FDA Advises that Robotic Devices Are not Approved For Cancer Surgeries

The United States Food and Drug Administration issued a warning, this week, to patients and doctors who are considering the use of robotic surgery for mastectomy and other procedures related to cancer.  According to the government agency, these robotic surgeries have not been approved to treat or to prevent cancer. 

FDA Center for Devices and Radiological Health assistant director for the health of women, Dr. Terri Cornelison, M.D., Ph.D., explains, “We are warning patients and providers that the use of robotically-assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency.”  The news release continues, “The survival benefits to patients when compared to traditional surgery have not been established.”

Robotic surgical devices assist doctors and surgeons in precise or risky procedures involving making small cuts in the body of a patient.  Using these assistance devices allows the surgeon to visualize the surgical site in three-dimensional high-definition.  They also provide better control over surgical instruments that are attached to mechanical arms.  Overall, robotically-assisted surgeries are minimally invasive and, in turn, contribute to a reduction in blood loss, infection, scarring, pain, and recovery time after surgery.  

Robotically-assisted surgery has been adopt across the surgical spectrum for non-cancer-related surgeries.  However, their popularity has moved into the cancer world, which is what has prompted the FDA to note that the devices have not yet been evaluated for non-cancer related surgeries.  

Cornelison goes on to say, “Our surveillance using multiple tools—medical device reports, patient registries, scientific literature—helps us monitor and identify potential problems with medical devices as they arise.”

This is not to say that these devices will not prove effective or beneficial; it is just that they have not proven to be safe as a result of vigorous testing. Indeed, there is still only limited data that robotically-assisted devices will benefit cancer surgeries. 

Cornelison continues, “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.”

All this in mind, the FDA says it will continue to review the existing safety and efficacy data and absorb the new material as it becomes available.  In the meantime, though, the agency urges that patients should discuss the benefits and risks—and, most importantly, alternatives—with their health care providers.

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