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The FDA warned patients and health care providers Thursday about using robotically assisted surgical devices for mastectomies and other cancer surgeries because of "preliminary" evidence that it may be linked to lower long-term survival.
The FDA's official safety communication said that while robotic "surgery may help reduce pain, blood loss, scarring, infection, and recovery time," there is "limited, preliminary evidence" that using the devices for cancers that affect women, specifically breast and cervical cancer, may be associated with diminished long-term survival.
In a statement, Dr. Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said the FDA is "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, and therefore the survival benefits to patients when compared to traditional surgery have not been established."
She also said the FDA was aware that "surgeons have been using the device for uses not granted marketing authorization by the FDA."
"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," said Cornelison.
In December, as part of an investigative series on medical devices, NBC News broadcast and published a story about the Da Vinci Surgical System, the surgical robot that dominates the U.S. medical marketplace.
The da Vinci has been touted as a breakthrough in minimally invasive surgery. It is known to have multiple advantages, including a monitor that lets surgeons see better inside patients, a steady robotic arm allowing for more precision, and a record of faster recoveries for patients. But the da Vinci also comes with risks, including injuries, as NBC News noted, in those surgical procedures for which it is approved.
The machine has had 175 recalls in the past decade, according to an NBC News review of recalls filed with the FDA. Recalls associated with the device have declined over the years. There were eight in 2018. Recalls in the past two years include minor adjustments such as instruction clarifications and software updates, as well as more serious recalls such as a surgical knife that may not move when needed to cut, surgical arms that could fail, and others that could unexpectedly move.
The robot is piloted by a surgeon who sits at a console and it costs on average $1.4 million. Introduced in 2000, there are nearly 3,000 da Vincis in use in the U.S., and Intuitive has launched new models and updates throughout the past two decades.
In a statement, a spokesperson for Intuitive Surgical,which manufactures the da Vinci, said the company recommended that "healthcare providers understand that robotic-assisted surgical systems have been cleared by the FDA for specific procedures, such as prostatectomy and hysterectomy, not specifically for the prevention or treatment of cancer."
Intuitive also recommended that surgeons discuss all treatment options with patients, and that patients ask surgeons about their training, experience and patient outcomes.
"To date," said the statement, "there are more than 15,000 peer-reviewed articles that, in aggregate, support the safety and effectiveness of robotic-assisted surgery. We value the FDA’s role in protecting and promoting public health, and will continue to look to the agency for guidance as we develop innovative solutions for surgeons and their patients."