DaVinci Robot Attorney


Davinci 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.

Intuitive 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.


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Statement on Robotic Surgery by ACOG President James T. Breeden, MD
March 14, 2013

Washington, 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.

The outcome 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.

Vaginal 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.

Robotic 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.

If most 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.

Aggressive 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 been demonstrated.

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.

In other words, this is a pseudo-innovation - a technology that increases costs without improving patients' health.


Intuitive Robot Probe Threatens Trend-Setting Surgeries

By 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 care.

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 Bloomberg.

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 said.

Incident reports are sent to the agency by patients, medical professionals and companies. They “can contain incomplete, inaccurate, duplicative and unverified information,” Rivers said.
‘System Redundancy’

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 identified.

Early Warning
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.

Stock Pressure
“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 patient.

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 surgery.

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.



Comparative Effectiveness of Minimally Invasive vs Open Radical Prostatectomy

Context Minimally invasive radical prostatectomy (MIRP) has diffused rapidly despite limited data on outcomes and greater costs compared with open retropubic radical prostatectomy (RRP).

Objective To determine the comparative effectiveness of MIRP vs RRP.

Design, 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).

Main Outcome 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.

Results 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).

Conclusion 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.