The FDA warned patients and health care providers 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 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,Dr. Ricardo Adbala trains with the da Vinci Surgical Robot SiHD in Sao Paulo, Brazil, in 2014.
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."
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