Since breaking into the medical market in the summer of 2000, the da Vinci Surgical System has been at the front line of the robotic surgical frontier in regards to offering minimally invasive procedures. The million-dollar device, manufactured by Intuitive Surgical, Inc., is now in thousands of locations around the world, and has been used for approximately 1.5 million surgeries, including general, urologic, gynecologic, thoracoscopic and thoracoscopically-assisted cardiotomy procedures. The technology is booming nationwide, with Intuitive Surgical, Inc., reporting that Southwest Florida is home to a handful of da Vinci robotic devices, with more than 140 qualified surgeons practicing with the device in Charlotte, Lee and Sarasota counties.
With the aid of this product, doctors use a remote-control computer console, which features multiple arms and tools with greater range of motion and stability than the human hand, to perform surgeries. The manufacturer reports that smaller and fewer incisions are needed to perform the same surgeries as a traditional open procedure, and the da Vinci method offers shorter hospital stays, a quicker recovery time, less scarring and fewer surgical complications from blood loss.
While the product continues to thrive within the medical community, the FDA has issued warnings that the da Vinci Surgical System has been tied to more than 100 deaths and thousands of adverse events. These include perforations, lacerations, tears and electrical burns of surrounding organs during surgery, as well as the development of post-op infections, internal bleeding and other serious injuries related to robotic parts remaining inside patients.
Product malfunctions are also on the rise. At the end of 2013, Intuitive Surgical released a warning stating the da Vinci system may briefly stall while performing a task, but will catch back up if a surgeon “pushed through the resistance.” Deemed a potential danger to patients, the FDA classified this issue as a Class II recall, stating the device could cause temporary or reversible problems to a patient’s health, with a small possibility of more serious complications developing. The FDA also conducted a survey of 11 da Vinci experienced surgeons. Although the doctors said the device led to fewer surgical complications and shorter recovery times, some of the doctors reported robotic malfunctions, where the da Vinci arms collided or missed their marks during surgery.
Inadequate training was also voiced in the recent survey, a topic business and financial news source Bloomberg investigated. As reported in an article, no universally accepted guidelines exist for training medical professionals on how to use the machines. Because of this, surgeons are being taught in workshops led by sales representatives from the California-based manufacturing company. Another Bloomberg article discusses the financial aspect of the da Vinci product, which is a million-dollar investment for hospitals and surgical centers. Paying off the price of the equipment means higher surgical costs, creating a burden for patients and insurance companies. This has led to high turnover rates for patients in an effort to fill beds to recoup money. High-profile surgeons have begun to take note of these studies and have begun to voice their own criticism:
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.
The major concern is that the robotic procedure really didn’t show a lower complication rate yet it was substantially more expensive. Why the robot took off so fast is the million dollar question.
If the 600,000 hysterectomies performed in the United States were all done robotically, the reported cost increases would result in an extra $960 million to $1.9 billion burden on the health care system.
Lawsuits are being filed nationwide naming da Vinci Surgical System’s manufacturer and some of the doctors who have used the robots in surgery as defendants. If you or someone you know has suffered severe complications as a result of a da Vinci robot-assisted surgery, please contact our law firm for a free and confidential consultation.