A recent Johns Hopkins University study found that da Vinci robotic surgery has actually resulted in more injuries than previously reported. The FDA approved the device in 2000 for use in urologic, laparoscopic, gynecologic, and non-cardiovascular thoracoscopic surgical procedures. Since then, a number of hospitals have shelled out millions of dollars for the privilege of having one of these high-tech machines in their operating rooms.
Now, a recent report in Bloomberg notes that it’s marketing, not medicine, that has resulted in the da Vinci’s popularity. The article echoes warnings given in 2009 by the Wall Street Journal, when doctors from Wentworth-Douglass Hospital noted the machine required considerable practice to gain proficiency”practice many physicians aren’t getting before operating on real patients.
General surgeon Warren Kortz from Porter Adventist Hospital in Denver might have been one of these physicians, as 10 patients he treated with robotic surgery allegedly suffered injuries or complications between 2008 and 2011.
Surgeon Charged with Unprofessional Conduct
Of the reportedly injured patients treated by Kortz, five had arteries punctured or torn, some had nerve damage, two were temporarily left with foreign objects inside them, one died, and one needed cardiopulmonary resuscitation. This, after the hospital reportedly advertised the machine as being easier on the patient.
A complaint registered by the Colorado Medical Board reportedly charges Kortz with 14 counts of unprofessional conduct. Still, robotic surgeries are on the rise, but it seems more from advertising and marketing than from a proven record of success.
Why the Uptick in Reported Problems?
Back in April 2013, the FDA started looking into a spike in reported problems, including death, resulting from robotic surgery. They began surveying surgeons who were using the system in the hopes of determining what’s causing the increase. Is it because the machine is being used more often than before? Because surgeons are lacking adequate training? Or are there design problems with the machine itself?
Complications can occur with any type of surgery, so the FDA is understandably cautious in singling out the Da Vinci Robot as being flawed. Manufacturer Intuitive Surgical insists the system has an excellent safety record. Yet in July 2013, the FDA issued a warning letter to the company after an inspection found they hadn’t adequately reported device corrections and patient adverse events in some cases.
Researchers from Johns Hopkins noted that in 2012, a total of 245 events were reported to the FDA, including 71 deaths and 174 nonfatal injuries. But another eight cases were identified in which FDA reports were improperly filed. In five of the cases, no report was filed at all”suggesting that perhaps there are many more unreported cases.
Other studies have noted that the benefits of robotic surgery do not outweigh its high costs. A March 2012 study in the Journal of Clinical Oncology found that women treated for endometrial cancer experienced no additional benefits when the da Vinci was used rather than traditional surgery.
The inconsistency in reports and results hasn’t stopped Intuitive Surgical from aggressively marketing their product. Peter Dunn, executive medical director for perioperative services at Massachusetts General hospital, said sales representatives from the company were constantly coming in with pitches geared toward selling the hospital a robot, and that their marketing pushed the limits of truth.
The company has also been reported as telling hospitals that the robot can help attract new patients, and therefore, new revenue. Their materials often contain only the most positive information, leaving out the potential risks. According to a September 2012 study, 44 percent of hospital websites, in turn, touted the benefits, yet only 1.6 percent mentioned potential complications.
Marketing of robotic gynecologic surgery is widespread, the researchers wrote. Much of the content is not based on high-quality data, fails to present alternative procedures, and relies on stock text and images.