisted Surgical Devices in Women's Health including Mastectomy and Other Cancer-Related Surgeries

PUBLISHED: Feb 28, 2019
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals

The U.S. Centers for Disease Control and Prevention (CDC) has issued a safety communication to ensure that health care providers and patients to understand 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.

According the FDA, there is limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival. 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.

This FDA Safety Communication reviews the current evidence on use of robotically-assisted surgical devices, provides recommendations for patients and the following recommendations for health care providers:

  • 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 you take training for the specific robotically-assisted surgical device procedures you perform.
  • Talk to your patients about your experience and training, and the clinical outcomes expected with the use of robotically-assisted surgical devices.
  • Discuss the benefits, risks, and alternatives of all available treatment options with your patients to help them make informed treatment decisions.
  • Be aware that clinical studies conducted in the United States involving a legally marketed device investigating a new intended use are subject to FDA oversight. For further information, please refer to the FDA's Investigational Device Exemption website.
  • If any of your patients experience adverse effects or complications with a robotically-assisted surgical device, we encouraged you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Follow the link below the review the Safety Communication.

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