When you're lying unconscious on the operating table under general anesthesia, the last thing you'd expect is for your surgeon to slap you. However, according to FDA reports, this did happen to a patient undergoing robotic surgery.
In 2012, a woman was undergoing a hysterectomy when the robotic arm swung loose and struck the patient's face. The surgeon suspended the robotic surgery and switched to a more invasive open operation. The hospital also filed a report with the Food and Drug Administration.
That report, according to the Associated Press, is one of 500 reports on file with the FDA regarding the Da Vinci surgical robot since January 2, 2012. The reports prompted the FDA to open an investigation of the Da Vinci robot in April 2013.
As more concerns arise about deaths or injuries during robotic surgery, a 2011 paper in the Journal or Healthcare Quality has become newly relevant. It forces hospitals to face some difficult questions about whether they are concerned more with revenue than safety.
The paper reviewed U.S. hospital websites to see where and how hospitals presented information about robotic surgical procedures. Around the country, 41 percent of hospitals were promoting surgery performed by Intuitive Surgical’s Da Vinci robot.
Of these hospitals, 89 percent claimed that robotic surgery was clinically superior to traditional surgery. Claims included less pain, less scarring, less blood loss, lower infection risk, fewer complications and faster recovery time.
A few hospitals also included emotional appeals to patients, using language such as "you owe it to yourself," "if you or a loved one" and "new hope" to market robotic surgery. The scary part: of the hospital websites surveyed, none disclosed any risks involved in robotic surgery.
Authors of the journal article, like Dr. Martin Makary of Johns Hopkins, have expressed concern that no research exists proving that robotic surgery outcomes are superior to traditional surgery. Each robot costs $2 million, and some worry that hospitals are marketing the machines aggressively in an effort to recoup costs.
Makary has co-authored an additional paper that reports findings that doctors don't always disclose negative incidents involving the Da Vinci robot. In fact, the manufacturer has a legal obligation to report any incidents to the FDA, but medical professionals do not.
Mistakes can happen during any type of surgery, but critics worry that hospitals have financial reasons for not disclosing robotic surgery incidents.
Until then, the problems continue to pile up. For example, during a robotic surgery on colorectal tissue, a robotic arm grasped some of the patient's tissue and wouldn't let go. Doctors had to shut the system down completely to get the grasper to open its jaws.
Robotic surgery can work for many patients. Just be sure to know the risks.
Edited by
Alisen Downey
