Number of Operating Room Injuries Linked to Robot Surgery Reportedly Increasing

Washington, DCPatients who have suffered an operating room injury during robotic surgery may not be surprised by reports that the number of robot-related surgical injuries is on the rise. Concerns about injuries linked to robotic surgery are conveyed in da Vinci robot lawsuits, alleging patients were seriously harmed because of the use of the robot during surgery--sometimes by surgeons who allegedly received inadequate training. Now, preliminary reports from the US Food and Drug Administration (FDA) suggest that such injuries may be on the rise.

Information from the FDA, and reported on by The Wall Street Journal (11/17/13) suggests an increase in adverse events - including injury and death - linked to robot surgery. Data collected by the FDA and analyzed by physicians from Rush University Medical Center, the University of Illinois and the Massachusetts Institute of Technology show an increase from 13.3 adverse event reports per 100,000 procedures in 2004, to 50 reports per 100,000 procedures in 2012.

There were reportedly 282 reports of injury in 2012, including 28 deaths to the FDA. Whether the increase in adverse event reports is because of an actual increase in such events or because more people are reporting injuries and deaths is not clear. According to Medscape, Intuitive Surgical filed a quarterly report with the US Securities and Exchange Commission (April, 2013) stating the number of procedures performed with the da Vinci system in the US during 2012 increased 26%, with the total number going from 292,000 to 367,000 procedures.

Furthermore, in a document sent by the FDA to Intuitive Surgical, maker of the da Vinci robot, on May 30, 2013, the agency noted that illnesses or injuries that were linked to the robot were not reported to the FDA. The agency also noted that a correction or removal, which was done to reduce the risk of injury linked to the da Vinci robot, was not reported to the agency.

In addition to those concerns, the American College of Obstetricians and Gynecologists (ACOG) has issued a statement on the use of robots during surgery. The statement, written by ACOG President James T. Breeden, MD, notes, "The outcome of any surgery is directly associated with the surgeon’s skill. Highly skilled surgeons attain expertise through years of training and experience. Studies show there is a learning curve with new surgical technologies, during which there is an increased complication rate. Expertise with robotic hysterectomy is limited and varies widely among both hospitals and surgeons. While there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations that require extensive surgery and removal of lymph nodes, studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes. Consequently, there is no good data proving that robotic hysterectomy is even as good as--let alone better--than existing, and far less costly, minimally invasive alternatives."

Dr. Breeden closes his statement by adding, "Aggressive direct-to-consumer marketing of the latest medical technologies may mislead the public into believing that they are the best choice. Our patients deserve and need factual information about all of their treatment options, including costs, so that they can make truly informed health care decisions. Patients should be advised that robotic hysterectomy is best used for unusual and complex clinical conditions in which improved outcomes over standard minimally invasive approaches have been demonstrated."

Intuitive Surgical now faces lawsuits alleging patients were seriously harmed by the use of the da Vinci robot. According to Bloomberg Businessweek (10/31/13), Intuitive also faces a lawsuit from an insurer, alleging Intuitive lied about the number of lawsuits it faced concerning the da Vinci robot. That lawsuit is Illinois Union Insurance v. Intuitive Surgical, 13-cv-04863, US District Court, Northern District of California.