FDA Issues Caution Statement on Use of Robotically Assisted Surgical Devices for Mastectomy
Posted: Friday, August 27, 2021
On August 20, the U.S. Food and Drug Administration (FDA) released a statement advising physicians to exercise caution when using robotically assisted surgical devices for mastectomy procedures or in breast cancer treatment. In the statement, the FDA notes that the safety and effectiveness of such devices for these purposes have not been established. The FDA advises patients to talk to their surgeons about the risks, benefits, and clinical outcomes with robotically assisted surgical devices during surgery.
Robotically assisted surgical devices allow surgeons to perform several surgical procedures by making small incisions in a patient’s body. Computer and software technology enable surgeons to precisely control surgical instruments attached to mechanical arms through the incisions while viewing the surgical site in three-dimensional high definition.
Robotically assisted surgical devices have been cleared for use by the FDA for certain surgical procedures including hysterectomy, prostatectomy, and colectomy. However, there is currently little evidence that robotically assisted devices are safe and effective for patients undergoing mastectomy for the prevention or treatment of breast cancer. As a result, the FDA has not granted marketing authorization for any robotically assisted device for mastectomy, cancer treatment, or cancer prevention.
For patients who experienced a complication after treatment with a robotically assisted surgical device for breast cancer or any cancerous condition, the FDA encourages filing a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.