da Vinci Surgical Robot has been used in surgeries nationwide,
including hysterectomies, prostate removal, and other
delicate procedures. The robot, which has long arms
controlled by a surgeon. The da Vinci robot was supposed
to perform faster surgery but that hasn't been truthful
with many cases.
believe there is a design defect in the da Vinci surgical
robot. The FDA has received reports that the robotic
arms may not be properly insulated. As a result, excess
electricity can cause severe injuries, including burns
and tearing of the internal organs, vaginal cuff dehiscence,
severed ureters, bowel injuries, excessive bleeding,
and even death.
only is the product considered defective, but there
is reason to believe that the device's manufacturer,
Intuitive Surgical, Inc, was aware of the issue and
its potential risk to patients. Several product liability
suits have claimed that Intuitive Surgical failed to
disclose the results of pre-marketing testing issues,
and also failed to perform "post-marketing surveillance"
of the injuries attributed to the device. The manufacturer
kept these matters secret from doctors and their patients.
you have been injured contact our da Vinci attorneys
Litigation News: March 31, 2013
A da Vinci
lawsuit claiming the system led to the death of a patient
is set to go to trial April 15, according to Bloomberg News
(3/26/13). In the same article, it was reported that defendant
Intuitive’s attempt to have the lawsuit thrown out was
Taylor’s family filed a robotic surgery lawsuit against
Intuitive Surgical for the death of Fred Taylor. The deceased
plaintiff, Fred Taylor, underwent robotic surgery for a prostate
procedure in 2008. The family maintains the surgeon who performed
the surgery with the da Vinci robotic system was insufficiently
trained, and elected to perform the procedure without supervision
Massachusetts Cautions Hospitals About Robotic Surgery Hospitals get advisory letter, March 26,
Reports of complications from robot-assisted
surgery are rising, according to Massachusetts health officials
who sent hospitals an “advisory” letter last week
alerting them about their safety concerns.
In some cases, it appears that doctors have
used the aggressively marketed robots to perform hysterectomies
and colorectal operations that were too complex for the technology,
or for the surgeons’ skill level in directing the robots’
During one hysterectomy, two surgeons failed
to coordinate their movement of the remote-controlled robotic
arms, damaging the patient’s bowel and causing excessive
bleeding, according to the letter from the Quality and Patient
Safety Division, part of the agency that licenses Massachusetts
In another hysterectomy, a woman was anesthetized
and placed for nearly four hours in a steep head-down angle
— a position often used during robotic operations. She
suffered shoulder injuries. The advisory described a number
of mishaps but did not identify the doctors or hospitals involved.
Robotic surgery — in which doctors sit
at a video console and remotely move robotic arms holding
surgical instruments and a tiny camera — has surged
in popularity for prostate operations and other procedures.
That’s partly because the manufacturer and hospitals
heavily advertise the technology as reducing complications
and speeding recovery.
Brigham and Women’s Hospital last fall
allowed shoppers to “test drive” a robot outside
Macy’s at the Natick Mall, by sitting at the console
and manipulating the arms. Community hospitals have jumped
on the bandwagon, too. St. Luke’s Hospital in New Bedford
invited the public to get behind the controls of its new robot
in January, while others including Beth Israel Deaconess Hospital
Milton have erected highway billboards.
The hospitals now say they are reviewing some
of their marketing activities.
The patient safety division urged hospitals
to make sure that surgeons are proficient in robotic surgery
before allowing them to operate and that doctors carefully
screen patients for risk factors. It also advised hospitals
to establish multidisciplinary committees to monitor results
of the surgeries.
Patient injuries during robotic surgery have
grown over the past two years, the division said, but it would
not provide the data. The advisory comes amid a growing number
of patient lawsuits nationally, some of which allege doctors
inexperienced with the robot took so long to complete operations
that patients suffered nerve and other injuries from the anesthesia
or from the angle of the operating room table.
“The marketing is not based on any data,”
said Dr. Peter Dunn, director of perioperative services at
Massachusetts General Hospital. “This tool was brought
to us [by the manufacturer] solely as a marketing device.
The medical community didn’t do what it should have
done — say, ‘Wait a minute, hold on.’?”
Surgeons who are enthusiastic about the technology
say it allows them to operate with more precision. The robotic
arms move in more directions than the human wrist, and the
machine’s software smooths out small hand tremors. Images
on the video screen are also highly magnified, allowing the
surgeon a better view of the patient’s anatomy. They
also tend to be less invasive.
Still, proof that these advantages lead to
better results has been elusive. In January, a national medical
safety organization, the ECRI Institute in Pennsylvania, concluded
based on an analysis of relevant studies that robotic surgery
is booming despite limited evidence that it works better than
Intuitive Surgical Inc. of California, the
manufacturer of the da Vinci robot — the only surgical
robot on the market — disputes that assertion.
“Numerous peer-reviewed studies including
large population studies have demonstrated lower complication
rates and mortality rates compared to open surgery,’’
company spokesman Geoff Curtis said in a written statement
to the Globe.
Curtis called the state advisory “balanced’’
and said the company “agrees with the report’s
“We think these key points align with
our mission to improve surgical outcomes for patients.’’
The state’s advisory recommended that
hospitals pay attention to whether direct-to-patient marketing
changes how they select patients, given that such advertising
has led patients to seek out the procedure from their doctors.
It also cautions hospitals to make sure their websites include
the risks as well as the benefits of robotic surgery. Few
do, according to a Globe sampling.
The Brigham said it plans to change its website
promotion of robotic surgery to reflect the recommendations,
while Milton Hospital and Southcoast Health System, which
includes St. Luke’s, are considering adding information
Dunn said that patients undergoing robotic
surgery to remove cancerous prostates are surprised when they
experience complications because hospitals have been so positive
about the technology.
“It’s just that the complications
are different’’ from those more common in traditional
surgery, he said. “They’re idiosyncratic. For
example, your instruments may be out of your field of view
so you may injure another organ.’’
Urologists urged Mass. General to buy a robot
in 2007, Dunn said, because they were fielding calls from
interested patients. The hospital purchased one but has decided
not to advertise it, he said.
Dr. Jim Hu, a surgeon at UCLA Medical Center
in Los Angeles who has researched robotic surgery, said the
da Vinci has been used in prostate cancer surgery since 2000.
Complications were high in the early days as surgeons learned
how to use the robot, he said, but have since leveled. As
surgeons expand their use of the robot to other surgeries,
patient injuries may be rising again, he said.
In 2008, more than half of all robot-assisted
surgeries were for prostate cancer. Now, hysterectomies are
the fastest-growing type of robotic surgery, comprising about
40 percent of operations, according to ECRI.
Still, just because surgeons have more experience
with robot-assisted prostatectomies does not mean patients
necessarily experience better results than with traditional
In fact, a study Hu led while he was at the
Brigham in 2009 found that cancer patients who underwent minimally
invasive prostate removal with the robot were more than twice
as likely to experience incontinence or impotence a year and
a half after their operations than patients who had traditional
surgery using an open incision, though the overall risk was
still small in both cases.
Tracy Gay, director of the Division of Quality
and Patient Safety, said the agency does not have the authority
to require hospitals to change procedures. “We were
saying, here are some lessons. We just want them to know this
should be on their radar screen,’’ she said.
In a third surgery described in the division’s
advisory, a colorectal operation, diseased rectal tissue was
left in the patient’s abdomen. It had to be removed
during a second operation. The hospital where the error occurred
found that the use of the new technology “greatly increased
the complexity’’ of the procedure and that the
surgeon “was still refining the surgical process.’’
The hospital hired a “robotic resource’’
nurse to improve surgical team communication.
In the two hysterectomy cases, the hospitals
also reported improvements, such as reserving the robot for
less-complex procedures and repositioning patients during
operations to prevent shoulder injuries, the advisory said.
Given the high cost of the robot equipment
— $1.5 million to $1.75 million, not including annual
service fees and the expense of buying disposable instruments
— hospitals must attract manypatients to reap a return
on their investment. ECRI said procedures nationwide rose
from 25,000 in 2005 to 360,000 in 2011.
“Hospitals have this equipment and they
have to use it,’’ said Diane Robertson, ECRI’s
director of Health Technology Assessment Information Service.
“Hospitals generally speaking in their advertising and
marketing have made some claims not necessarily supported
by the evidence.’’
Hu said hospitals have engaged in an arms
race, while not paying close enough attention to standards
for allowing doctors to use robots in surgery. “It’s
a great tool,” he said, “but it’s not good
if people don’t know how to use it.”
Intuitive Surgical's Robot Surgeons Encounter Human Lawyers
Michelle Zarick complained of excessive vaginal bleeding in
2008, her doctor found growths in her uterus and suggested
she undergo a hysterectomy. Her gynecologist described one
option, robotic surgery, as “the latest, greatest”
minimally invasive technique available. With robotic instruments
doing the delicate work usually performed hands-on by doctors,
there’d be less pain and bleeding, Zarick was told.
“In my mind,” she recalls, “there was no
alternative but to use this fabulous technology.”
following her 2009 surgery, in which a robot made by Intuitive
Surgical (ISRG) was used to remove her uterus, Zarick felt
something pop while she was in the bathroom. She looked down
and saw her intestine protruding from her vagina. Four years
later, the now 41-year-old sports-medicine student from Lincoln,
Calif., says she has a hip-to-hip scar from corrective surgery,
constipation from damaged rectal muscles, and a diminished
sex life. The robot “forever changed my life for the
worse,” says Zarick, who in December filed a product
liability suit against Intuitive. Damages were not specified.
Wonson, an Intuitive spokeswoman, says it’s company
policy not to comment on litigation. In a filing in the Zarick
case, Intuitive “denies each and every allegation,”
arguing the injuries were caused by events that “were
extraordinary,” not foreseeable, and outside the company’s
suit is one of at least 10 filed in the past 14 months that
stem from serious complications involving Intuitive’s
robots. According to a federal lawsuit filed in California,
the liver and spleen of a Michigan man were allegedly punctured
during a heart valve repair, leading to 15 hours of internal
bleeding. Another federal suit in Alabama describes a man
who suffered damage to his rectum and bowel after prostate
Food and Drug Administration in January sent out surveys to
surgeons about the safety of Intuitive’s robo-surgery
gear. The FDA hoped to determine whether a rise in reported
mishaps is “a true reflection of problems,” says
FDA spokeswoman Synim Rivers.
cast a shadow over one of the fastest-growing medical technologies
in the U.S.—and Intuitive, which dominates the field.
The Sunnyvale (Calif.)-based company received almost all its
$2.2 billion in revenue in 2012 from its da Vinci Surgical
System and related products. The original prototype was developed
under a U.S. Army contract in the 1980s to build a system
for remote-controlled battlefield surgery. Intuitive’s
robot was cleared for use in 2000, and the company’s
products remain the only robotic systems approved in the U.S.
for soft-tissue procedures that include general surgery, gynecological
surgery, and prostate operations. The machines, which can
cost about $1.5 million apiece, were used in 367,000 U.S.
procedures in 2012, up from 228,000 two years earlier. That
growth helped boost Intuitive’s stock market value 83
percent in the three years ended Feb. 1, to about $23.2 billion.
of what’s driven this market is people seeking out robotic
surgery,” says Michael Matson, an analyst with Mizuho
Securities USA in New York. “Hospitals market it, and
the patients seem to think it’s better.” The real
threat to Intuitive is “that the patients would get
scared,” he says, and stop seeking robot operations.
a doctor peers into a video game-style console several feet
from the patient. Foot pedals and hand controls allow the
physician, guided by a 3D camera, to maneuver mechanical arms
equipped with surgical tools. This differs from other minimally
invasive operations in which doctors stand over a patient
and manually manipulate instruments and cameras through small
incisions. (Many surgeries are still of the traditional variety,
with doctors making larger incisions that take longer to recover
machine’s benefits include a high-definition camera
system and robot arms and joints designed to precisely mimic
natural hand movements, the company says. Critics point to
the high price and the lack of large, controlled trials showing
clear long-term benefits, compared with standard less invasive
operations. A study published in February in the Journal of
the American Medical Association found that robotic uterus
removal costs 33 percent more than standard minimally invasive
hysterectomies, without lowering the complication rate.
of adverse event reports—self-reported filings of procedures
that don’t go according to plan—sent to the FDA
since 2009 shows that reported injuries involving procedures
done using Intuitive machines jumped to at least 115 in 2012,
from 24 in 2009, and deaths rose to 30 from 11. The robots
have been linked to at least 70 deaths since 2009.
doctors, patients, and companies—don’t necessarily
mean the robots caused any deaths, only that they were involved
in procedures in which deaths occurred. Yet adverse event
reports have in the past served as an early warning system
on medical-device safety. While the number of complications
reported may be small given the large volume of operations
done, it’s set off warning bells. In January the FDA
sent out letters to major hospitals asking surgeons about
complications, training, and which procedures Intuitive’s
robots may be most and least suited for. Dr. Myriam Curet,
Intuitive’s chief medical adviser, says she’s
confident the robots are “extremely safe,” noting
that the “extraordinarily small” percentage of
deaths and injuries hasn’t grown over time.
Makary, a surgeon at Johns Hopkins Hospital, says all complaints
may not be reported by hospitals, which often use the machines
as a draw to gain patients. “No one knows the [complete]
numbers,” says Makary, who’s studied how hospitals
market the robots. “But we all have seen or heard of
cases of inadvertent injuries.”
bottom line: Intuitive Surgical, whose sales
have more than tripled since 2007, has been sued over complications
from robot-assisted surgeries.
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
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.
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.
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.