With the number of injuries related to robotic surgery on the rise, officials at the federal level have already embarked on a course of action. Now, Massachusetts health officials are joining them by calling on the state to advocate for better training for doctors and deeper disclosure regarding potential risks.
The robotic surgery category consists of Intuitive Surgical Inc.’s da Vinci – as it is the only robotic surgical system that has been cleared in the U.S. for soft-tissue surgery. It is already facing a formal investigation by federal health officials into the safety of the surgeries it has performed. In addition, the American Congress of Obstetricians and Gynecologists (ACOG) recently issued a statement about the da Vinci surgical robot, highlighting how little evidence there is to suggest that the device is as effective as other procedures for performing hysterectomies, and that is only one of the many procedures that the unit is touted as being able to perform.
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 the surgery have been piling up during the past two years. The board does not highlight the fact that the da Vinci is the only such device on the market at present.
“Risks for robot-assisted surgery should be thoroughly explained” to patients, the board said in its statement, noting, according to a Bloomberg report, that the explanation should include information regarding exactly how much experience a surgeon has performing a particular robotic procedure.
The state board listed examples of specific complications that have developed in the wake of robotic surgery: rectal tissue was left in the abdomen after a procedure for ulcerative colitis; and a patient undergoing a robotic hysterectomy and ovary removal experienced damage to the bowel and left ureter, which required numerous corrective treatments.
According to marketing materials for the device, with the da Vinci, specifically, the doctor sits at a console described as video-game style, which is located several feet away from the patient. The doctor observes the process on a high-definition display, using both foot pedals and hand controls to maneuver the mechanical arm, which are equipped with the required surgical tools for the operation being performed. One arm consist of a 3-D camera at the tip that captures the image being displayed on the screen for the doctor, allowing him to closely view the work as it occurs on the patient.
The cost, usefulness and safety of Intuitive’s da Vinci robots are also part of the debate taking place among doctors, as well as in the court room. But training remains a major issue.
So far, nearly all the lawsuits filed in the past 14 months alleging injuries from robotic surgery allude to the training regimen for doctors who use the da Vinci.
Hospital’s often use their websites to exaggerate the benefits of robotic surgery, according to a 2011 study in the Journal of Healthcare Quality, according to Bloomberg.
That study found that 86 percent of the websites that mentioned robot surgery claimed superiority – and not a single one described the risks of using the robotic method.
Often the websites were made up – both text and images – directly from the marketing materials supplied by the manufacturer, the researchers indicated.