Shares of the leading robotic surgery device makers all fell today, after a Massachusetts medical board issued an advisory to surgeons warning of possible risks with the cutting-edge technology.
Intuitive Surgical (NSDQ:ISRG), Mako Surgical (NSDQ:MAKO) and Hansen Medical (NSDQ:HNSN) all watched their stocks’ values plummet, with MAKO shares down the most at more than 7% as of the end of trading today.
Investors were reacting to a Bay State Board of Registration in Medicine letter sent to physicians detailing possible risks from robotic surgery. Intuitive’s da Vinci surgical robot is the market leader with about 367,000 U.S. operations performed in 2012; followed by Mako, which focuses on the orthopedic space; and Hansen with its eye on the cardiology space.
The bureau said it received an increasing number of reports over the past 2 years of patient complications associated with with robotic surgery, prompting it to issue the advisory. Few studies have been run comparing robot-assisted procedures with their open or laparoscopic forebears, according to the advisory [PDF], and although the technique has advantages "such as an improved field of view and articulated instruments," there are risks of complications and "poor outcomes."
"Clinical studies and reviews of training guidelines discuss variable learning curves for surgeons, the need for significant mentoring, and greater risks associated with pursuing lengthier and more complex cases," according to the Commonwealth’s advisory.
Citing 3 case studies, none of which was due to a malfunction of the robotic device, the advisory said hospitals using the systems should focus on ensuring high levels of surgeon training and proper patient risk assessment and selection.
"Healthcare facilities should utilize a ‘systems approach,’ as they move into the emerging and expanding field of robot-assisted surgery. Developing innovative and adaptive credentialing, pre-operative assessment and other processes that reflect the evolving nature of the field will help to ensure adequate patient protection," according to the bureau’s Quality & Patient Safety Division. "As with any new technology, care should be taken that protocols are in place to ensure appropriate patient selection and the full explanation of risks and benefits for all surgical options. Education and guidelines for the perioperative and post-operative teams, particularly those personnel or units new to robotic surgery, are important steps for assuring that these surgeries are performed safely, and that there is prompt recognition and treatment of any patient complications."
ISRG shares closed at $486.79 apiece, down 1.8%. MAKO shares fell 7.1% to close at $11.16 each; HNSN shares shed some 2.0% to close at $1.92 per share.
Lawsuits reflect low training levels?
Personal injury lawsuits filed against Intuitive Surgical claim that the company deliberately tries to skimp on training physicians to use the da Vinci surgical robot, according to Bloomberg.
A state lawsuit filed in Washington alleges that sales reps pushed hospitals to scale back the expensive and time-consuming programs to train surgeons on the devices, including 1 case in which a sales manager urged reps not to "let proctoring or credentialing get in the way" of procedure volume goals, according to the news service. In almost all of 10 lawsuits filed over the past 15 months, the plaintiffs cite Intuitive’s training regimen as a factor in the injuries allegedly suffered because of the da Vinci device, Bloomberg reported.
Intuitive’s chief medical advisor Myriam Curet told the news service that its training programs is "quite extensive" and includes an online quiz, simulators and a 1-day training course offered at Intuitive’s headquarters in Sunnyvale, Calif., and 14 hospitals across the country. Surgeons training on the device are also supposed to observe at least 1 robotic surgery and perform mock procedures; most hospitals require supervision by an expert proctor for the 1st few surgeries.
But, ultimately, it’s up to physicians and their hospitals to decide how much training is sufficient, Curet said.
"We cannot require anything," she said.
That’s because of an FDA reviewer’s decision not to hold Intuitive to a pledge to create a 70-question quiz and 3-day training program for all operating room workers, according to Bloomberg. Philip Phillips, a former deputy director for science & regulatory policy at the FDA’s Center for Devices & Radiological Health, testified in 1 lawsuit that he reversed a prior decision to require more stringent pre-market approval for the da Vinci, instead allowing the 510(k) clearance process. The FDA cleared the da Vinci for the U.S. market in 2000 and the initial pledge for a 3-day training period "was never required," Phillips said, according to the news service.
