FDA Issues Warning About Robotic Mastectomies, Other Cancer Surgeries

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.

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

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.

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.”

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

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.