Risk of Robot Surgery Complications Highlighted by Mass. Health Officials

A medical board in Massachusetts is warning doctors to exercise more care when conducting and recommending robot-assisted surgery, such as those performed with the da Vinci surgical system.  

The Massachusetts Board of Registration in Medicine issued a robot-assisted surgery advisory (PDF) this month, indicating that hospitals should look more carefully at the risks of robot surgery, which have been linked to reports of various internal injuries.

The board also called for better patient selection criteria and improved training for surgeons conducting robotic surgery; a concern increasingly being voiced in connection with the da Vinci robot, which is the only robotic surgery device approved in the U.S.

“As with any new technology, care should be taken that protocols are in place to ensure appropriate patient selection and the full explanation of risks and benefits for all surgical options,” the report concludes. “Education and guidelines for the perioperative and post-operative teams, particularly those personnel or units new to robotic surgery, are important steps for assuring that these surgeries are performed safely, and that there is prompt recognition and treatment of any patient complications.”

Among the board’s recommendations are calls for increased awareness of potential da Vinci robot complications, such as organ perforation, and ongoing and comprehensive training for personnel using the robots.

Concerns Over Robot Surgery Injuries and Training Growing Industry-Wide

The da Vinci Surgical System is a complex, remote-controlled robot that has been heavily marketed and increasingly used in recent years for a number of surgical procedures to provide a less invasive surgery, which reduces recovery time. The device is controlled by a surgeon looking at a virtual reality representation of the patient’s internal organs and manipulating its four metal arms with hand and foot controls.

Since it was introduced, use of the da Vinci robotic surgery system has increased dramatically amid aggressive marketing and promotions by the manufacturer, Intuitive Surgical. However, there have also been concerns that the device is overused, as doctors may feel pressure to recommend robotic surgery to help hospitals recover the costs associated with the expensive machine.

The advisory comes shortly after the American Congress of Obstetricians and Gynecologists (ACOG) issued a report recommending against robotic hysterectomy surgery, indicating that there is a lack of evidence showing any benefit to patients compared to other means of doing a hysterectomy, yet there are increased costs and a serious risk of complications.

The stock price for Intuitive Surgical, the manufacturer of the da Vinci robot, has fallen dramatically over the past two months, and several financial analysts have predicted that the value of the company will fall even further as more information surfaces about the risk of problems with their main product and as the number of the number of da Vinci robot surgery lawsuits continue to be filed on behalf of consumers who have experienced problems.

According to allegations raised in product liability lawsuits filed against Intuitive Surgical, the company sold the da Vinci surgical system without ensuring proper training and instructions for surgeons and without providing adequate warnings about the risks of complications.