Researchers Find Complications in Robotic Surgery Often Unreported

Hospitals and physicians throughout the country have been quick to adopt the use of robotic surgery, an approach that uses robotically controlled instruments and 3-D imaging to perform surgical procedures. Although robotic surgery – including robotic hysterectomy – has become an increasingly popular treatment option, evidence that the robotic approach offers few, if any, benefits over other surgical options is mounting. According to the results of a study conducted by Johns Hopkins, there is even more reason to question the effectiveness and safety of robotic surgery.

Roughly one million robotic surgeries have been performed since 2000. Of these, only 245 complications – including a total of 71 deaths – were reported to the U.S. Food and Drug Administration (FDA). According to an associate professor of surgery at Johns Hopkins University School of Medicine, the number of reported complications is very low, especially for a complex procedure used more than a millions times.

Standard protocol for reporting complications or adverse events begins with hospitals reporting any malfunctions or complications directly to the device manufacturer. Manufacturers are then required to report these complications to the FDA. With robotic surgery, however, this didn't seem to always be the case. Researchers found multiple incidents of unreported complications. In some instances, complications were not reported to the FDA until they had been made public on national media outlets. In others, civil lawsuits were filed for robotic surgery complications that were never reported to the FDA.

Why Reporting Complications is Important

Reporting complications enables device manufacturers, regulators, hospitals, physicians, and patients to view accurate data about a particular procedure. This in turn can help medical professionals better improve procedures or methods and can help patients make more informed decisions about treatment. For example, researchers found that robotic hysterectomy had the highest rates of complications among those that were reported. If all adverse events were reported, patients would be better able to assess the risks for complications associated with hysterectomy.

Unfortunately, researchers say that won't happen with the current reporting system in place. They suggest that a standardized system is needed for reporting all device-related errors and complications, and pointed toward the use of a database. You can read more about the study on this article.

Making Informed Decisions

Robotic surgery has come under scrutiny as of late and there have been concerns about overstated benefits, misleading claims, and aggressive marketing tactics used by device manufacturers. With a new study showing that robotic surgery complications are not always reported, anyone considering a robotic hysterectomy should make it a priority to thoroughly understand the procedure, become acquainted with the potential risks, and explore alternative options.

Making informed decision about your treatment is crucial and, unfortunately, not always easy. With, you can find the information, support, and connections you need as your navigate your decision process. To learn more, fill out a contact form or call (888) 885-8311.