FDA warns against robotic devices for mastectomy and other cancer surgeries

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Double mastectomies for breast cancer tripled in 10 years

"We are warning patients and providers that the agency has not authorized the marketing of robot-assisted surgical devices for any cancer-related surgery," said Dr. Terri Cornelison, Assistant Director of Women's Health. at the FDA Center. Apparatus and radiological health, said in a press release. "The survival benefits for patients compared to traditional surgery have not been established."

Robot-assisted surgical devices allow surgeons to perform procedures by performing small cuts in the body of a patient. The surgeon can then visualize the surgical site in three-dimensional high definition and control the surgical instruments attached to the mechanical arms via computer and software technology. Due to its minimally invasive nature, this approach can in turn reduce the time required for pain, blood loss, scars, infections and recovery time after surgery, compared to traditional surgical procedures.

According to one study, in cervical cancer surgery, non-invasive treatment is worse than open-open.

Robotic surgery has been widely adopted by surgeons for non-cancer surgeries, their popularity joining the world of cancer surgery, according to the report. The FDA has evaluated and approved robot-assisted surgical devices intended for use in certain types of procedures, but not for mastectomy, claiming that their safety and efficacy have not yet been established.

The limited data available on the use of robot-assisted surgical devices in cancer surgery is not encouraging. A study published in the New England Journal of Medicine found that minimally invasive surgery, including robotic surgery, seemed associated with a lower long-term survival rate than traditional abdominal surgery. Yet, other researchers have reported no difference in long-term survival when comparing these types of surgeries.

Although the FDA continues to review safety and efficacy data as it becomes available, it urges patients to discuss the risks, benefits, and alternatives of all available treatment options with healthcare providers. health. The agency also suggests patients ask surgeons for information about their training, experience and results in robotic surgery.

With respect to physicians, the FDA encourages them to undergo training on robot-specific surgical device-specific procedures that they perform and openly discuss their level of experience and their clinical results with their patients.

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