robotic surgeries have had problems due to the surgeon’s
lack of training with the Davinci equipment. A growing
complication is the return of sexual function. The prostate
is surrounded by a “veil” of nerves which
are responsible for a man’s erection, and when
the robotic “arms” attempt to remove the
cancerous prostate, often times these nerves are disturbed,
stretched or cut, resulting in erectile dysfunction.
Surgical provides two days of training for two surgeons
when the unit is purchased. While some hospitals have
initiated intensive da Vinci training programs, other
hospitals allow surgeons to operate this complex machine
after very brief training. According to interviews the
Wall Street Journal conducted with a number of surgeons
experienced in using the system, it requires hundreds
of cases to reach true proficiency with the device.
on Robotic Surgery by ACOG President James T. Breeden, MD
March 14, 2013
DC -- Many women today are hearing about the claimed advantages
of robotic surgery for hysterectomy, thanks to widespread
marketing and advertising. Robotic surgery is not the only
or the best minimally invasive approach for hysterectomy.
Nor is it the most cost-efficient. It is important to separate
the marketing hype from the reality when considering the best
surgical approach for hysterectomies.
of any surgery is directly associated with the surgeon’s
skill. Highly skilled surgeons attain expertise through years
of training and experience. Studies show there is a learning
curve with new surgical technologies, during which there is
an increased complication rate. Expertise with robotic hysterectomy
is limited and varies widely among both hospitals and surgeons.
While there may be some advantages to the use of robotics
in complex hysterectomies, especially for cancer operations
that require extensive surgery and removal of lymph nodes,
studies have shown that adding this expensive technology for
routine surgical care does not improve patient outcomes. Consequently,
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.
hysterectomy, performed through a small opening at the top
of the vagina without any abdominal incisions, is the least
invasive and least expensive option. Based on its well-documented
advantages and low complication rates, this is the procedure
of choice whenever technically feasible. When this approach
is not possible, laparoscopic hysterectomy is the second least
invasive and costly option for patients.
hysterectomy generally provides women with a shorter hospitalization,
less discomfort, and a faster return to full recovery compared
with the traditional total abdominal hysterectomy (TAH) which
requires a large incision. However, both vaginal and laparoscopic
approaches also require fewer days of hospitalization and
a far shorter recovery than TAH. These two established methods
also have proven track records for outstanding patient outcomes
and cost efficiencies.
At a time
when there is a demand for more fiscal responsibility and
transparency in health care, the use of expensive medical
technology should be questioned when less-costly alternatives
provide equal or better patient outcomes. Hysterectomy is
one of the most common major surgeries in the US and costs
our health care system more than $5 billion a year.
At a price
of more than $1.7 million per robot, $125,000 in annual maintenance
costs, and up to $2,000 per surgery for the cost of single-use
instruments, robotic surgery is the most expensive approach.
A recent Journal of the American Medical Association study
found that the percentage of hysterectomies performed robotically
has jumped from less than 0.5% to nearly 10% over the past
three years. A study of over 264,000 hysterectomy patients
in 441 hospitals also found that robotics added an average
of $2,000 per procedure without any demonstrable benefit.
women undergoing hysterectomy for benign conditions each year
chose a vaginal or laparoscopic procedure—rather than
TAH or robotic hysterectomy—performed by skilled and
experienced surgeons, pain and recovery times would be reduced
while providing dramatic savings to our health care system.
Conversely, an estimated $960 million to $1.9 billion will
be added to the health care system if robotic surgery is used
for all hysterectomies each year.
direct-to-consumer marketing of the latest medical technologies
may mislead the public into believing that they are the best
choice. Our patients deserve and need factual information
about all of their treatment options, including costs, so
that they can make truly informed health care decisions. Patients
should be advised that robotic hysterectomy is best used for
unusual and complex clinical conditions in which improved
outcomes over standard minimally invasive approaches have
The critics are right - if they're talking about innovations
like the da Vinci robot, which costs more than a million dollars
and yet has never been shown by a randomized trial to improve
the outcomes of prostate surgery. Indeed, a 2009 study showed
that while patients had shorter hospital stays and fewer surgical
complications like blood loss when they underwent this kind
of robotic surgery, they later "experienced more ...
incontinence and erectile dysfunction." Similar problems
are occurring with robotic surgery for other cancers.
words, this is a pseudo-innovation - a technology that increases
costs without improving patients' health.
Robert Langreth - Mar 1, 2013
The safety of robots made by Intuitive Surgical Inc. (ISRG)
is being probed by U.S. regulators, raising questions about
the prospects of one of the hottest technologies in health
The Food and Drug Administration asked surgeons at key hospitals
to list the complications they may have seen with the machines,
which cost about $1.5 million each and were used last year
in almost 500,000 procedures. The doctors were also surveyed
on which surgeries the robots might be most and least suited
for, and asked to discuss their training, according to copies
of the survey obtained by Bloomberg News.
The answers may sway debate on whether robotic surgeries promoted
as being less invasive are worth the extra cost. The findings
may also determine the outlook for Intuitive. The da Vinci
surgical system and related products generated most of the
Sunnyvale, California-based company’s $2.2 billion revenue
in 2012, and helped boost market value 70 percent over three
years to about $23 billion, according to data compiled by
The surveys were sent to hospitals that belong to a product
safety network overseen by the FDA. What the agency is trying
to determine is whether a rise seen in incident reports sent
to the agency are “a true reflection of problems”
with the robots, or the result of other issues, said Synim
Rivers, an agency spokeswoman, in an e-mail. “It is
difficult to know why the reports have increased,” she
Incident reports are sent to the agency by patients, medical
professionals and companies. They “can contain incomplete,
inaccurate, duplicative and unverified information,”
Intuitive fell 11 percent yesterday to close at $509.89. The
stock recovered prior to the market opening today, rising
8.8 percent to $554.62 at 9:10 a.m. New York time when at
least four analysts reiterated their recommendations of the
shares. Jeremy Feffer, a Cantor Fitzgerald LP analyst, raised
his rating to buy from hold, saying “We see limited
risk of this investigation materializing into significant
punitive measures against the company.”
The adverse event reports sent to the FDA outline serious
complications, including those involving gynecological surgeries
that make up about half of the procedures involving Intuitive’s
robotic system. They include damage to ureters and bowels
as well as instances when instruments broke off from the robot
and fell into patients. Reports also cited burns to various
organs or vessels, most repaired during the surgery itself.
Many of the reports were filed by Intuitive Surgical and state
that no robot malfunction was found or that the problem came
from user error. Several originated from patients, who aren’t
The robots are “extremely safe,” said Myriam Curet,
Intuitive’s chief medical adviser, in a telephone interview.
“There is a lot of redundancy in the system to make
it as safe as possible.” The percentage of deaths and
injuries involving the company’s da Vinci robotic system,
“is extraordinarily small,” she added, and “hasn’t
grown” over time.
While the number of adverse-event reports to the FDA is small
compared with the total number of procedures, the agency’s
reporting system has in the past served as an early warning
system on concerns about medical-device safety.
“One of the risks is that the FDA could recall parts
of the product or certain instruments, or somehow put restrictions
on certain surgeries,” said Michael Matson, an analyst
with Mizuho Securities USA in New York. “But I don’t
think that’s very likely,”
A rise in adverse events isn’t necessarily alarming
because the number of surgeries done with the robot has been
growing rapidly, said Matson, who is based in New York and
has a buy recommendation on Intuitive.
“The bigger concern would be that the patients would
get scared,” he said. “Part of what’s driven
this market is people seeking out robotic surgery; hospitals
market it and the patients seem to think it’s better.”
Intuitive’s stock is likely to be under pressure until
the company can prove the safety worries aren’t a significant
issue, Matson said. In the meantime, “there’s
going to be an overhang,” he said.
In robotic surgery, the physician sits at a video-game style
console several feet from the patient, peering into a high-definition
display while using foot pedals and hand controls to maneuver
mechanical arms equipped with surgical tools. A camera provides
a three dimensional view of the work being done inside the
Martin Makary, a surgeon at Johns Hopkins Hospital in Baltimore
who has researched the marketing of the systems, said safety
should now become part of the debate.
“Patients need to know the truth about robotic surgery,”
Makary said in a telephone interview. “The Achilles-heel
feature” of the robot is its lack of tactile feedback,
which can spur “inadvertent injuries if added caution
is not taken.”
Among surgeons, there has been an intensifying debate about
whether the benefits of robotic surgery justify the increased
costs. A report published in the Journal of the American Medical
Association on Feb. 20 found that surgery to remove the uterus
with the Intuitive robot costs thousands of dollars more without
reducing complications, compared with standard less-invasive
Examining data from 264,758 women who had a hysterectomy for
benign conditions at 441 U.S hospitals, the study found that
robotic operations cost hospitals $2,189 more per procedure
than performing the same surgery without the robot.
A version of the letter sent to doctors by the FDA in January
said the survey was being done because “a recent review
of medical device report data is showing an increase in patient
adverse reports.” A revision of the document requested
by Intuitive and sent again on Jan. 22 deletes that wording,
according to the company.
The first version was a draft that was sent out inadvertently,
the FDA’s Rivers said. The agency only realized this
after the company contacted the regulators, she said.
“We do not ask companies to weigh in” on this
type of survey, she said.
The first version of the letter “did not accurately
characterize what assumptions can or should be made from the
number of reports in the FDA database,” Rivers said.
JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Comparative Effectiveness of Minimally Invasive vs Open Radical
Minimally invasive radical prostatectomy (MIRP) has diffused
rapidly despite limited data on outcomes and greater costs
compared with open retropubic radical prostatectomy (RRP).
To determine the comparative effectiveness of MIRP vs RRP.
Setting, and Patients Population-based observational cohort
study using US Surveillance, Epidemiology, and End Results
Medicare linked data from 2003 through 2007. We identified
men with prostate cancer who underwent MIRP (n = 1938) vs
RRP (n = 6899).
Measures We compared postoperative 30-day complications, anastomotic
stricture 31 to 365 days postoperatively, long-term incontinence
and erectile dysfunction more than 18 months postoperatively,
and postoperative use of additional cancer therapies, a surrogate
for cancer control.
Among men undergoing prostatectomy, use of MIRP increased
from 9.2% (95% confidence interval [CI], 8.1%-10.5%) in 2003
to 43.2% (95% CI, 39.6%-46.9%) in 2006-2007. Men undergoing
MIRP vs RRP were more likely to be recorded as Asian (6.1%
vs 3.2%), less likely to be recorded as black (6.2% vs 7.8%)
or Hispanic (5.6% vs 7.9%), and more likely to live in areas
with at least 90% high school graduation rates (50.2% vs 41.0%)
and with median incomes of at least $60 000 (35.8% vs 21.5%)
(all P < .001). In propensity score–adjusted analyses,
MIRP vs RRP was associated with shorter length of stay (median,
2.0 vs 3.0 days; P<.001) and lower rates of blood transfusions
(2.7% vs 20.8%; P < .001), postoperative respiratory complications
(4.3% vs 6.6%; P = .004), miscellaneous surgical complications
(4.3% vs 5.6%; P = .03), and anastomotic stricture (5.8% vs
14.0%; P < .001). However, MIRP vs RRP was associated with
an increased risk of genitourinary complications (4.7% vs
2.1%; P = .001) and diagnoses of incontinence (15.9 vs 12.2
per 100 person-years; P = .02) and erectile dysfunction (26.8
vs 19.2 per 100 person-years; P = .009). Rates of use of additional
cancer therapies did not differ by surgical procedure (8.2
vs 6.9 per 100 person-years; P = .35).
Men undergoing MIRP vs RRP experienced shorter length of stay,
fewer respiratory and miscellaneous surgical complications
and strictures, and similar postoperative use of additional
cancer therapies but experienced more genitourinary complications,
incontinence, and erectile dysfunction.