The New Yorker - USA (2019-09-30)

(Antfer) #1

28 THENEWYORKER,SEPTEMBER30, 2019


computer from the nineties. He slid off
his hospital shoes—green Crocs—and
placed his stockinged feet on the ped-
als and his hands on the joysticks. He
sank his face deep into the stereoscopic
viewer. A nurse rolled a cart with four
praying-mantis-like arms toward the pa-
tient’s exposed belly and connected them
to the cannulas. The machine whirred as
it gently adjusted its height,
calculating a position that
would allow its arms to
move optimally inside the
woman’s abdomen. Giu-
lianotti asked for forceps,
a hook, and a grasper, and
the nurses attached them
to the robot’s appendages.
At seven-thirty-seven, the
da Vinci inserted the instru-
ments into the woman’s
body, and they instantly appeared on
the monitor. It was time to begin cutting.

I


n the nineteen-nineties, the Defense
Advanced Research Projects Agency,
the military organization that first devel-
oped the Internet, attempted to design a
robotic-surgery device. The goal was for
a doctor to sit securely behind enemy
lines and remotely repair soldiers’ wounds
on the battlefield. The project, which was
based at the Stanford Research Institute
International, was abandoned: the band-
width available at the time was insufficient
to operate a sensitive instrument halfway
across the world without a devastating
time lag. Some innovations pioneered at
Stanford did work well, though, such as
a method that offered better visualiza-
tion of wounds. In 1995, a California sur-
geon named Fred Moll licensed the tech-
nology, with two colleagues, for tens of
millions of dollars, and launched a startup,
Intuitive Surgical.
Moll knew that laparoscopy, for all
its benefits, could exhaust and frus-
trate surgeons, who often had to spend
several hours manipulating their tools
through tiny holes. But, if scalpels and
forceps were attached to a remote-con-
trolled robot, surgeons could easily go
as deep as they wanted, at any angle.
Moll and his colleagues built a device
and called it the da Vinci. (Leonardo,
the protean genius, had made drawings
of a humanlike robot.)
Initially, sales were slow. Hospitals
were wary of the high costs of the de-

vice, and many surgeons found it alien-
ating. David Cassak, the editor of the
journal MedTech Strategist, explained to
me, “These are guys who like to be up
to their elbows in gore.” He added that,
when the da Vinci was new, “many re-
ally didn’t want to entertain the idea
there was some machine out there that
could replace them.” Moll began promot-
ing the da Vinci for heart-
bypass surgery, a gruelling
operation for which no min-
imally invasive procedure
was generally available—
the patient’s ribs had to be
cracked open. This turned
out to be a strategic mis-
take. According to the com-
pany, one problem the re-
searchers faced was that a
patient undergoing a bypass
can’t survive for very long on a mechan-
ical heart pump: surgeons must race the
clock. The procedure was too stressful
for use as an introduction to the da Vinci.
One day in 2000, a German urolo-
gist named Jochen Binder decided to
use a da Vinci to remove a prostate gland.
He was impressed with the freedom
of movement and the 3-D view offered
by the da Vinci, and felt that robotic
appendages, with their accuracy and
strength, were especially well suited to
the narrow space where the gland is
tucked away. In laparoscopic prostate
surgery, suturing was almost impos-
sible—it was, as a medical executive
explained to me, “like two chopsticks try-
ing to tie a knot.” The da Vinci com-
pleted the sutures with ease. Quickly, a
majority of urologists adopted the ro-
botic approach. Intuitive Surgical exec-
utives now like to joke, “We aimed for
the heart and hit the prostate.” (Around
this time, Moll left the company.)
The company, like any West Coast
startup, was consumed with making its
platform ubiquitous: if it could get
enough of its machines into hospitals,
it would be hard for anyone to get them
out. The sales force worked to create
excitement not just among surgeons but
also among potential patients, tapping
into the futuristic appeal of robots. Da
Vinci simulators were set up in malls.
In radio ads, hospitals that owned da
Vincis boasted about having the latest
technology, using talking points that In-
tuitive Surgical had provided for them.

Many surgeons clearly preferred using
the da Vinci for certain procedures, but
were they sending patients home sooner
and in better shape? The Food and Drug
Administration hadn’t forced Intuitive
Surgical to offer proof. The agency di-
vides medical-device applications into
various categories. The manufacturer of
a product that employs new technology
is required to demonstrate that it works
and is safe. In other cases, companies
need only show that their devices are
substantially similar to products already
in the marketplace. The F.D.A. judged
the da Vinci to be a variant of laparo-
scopic surgery, and cleared it for sale.
Intuitive Surgical, in its early push for
profit, developed a reputation for some
sloppy practices. The training that sur-
geons were offered on the da Vinci often
lasted only a day. In 2013, the F.D.A. sent
the company a warning letter, accusing
it of failing to keep the agency informed
about updates to the da Vinci’s operat-
ing instructions, on matters such as the
proper cleaning of instruments. Two years
later, the American College of Obstetri-
cians and Gynecologists declared that
“the rapid adoption of robotic technol-
ogy for gynecologic surgery is not sup-
ported by high-quality patient outcomes,
safety, or cost data.” At about the same
time, shareholders began filing lawsuits
alleging that, among other things, Intu-
itive Surgical had made false statements
about the da Vinci’s capabilities. Two of
the cases were eventually settled, for fifty-
five million dollars. Other lawsuits were
filed by patients who said they had been
harmed during surgery involving a da
Vinci. A urologist, who caused a tear in
the rectal wall of an obese patient while
performing robotic prostate surgery,
claimed that the company hadn’t warned
him that the operation was not suited to
seriously overweight patients. (Intuitive
denied this, but settled the case.) Doc-
uments filed in that lawsuit revealed that
sales representatives at Intuitive Surgi-
cal had pressured doctors to increase the
number of procedures they performed
with the da Vinci, so that the company’s
numbers would be more impressive.
In 2014, Intuitive Surgical paid for an
ad that featured a photograph of Giu-
lianotti and other white-coated employees
at the University of Illinois medical cen-
ter. “We believe in da Vinci Surgery be-
cause our patients benefit,” the copy said.
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