The FDA is warning patients and health care providers that some clinical studies using robotically-assisted surgical devices for mastectomies may not have the proper regulatory supervision.
The FDA said it is “aware of allegations that clinical studies are being conducted using RAS devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant risk studies.”
The agency has cleared robotically-assisted surgical devices for use in hysterectomies, prostatectomies and colectomy based on 30-day follow-ups with patients, but cautioned that it “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.”
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