What if you need a hysterectomy, and the surgeon wants to do the surgery with a robot? Instead of working directly with his hands, he will sit at a console manipulating a set of robotic arms outfitted with tiny surgical instruments.
Should you go for it?
You’d be forgiven for some hesitation. There have been widely publicized horror stories, including patients who have bled out after a robotic instrument inadvertently nicked a blood vessel or those who have been injured in other ways, such as accidental punctures, tears or burns.
The rise of such “adverse events” during various robotic procedures has led to new government scrutiny, as well as a cautionary statement from the American College of Obstetricians and Gynecologists: “Robotic surgery is not the only or the best minimally invasive approach to hysterectomy…nor is it the most cost-effective.”
Does any of this warrant your flatly rejecting robotic surgery? Many experts say no. Every patient profile is different, and a robot is just another surgical instrument: It’s only as good as the surgeon using it.
Before making a decision on what kind of procedure to elect, here are some things to consider:
Why the spike in robotic usage?
Back in 2000, there were only 1,000 robotic surgeries world-wide. That number surged to 360,000 in 2011 and 450,000 last year. Boosters say the practice is on the rise because of its strong benefits. For the patient, there’s usually less blood loss, a shorter hospital stay and less reliance on postoperative pain medication. There’s also the cosmetic benefit of no big scars: As in laparoscopic surgery, the instruments enter the body through small incisions.
For surgeons, the procedures can be less tiring. They don’t have to bend over an operating table—they can sit in front of a screen with a magnified, full-color 3-D view of the surgical field. For maneuvering in very tight spaces, like the back of the throat, the enhanced screen image makes it “much easier to see what I’m doing,” says Eric Genden, chief of otolaryngology at New York’s Mount Sinai Hospital.
But some doctors say robotics is catching on not just because of its merits—there’s a “wow” factor at work. Martin Makary, a pancreatic surgeon at Johns Hopkins, believes the technique is safe and useful for certain procedures. But, he says, it’s spreading too fast. We have a “culture that marvels at new technology,” he says, and a propensity to embrace innovations “without a lot of rigorous, standardized evaluation.”
Some doctors also say there’s an arms race by hospitals eager to attract new patients and get a competitive edge. Highway billboards and websites sometimes suggest robots improve cancer outcomes, a claim that many doctors say isn’t backed up by studies.
Government officials have shown concern about oversight as well. For example, responding to an increasing number of reports of patient complications from robotic surgery, Massachusetts health officials last March sent an advisory to the state’s hospitals urging caution: “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.”
What about risks?
Reports of adverse robotic events to the Food and Drug Administration are on the rise. Based on a draft analysis of these reports by physicians at Rush University Medical Center, the University of Illinois and the Massachusetts Institute of Technology, there has been a sharp increase in the injury and death rate from robotic surgery to about 50 reports per 100,000 procedures last year from only 13.3 in 2004.
Intuitive Surgical Inc.—the dominant manufacturer of robotic-surgery gear—disputes this analysis, claiming there isn’t any “statistically significant trend.”
Because of the rising number of incidents—282 injury reports last year, including 28 deaths, up 34% from the year before—the FDA inspected Intuitive earlier this year and in July issued a warning letter stating the company hadn’t reported certain safety changes to its da Vinci robotics system, asking for “additional corrective actions.”
In a recent filing with the Securities and Exchange Commission, Intuitive said that it had responded to the letter “with plans for corrective action” and that the FDA action had placed limits on the company’s ability to obtain FDA certification for “new and re-registration of products in certain foreign countries.”
Intuitive is a defendant in about 50 lawsuits alleging product liability, according to the SEC filing. The company declines to comment on specific lawsuits or on adverse events during surgeries but says, “We take any claim seriously, evaluate them on their merits and trust in the legal system to resolve these matters.”
How should patients weigh all of this?
The wisest approach is to have your surgeon explain the alternative procedures, including typical postoperative scenarios and why the suggested approach is the best option in your particular case. No single approach is a one-size-fits-all answer for all conditions requiring surgery.
How much training is required to perform robotic surgery?
Dr. Makary, the Johns Hopkins surgeon, believes that overall, robotic surgery is safe. But, he says, problems can get magnified if a surgeon doesn’t have advanced laparoscopic surgical skills to begin with and doesn’t have full command of the device. That means it’s easier to cause inadvertent injury.
Training protocols vary by hospital. There’s no magic number of supervised procedures that must be performed before a surgeon is deemed ready. A sign-off usually comes after a more experienced colleague or a committee is satisfied with a surgeon’s skill set on the machine.
Critics have said—and one Washington state lawsuit alleges—that Intuitive salespeople, to meet certain quotas, have pressured doctors to convert open surgeries to robotic. Intuitive says, “Our sales team engages surgeons to educate them about the benefits of using da Vinci as compared to other surgical approaches. We strongly believe that medical advantages, including proven safety advantages, are the primary driver of the growth in da Vinci Surgery use and that improved clinical outcomes are the most important patient benefit.”
Obviously, ask your surgeon how experienced he or she is in the procedure and whether there have ever been any complications. Good question for the hospital, too.
What about the cost?
Generally, robotic procedures cost more than other comparable types of surgery. A study published last year by surgeons at Brigham and Women’s Hospital in Boston showed these average total patient costs for different types of hysterectomies: $49,526 for a robotic procedure, $43,622 for abdominal, $28,312 for laparoscopic and $31,934 for vaginal.
Bear in mind, though, that patients may end up saving on their overall costs. A robotic procedure may mean less need for pricey items like blood transfusions and post-op pain meds. Patients may also spend less time in the hospital and have a lower chance of readmission for complications.