FDA Issues Warning About Robotic Mastectomies, Other Cancer Surgeries

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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.

Read the FDA announcement.

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 to 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.

Why the FDA put out the warning

The FDA said that it decided to send out the safety communication after seeing scientific literature and media publications describing surgeons and hospital systems that use robotic surgery for mastectomy.

The agency specifically called out a “limited report that compared long term survival after radical hysterectomy for cervical cancer either by open abdominal surgery or by minimally invasive surgery (which included laparoscopic surgery or robotically-assisted surgery). In this report minimally invasive surgery appeared to be associated with a lower rate of long-term survival compared with open abdominal surgery; however other researchers have reported no statistically significant difference in long term survival when these types of surgical procedures are compared.

“To date, the FDA has not granted marketing authorization for any robotically-assisted surgical device for use in the United States for the prevention or treatment of cancer, including breast cancer,” the statement continued. “The labeling for robotically-assisted surgical devices that are legally marketed in the United States includes statements that cancer treatment outcomes using the device have not been evaluated by the FDA.”

What this means for you

Before you have robotic surgery to prevent or treat 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 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?
    • How many robotic surgery procedures like mine have you done?
    • What are the possible complications from this procedure, 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 this FDA safety communication. You also may want to ask your surgeon why a procedure that is not approved by the FDA is being recommended for you and ask about alternatives.

Written by: Jamie DePolo, senior editor

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

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Published on March 8, 2019 at 11:28 AM

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