FDA Cautions on Robot Surgical Devices for Mastectomies

FDA has issued a safety alert reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of  breast cancer has not been established. In addition, FDA says it is aware of reports on clinical studies being conducted using RAS devices to perform mastectomies without FDA oversight required for such significant risk studies.
 

“RAS devices have been cleared for use in certain types of surgical procedures commonly performed in patients with cancer, such as hysterectomy, prostatectomy, and colectomy,” FDA’s alert says. “These clearances are based on short-term (30 day) patient follow up. The FDA has not evaluated the safety or effectiveness of RAS devices for the prevention or treatment of cancer, based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.”