FDA Urges Caution in Use of Robotic Surgical Devices for Cancer-Related Procedures

Regulatory NewsRegulatory News | 28 February 2019 |  By 

Patients and health care providers should know that the safety and effectiveness of robotically-assisted surgical devices for the prevention or treatment of cancer has not been established for use in the US, a US Food and Drug Administration (FDA) safety communication warned on Thursday.

The safety communication urges caution when using robotically-assisted surgical devices for mastectomy and any other cancer-related surgery, citing the lack of FDA evaluation on use of the technology for the specified indications. There are currently no FDA approvals or clearances for use of any robotically-assisted surgical devices for the prevention or treatment of cancer in the US, the agency warned.

In addition, the benefits and risks of oncological surgery procedures using the device type relative to conventional approaches have not been established either. Yet the agency pointed to “scientific literature and media publications describing surgeons and hospital systems that use robotically-assisted surgical devices for mastectomy.” An article published last November in the New England Journal of Medicine reported results of a trial in which certain patients with cervical cancer had been assigned to undergo robotic-assisted surgery, FDA noted.

The agency said it is monitoring adverse events in literature and those reported to FDA to enrich its understanding of the benefit-risk profile of robotically-assisted surgical devices for specific indications. It recommended that providers train for specific robotically-assisted surgical device procedures and discuss this experience and expected clinical outcomes with patients, among other recommendations issued for both patients and providers.

“We want doctors and patients to be aware of the lack of evidence of safety and effectiveness for these uses so they can make better informed decisions about their cancer treatment and care,” said Terri Cornelison, assistant director for women’s health at FDA’s Center for Devices and Radiological Health.



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