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FDA, others increasingly focused on robotic surgery claims

On Behalf of | Oct 16, 2013 | Surgical Errors

We last reported on robotic surgery in the United States in a September 5, 2013, blog post. We noted therein a related comment from Martin A. Makary, a noted doctor and medical commentator. In discussing the scope and dimensions of surgical error in connection with robot-assisted surgery, Makary said, “We still don’t really know what the true answer is.”

The reasons for that stated uncertainty are many, and a number of commentators in addition to Makary are stepping forward to voice criticisms and concerns. The robot tool named the Da Vinci Surgical System is now employed in many hospitals across the country, including in New Jersey, and a growing band of critics say that the general hype associated with the product is obscuring the risks and adverse patient outcomes associated with it.

One central charge being leveled at Intuitive Surgical Inc., the maker of the Da Vinci system (which was approved for domestic use by the FDA in 2000), is that it plays loose with facts. The FDA recently issued the company an official warning letter regarding understated reporting of patient adverse outcomes. The agency has also polled surgeons using the tool, seeking their input amidst reports that 70 deaths have been linked to robotic surgery since 2009. Another concern: Injury reports have ticked sharply upward this year.

And it’s not just the FDA that is voicing concerns. Barbara Levy, a vice president at the American Congress of Obstetricians and Gynecologists, charges Intuitive with disseminating “very misleading marketing information.” Other persons from within the medical industry have made similar comments.

Unsurprisingly, an Intuitive official calls the company’s marketing materials “fair and balanced.”

The FDA currently has a hard time evaluating such claims, given that it presently has only two employees working full time on evaluating medical device marketing and advertising. The agency states that it is working to increase that number.

Source: Bloomberg, “Robot surgery damaging patients rises with marketing,” Robert Lengreth, Oct. 7, 2013

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