Robot
surgery can mean less blood loss, smaller scars and quicker recovery time, but
what if there are complications?
IN 2007, surgeons in Aalst, Belgium, were taken aback when part of a
surgical robot's arm broke off inside a patient with prostate cancer. The
fracture bent the da Vinci robot's
instrument so badly that it could not be removed through the original keyhole
incision. That meant the urologists had to enlarge the wound to get the
instrument out (Journal of Robotic Surgery, doi.org/crm8p6).
Today more than 2500 of the $1.7 million da Vinci robots are at work in
hospitals worldwide, taking part in nearly 1.5 million operations in the past
decade. Most patients go home with smaller scars, and the firm that makes da
Vinci, Intuitive Surgical of Sunnyvale, California, claims post-operative pain
and recovery time are also reduced. But reports of adverse events have risen recently,
prompting the US Food and Drug Administration (FDA) to survey surgeons about
the system in January. Bloomberg Businessweekreported
earlier this month that 10 product liability lawsuits have been filed against
da Vinci's makers in the past 14 months.
The lawsuits, which the firm is defending, make for grisly reading –
they allege, variously, that da Vinci has caused liver and spleen punctures
during heart surgery, rectal damage during a prostate operation, and a vaginal
hernia after a hysterectomy. There are also a number of cases of unintended
burns from the robot's cauterising tools. The FDA's inquiry, says spokeswoman
Synim Rivers, aims to "determine if the rise in reports is a true
reflection of problems, or simply an increase due to other factors".
Is there cause for concern? "Rates of adverse events or death for
da Vinci surgery have not increased over the past several years," says
Intuitive Surgical spokeswoman Lauren Burch, who refused to comment on the
lawsuits. "The clinical evidence shows that da Vinci is safer than open
surgical alternatives in many common procedures," she says.
The robot aims to offer minimally invasive, highly accurate surgery with
a human in control at all times. The surgeon handles the instruments on the
robot's four arms from a console with a stereoscopic 3D view of the operation,
magnified up to 10 times.
"The console has brilliant, unsurpassed 3D vision, unlike
laparoscopic systems with 2D screens," says Ben Challacombe,
a consultant urologist at Guy's and St Thomas' NHS Foundation Trust in London.
"It also has fantastic control instruments that filter out hand tremors,
whereas long laparoscopic tools only enhance tremor." As a regular da
Vinci user, Challacombe says the legal issues Intuitive Surgical faces are far
more likely to be down to incorrect use by surgeons rather than robot faults.
That view is backed by James Breeden,
president of the American Congress of Obstetricians and Gynecologists.
"Studies show there is a learning curve with new surgical technologies,
during which there is an increased complication rate," he says. And some surgeons only get two days' training on da Vinci.
What's more, healthcare providers are pushing the benefits of robot
surgery, Breeden says, advertising less pain, lower blood loss and faster
recovery. That drives demand beyond the evidence, he believes. There may not
even be good data, claims Breeden, showing "that robotic hysterectomy is
even as good as, let alone better than, far less costly minimally invasive
alternatives".
This
article appeared in print under the headline "Four arms better than
two?"
http://www.newscientist.com/article/mg21729105.800-robosurgeon-da-vinci-faces-lawsuits.html
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