Robotic surgery promises less invasive surgery resulting in less blood loss during surgery, less pain, and a faster recovery time than with other surgical methods. One of the most common surgical robots is called the da Vinci, which is manufactured and sold by Intuitive Surgical (“Intuitive”). Intuitive has been designing, manufacturing, and installing the da Vinci Surgical System since 1999. Intuitive promotes the da Vinci Surgical System (“da Vinci”) as “combin[ing] superior 3D high definition vision with our patented EndoWrist® Instruments allowing for enhanced dexterity, precision and control. The end result: a breakthrough in surgical capabilities.” Source
Intuitive has stated, “In any definitive treatment for complex disease, such as surgery of the cancerous prostate, heart, or other major organs there are risks of complications. Robotic surgery has proven benefits in reducing the risk and complications associated with open surgical procedures thereby extending the benefits of minimally invasive surgery to a broader population of patients. Overall, adverse event rates are very low. Da Vinci surgery has been shown to be safer than the open surgery alternatives in numerous independent large scale, peer reviewed studies.”
Intuitive went public in 2000 and has enjoyed much financial success ever since. In 2012, installation of the da Vinci Surgical System in hospitals rose by 21% and Intuitive’s revenue in 2012 rose to over $2 billion. The number of robotic surgeries increased by 25% to 450,000 procedures in 2012. There are about 2,585 da Vinci Surgical Systems that are currently in use, at a cost in excess of $1.5 million for each. Intuitive charges in excess of $100,000 for service maintenance contracts for each da Vinci it installs and also sells the disposable instruments used during da Vinci surgeries.
Along with the rapid growth in robotic surgeries in recent years, concerns have surfaced regarding the safety of such procedures, the aggressive marketing of robotic surgery systems, and the training and experience of those perfroming da Vinci surgeries. One of the issues involving robotic surgery is the lack of tactile feel when using a robot but many surgeons argue that the limitation is more than offset by the enhanced 3-D vision used during da Vinci surgery.
Recently there has been a sharp increase in the number of medical malpractice lawsuits filed where the da Vinci was used, including at least ten filed in the past two years. The da Vinci lawsuits allege that patients have been injured during the surgical procedures (including burns and other heat-related damage to intestines, ureter, bowels, and other organs that may occur outside of the surgeon’s range of vision, without the surgeon’s knowledge, and may show up days after the surgery) and have suffered other complications, including death. Some of the medical malpractice lawsuits have questioned the extent and quality of the training that da Vinci surgeons have received before performing da Vinci procedures on patients (da Vinci training typically consists of seven hours of training over a weekend, with the training usually involving using the da Vinci on a pig). There have been allegations that the sales force for the da Vinci Surgical System have pressured surgeons to perform more da Vinci surgeries in order for the sales people to meet their quotas.
There have been at least 85 deaths and 245 da Vinci-related injuries reported since 2000 (about 1.5 million robotic procedures have been performed since 2000); however, the number of da Vinci mishaps may be massively under-reported (by how much is anyone’s guess). There have been 4,600 adverse events, including machine malfunctions, reported involving da Vinci since 2000.
In a study published in The Journal of the American Medical Association in February 2013, it was reported, “Between 2007 and 2010, the use of robotically assisted hysterectomy for benign gynecologic disorders increased substantially. Robotically assisted and laparoscopic hysterectomy had similar morbidity profiles, but the use of robotic technology resulted in substantially more costs … To date, robotically assisted hysterectomy has not been shown to be more effective than laparoscopy. Nevertheless, robotic gynecologic surgery may confer benefits that are difficult to measure. Proponents of robotic surgery have argued that robotic technology allows women who otherwise would undergo laparotomy to have a minimally invasive procedure. However, there is little to support these claims, and because both laparoscopic and robotic-assisted hysterectomy are associated with low complication rates, it is unclear what benefits robotically assisted hysterectomy offers.” Source
In a study published in the Journal of Clinical Oncology in 2011, it was reported, “Risks of problems with continence and sexual function are high after both procedures [robotic-assisted laparoscopic radical prostatectomy and open radical prostatectomy for men with clinically localized prostate cancer]. Medicare-age men should not expect fewer adverse effects following robotic prostatectomy.” Source
Earlier this month, the president of the American Congress of Gynecologists and Obstetricians reportedly stated, “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.” Source
If you or a family member suffered injuries or complications during or after daVinci surgery or other robotic surgery, you should promptly contact a local medical malpractice attorney to investigate whether medical negligence was the cause of your harms.
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