Not Proven

The complexity of medical devices makes safety and efficacy claims hard to evaluate, creating an environment ripe for misleading advertising, including by hospitals, said Robert Steinbuch, a professor of law at the University of Arkansas at Little Rock. "Hospital advertising is essentially a free-for-all," he said.Bloomberg News reported in February that the FDA was surveying surgeons about the robots after an increase in reported adverse events, including 70 deaths since 2009. Reports of injuries linked to robotic surgery have more than doubled in the first eight months of this year, based on when the reports were received by the FDA, compared with the same period last year.Intuitive Surgical says looking at reporting dates, rather than the dates the incidents occurred, "is likely to seriously misrepresent the true performance of a device."

While Porter Adventist Hospital cannot comment on the Kortz cases due to privacy laws, safety is its top priority and it responds "with swift and immediate action" to clinical concerns, said Thomas Drake, chief medical officer for the hospital, in a statement. "Our approach to robotic surgery marketing is focused on consumer awareness," Drake said.In July, the FDA issued a warning letter to Intuitive Surgical after an inspection found the company hadn't adequately reported device corrections and patient adverse events in some cases.There are questions Sales growth slowed in the second quarter on a decline in robot system sales. Since the first Bloomberg report in February, Intuitive Surgical's shares have fallen 34 percent to $380.99.

"The marketing material that Intuitive puts out is fair and balanced," said Myriam Curet, chief medical adviser for Intuitive Surgical. The company has "a robust program where we review all of the marketing material that goes out and we make sure that discussions of alternative procedures are on the marketing materials as well as discussions about risks," she said.Intuitive Surgical follows regulatory guidance in every market in which it operates, said Angela Wonson, a spokeswoman for the company. It also continually evaluates and updates the informational materials it provides to medical professionals and the public to ensure they reflect recent research, she said."Ultimately, decisions about treatment must be made between the surgeon and the patient during the informed consent process," Wonson said.