Robotic surgery for hysterectomies doesn’t improve outcomes and shouldn’t be the first choice for most women, a doctors’ group said, sending Intuitive Surgical Inc. (ISRG) to its lowest value in almost 14 months.
The American Congress of Obstetricians and Gynecologists, which represents 56,000 U.S. physicians, said expertise with Intuitive’s da Vinci robot system is limited and surgeons learning the new technology may have higher rates of complications. Intuitive, based Sunnyvale, California, sells the only robotic system approved in the U.S. for soft tissue procedures that include gynecological surgery.
“There is no good data proving that robotic hysterectomy is even as good as -- let alone better -- than existing, and far less costly, minimally invasive alternatives,” James T. Breeden, the organization’s president, said in a statement posted yesterday on the group’s website.
Angela Wonson, a spokeswoman for Intuitive, defended the product, saying in an e-mail that “evidence supports that robotic surgery has dramatically decreased the number of open hysterectomies in the U.S.”
The U.S. Food and Drug Administration is surveying surgeons about the safety of the machines, their training and how the robots are used, Bloomberg News reported last month. Data published in February found that use of the Intuitive robots, priced at $1.5 million each, drives up surgical costs by as much as $2,189 per procedure without reducing complications compared with standard less-invasive procedures.
Intuitive fell 6.2 percent to $459.44 in New York, its lowest closing price since Jan. 30, 2012. The company has declined 20 percent since Feb. 27, the day before the FDA survey became public.
The ACOG statement is “misguided” and “reflects a lack of desire to move the surgical field forward,” said Mario Leitao, a gynecologic oncology surgeon who uses the robot at Memorial Sloan-Kettering Cancer Center in New York. Leitao, who has consulted for Intuitive, also said that the robot has been marketed “inappropriately and aggressively” by the company, and by many hospitals that hadn’t learned how to use the device.
In robot surgery, a doctor sits at a video-game style console several feet from the patient and peers into a high- definition display. Foot pedals and hand controls maneuver mechanical arms equipped with surgical tools, guided by a 3-D camera that shows the work as it is done inside a patient.
About 600,000 hysterectomies are done each year in U.S., mostly for benign conditions, said Barbara Levy, vice president for health policy at the doctors’ group. Intuitive’s da Vinci system was used in about 176,000 uterus removals in the U.S. in 2012, according to a Feb. 4 regulatory filing.
The robots were used for about 367,000 total procedures in the U.S. last year, including prostate surgeries and gall bladder removals, the company has reported.
The robot “is absolutely not” the least invasive type of hysterectomy,” Levy said in a telephone interview. Among other things, scars with the robot often “are higher up; they are more visible; there are more of them; and they are bigger” than the scars produced with other less invasive uterus removal techniques, she said.
Meanwhile, the robot comes with a significant learning curve, Levy said. Until a doctor becomes proficient on the machine, there may be more complications using the robot, not less, she said.
Hospital and industry marketing touting the robot surgical systems often contain “cherry picked and very misleading information” comparing hysterectomies done with the robot against traditional operations with large incisions, rather than other minimally invasive options, such as removing the uterus through the vagina, Levy said.
The location and number of robotic incisions “depends on the technique” and “can be as invisible as traditional laparoscopy,” said Michael Pitter, a gynecological surgeon and robot user in Newark and Hackensack, New Jersey, who sometimes conducts training sessions for Intuitive.
Intuitive’s Wonson said the company’s website “is fully sourced with clinical outcomes data.”
A review of adverse incident reports sent to the FDA since 2009 by Bloomberg News shows that injury reports involving the procedures jumped to at least 115 in 2012 from 24 in 2009, while deaths rose to 30 from 11. The robots are also linked to at least 70 deaths since 2009, the review found.
The reports from doctors, patients and companies, don’t necessarily mean the robots caused deaths, only that they were involved in procedures in which deaths occur. They’re largely unverified by the agency, and can be incomplete or misleading, the FDA has said.
Adverse event reports have served in the past as a valuable early-warning system on medical-device safety. While the number of complications reported may be small compared with the operations done, it has set off warning bells. In January, the FDA sent letters to hospitals asking its surgeons about complications, training and the procedures the robots may be most and least suited for.
Myriam Curet, Intuitive’s chief medical adviser, said in an interview in response to the review that she is confident the robots are “extremely safe.”
Intuitive, in a statement yesterday, said it had changed its practices for reporting adverse events to U.S. regulators in September 2012, resulting in an increased number of reports of device malfunctions, none of which involved injuries or deaths. The company also said it changed how certain adverse events were characterized, which will result in higher numbers of reported serious injuries, and fewer adverse events listed in the “other” subcategory.
To contact the reporter on this story: Robert Langreth in New York at firstname.lastname@example.org
To contact the editor responsible for this story: Reg Gale at email@example.com