For example, 22 of the 71 patients who died underwent gynecologic robotic surgery, which also resulted in 89 of the 174 non-fatal adverse events. Of the patients who survived 34 had permanent injuries and 49 had damage to soft organ tissue. The next greatest incidence of harm from the robot was found in urological surgeries, with 30 of 36 patients suffering harm during prostatectomy.
The Johns Hopkins researcher and author of the recent book Unaccountable, says the paucity of these reports points to the critical need for a robotic surgical registry, similar to that which collects outcome reports for thoracic procedures.
Makary asks rhetorically, "Why are we having the debate about robotic surgery now, (more than a decade) after it was FDA-approved, when there have been over one million people who have had robotic surgery. The data could have been captured and analyzed in the first few years and we could have had the discussion about which procedures robotic surgery provides benefit for, and for which procedures there is no difference, and for which procedures are there added risks and costs that make it unwise."
"We would do a much better job informing our own community and patients about the risks and options if we had this information."
Made by Intuitive Surgical Inc. of Sunnyvale, CA, the Da Vinci system received FDA market approval in 2000 and by 2011, more than 1,400 units were operating on patients in U.S. hospitals, and another 200 to 400 in hospitals outside the U.S.