Robotic Surgery Safety Questioned
By Katie Wike, contributing writer
Despite claims of being easier on the patient, robotic surgery risks are not being made clear to patients
A study from Johns Hopkins claims robotic surgery complications are often underreported and “haphazard” reporting leads to a misleading sense of security. The Johns Hopkins team writes, "Of the 1 million or so robotic surgeries performed since 2000, only 245 complications - including 71 deaths - were reported to the U.S. Food and Drug Administration. When an adverse event or device malfunction occurs, hospitals are required to report these incidents to the manufacturer, which in turn is required to report them to the FDA. But this doesn’t always happen, the researchers say."
“The number reported is very low for any complex technology used over a million times,” says Martin A. Makary, M.D., M.P.H., an associate professor of surgery at the Johns Hopkins University School of Medicine. “Doctors and patients can’t properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent. There may be some complications specific to the use of this device, but we can only learn about them if we accurately track outcomes.”
The team found that a number of complications were not reported to the FDA until after they had appeared in the media while many are never reported at all. “We need innovation in medicine and, in this country, we are tremendously good at introducing new technologies,” says Makary. “But we have to evaluate new technology properly so we don’t over-adopt — or under-adopt — important advances that could benefit patients.
“Decisions should not be made based on the information in the FDA database,” Makary continues. “We need to be able to give patients answers to their questions about safety and how much risk is associated with the robot. We have all suspected the answer has not been zero. We still don’t really know what the true answer is.”
Bloomberg reported that the FDA has only two employees watching ads for robotic surgery - compared to 60 people monitoring prescription drug ads. In February, Bloomberg reported that the FDA was surveying surgeons regarding robots used in surgery after an increase in related deaths. “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.”
Fierce Health IT writes, “In March, the American Congress of Obstetricians and Gynecologists said that robotic surgery for hysterectomies should not be a first or even second choice for women undergoing routine procedures, due, in part, to the learning curve associated with the robotic system. That same month, health officials in Massachusetts sent a letter outlining safety concerns about robotic surgery after two damaging incidents involving robots performing hysterectomies.”