The U.S. Food and Drug Administration (FDA) issued a safety communication warning that the safety and effectiveness of robotically-assisted surgical devices for mastectomy procedures or treatment of other cancers has not been established.
“There is limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival,” the agency wrote. “Healthcare providers and patients should consider the benefits, risks, and alternatives to robotically-assisted surgical procedures and consider this information to make informed treatment decisions.”
Limited data to support robotically-assisted devices
The relative benefits and risks of robotically-assisted surgical devices compared with conventional surgical approaches in cancer treatment have not been established.
The FDA said it is monitoring adverse events in the literature and reported to the agency to gather more information. The FDA also encourages academic and research institutions, professional societies, robotically-assisted surgical device experts, and manufacturers to establish patient registries to further expand the available data on these devices for all uses, including the prevention and treatment of cancer.
The FDA said it has not approved marketing authorization for robotic surgery in mastectomy; however, robotic devices are approved for use in prostate cancer.
Robotically assisted surgical devices enable surgeons to perform a variety of procedures through small incisions, which may reduce pain, blood loss, scarring, infection, and recovery time after surgery in comparison to traditional surgical procedures, according to the agency.
FDA Warning About Robotic Mastectomy, Other Surgeries #BreastCancer https://t.co/6QmrrjdMA3
— Tahir Mohammad, MD, PhD (@TahirMohammd) February 28, 2019
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