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."
Canada Latest News, Canada Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
'Young blood' infusion company Ambrosia halts patient treatments after FDA warningThe FDA warned consumers against infusions of plasma from young donors, saying there is no evidence that they slow aging or memory loss, and can be dangerous.
Read more »
'Wacky' drug price system keeps costs high for patients paying for prescriptions, FDA Chief saysRebates are a favorite target of pharmaceutical companies, who say pharmaceutical benefit managers extract huge discounts but keep them for themselves instead of sharing the savings with patients.
Read more »
FDA plans first public hearings on legalizing CBD foods in AprilGottlieb said he has heard Congress 'loud and clear' when it legalized hemp products, including CBD, in December and is putting together a working group of senior officials to work on the new rules.
Read more »
Senator Sanders urges FDA to allow older versions of $375K drugU.S. Senator Bernie Sanders this week urged regulators to allow pharmacies and m...
Read more »
Cannabis stocks mostly higher after FDA head promises April talks on CBD regulationCannabis stocks were mostly higher Thursday, as investors digested the latest earnings reports from the sector and comments from the head of the U.S. Food and Drug Administration on plans for regulation of CBD.
Read more »
U.S. Senator Sanders urges FDA to allow older versions of $375,000 drugU.S. Senator Bernie Sanders this week urged regulators to allow pharmacies and m...
Read more »