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FDA warns of robotics mastectomy, other operations

The US Food and Drug Administration (FDA) today issued a safety notice to healthcare providers on the use of robotic surgical devices for mastectomy and other cancer-related operations that have not yet been approved by the FDA.

The Agency urged caution regarding such use.

Robotic devices are approved for use in prostate cancer, but not in most cancers.

The safety and efficacy of robotic devices in mastectomy and other cancer operations have not been established, as compared to current standards, said Terri Cornelison, MD, PhD, Assistant Director of Women's Health at the FDA Gender and Radiological Center.

The FDA stressed that it had not granted a marketing authorization for robotic surgery in mastectomy.

FDA Letter comes 3 weeks after a Medscape Medical News a story that raised questions about the safety of robotic robots and the suitability of using it in one community hospital in New Jersey.

"It's a really powerful advisor," Philadelphia Medical Surgeon, Dr. Medscape Medical News.

The content of the FDA letter, Noorchashm, suggests that the agency will hold robotic devices for cancer surgery to a higher standard than other 510K devices, demanding long-term data on cancer outcomes and not just 30-day complication rates, he observed.

The FDA's letter states: "So far, the FDA's assessment of robotic surgical devices is generally aimed at finding out whether the level of complications over 30 days is clinically comparable to other surgical methods."

The letter then goes on with an important wording, Noorchashm said: "To assess robotic surgical devices used for cancer prevention or treatment, including breast cancer, the FDA foresees that these applications will be supported by specific clinical results such as local cancer-free survival without disease, or overall survival beyond 30 days. "

Youth's interest in patient safety stems from his wife Amy Reed, MD, who died of uterine cancer in 2017 following a laparoscopic hysterectomy procedure, revealing unobtrusive cancer.

FDA Cornelison said that "Today's Safety Statement reflects the Agency's commitment to improving the safety monitoring of our devices as part of our Medical Device Safety Action Plan, as well as the Agency's continuing commitment to women's health."

Robotically supported surgical devices allow surgeons to perform various procedures with small incisions that can reduce pain, blood loss, and scarring by observing the FDA.

But these small cuts are just what worry Noorchashm about robot mastectomy.

He explained that traditional open mastectomy optimally leads to the removal of a tumor – one whole piece – to avoid the fragmentation of cancer tissue and possibly leaving the remaining disease. These events are associated with a higher risk of repetition and treatment failure, he commented.

Noorchashm believes – but there is no evidence – that robotic mastectomy can be particularly sensitive to tissue fragmentation precisely because it uses a small incision, which is "the main point of sale", he said.

The new FDA communication does not prevent breast surgeons from using a robotic device for mastectomy.

However, as Noorchashm said, it will work to slow down the "wrong" acceptance of the device and procedure in currently unapproved indications such as mastectomy.

FDA Security Notice. February 28, 2019 Short, full text

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