FDA Clarifies Recent Warnings for Robotic Surgeries

By Sara Bondell - April 12, 2019

Earlier this month, the U.S. Food and Drug Administration (FDA) cautioned patients and healthcare providers about using robotic surgery for mastectomy and other cancer-related surgeries.

“We are warning patients and providers that the use of robotically-assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency, and therefore the survival benefits to patients, when compared to traditional surgery, have not been established,” said Dr. Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health.

The FDA has now published additional information in the form of four questions on the safety warning after concerns were raised about what the message meant for patients and women’s health care providers across the country.

1. Why did the FDA issue the February 28, 2019, Safety Communication?
The FDA has become aware of the increasing use of Robotically-Assisted Surgical Devices (RASD) for the prevention of cancer and treatment of patients with cancer. It is important for health care providers and patients to understand that the FDA has not granted marketing authorization to any RASD system specifically for the prevention or treatment of cancer.

2. Are RASD permitted to be used in patients who have cancer?
RASD have been evaluated by the FDA and cleared for use in certain types of surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy, and colectomy. These clearances are based on short-term (30 day) patient follow up. The safety and effectiveness of RASD, for the prevention and treatment of cancer, based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival have not been established.

3. What is known about using RASD to perform mastectomy procedures for the prevention and treatment of breast cancer?
There is little evidence on the safety and effectiveness of the use of RASD in patients undergoing mastectomy for the prevention or treatment of breast cancer, and the FDA has not granted any RASD system marketing authorization for mastectomy. For patients undergoing mastectomy, the surgical approach used with RASD 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.

4. What is known about using RASD for the treatment of cervical cancer?
We are aware of limited reports that conclude that minimally invasive surgery (which included laparoscopic surgery or surgery using RASD) was associated with a lower rate of long-term survival compared with open abdominal surgery. Other reports have demonstrated no significant difference in long term survival when these types of surgical procedures are compared. Clinicians and patients should be aware of this information when making treatment decisions.

To read more about the initial warning and Moffitt’s robotic program, click here.

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