Maybe more than any other industry, the healthcare industry has been rapidly developing in the past couple of decades. From ambitious drugs and pills to completely new surgical techniques, it seems like every year has a new and exciting possibility in store for people who suffer from serious medical problems. One of the new developments to come out since the turn of the century has been robotic surgical systems, in general, and the da Vinci Surgical System, in particular.
Unfortunately, the da Vinci Surgical System has not exactly lived up to the hype and has even caused numerous problems, of its own accord. Many of these have stemmed from the lack of oversight from the Food and Drug Administration (FDA), the aggressive marketing and profit-generating tactics of the company that makes the da Vinci system, Intuitive Surgical, as well as a lack of training on the new apparatus for many surgeons who use it. Altogether, these issues make the da Vinci Surgical System a serious medical malpractice and products liability problem.
The da Vinci Surgical System
The da Vinci Surgical System is the second wave of robotic surgical machines, entering hospital operating rooms on the heels of the less ambitious but more natural laparoscopic devices. These laparoscopic devices – essentially tiny cameras that put video taken from inside a patient onto a computer screen that a surgeon could see – drastically reduced the amount of cutting that needed to happen immediately before many surgeries: For example, laparoscopic devices reduced the incision required for cholecystectomies from one 20 centimeter incision down to four incisions of less than a centimeter. The lack of major incisions – needed to help surgeons see what they were doing before the advent of laparoscopic devices – helped patients recover from the procedure much quicker.
Building on the success of laparoscopic devices, da Vinci Surgical System is a far more advanced surgical robot of two parts: A large, spider-like part called the “tower” hangs over the patient, with numerous tools, scalpels, cameras, and other medical equipment held at the ready for the surgical procedure, while a vast computer console sits in the corner of the operating room for the surgeon. Using the console to move the “arms” of the spider-like part of the machine has been likened to playing a video game. Various safety factors allow the machine to reduce the tremors that even surgeons have to deal with during an operation. Additionally, the machine's arms are designed to allow for wider, smoother, and more precise movements that cannot be replicated by a human hand.
An Expensive Machine that Raises the Cost of Surgery
While using it has been compared to a video game, the da Vinci Surgical System is an expensive video game, costing hospitals between $1 million and $2.5 million to install a single device in their facilities. Additionally, many of the parts that the System uses are disposable, and cost money to replace. Finally, the machine runs on proprietary software, preventing hospitals or even researchers from developing it outside of Intuitive's own business and making it better at particular surgeries, more cost-effective, or adaptable to a facility's peculiar needs.
Recovering the purchase price of such a machine is no small feat, especially for some of the smaller hospitals that buy one. Many hospitals try using volume to help recover the price, pushing patients to have some surgeries that can be done manually – and that is even safer to do, manually – into a robotic surgery. Those extra procedures, though, increase the chance that the normal wear and tear on the da Vinci Surgical System can cause a serious injury during a surgery.
But that is not all: As is the case with complex devices like the da Vinci Surgical System, the costs of getting a robotic surgery rather than a manual one also get passed on to the patient. The New England Journal of Medicine found that robotic surgeries cost 13% more than the price of a manual one, and this was back in 2007.
Some surgeries cost even more. According to a study that was published in the Journal of the American College of Surgeons, researchers found that removing a gallbladder through a robotic surgery, like with the da Vinci Surgical System, cost three times more than it would if it were done with a laparoscopic system. Additionally, they found that the patient outcomes through each procedure were the same.
Studies Examining The da Vinci Robot
Other studies have also found that surgeries performed by robotic systems like the da Vinci are no better than surgeries performed via other methods. A study published in The Lancet followed 308 men with prostate cancer who got either robotic surgeries to remove their prostate or received traditional, manual surgeries that required more or wider incisions. After twelve weeks, the outcome for each group of patients was the same. The only difference was that patients who received a robotic surgery spent less time in the hospital after the procedure.
Of course, Intuitive Systems, the makers of the da Vinci Surgical System, claims that results get better as surgeons become more used to the program. However, there are no numbers to show that this is the case. In fact, the patients involved in the study done by The Lancet were all treated by the same surgeon, who had performed 200 robotic prostatectomies before the study began, far more than most surgeons who use da Vinci Surgical Systems for procedures, even if those surgeons have been certified to use the machine.
Lack of Uniform Training for Surgeons
One of the hallmarks of the da Vinci Surgical System is that it moves the surgeon away from the patient on the operating table, so the machine's arms come into contact with the patient, instead. However, getting accustomed to this radically different format for a surgical procedure does not come easy for many surgeons, especially those who have been working in the field for years or decades and who are accustomed to standing over the patient and using their own hands. Training and practicing with the da Vinci Surgical System is an absolute must for surgeons if they want to avoid making a mistake with the machine and hurting the patient.
Unfortunately, there is no standard training for surgeons to use the da Vinci Surgical System, with each hospital creating its own set of training policies. While these policies are rarely if ever made public, some have been found to require surgeons to perform up to 100 practice operations before working on live patients. Other hospitals, however, certify their surgeons to use the da Vinci Surgical System after only three practice procedures. To make matters worse, hospitals turn a profit when their surgeons are operating on patients – not when they are training on a new surgical machine like the da Vinci. The financial incentive to get their surgeons out of training and into the operating room makes hospitals much more willing to let their surgeons “learn on the job,” instead of spending extra time practicing with the da Vinci Surgical System to fully understand how it works.
Intuitive Systems, though, has complicated the issue further by actively lobbying hospitals and healthcare advocates to reduce the training that surgeons need to undergo before they can use their da Vinci machines. Worse, Intuitive has followed in the footsteps of drug manufacturers and marketed their da Vinci robot surgeries directly to the patients who need the procedure done. Increasingly, doctors and surgeons across the United States are seeing patients insist that their surgery be done by a robot rather than by a human surgeon.
This attitude is the result of a vigorous ad campaign by Intuitive to make people think that they are more likely to get a good outcome if it is a robot that does the operation. Unfortunately, those marketing schemes are rarely supported by studies and facts, and often push the da Vinci machine for surgeries that it is poorly equipped for, and which it is no better at than a human, like a gallbladder removal. Hospitals have, in turn, responded to the increased demand for robotic surgeries by, of course, buying more da Vinci machines, padding Intuitive's bottom line and earning them the significant return on investment for their marketing schemes which was the whole point. According to Intuitive's numbers, there were 3,803 da Vinci Systems installed across the world as of September 30, 2016, with 2,501 of those in the U.S.
Lack of Full FDA Approval Process for da Vinci System
Many of these problems with the da Vinci Surgical System could have been better handled with oversight, particularly through the FDA's approval process. However, Intuitive arranged for a short-cut to get past much of this process by claiming that the da Vinci Surgical System was similar to surgical robots that had already been approved by the FDA, effectively piggybacking on their approved status.
Typically, the FDA puts new medical devices through rigorous testing and experimentation to ensure that it is as safe as possible. However, when a new device is especially similar to one that is already in wide use, the FDA will give the new device a Premarket Approval to speed the process along. Despite Intuitive's constant claims that the da Vinci was a new and revolutionary machine, the FDA gave it a Premarket Approval, allowing it to bypass much of the clinical testing that it otherwise would have had to go through, and allowing it to be sold far quicker.
Medical Malpractice Issues with the da Vinci Surgical System
In all, there has been numerous medical malpractice and products liability issues with the da Vinci Surgical System since its introduction in 2000, and more will likely crop up as the device is used to perform procedures that it is increasingly ill-equipped to do. A small handful of the problematic parts of the da Vinci, though, have been:
- Defective Instrument Tip Covers. One of the medical devices that the da Vinci Surgical System uses is a curved set of 8mm monopolar scissors. The blades of this pair of scissors are electrified so they can better cut and coagulate tissue, leaving the tip covers to insulate much of the rest of the device from the electrical current. However, those tip covers proved to be so defective and hurt so many patients that they warranted a recall.
- Electrical Arcing. Many of the medical devices that the da Vinci Surgical System, including the 8mm monopolar scissors, above, are electrified. In order to control the electrical current, the da Vinci System uses a variety of techniques. However, not all of them are effective. In some cases, patients have been hurt by electrical arcing – sparks flying from the surgical equipment and landing on the patient's body during the procedure – and suffered long-term injuries from the resulting burns, many of which occur internally and can cause infections.
- Lack of Training. Other patients of da Vinci surgeries have suffered from a much simpler issue: The surgeon using the machine simply did not understand how to make it work properly, and this caused them to make a serious mistake.
Maryland Medical Malpractice Attorneys at Gilman & Bedigian
Robotic surgeries like those performed by the da Vinci Surgical System are supposed to be the pinnacle of medical achievement. However, it is clear from the results that there are a lot of bugs to work out. Unfortunately, if you were one of the people who get a surgery that was performed by a surgeon through a da Vinci machine, you might be left with an injury that you would not have suffered, otherwise. These medical malpractice injuries can be life-changing or even fatal.
That is why the personal injury lawyers at the law office of Gilman & Bedigian fight for the rights and interests of malpractice victims. By representing you in court, we can get you the compensation you need and deserve. Contact us online or call our law office at (800) 529-6162 for a free consultation.