Questions Raised Over Safety Of Da Vinci Surgical Robots

Some people have hailed the recent development of robotic surgical systems, particularly da Vinci, and credited the development with revolutionizing some operations. Though some surgeons tout the supposed benefits of robotic surgery, such as improved healing times, the FDA has begun turning a skeptical eye towards the devices and has announced that it will launch an investigation into a recent uptick in reported problems with robotic surgical systems.

The explosion in the use of robotic surgery systems is undeniable. Numbers show that nearly 400,000 procedures were performed by robots in 2012. This represents an enormous increase from the 114,000 procedures performed by robots in 2008. The leading system, and the only one approved by the FDA for soft tissue surgeries, is known as da Vinci. While most people agree that the da Vinci system can be great in certain circumstances, especially surgeries in tight spaces that require very precise movements, not everyone is convinced that they are useful in other cases.

So far, robots have been popular for conducting prostate surgeries, gallbladder removals and hysterectomies. Some doctors and hospitals are aggressively expanding the areas where the robots may be used with robots frequently advertised as the method of choice for stomach stapling surgeries and even some organ transplant procedures. Experts in the industry say that da Vinci systems are great advertising tools for hospitals that are eager to draw in customers with the latest technology and that expanding the surgeries where robots are used is another way of coping with the high cost for the devices. It’s estimated that a da Vinci system costs nearly $1.5 million upfront along with at least $100,000 per year in service contracts. The expense hasn’t scared away customers though, as it is believed that four in ten hospitals own a da Vinci system.

Though doctors often hype the wonders of robotic surgery, claiming there is less bleeding and shorter hospitalization times, few if any studies have been done to corroborate this conclusion. Instead, many in the medical business question whether there is any evidence that da Vinci performs surgeries better than an experienced surgeon would, especially given the incredibly high cost of the product.

Not only are the benefits dubious, but a recent increase in adverse event reports filed with the FDA has raised some safety concerns. Since the beginning of 2012, 500 adverse event reports have been sent to the FDA about da Vinci systems. These include five reports of death. In once case a woman died during a hysterectomy after the robot clipped a blood vessel. In another case, a man died after the da Vinci robot perforated his colon, which led to a terrible infection.

Instances of malfunction or glitches are especially terrifying given the incredibly delicate nature of surgery. One report discussed how a patient who was having hysterectomy surgery was slapped in the face by the robot, causing enough of a scare that the doctor decided to finish the procedure himself. In another case, a robot grasped onto a patient’s tissue during a colon surgery and would not let go, essentially freezing with a man’s colon in hand. The doctor had to reboot the system to get it to release, a scary moment for everyone involved.

Though none of this proves that robotic surgery systems should never be used, the reports do raise serious red flags. We can only hope that the FDA does its job and rigorously investigates the use of the da Vinci system to ensure future patients are safe.

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Source: “Verifying da Vinci: Robot hot among surgeons, but FDA taking fresh look,” by The Associated Press, published at Missoulian.com.