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Da Vinci Robotic Surgery Cost

Da Vinci Surgical System Complications

Da Vinci Robotic Surgery Program: Robot-Assisted Laparoscopic Surgery l Cleveland Clinic Abu Dhabi

Any surgery carries with it the potential for complications. While minimally invasive surgery using smaller incisions is typically easier on the patient than traditional surgery, there is still the risk of complications resulting from anesthesia, bleeding and infection. Additionally, robotic surgery has its own unique set of possible complications.

Complications of Minimally Invasive Surgery

  • Longer operation and anesthesia times
  • Device malfunction or failure
  • Increase in complications can result from switching to another surgical approach
  • Conversion to open or hand-assisted surgery
  • Inadvertent injury to surrounding organs
  • Temporary pain/nerve injury
  • Internal scarring
  • Reactions to anesthesia or other medications

Some of these complications can be severe, require additional surgical procedures to correct or can even result in death. A 2022 report in the journal Digital Medicine also pointed to the risk of cyberattacks against surgical robots.

Should You Consider A Da Vinci Lawsuit

In past medical injury lawsuits, plaintiffs who have been injured have been awarded compensation for medical costs, lost wages, future medical costs, and pain and suffering. Family members of those who have died due to a defective medical device have been awarded compensation for wrongful death. Each case is unique and must be evaluated separately but people who have suffered injury or loved ones of those who died due to a da Vinci robotic procedure should seek legal advice.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.

What Are The Most Common Da Vinci Surgery Injuries

Between 2000 and 2013, 10,624 reports for injuries or adverse events associated with the da Vinci robotic surgery system were listed in the FDAs MAUDE database. These reports included 8,061 device malfunctions, 1,391 injuries, and 144 deaths associated with the da Vinci system.

Though it represents only a fraction of the 1.5 million surgeries that were performed in the same period, some experts believe that the number of serious adverse events may be severely underreported. In addition, many of these events may have been preventable.

The most common da Vinci robot injuries include:

  • Bowel or bladder injuries
  • Perforations or tears in organs
  • Burns to organs

Many of these issues may be attributable to either a lack of proper training or Da Vinci robot malfunctions.

How Can Surgeon Inexperience Cause a da Vinci Surgery Injury?

Surgeon inexperience has been cited as a major cause of da Vinci robot injuries. The use of robot-assisted technology may not come naturally to all physicians. It requires the surgeon to become comfortable operating on a patient using an electronic control panel and hand/wrist controls that may be similar to a joystick. The company requires only a few sessions for training but many have said this is inefficient.

Surgeons must complete the following steps to use the device:

How Can da Vinci Device Malfunction Cause Injury?

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Warning Letter Signals Need For Corrections

The FDA issued a Warning Letter to Intuitive in July 2013 addressing the companys need to remedy certain violations of federal regulations. An inspection conducted by the federal agency revealed that certain components of the da Vinci system were misbranded devices, because Intuitive failed or refused to provide information regarding the device.

More specifically, the FDA pointed out that various written reports of corrections to the device and/or removal of certain devices as the result of findings of potential risk to the public were not submitted to the agency as required. The letter referenced four areas subject to Class II recalls in April 2013, for which separate field corrections were initiated but field action was never reported to the FDA.

The 4 areas subject to Class II recall included:

  • Recommendations for the proper use of the Tip Cover Accessory and the correct generators that should be used with monopolar instruments
  • Use of the da Vinci Surgical System for thyroidectomy indications, which the device was not cleared for
  • Information for inspecting instrument cannulas , proper flushing of the instruments and proper transport of the system between buildings
  • Replacement user manual addendum that included changes to the types of patients and conditions for which da Vinci TORS is indicated, including use in pediatric patients

What Procedures Can Be Done With Da Vinci Robotic Surgery

Review: The da Vinci Robotic Surgical System

The da Vinci robotic surgery system is used for conditions that affect soft tissue and organs. The FDA approval for the da Vinci robotic surgery system includes general laparoscopic surgery, gynecological surgery, urological surgery, general non-cardiovascular thoracic surgical procedures, and thoracoscopically assisted cardiotomy procedures.

Da Vinci can be used to treat:

  • Kidney disorders

The Da Vinci robotic surgical system can also be used to perform hysterectomies and prostatectomies.

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Follow The Money Trail Into The Future

With each da Vinci robotic device costing an average of $1.5 million, many questions remain not only about the purported medical advantages of robotic hernia surgery but about the economic impacts. In the 2016 study mentioned earlier, which was conducted between 2012 and 2016, robotic surgeries averaged $7,162 each versus $4,527 for laparoscopic procedures and $4,264 for conventional open surgery.

Are there benefits to paying more for longer operations with potentially increased infection rates? Only time will tell.

Keywords

Lowering Costs Via Increased Volume

The increased costs of robotic surgery are partly related to the high fixed costs of equipment. If these fixed costs can be spread across higher volume, robotic surgery can potentially be cost effective. A 2010 study by Satava et al. noted that in robotic procedures which demonstrated the ability to reduce hospital LOS, such as robotic prostatectomy, may have a significant cost advantage . The justification behind this finding is based on that the availability of inpatient beds limited the volume of inpatient surgeries that could be performed therefore, by decreasing LOS, robotic surgery can potentially increase volume, thus spreading its fixed costs. However, some hospitals may not be limited by bed availability instead are limited by OR availability. So then, a hospital looking to lower costs of robotic surgery can increase volume by making robotic surgery cases a priority, investing in staff training to facilitate efficiency, and fostering the development of highly skilled robotic surgeons. While robotic surgery has a significant learning curve, surgeons with higher volumes can likely achieve significant improvements in efficiency over time that can create value.

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What Are The Side Effects Of A Da Vinci Surgery

Robot-assisted surgical technology like the da Vinci robotic surgery system allows the surgeon to perform precise, complex movements through wrist movements using an electronic console. It was designed to reduce the risks inherent in a traditional open surgery by operating through a small incision reducing infection risk, blood loss, and recovery time.

Unfortunately, robot surgery is not without risks and the da Vinci robotic surgery may cause serious side effects, complications, and injuries.

Is Robotic Hernia Surgery Really Any Better

da Vinci Robotic Surgery System

Surgical robot manufacturer Intuitive Surgical features research published in the journal Hernia in 2018 on its website, which found that robotic hernia surgery leads to fewer post-surgical complications from conventional surgery 30 days later. However, another 2018 study published in Surgical Endoscopy concluded that outcomes from robotic groin hernia surgeries were similar to those from laparoscopic and conventional surgery. Not only that, but the longer robotic operation times may be contributing to increased rates of skin and soft tissue infections.

There have also been serious concerns when using the da Vinci robot for hysterectomies, according to Kaiser Health News, and with cancer-related robotic surgeries in women, according to the Food and Drug Administration.

More definitive information is on the way. Results from randomized clinical trials comparing robotic hernia surgery outcomes with conventional laparoscopic surgical outcomes are expected this fall.

Robots or Doctors?

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Robots Dont Perform Surgeries Doctors Do

The da Vinci System robot uses a 3D HD vision system and special wristed instruments that bend and rotate far greater than the human hand, according to the Austin Regional Clinic. This is sophisticated technology, and theres some question as to whether surgeons are being properly trained to use it.

So you have surgeons who operate for half a day on pigs, take a ten-question multiple-choice test and have a proctor, another surgeon, do two surgeries and then theyre turned loose with the machine, attorney Richard Friedman said to imarc Research.

Considering The Effect Of Competition

New entrants to the robotic surgery market are focused on improving value via lowering cost and improved quality. For example, TransEnterix hopes to lower costs via its reusable instruments, which will result in significant cost-savings over Da Vinci. In fact, a recent internal review by our local healthcare system revealed an average instrument cost of $3,400 per da Vinci procedure, which is significantly higher than the projected $8001,600 instrument costs for Senhance . CMR has a unique business model which will lower the initial costs of robotic surgery thus, potentially improving access to robotic surgery across more health systems and procedures. New entrants have also cited new technology such as haptic feedback improved instrumentation, etc., which can have a potentially positive effect on the quality of care. However, significant research will be needed to make that determination. Finally, as with all technologies before it, as competition expands, the costs of robotic surgery will inevitably decrease.

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Increase In Medical Device Reports

In 2015, the FDA posted an informational article on computer-assisted surgical systems citing an increase of medical device reports related to robotically-assisted surgical devices. While the majority of the reports complained of device malfunctions, including component breakage, mechanical problems and image/display issues, others alleged injuries and even deaths related to the use of the device. But the agency pointed out that the submission of a report to the federal agency does not necessarily indicate a faulty or defective medical device.

The FDA listed various possible reasons for the increase in reports, including:

  • Increase in the number of devices being used or surgeries being conducted
  • Better awareness of how to report device issues to the FDA
  • Increased publicity resulting from product recalls

The federal agency further stated that because submissions can potentially contain incomplete, inaccurate, duplicative and unverified information, it is impossible to confirm whether the device actually caused a specific negative event based solely on the information provided in the report.

Changing Our Point Of Comparison

Intuitive

As demonstrated above, robotic surgery has not proven significantly better than laparoscopic surgery. It is also clear that open surgery is associated with increased patient hospital LOS, complications, pain, return to work time, and reoperations. Therefore, robotic surgery can derive its value as a means to convert an open procedure to a minimally invasive one. For example, the 2013 study by Wright et al. evaluating robotic hysterectomy noted that while laparoscopic hysterectomies had been performed since the early 1990s, it was not until the advent of robotic surgery that the minimally invasive approach to hysterectomy began to gain traction . The value of robotic surgery can be partly derived from the fact that it can accelerate the transition to minimally invasive surgery the benefits that accompany it.

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How Often Are Adverse Effects From Da Vinci Reported

A study authored by a Johns Hopkins Hospital physician showed that many cases of da Vinci robot injury are incorrectly reported or simply, not reported at all. Many injuries and deaths that may be linked to da Vinci robot-assisted surgery may not occur during the patients hospital stay but may be delayed for weeks, months, or even years before requiring treatment.

When symptoms occur after the patient has returned home, both the patient and their primary care physician may be unaware that an illness or event is related to the surgery. The operating surgeon may not be informed of the event if the illness is treated only by the primary physician and no report is ever filed with the FDA. FDA adverse event reporting is voluntary and though the agency recommends that they be notified, there are no regulations that require reporting.

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Robot Wars: $60b Intuitive Surgical Dominated Its Market For 20 Years Now Rivals Like Alphabet Are Moving In

t was the femoral artery of a rat that piqued the curiosity of Gary Guthart. Then a new hire at a research institute spun from Stanford University, he was assigned to a surgical robotics lab. He was asked to sew a severed artery back together by hand, and then to try it again with a prototype robot.

Thats what people have to do in surgery? Guthart recalls thinking. That looks like both a really interesting, important problem and a really hard problem, and that got me really excited.

Three years later, in 1996, Guthart was working at a startup called Intuitive Surgical, which had licensed technology from the institute, SRI International. Intuitive launched a robotic surgical helper, branded da Vinci, in 1998. The da Vinci would go on to change surgery in the same way the iPhone has transformed cellphone use.

Today, nearly 5,000 da Vincis are in operating rooms, used in one million surgeries per year. Intuitive went public just after the tech bubble peaked in 2000, and still the stock ended the decade 17 times higher than at its IPO. Why? Because, until now, Intuitive has had the business to itself. The price tag on a da Vinci is about $1.5 million. Plus, it sells about $1,900 in replacement parts per operation. The companys 30% net profit margin eclipses Microsofts.

Cover photograph by Timothy Archibald for Forbes.

A version of this story appears in the February 28, 2019 issue of Forbes.

The Evidence Behind Robots Effectiveness

da Vinci® Robotic Surgical System

In general, robotic-assisted laparoscopic surgery is safe and feasible, says Christopher Schabowsky, a program manager at the ECRI Institute, an American non-profit that evaluates new health care technologies. Overall, if your surgeon and surgical team are adequately trained, it is as safe as open surgery and laparoscopic surgery.

But robotic surgerys benefits are procedure specific, says Schabowsky. For many surgeries, especially those that are traditionally done in a minimally invasive way, it appears to be equal. For some mostly those that are difficult or impossible to do minimally invasively without the robot robotic surgery results in less blood loss, shorter hospital stays and faster recovery times.

An example is radical prostatectomy, which is difficult to do in a minimally invasive way without the robot. Before the Ottawa hospital got its da Vinci robot, it did most of its procedures openly. Only about 5% of radical prostatectomies were performed laparoscopically before we got the robot, and now its 95%, says Breau.

A 2014 review from HQO looked at results for Ontario patients. It found that people who had robot-assisted radical prostatectomies were significantly less likely to require blood transfusions and had shorter hospital stays.

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Fda Conducted Surgeon Survey

In November 2013, the FDA conducted a voluntary survey targeting experienced surgeons using the da Vinci Surgical System. The study was designed to better understand the surgeons perspectives on the different challenges that came about with the use of the system to perform surgery versus conventional surgical procedures.

The surgeon survey included:

  • 11 surgeons from 10 different institutions participated
  • 4 obstetricians/gynecologists 3 otolaryngologists 3 urologists 1 cardio-thoracic surgeon were among the medical specialist that attended
  • Most were from hospitals with a bed size of 100 or more one was from a smaller hospital
  • All were within the range of 3 28 years of experience
  • 70 600 surgeries were performed using da Vinci Surgical Systems over 3 years

Participants Responses and Comments:

All participants reported they needed to perform multiple surgeries before feeling fully proficient with the systems use

The biggest challenges included hand-eye coordination, use of foot pedals and learning the system platform

Although available, training is inconsistent

Patient selection varies by age, anatomy, Body Mass Index , risks/benefits, potential side effects, anticipated post-operative recovery time

Patient problems with the use of the da Vinci system include bleeding, pulmonary embolism , and heart attack

Only 3 of the 11 participants were aware of manufacturer recalls

Worth The Cost A Closer Look At The Da Vinci Robots Impact On Prostate Cancer Surgery

Urology fellow, Jeremy Fallot, and nurse, Shauna Harnedy, assist in robotic surgery by Ruban Thanigasalam in Sydney, Australia.Credit: Ken Leanfore for Nature

Loved by surgeons and patients alike for its ease of use and faster recovery times, the da Vinci surgical robot is less invasive than conventional procedures, and lacks the awkwardness of laparoscopic surgery. But the robots US$2-million price tag and negligible effect on cancer outcomes is sparking concern that its crowding out more affordable treatments.

There are more than 5,500 da Vinci robots globally, manufactured by California-based tech giant, Intuitive. The system is used in a range of surgical procedures, but its biggest impact has been in urology, where it has a market monopoly on robot-assisted radical prostatectomies , the removal of the prostate and surrounding tissues to treat localized cancer. Uptake in the United States, Europe, Australia, China and Japan for performing this procedure has been rapid. In 2003, less than 1% of surgeons in the US performed a RARP in preference to open or laparoscopic surgery. By 2014, RARP accounted for up to 90% of radical prostatectomies across the country. When it comes to prostate cancer surgery in the United States, says Benjamin Davies, surgeon and professor of urology at the University of Pittsburgh, the die is cast there is only robotic surgery.

Nature Index Cancer 2020

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