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Robotic Surgery Complications, Deaths Underreported to FDA

Nov 5, 2013

With the use of surgical robots on the rise, hospitals, patients, and regulators may not be getting the information they need to determine whether the high-tech system is worth its cost.

A recent research study says problems—including deaths—resulting from robotic surgery have not been appropriately reported to the U.S. Food and Drug Administration (FDA), reports Kaiser Health News.

Some incidents were reported late, inaccurately, or not at all, the study reveals. The study, published earlier this year in the Journal for Healthcare Quality, focused on incidents involving Intuitive Surgical's da Vinci Surgical System that happened during its nearly 12 years in use. In examining databases for adverse events, the researchers found 245 incidents reported to the FDA, including 71 deaths and 174 nonfatal injuries, Kaiser Health News reports. But they also found eight cases in which reporting fell short, including five cases in which no FDA report was filed at all.

Since 2007, the number of da Vinci systems installed in U.S. hospitals increased by 75 percent, from 800 to 1,400, according to the study. Some healthcare professionals say the benefits of robotic surgery include smaller incisions, shorter hospital stays and less pain after the operation. But Dr. Martin A. Makary, an associate professor of surgery and health policy and management at John Hopkins University and one of the study's authors, said there are challenges in assessing surgical robot problems; in particular, knowing the difference between doctor and device error. And the benefits are not consistent for all types of procedures. Robotic surgery has shown benefits in head and neck surgery, for example, but it is not necessarily superior to traditional methods in gall bladder removals.

Hospitals and insurers need standards for judging whether the robotic system is worth the extra cost. In a three-year comparison of robotically assisted hysterectomies versus traditional laparoscopic surgeries, the Journal of the American Medical Association reported that the robot added an average of $2,000 per procedure, with no significant clinical advantages. The American Congress of Obstetrics and Gynecology noted that "if robotic surgery is used for all hysterectomies each year," it would add an estimated $960 million to $1.9 billion to the annual cost of hysterectomy surgeries, according to Kaiser Health News.

Medical experts want to see a fair and timely reporting system that will allow for the best assessment of robotic surgery’s benefits and risks, and will address the question of liability in cases of device malfunction. Surgeon training is also a factor. A number of lawsuits brought against Intuitive Surgical allege the doctor wasn’t adequately prepared to use the da Vinci system.

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