Da Vinci Surgical Robot Complications: Do the Risks Of Complications Outweigh the Benefits?

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The Da Vinci Surgical System, brought to market in 2000, is a robotic surgery system marketed by Intuitive Surgical, and is used in everything from hysterectomies and prostrate removals to heart bypass operations. The machine is remotely controlled by a surgeon, who uses joystick-like controls to maneuver its arms. Patients are promised a host of benefits, including smaller incisions, less blood loss and quicker recoveries. The Da Vinci Surgical System is now used in well over 2,000 hospitals.

Yet, as mentioned in news articles and commentaries very little clinical evidence exists to show that robotic surgery offers patients additional benefits over traditional surgery. In a Los Angeles Times article Dr. Marty Makary, a surgeon at the Johns Hopkins University School of Medicine in Baltimore says “There’s never been a study showing clinical superiority.” Dr. Makary goes on to say, “For the patient, there’s clearly no difference.” Makary made the case that the robot is more of a marketing tool to attract patients than a medical one to improve their care, in a paper published in May by the Journal for Healthcare Quality
[ http://articles.latimes.com/2011/oct/17/health/la-he-robotic-surgery-20111017 ]

In A Citron Research commentary by Andrew M. Kaunitz, MD, Professor and Associate Chairman, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville, it states that “evidence of its effectiveness is limited. Of the studies that have been conducted, many found no benefit or only slight benefit for the robot, compared with laparoscopic surgery. Nevertheless, the use of the robot in gynecologic surgery has spread rapidly, accounting for more than 200,000 operations in 2009.”
[ http://www.citronresearch.com/wp-content/uploads/2012/12/OBG-Management-Kaunitz.pdf ]

In a Seattle Times article it states that, “Only a handful of studies included random assignment to robotic or manual laparoscopic surgery. Of those, two found that robotic surgery took longer than the hands-on alternative; in another study, the robot was faster. One study of 20 patients published in the journal Surgical Endoscopy in 2004 suggested that people who had an adrenal gland removed with the robot were more likely to have complications that required the surgeon to open them up all the way than those who underwent traditional laparoscopic surgery.”
[ http://seattletimes.com/html/localnews/2018631542_robot08m.html ]

In an American Journal of Obstetrics and Gynecology report, it states that, “many web sites report claims of superiority for robotic surgery that are not currently supported by high-quality data.”
[ http://www.ajog.org/article/S0002-9378%2812%2900664-3/fulltext ]

In regards to the Da Vinci surgical robot used in robotic prostatectomy, the ProstateCancer.com.au states that, “the evidence to date shows that, in many respects, outcomes following the robotic procedure are quite similar to those following open surgery.” ProstateCancer.com.au also states that, “From the patient’s point of view, robotic prostatectomy offers quicker time to full recovery, a reduced risk for blood loss, and slightly less postoperative pain. However, it does not offer any advantage in functional outcomes, nor does it result in better cancer control.”
[ http://www.prostatecancer.com.au/journal_a22.html ]

In an Associated Press article regarding a Journal of the American Medical Association study conducted that “analyzed Medicare data for nearly 9,000 prostate cancer patients who had surgical treatment from 2003-07″ and compared standard surgery to minimally invasive surgery, it states that, “There was no difference in the rate of additional cancer therapy down the road, suggesting the two techniques were about the same for cancer control.”

But the report goes on to further state that patients who had minimally invasive surgery, “were more likely to report complications in the first 30 days after surgery involving genital and urinary function. About 5 percent of the minimally invasive surgery patients vs. about 2 percent of the standard surgery patients had these complications. And after 18 months, they had more incontinence and erectile dysfunction.”
[ http://www.nbcnews.com/id/33291388/ns/health-cancer/#.US5z9hmrhF8 ]

Da Vinci Surgical Robot Complications And Injuries During Surgical Procedures

With the Da Vinci Robot, patients are promised a host of benefits, including smaller incisions, less blood loss and quicker recoveries.
Unfortunately, those promises may not tell the whole story. Not surprisingly, a growing number of critics are raising concerns that the Da Vinci Robot may be putting patients at risk and causing serious Da Vinci Surgical Robot Complications.

In 2010, multiple Wall Street Journal articles detailed a number of instances where patients sustained injuries in Da Vinci Surgical Robot procedures, including lacerated bladders, perforated organs, and cut ureters. In one of the cases detailed by the Journal, a patient died, while others had to undergo multiple corrective procedures to fix the damage done by the Da Vinci Robot.

The Wall Street Journals says, “Sherry Long, a 47-year-old resident of Rochester, N.H., sued Wentworth-Douglass Hospital in Dover, N.H., alleging that both of her ureters were severed during a robotic hysterectomy performed on March 2, 2009. The injury resulted from the two surgeons’ lack of training on the da Vinci, the suit alleges.”

In another case, a “42-year-old doctor named Carlos Chiriboga died following a robotic surgery performed at West Boca Medical Center in West Boca Raton, Fla. Darla Keen, an attorney representing Dr. Chiriboga’s family, says the urologist who operated on Dr. Chiriboga had never performed the surgery he was attempting with the robot before.” The response from a spokeswoman for West Boca Medical Center were the operation was performed stated, “the surgeons who have performed robotic surgery at West Boca have had a solid success rate since they began performing the surgery at the hospital more than two years ago.”

Other cases of complications occured when Wentworth-Douglass gynecologists started using the robot. The Wall Street Journal article states, “The bladders of two female patients were lacerated during routine gynecological surgeries performed with the robot, a person with direct knowledge of those cases says.” The injury was serious enough had to be “sent to the Lahey Clinic in Burlington, Mass., for another surgery to repair the damage, the person says. The patients survived.”

In another case in June 2007, at Seacoast General Hospital one of “general surgeon David Coppola’s first da Vinci patients was an elderly man with a stomach condition. Under the supervision of a proctor, Dr. Coppola operated on the man for several hours with the robot, people with knowledge of the case say. But Dr. Coppola eventually gave up on using the robot and switched to open surgery. The patient died after his esophagus was perforated.” The article further states, “It’s unclear whether the esophagus was injured during the robotic part of the surgery or after Dr. Coppola opened the man’s abdomen and reverted to traditional surgery.”
[ http://online.wsj.com/article/SB10001424052748703341904575266952674277806.html ]
[ http://online.wsj.com/article/SB10001424052702304703104575173952145907526.html ]

In these articles mentioned in the Wall Street Jornal, the maker of Da Vinci was not sued. But a recent robotic surgery lawsuit now names the maker of the robot, Intuitive Surgical. In April of 2012 Intuitive Surgical was sued by the father of a 24-year-old woman alleging her death “was caused by the company’s da Vinci surgical robot in addition to errors the surgeon made during the hysterectomy,” as stated in www.outpatientsurgery.net. The article further states that, “The lawsuit alleges design flaws in the da Vinci, such as poorly insulated surgical arms and electrical current that was strong enough to jump to healthy tissue. The patient allegedly had burns to an artery and her intestines from the da Vinci and died 2 weeks after the procedure.”
[ http://www.outpatientsurgery.net/news/2012/04/6-Robot-Maker-Sued-Over-Hysterectomy-Patient-s-Death ]

Even in side by side comparisons of standard surgery to minimally invasive surgery complications are arising. In an Associated Press article regarding a Journal of the American Medical Association study conducted that “analyzed Medicare data for nearly 9,000 prostate cancer patients who had surgical treatment from 2003-07″ and compared standard surgery to minimally invasive surgery, it states that, “There was no difference in the rate of additional cancer therapy down the road, suggesting the two techniques were about the same for cancer control.”

But the report goes on to further state that patients who had minimally invasive surgery, “were more likely to report complications in the first 30 days after surgery involving genital and urinary function. About 5 percent of the minimally invasive surgery patients vs. about 2 percent of the standard surgery patients had these complications. And after 18 months, they had more incontinence and erectile dysfunction.”

The Associated Press article also states that Dr. Ashutosh Tewari, director of the Prostate Cancer Institute at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, and who receives research funding from Intuitive Surgical and had no role in the study, faulted the research for lumping all minimally invasive surgeries together, both robotic and those using older laparoscopic techniques. Ryan Rhodes, a spokesman for Intuitive Surgical, said there have been more than 800 previous studies on robot-assisted prostate surgery. “The overwhelming majority of these show superior results,” both for cancer treatment and urinary continence and sexual function, Rhodes said in an e-mail.
[ http://www.nbcnews.com/id/33291388/ns/health-cancer/#.US5z9hmrhF8 ]

These Da Vinci surgical robot complications or injuries may include:

  • Pain
  • Excessive bleeding
  • Surgical burns to organs
  • Surgical burns to arteries
  • Tears and/or burns of the intestines
  • Punctured blood vessels
  • Punctured organs
  • Punctured arteries
  • Torn, cut, or punctured ureters
  • Serious bowel injuries including punctures, tears, and burns
  • Vaginal cuff dehiscence (reopening of the incision )
  • Peritonitis (painful and tender inflammation of the lining of the abdomen)
  • Sepsis
  • Wrongful Death

The Da Vinci Surgical Robot: A Medical Arms Race

The Da Vinci Robot is an expensive piece of equipment for any hospital, costing around $1 million to $2.25 million, depending on the model. In addition, hospitals pay another $140,000 a year for the robot’s maintenance and $1,500 to $2,000 per surgery for replacement parts. For most health care facilities this is big money. But according to the Wall Street Journal article, “Intuitive Surgical has marketed the da Vinci to hospitals as a way for them to increase their revenues and gain market share.” Not surprisingly, hospitals that invest so much in the Da Vinci Surgical System are quick to promote it via TV and radio advertising. In most cases, the Da Vinci features prominently on hospital websites. Some facilities even invite the public to see the Da Vinci first hand, going so far as to offer a chance to “test drive” the robot.
[ http://online.wsj.com/article/SB10001424052702304703104575173952145907526.html ]

Hospitals hope this type of promotion will inspire patients to seek out the Da Vinci should they need a minimally invasive procedure. Once a Da Vinci Robot has been purchased, hospitals face a great deal of pressure to use it and recoup their investment. According to The Wall Street Journal, one study published in the Journal of Urology found that a hospital needs to do at least 520 surgeries a year with the robot to bring its costs in line with traditional surgery.

“There’s a medical arms race,” Paul Levy, chief executive of Beth Israel Deaconess Medical Center in Boston, told The Wall Street Journal. “Technologies are being adopted and becoming widespread based on the marketing prowess of equipment makers and suppliers, not necessarily on the public good.”

At least one doctor told the Journal that he felt pressured to use the Da Vinci Robot after his hospital had one installed. Eventually, he chose to leave the facility.

Is the Da Vinci Robot Superior?

According to a report from The LA Times, Intuitive points to 4,000 published studies on the Da Vinci as evidence of its quality. But one critic called those studies “sloppy,” and said ideally researchers would test the robot’s effectiveness by randomly assigning patients to the robot or a traditional laparoscopic procedure. So far, only a handful of studies involving the robot have been conducted that way. One, published in the journal Surgical Endoscopy in 2004 suggested that people who had an adrenal gland removed with the robot were more likely to have complication that would force a doctor to revert to an open procedure compared to traditional laparoscopy.

“There’s never been a study showing clinical superiority,” Dr. Marty Makary, a surgeon at the Johns Hopkins University School of Medicine in Baltimore, told the LA Times. “For the patient, there’s clearly no difference.”

Da Vinci Surgical Robot Lawsuits

A number of Da Vinci Surgical Robot Lawsuits have already been filed by people who allegedly suffered serious, life-threatening injuries in robotic surgery procedures. For a free, no obligation legal evaluation of your Da Vinci Surgical Robot lawsuit, simply fill out the online form on the right, or give Wright & Schulte LLC a call, toll-free, at 1-800-399-0795.

More info about Da Vinci surgical robot complications

http://online.wsj.com/article/SB10001424052702304703104575173952145907526.html

http://seattletimes.com/html/localnews/2018631542_robot08m.html

http://articles.latimes.com/2011/oct/17/health/la-he-robotic-surgery-20111017

http://www.citronresearch.com/wp-content/uploads/2012/12/OBG-Management-Kaunitz.pdf

http://www.outpatientsurgery.net/news/2012/04/6-Robot-Maker-Sued-Over-Hysterectomy-Patient-s-Death

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