With federal health officials already investigating the safety of operations performed with the assistance of robotic surgical systems, it seems health officials at the state level, alerted to the potential dangers, are opening their eyes, as well.
In addition to the Food and Drug Administration (FDA)’s investigation into the safety of these procedures, the American Congress of Obstetricians and Gynecologists (ACOG) issued a statement about the surgical robots, highlighting how little evidence there is to suggest robotic-assisted surgery is as effective as other methods for performing a hysterectomy – one of the many procedures that the devices are said to be capable of performing.
Massachusetts health officials are calling for better training for doctors, as well as deeper disclosure regarding the potential risks robotic surgery poses for potential candidates of the procedure.
Now the New Hampshire Board of Medicine is joining the critics of robotic surgery, which has grown into one of the healthcare industry’s hot-button issues.
The ability to perform less invasive surgery, coupled with a swifter recovery period for the patient are key benefits of robot-assisted surgery, according to its manufacturer, Intuitive Intelligence, the only manufacturer of robotic surgical devices – under the da Vinci brand – cleared in the U.S. for soft-tissue surgery. Models in the da Vinci line can cost hospitals anywhere between about $1.5 million and $2 million, plus additional fees.
The devices have been used in a growing variety of procedures, including kidney cancer and other kidney disorders, prostate removal, throat cancer, coronary artery disease, heavy uterine bleeding and obesity surgery, according to the marketing materials accompanying the unit.
But while the uses for the devices are on the rise, so too are reports of injuries and complications experienced during and after robotic-assisted surgeries.
Serious injuries associated with use of these devices are tears, burns and perforations to arteries and organs. In some cases, injuries related to surgery with a da Vinci surgical robot have allegedly caused death. As a result, Intuitive Intelligence is facing an accrual of lawsuits specifically charging it with failing to provide sufficient training for the doctors who use its robotic systems. Still, hospitals are increasingly using the da Vinci surgical robot to perform a wide and growing range of surgeries.
New Hampshire’s Board of Medicine is expected to start a discussion in the next week regarding its concern that complications from robot-assisted surgery are on the rise nationally, the New Hampshire Union Leader reported.
But health officials from the Granite State may not be as critical as other groups have been.
"It will be up for discussion, but at this time, I don't know if the board would choose to issue a similar advisory here in New Hampshire," Kathy Bradley, executive director for the New Hampshire Board of Medicine, told the New Hampshire Union Leader.
The reason, she added, is that no complaints have been filed with the New Hampshire board, though Bradley is fully aware, she said, that Massachusetts "has received an increasing number of safety and quality review reports of patient complications associated with robot-assisted surgery."
Massachusetts’s Board of Registration in Medicine noted in a statement on its website that “an increasing number” of reports of patient complications related to robotic-assisted surgery has been accumulating over the past two years.
“Risks for robot-assisted surgery should be thoroughly explained” to patients, the board said in its statement, noting that, according to a Bloomberg report, the explanation should include information regarding precisely how much experience a surgeon has at performing a particular robotic procedure.
While cost, usefulness and safety are all subjects of debate regarding Intuitive’s da Vinci robots, training remains the major issue – in fact, all the lawsuits filed allege inadequate training was the cause of the injury or development that engendered the lawsuit.