The Da Vinci surgical robot was first sold in the United States in 2000 to assist in numerous surgical procedures including heart surgeries, prostate surgery, and hysterectomies. It is designed to increase a surgeon’s range of movement through laparoscopic incisions, resulting in decreased blood loss and shorter recoveries. But now alleged Da Vinci surgical robot complications are on the rise and may be problematic.
Since its introduction, the device has been heavily marketed to hospitals and patients as part of what some call a ‘medical arms race.’ Four years ago, the device was in 853 hospitals and at costs between $1 million and $2.5 million, plus hundreds of thousands in yearly maintenance and replacement parts, it earned Intuitive Surgical $1.05 billion in sales in 2009 alone. By 2011, over 2,000 hospitals were using the Da Vinci robot, which has been deemed by some as a tool to attract patients, not necessarily to improve their care.
Robotic Surgery: More Marketing Hype than Surgical Necessity?
While the use of robotic-assisted surgeries has significantly increased in the last four years, data in a Citron Research report ( http://www.citronresearch.com/wp-content/uploads/2012/12/OBG-Management-Kaunitz.pdf ) indicates that the benefit of their use is limited, while “cost and operative times are increased.” Further, experts are questioning the evidence regarding marketing practices and manufacturer influence on the wide spread use of these types of devices.
The Citron Research report also states “In a randomized, controlled trial of 95 women undergoing hysterectomy, the robotic approach was associated with a longer mean operative time than the laparoscopic approach (106 vs 75 minutes), but produced similar results in other measures (blood loss, complications, analgesic use, and return to activity).”
In an article by the New York Times regarding one large national study that compared outcomes among Medicare patients, “surgery with a robot might lead to fewer in-hospital complications, but that it might also lead to more impotence and incontinence. But the study included conventional laparoscopy patients among the ones who had robot-assisted surgery, making it difficult to assess its conclusions.”
In fact, one heart surgeon told the Seattle Times, “What disturbs me is that we haven’t done the thing we always say we should do — which is look at a detailed, randomized trial across institutions to assess whether what we’re offering patients is better.”
No Standardized Training Leaves Patients Vulnerable
Training is an issue that is also being questioned. According to the Wall Street Journal, the manufacturer offers two surgeons from a hospital that purchases the device a paid two-day training course for two surgeons when a new hospital client buys a robot, but it says further training and credentialing are at hospitals’ discretion.” In some hospitals, surgeons were able to use the device unsupervised after just a few surgeries, while “Some hospitals have rigorous robotic-training programs.”
One hospital in New Hampshire that is being sued allegedly due to errors that happened during a robotic assisted surgery, says the training it requires of its surgeons on the robot—-a two-day course operating on human and pig cadavers followed by four live cases supervised by a proctor—-is adequate and that its da Vinci complication rates are below rates published in recent studies. ( http://online.wsj.com/article/SB10001424052748703341904575266952674277806.html )
The Seattle Times states that today, 12 years after the FDA first approved the da Vinci, there is still no industry standard for training and credentialing of doctors to use the robot, beyond a basic course by the manufacturer. ( http://seattletimes.com/html/localnews/2018631542_robot08m.html )
Many serious injuries have been reported through voluntary adverse event reports and through lawsuits. These injuries may include:
- Peritonitis or sepsis
- Excessive bleeding
- Burning of nearby organs including the intestines
- Punctured blood vessels or arteries
- Punctured or cut ureters
- Vaginal cuff dehiscence
According to court filings, many of these robot-assisted surgeries required additional surgeries to try to repair the damage, though these surgeries were not always successful.
The Da Vinci Surgical Robot Complications May Be Causing Da Vinci Surgical Robot Lawsuits
At least nine lawsuits have been filed against Intuitive Surgical over the Da Vinci robot, including one filed by a father whose daughter died two weeks after a hysterectomy because of an alleged design flaw in the robot that allowed electrical current to jump and burn her intestines and an artery.
If you or a loved one suffered serious complications, including tears and burns to blood vessels, intestines and other internal organs, following a surgical procedure involving a Da Vinci Surgical Robot, you may be eligible to file a personal injury or wrongful death Da Vinci Surgical Robot lawsuit seeking compensation from Intuitive Surgical. To learn more about the legal options available to you, please contact the Da Vinci Surgical Robot lawyers at Alonso Krangle LLP by filling out our online form or calling 1-800-403-6191