Da Vinci Surgical Robot Subject of FDA Probe

Last summer we published a post about growing numbers of injuries sustained by patients during surgeries with the da Vinci surgical robot system, e.g. “tears and burns, to blood vessels, intestines, uterus and vaginal cuff dehiscence.” Complaints have also been leveled against the electrical arms of the machine, which may be prone to electrical arcing during surgery which may cause burns. Even more recently, we posted an article in which we quoted stock market analysts at Citron Research who predicted da Vinci’s stock will drop by more than half in the coming months as a result of the company’s “excessive and unjustified marketing claims” and “the lack of any scientific evidence that the da Vinci benefits patients.”

AboutLawsuits.com points out that the most devastating evidence against the da Vinci system to date came out last month in the Journal of the American Medical Association.  A study found that “robotic hysterectomies performed with the da Vinci surgical system cost hospitals thousands of dollars more than other surgical methods, without improving outcomes or reducing the rate of complications experienced by patients. The study found that using the da Vinci cost an average of $2,189 more per procedure, when compared to hysterectomies done without the robot. However, the rate of complications was 5.5 percent [in robot-assisted surgeries] compared to 5.3 percent for laparoscopic hysterectomies. The difference is considered statistically significant.”

These findings come on the heels of a probe by the Food and Drug Administration (FDA) in January asking doctors to write in with problems they have had in using the device or training others to use it. Another component of this investigation aims to establish whether some procedures are better suited to robotic assistance than others.

High profile Johns Hopkins surgeon and author Marty Makary commented in the Chicago Tribune in February 2012 : “The robot is the symbol of the current American health care marketplace–rapid widespread adoption with little to no evidence to support it and increased costs.”

The idea that robotic surgeries cost thousands of dollars more without necessarily being any better may spell disaster for Intuitive Surgical, manufacturers of the da Vinci device, especially when health care costs in the United States are already very high. Moreover, the unit itself can cost hospitals up to $2 million, and many hospitals feel pressure to buy them in an effort to attract patients with the newest and most cutting-edge technology–setting aside the risks of increased medical malpractice.

Our previous posts about the da Vinci system they detail specifics about the robot and ways in which its use could involve medical negligence, a potentially defective medical device, and under trained doctors.