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FDA: Robotic Surgery Unapproved for Cancer

WASHINGTON — Patients and providers considering robotic surgery for cancer-related procedures such as mastectomy should be aware that currently available devices are not necessarily as safe or effective as conventional surgery, the FDA said Thursday.

“The relative benefits and risks of surgery using robotically-assisted surgical devices compared to conventional surgical approaches in cancer treatment have not been established,” the agency stated in a Safety Communication. The FDA said it decided to issue the cautionary notice after seeing “scientific literature and media publications describing surgeons and hospital systems that use robotically-assisted surgical devices for mastectomy.”

One particular publication got the agency’s attention: a “limited report that compared long term survival after radical hysterectomy for cervical cancer either by open abdominal surgery or by minimally invasive surgery (which included laparoscopic surgery or robotically-assisted surgery).” (The agency didn’t specify the publication; a PubMed search for “long term survival cervical hysterectomy robotically assisted” yielded only a single hit, from 2010.)

The FDA statement continued, “In this report minimally invasive surgery appeared to be associated with a lower rate of long term survival compared with open abdominal surgery; however other researchers have reported no statistically significant difference in long term survival when these types of surgical procedures are compared,” citing a November 2018 New England Journal of Medicine report. (Preliminary results were presented earlier last year at a meeting.)

Another point raised in the statement was that current devices were approved mainly from studies comparing 30-day complication rates with robotic devices versus conventional manual surgery. “To evaluate robotically-assisted surgical devices for use in the prevention or treatment of cancer, including breast cancer, the FDA anticipates these uses would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days,” the FDA noted.

In essence, the agency advised patients and providers that using robotic assistance devices for oncologic purposes is poorly charted territory. Surgeons in particular should make sure patients understand that, and should discuss alternative treatments so patients can make informed decisions, the FDA urged.


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