Home >  News >  April, 2013

Robotic Surgery Failure Rates Up, FDA Wants to Know Why

Mounting evidence shows robots drives up costs, don't improve outcomes.

Published: April 29, 2013

Robotic surgeries failure rates have tripled in the last 5 years, and the FDA has begun to investigate reasons for the increase, reports Business Week.

According to a report by investment advisors Citron Research, there have been more than 4,600 adverse events associated with robotic surgery reported to the FDA's MAUDE database — about 3,900 of which (82%) were reported between 2007 and 2012. The issue may not be the robots themselves, but rather manufacturer training or improper use by operator.

Either way, mounting evidence indicates robotic surgery drives up costs and doesn't improve outcomes. According to an article, published in JAMA, robotic hysterectomy costs more than laparoscopic hysterectomy, without added benefits. In addition, research in Urology found robotic surgery didn't improve outcomes compared with laparoscopic prostatectomy.

And the largest analysis of robotic surgery cases, published in the Journal of the American College of Surgery found the robotic approach improves outcomes compared with open, but not with laparoscopy. That study also found higher costs for robotic surgery. Up next in opponents' arsenal: a paper authored by safety expert and Johns Hopkins University surgeon and professor Martin Makary, MD, MPH. Embargoed while awaiting publication in the Journal of Healthcare Quality, "it's a study about FDA under-reporting" of robotic-related complications, he says.

There's speculation the forthcoming paper was the impetus for the FDA's investigation, according to a press release. Proponents posit that more widespread use of the robotic devices is behind the uptick in complications.

"When it comes to nationally published clinical data that is widely distributed as patient education materials, there is often a general misconception that results from clinical centers of excellence are easily replicated on a localized level by neighborhood physicians," says James Gibson, President of Integrity Life Sciences. The release suggests better surgeon training would ameliorate the issues.

Lauren Roberts


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