2013 Intuitive Surgical, Inc
When he awoke, he had no feeling in his shoulders and arms. During the eight-hour operation, his body had been suspended in a steep head-down position to accommodate the positioning of the robot used to assist the surgeon. Elliott suffered nerve damage and never regained full use of his left hand.
Elliott is one of more than a million people in the U.S. who have undergone robotic surgery since it was introduced in the 1990s. He is also one of a growing number of casualties.
While robotic surgery dates to 1992, when a 64-year-old man had his hip successfully replaced with the assistance of a machine called Robodoc, it wasn't until the U.S. Food and Drug Administration (FDA) cleared the da Vinci robotic system in 2000 for a large swath of minimally invasive procedures that the concept took off.
Calling Dr. Robot
Over the past decade, some 2,000 surgical robots have been sold in the U.S., and the number of robotic procedures, for everything from delicate head and neck surgery to routine hysterectomies, has soared by 30 percent each year. Experts attribute the surge to aggressive marketing that plays up the robot's wow factor.
"Billboards and TV commercials can make hospitals that have the robot seem more high tech and cutting edge," says Karen Schoelles, M.D., medical director of the ECRI Institute, a nonprofit research organization that assesses safety and cost-effectiveness in patient care.
But robots in the OR may not be living up to their promise. "Years of data tell us that for many procedures, there's no benefit to the patient over standard minimally invasive surgeries," says Marty Makary, M.D., a surgeon at Johns Hopkins Hospital in Baltimore and author of several studies on robotic surgery. "While the robot provides a benefit in some operations, most uses are for procedures where there are no advantages and there may be potential risks."
Hysterectomy, the second-most-common surgery for American women, is a good example. According to a recent Journal of the American Medical Association study of more than 250,000 procedures, hysterectomies performed with the da Vinci robot had no better outcomes than those done through laparoscopic surgeries.
"All of the studies so far show it's no better or worse, but it takes longer and is more expensive," says James T. Breeden, M.D., immediate past president of the American Congress of Obstetricians and Gynecologists.
Reviews of studies on other operations, including gallbladder removal, colorectal surgery and procedures to reverse reflux, have reached similar conclusions.
The FDA originally cleared the use of surgical robots for general laparoscopic surgery — minimally invasive procedures done through small incisions — which reduces the risk of infection and speeds recovery. Other uses have been added since.
While robotic surgery is considered generally safe, the FDA is reviewing the data after a growing number of reports of related complications. As of August 2012, some 71 deaths had been logged by the FDA's online reporting database since the robot was introduced. And adverse events involving the robot increased 34 percent between 2011 and 2012 alone, prompting the FDA to launch an inquiry. Furthermore, a new Johns Hopkins study shows that such problems are likely underreported.
Still, surgeons see many advantages to performing procedures with a robot. A computer screen magnifies everything in 3-D, greatly improving the surgeon's field of vision; the robot's "hands" can reach into tighter spots and move in ways that human hands cannot; and the machine's software corrects for a surgeon's hand tremors. The robot may also reduce physician fatigue because surgeons work the robot's controls while sitting at a console instead of standing over the patient for hours.
Minimally invasive robotic surgeries usually result in less blood loss and faster recoveries, since there's a smaller incision to heal. This is a particular advantage for surgeries in which there were few minimally invasive procedures until the robot came along, such as prostate removal and other complex cancer surgeries.
"The system brings the most value when the procedure would otherwise be open," says Myriam Curet, M.D., the medical adviser of Intuitive Surgical, which manufactures the da Vinci.
Of course there are risks with any type of surgery. But some experts say prospective robotic-surgery patients are rarely told about the risks specific to this high-tech approach. Some patients, like Paul Elliott, have suffered permanent nerve damage due to being held in an unnatural position, as required for some robotic procedures. Surgeons using a robot don't get the tactile feedback that comes from cutting directly into a patient's tissue, and that can increase the risk of injury from hitting adjacent organs. The machine may also cause burns from the electric current.
Patients may be surprised to learn that there are no national training standards for robotic surgery. The training provided to surgeons new to the technique typically consists of online instruction, a one-day session at the manufacturer's headquarters in California and two supervised surgeries. It's up to the individual hospital to decide when doctors can perform robotic operations on their own. Yet "it takes a long time to master this technology," says Jim C. Hu, M.D., director of the robotic and minimally invasive urology surgery program at the University of California, Los Angeles. Hu has performed more than 2,000 robotic surgeries.
If you're scheduled for robotic surgery
1. Ignore the hype: According to a 2011 Johns Hopkins study, hospital websites often cite studies comparing robotic surgery with open surgery instead of with minimally invasive procedures. "Many claims of superior safety and effectiveness are misleading," says Marty Makary, M.D., of Johns Hopkins.
2. Weigh the options: Think twice about having robotic surgery for routine procedures such as hysterectomy, gallbladder removal, hernia repair, appendix removal, gastric bypass and standard colon surgery. Conversely, the robot's dexterity may pay off for complex cancer surgeries, head and neck tumors, and throat cancer, as well as procedures for which there is no minimally invasive choice.
3. Ask questions: Some patients aren't told that their surgery will be performed with the assistance of a robot, so if you're scheduled for surgery, ask. If a robot will be used, ask whether there are alternatives.
4. Select the right doctor: That is, one who has had practice with the robot — has performed routine surgeries at least 20 times, experts say. UCLA's Jim C. Hu, M.D., advises finding a surgeon who has fellowship training in robotic surgery, and who has practiced robotic surgical skills for more than a year.
The bottom line: It's important to weigh the pros and cons of robotic surgery carefully. Ultimately, your comfort level and your doctor's experience should trump all other considerations.
Beth Howard is a freelance writer.
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