Intuitive’s stock is likely to be under pressure until the company can prove the safety worries aren’t a significant issue, Matson said. In the meantime, “there’s going to be an overhang,” he said.
In robotic surgery, the physician sits at a video-game style console several feet from the patient, peering into a high-definition display while using foot pedals and hand controls to maneuver mechanical arms equipped with surgical tools. A camera provides a three dimensional view of the work being done inside the patient.
Martin Makary, a surgeon at Johns Hopkins Hospital in Baltimore who has researched the marketing of the systems, said safety should now become part of the debate.
“Patients need to know the truth about robotic surgery,” Makary said in a telephone interview. “The Achilles-heel feature” of the robot is its lack of tactile feedback, which can spur “inadvertent injuries if added caution is not taken.”
Among surgeons, there has been an intensifying debate about whether the benefits of robotic surgery justify the increased costs. A report published in the Journal of the American Medical Association on Feb. 20 found that surgery to remove the uterus with the Intuitive robot costs thousands of dollars more without reducing complications, compared with standard less-invasive surgery.
Examining data from 264,758 women who had a hysterectomy for benign conditions at 441 U.S hospitals, the study found that robotic operations cost hospitals $2,189 more per procedure than performing the same surgery without the robot.
A version of the letter sent to doctors by the FDA in January said the survey was being done because “a recent review of medical device report data is showing an increase in patient adverse reports.” A revision of the document requested by Intuitive and sent again on Jan. 22 deletes that wording, according to the company.
The first version was a draft that was sent out inadvertently, the FDA’s Rivers said. The agency only realized this after the company contacted the regulators, she said.
“We do not ask companies to weigh in” on this type of survey, she said.
The first version of the letter “did not accurately characterize what assumptions can or should be made from the number of reports in the FDA database,” Rivers said.