Most of us have experienced the anxiety and frustration of a computer, smartphone, iPad or other device malfunctioning. But what would we do if our lives depended on an electronic device performing perfectly?
That’s not an exact analogy to a robotic surgery machine, but since most of us don’t own robots, it’s close enough. There are literally hundreds of thousands of robotic surgeries performed in the United States, and most are done safely. However, the more these machines are used, the more injuries are reported.
Since 2007, the U.S. Food and Drug Administration has received over 200 reports of burns, cuts, infections and close to 100 deaths after robotic surgeries. Further, prompted by a recent study that found doctors using expensive robots to perform surgeries produced no better results for patients than regular, less expensive procedures, the American Congress of Obstetricians and Gynecologists spoke out against the use of robots for surgeries, which are often hysterectomies.
A hysterectomy is the most common surgical procedure for women. In fact, one in nine women will have one within her lifetime. Now more and more women are opting for robot-assisted procedures in lieu of large abdominal incisions or laparoscopic surgeries involving small incisions in the abdomen.
The most popular among these machines is the da Vinci Surgical System, and here’s how it works: The surgeon sits some distance away from the “robot” at a console and uses surgical tools attached to the robot’s arms to perform the actual procedure. Think about that for a second. A good surgeon’s hands are supposed to be precise and most learned how to perfect that hands-on technique in medical school. Instead, now they are opting for a machine to do the work for them. It makes you wonder, doesn’t it?
So do many critics of the da Vinci. The FDA is currently investigating whether the rapid number of reported injuries is because more robotic surgeries are being performed, caused by the machine itself or by surgeons having inadequate training. Intuitive Surgical, the manufacturer of the da Vinci, requires surgeons to take online training. They must also practice the robotic surgery at the company in Sunnyvale, California. First, practice is done on inanimate objects. Then they move on to cadavers or animals. Internal emails from Intuitive have shown a desire to shorten the required training time for surgeons. The bottom line is robotic surgery critics worry that surgeons don’t receive enough training, and aren’t performing actual procedures. After the practice on a cadaver or animal, the surgeon is given a certificate of completion, and then it’s up to the hospital’s training and certification process to decide if a surgeon’s robotic skills are up to par.
Advocates of robot-assisted surgery claim that it’s minimally invasive and results in less blood loss, pain, and shorter post-op recovery than traditional surgery. However, it’s also more expensive. A study of 260,000 hysterectomy patients found that the average cost for robot-assisted surgery is $8,868 compared with $6,679 for a laparoscopic hysterectomy.
Given that the costs of these high-tech behemoths are over $1.5 million, hospitals that own them will definitely use them. In fact, between 2007 and 2010, robotically assisted hysterectomies rose from 0.5 percent to 9.5 percent, and accounted for 22.4 percent of all hysterectomies three years after hospitals purchased the equipment.
Angela Wonson, a spokesperson for Intuitive Surgical, the company that manufactures the da Vinci system, said “As a tool, robotic surgery helps surgeons overcome the limitations of traditional [minimally invasive surgical] techniques to provide patients with a less invasive option and prevent the downstream costs and complications of an open procedure.” But according to Dr. Francois Blaudeau, a lawyer and practicing Alabama gynecologist serving as the lead plaintiffs’ attorney on several cases over da Vinci-related injuries, “Most robotic procedures take place without a hitch, but there are a growing number of complaints and lawsuits that allege complications and even deaths from the da Vinci surgery.”
Last year alone, 450,000 people had robot-assisted surgery, which has made Intuitive Surgical’s stocks soar. But there is a lot of controversy over these machines, along with a growing number of lawsuits. Several of the reported injuries are burns and other heat-related damage to intestines, ureter, bowels, vagina and other vital organs. And Dr. Blaudeau claims the injuries aren’t often for days after the procedure. The da Vinci uses monopolar energy, which can cause sparks that leave residual damage. To reduce criticism of its da Vinci product, Intuitive has introduced new tip covers for its instruments.
“So the real question is – is it safe? In the hands of a good surgeon, yes, said Dr. Marty Makary, a surgeon at Johns Hopkins in Baltimore. “In the hands of someone who may not have advanced skill sets, it could be a real danger.” The good doctor seems to be stating the obvious. Also of concern is the profit motivation at Intuitive Surgical, who has already shown the ability to place profits in front of patient safety by pushing for reduced hospital training periods. Furthermore, you have to wonder what comes next – robotic nurses assisting robotic surgeons, who are using robotic surgery equipment to perform surgeries? One only hopes they don’t completely eliminate humans from the process. Anything is possible in this day and age.
The defective medical device attorneys at Reyes | Browne | Reilley is currently helping da Vinci Surgical Robot victims and their families recover damages from their devastating complications. If you or someone you know suffered injuries from a procedure performed with the da Vinci robot, please call us for a complementary and confidential consultation. You are under no obligation to use our services. Call us today at 214-526-7900, or submit the short case review form on the right.