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FDA Expresses Concern on Use of Robotic Devices in Cancer Surgeries

Posted Wednesday, March 27, 2019 by Carl-Erich Kruse

The FDA recently issued a safety communication warning against the use of robotically assisted surgical devices in cancer treatments, including mastectomies. The FDA was careful to reiterate that it has never granted marketing authorization of robotically assisted surgical devices for use in cancer treatment, though surgeons continue to use the machines at an increased pace. Patients are cautioned to take a closer look at the surgical options offered by their surgeon.

In fact, a pair of studies published in the fall of 2018 showed that robotic, “minimally invasive hysterectomies” performed on women with cervical cancer result in lower rates of disease-free survival and overall survival than “open” surgeries performed without a robot. One study revealed that four years after surgery nearly twice as many patients died following robotic surgery than those who had open surgery.

It was unclear why the outcomes were significantly different. This lack of clarity contributed to the FDA’s recent communication.

On the one hand, patients and providers are attracted to the faster recovery times of robotic surgeries. But these two studies and the FDA safety communication show that there is far more to consider when evaluating treatment options.

The FDA communication recommends that patients discuss the risks, benefits, and alternatives of all treatment options with health care providers. It specifically recommended patients ask about possible complications and how they happen as well as the surgeon’s training, experience (including number of procedures performed), and patient outcomes with robotic surgery. The FDA in turn recommended “that [surgeons] take training for the specific robotically-assisted surgical device procedures….”

You can read the FDA’s safety communication here.

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