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FDA Updates Warning About Robotic Mastectomies

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On Feb. 28, 2019, the U.S. Food and Drug Administration (FDA) warned that the safety and effectiveness of robotic devices for mastectomy and other cancer surgeries have not been established.

On Aug. 20, 2021, the FDA put out a new safety communication, reminding both patients and healthcare providers that the safety and effectiveness of robotic surgery devices for mastectomy or for the prevention or treatment of breast cancer have not been established.

Read the 2021 FDA announcement.

What is robotic surgery?
Why the FDA put out the updated warning
What this means for you

What is robotic surgery?

Robotic surgery devices allow surgeons to perform procedures through small incisions in the body. Robotic surgery may help reduce pain, blood loss, scarring, infection, and recovery time after surgery compared with traditional surgical procedures.

Computer technology allows a surgeon to precisely control surgical instruments attached to mechanical arms through small incisions while viewing the surgical site in 3D high definition.

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Why the FDA put out the updated warning

The FDA said that it decided to send out the 2021 safety communication because studies are being done on robotic mastectomy devices without FDA oversight.

“[T]he FDA is aware of allegations that clinical studies are being conducted using [robotically-assisted surgical] RAS devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant risk studies,” the communication said.

“The FDA considers clinical studies performed in the United States involving RAS devices for mastectomy and the prevention and treatment of cancer to be significant risk studies. These clinical studies require FDA oversight under an approved investigational device exemption.

“There is little evidence on the safety and effectiveness of the use of RAS devices in patients undergoing mastectomy for the prevention or treatment of breast cancer, and the FDA has not granted any RAS system marketing authorization for mastectomy. For patients undergoing mastectomy, the surgical approach used with RAS devices differs from conventional surgical approaches. The impact of these differences on prevention of cancer, overall survival, recurrence, and disease-free survival have not been established.”

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What this means for you

Before you have robotic surgery to prevent or treat breast cancer, the FDA recommends that you:

  • Be aware that the safety and effectiveness of robotic surgery for mastectomy or for the prevention or treatment of breast cancer has not been established.
  • Discuss the benefits, risks, and alternatives of all available treatment options with your doctor to make the most informed treatment decisions.
  • Ask the following questions before choosing your surgeon:
    • What is your training, experience, and patient outcomes with robotic surgery for breast cancer?
    • How many robotic surgery procedures like mine have you done?
    • What are the possible complications from this procedure, both short- and long-term, and how often do they happen?

The bottom line is that no robotic surgery devices have been approved for mastectomy. If your surgeon suggests robotic surgery for mastectomy, definitely bring up these FDA safety communications. You also may want to ask your surgeon why a procedure using a device not approved by the FDA is being recommended for you and ask about alternatives.

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Written by: Jamie DePolo, senior editor

Reviewed by: Brian Wojciechowski, M.D., medical adviser

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