Claimed benefits not supported by evidence, surgeons and regulators say.
The march of robots into the operating room has hit a speed bump, with authors of an opinion piece in the journal JAMA warning that poor outcomes in robot surgery for cancer mean safeguards must be put in place to protect patients.
Surgical resident Kyle Sheetz and Professor of Surgery Justin Dimick, both from the Department of Surgery at the University of Michigan, Ann Arbor, US, seize on a recent safety communication from the US Food and Drug Administration (FDA) to call for urgent reforms to surgeon credentialing, patient informed consent and insurance coverage for robotic surgery.
In February, the FDA advised that, while robots have been cleared for use in some procedures, “The safety and effectiveness of robotically-assisted surgical devices for use in mastectomy procedures or prevention or treatment of cancer has not been established”.
The warning referred specifically to recent studies suggesting robot and other “minimally invasive” keyhole surgery may lead to worse outcomes for cancer of the cervix.
Read the full article in Cosmos magazine here