FDA on High Alert Amid Rise in Robotic Surgical Injuries

Every year, new medications and technological advancements are expanding and improving the quality of human life. These new inventions shorten surgical and recovery times for patients. A more recent innovation involves the utilization of robotic instruments during surgery.

However, according to the latest data from the Food and Drug Administration, this particular invention may be doing more harm than good. The FDA reports that surgical mistakes are occurring as a result of the use of many of these systems.

What is robotic surgery?

Robotic surgery is a type of procedure where a surgeon performs surgery via a robotic console or machine. Using this robotic machinery is generally thought to be minimally invasive because doctors utilizing the equipment do not have to open up the patient to manually perform the surgery.

Since the advancement became available, more and more hospitals began using these instruments-specifically the popular da Vinci Surgical System, manufactured by Intuitive Surgical. This system is often used to repair heart valves and perform gynecologic procedures. According to the company’s quarterly report filed with the SEC this past April, the number of surgical procedures using the da Vinci System increased from 292,000 to 367,000 in 2012 alone.

However, despite its popularity, the da Vinci and other robotic systems have caused problems. The Wall Street Journal released an article on an FDA report that shows an overall increase in both injuries and fatalities from surgical robots.

The report

The FDA report utilized information from three different entities including Rush University Medical Center located in Chicago, the University of Illinois, and the Massachusetts Institute of Technology. The data reveals that adverse events from robotic systems have increased almost 4 times the rate that they were in 2004.

Specifically, in 2004 roughly 13.3 adverse events occurred per 100,000 robotic surgical procedures. In 2012, that number rose to 50 reports per 100,000 procedures conducted.

However, this number may actually be inaccurate. The FDA indicates that Intuitive Surgical may not be adequately reporting all illnesses and injuries linked to the robot such as surgical corrections performed as a result of complications from the system.

Medical errors due to lack of surgical training

Along with malfunctioning systems, lack of training may also be to blame for the rise in injuries related to robotic surgical procedures.

According to a recent statement issued by the President of the American College of Obstetricians and Gynecologists, there is a learning curve that goes in tandem with any new surgical technology that takes years of training to master.

Some research indicates that it takes 50 surgeries to become proficient plus 250 surgeries to become an expert at performing robotic surgeries. Unfortunately, the learning curve for doctors is causing injuries and damages to their patients.

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