Following increase in complications, FDA questions use of robot in surgery
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
The latest thing in the nation's operating rooms is a multi-armed robot marketed as a safer and better alternative to traditional surgery. It is an expensive piece of machinery, costing hospitals in excess of a million dollars, plus service fees of $100,000 per year. To help cover the steep cost, many hospitals have promoted robotic surgery in patient brochures, online and even on some billboards along the highway. Additionally some have asked their staff to encourage their patients to undergo robot-assisted surgery over traditional surgery.
How robotic surgery works
Robotic surgery is similar to conventional laparoscopic surgery, except the surgeon uses a robot to perform the procedure. The surgeon controls the robot while sitting at a computer screen. The surgeon can see inside the keyhole-sized incision by using a camera. The surgeon uses hand or foot controls to control surgical instruments that are attached to the robot's arms to perform the requisite surgical procedure.
One of the most popular robots in use is called the da Vinci. As it is the only robot cleared for soft tissue surgery by the Food and Drug Administration (FDA), it is used in hysterectomies, to remove prostates or gallbladders, to repair heart valves and in transplant operations. In 2012 alone, the da Vinci was used in 400,000 surgeries across the nation. Nearly 25 percent of hospitals have a da Vinci system.
Use of robot questioned
The da Vinci system had come under scrutiny by the FDA. The agency began a survey of surgeons using the da Vinci robot earlier this year in order to learn about their experiences using the device. The reason: in the past year, there has been a significant increase in the number of complications and surgical errors occurring while the da Vinci robot was in use.
In one instance, the robot would not let go of a piece of a patient's tissue during an operation. The surgical staff had to shut down the entire system before this was corrected. In other instances, the robot inexplicably damaged heart tissue and cauterized a fallopian tube during a hysterectomy.
Although the survey of surgeons is a routine response to a reported increase in complications, the FDA has not ruled out further action. Whether it takes additional action regarding the da Vinci system will likely depend on what is uncovered during the survey.
Lack of training blamed
Surgical experts blame the rise in robot-related surgical errors on surgeons not being adequately trained to use the machine. There is currently no agreement on how much training is needed to operate the robot safely, but a 2010 article in the New England Journal of Medicine estimated that it would take about 150 procedures before the surgeon could be called proficient. Frighteningly, as there are no formal regulations, it is left up to the hospitals and surgeons to decide whether a surgeon can competently use a robot to perform operations.
Regardless of whether a robot is used, under New York law the surgeon must perform an operation with a minimum level of skill. If he or she fails to do this, it can constitute medical malpractice. If you or a loved one has suffered complications following robotic surgery, contact an experienced medical malpractice attorney to learn about your right to compensation.