Da Vinci Robotic System’s Incident Underreporting May be Concealing Surgical Dangers
According to the manufacturer of the da Vinci Robotic Surgical System, the system has already been purchased by nearly 1,400 hospitals in the United States. The company touts that many facilities actually bought two or more surgical devices. While Intuitive Surgical presents the da Vinci system as an unparalleled commercial and medical success story, the truth is that the claims about the device’s benefits without major drawbacks deserve a second look.
According to Dr. Martin Makary, who performed a study on medical injury underreporting and was interviewed by the New York Times for a piece on the da Vinci system, the situation surrounding the medical device is indicative of larger problems in American healthcare. He believes that despite the healthcare industry adopting new medical technologies time and time again these technologies are not adequately evaluated or analyzed to see if they are worth the cost or if they are leading to better medical outcomes. He states that, “[Hospitals] adopt expensive new technologies, but we don’t even know what we’re getting for our money — if it’s of good value or harmful.”
In the case of da Vinci surgical robots, aggressive marketing tactics and underreporting of problems and incidents involving the machines may be concealing serious problems affecting the devices.
What Medical Benefits are Promised Through the Use of a Da Vinci System?
The typical da Vinci surgical system consists of two main pieces. First, there is a surgical console that the surgeon will sit at and work from. This console is typically placed in the same room as the patient. Second, there is a cart for the patient to rest on while the procedure is performed. The cart is equipped with four robotic arms. The robotic arms are equipped with miniature surgical tools that the doctor can control. Features of the da Vinci design intended to promote improved medical outcomes include:
- Superior visualization capabilities.
- Elimination of the need for camera repositioning which is common in traditional laparoscopy
- Tremor reduction features can refine the precision of movement beyond what a human hand is capable of.
- A jointed design allows for a greater.
- Reduced incision site size.
The da Vinci robotic system is marketed as allowing a greater number of specialists and physicians to perform minimally invasive procedures. Invasive procedures are typically less likely to lead to complications and permit for faster recovery. One of the promises of widespread da Vinci deployment was that patients would be able to recover more quickly and would not require as prolonged of stays in the hospital or as intensive of post-operative care.
However, the promise of medical benefits is not as clear-cut as it once appeared to be. One study published in the Journal of the American Medical Association analyzed the outcomes among 264,758 women who had a hysterectomy performed. The study found no overall difference in complication rates between those who had a traditional laparoscopic procedure and those who had a robotically assisted procedure.
Da Vinci Was Approved for Sale Through the Premarket Notification Procedure
The da Vinci system did not come to market after a full evaluation of the product by federal regulators. Rather, the device was approved using a process known as “premarket notification.” The premarket notification process is controversial because it can allow a medical device to come to market without undergoing the rigorous testing that most people would expect a surgical tool, medical device or new drug to undergo. However, the premarket notification approval process is only available if the new device is similar to a device already existing on the market.
Further exacerbating problems, when a product is approved for sale using the premarket notification procedure, the FDA cannot mandate or otherwise require training programs as a condition of approval. However, at least at the outset, the level of training provided to doctors did not appear to be a problem or a concern. Intuitive promised that it would provide physicians with a 3-day hands-on training program. Following the training, the doctors would be a 70 item exam to check their understanding of the surgical robot. However, by 2002, the rigorous training and testing procedures had been scrapped. The new program consisted of a single day of hands-on training and a 10 question online quiz.
Coming to market in this fashion may have deprived regulators and researchers of useful data that could have been used to identify problems with the device. Furthermore, the level of training provided by the company may have caused doctors to miss warning signs that could have resulted in stopping the procedure and avoiding injury to the patient.
Aggressive Marketing Tactics Drove Da Vinci’s Rapid Growth
Concern over the process utilized to secure approval and the number of injuries has spurred watchdogs to look into the tactics used to sell and market the robotic tools. A report for the New York Times identified a number of troubling practices and emails sent from the sales department. One May 2011 email urged sales staff to persuade surgeons to covert standard procedures to robotic operations to meet company goals urging sales staff, “Don’t let proctoring or credentialing get in our way.” Proctoring and credentialing refers to the training, supervised surgery and other hospital certification procedures a doctor must undergo before being considered qualified to operate a da Vinci device.
In other situations, company sales staff presented themselves as medical experts and urged for relaxation of credentialing requirements. One email to a hospital in Billings, Montana claimed that requiring 5 supervised robotic surgeries as part of the credentialing process was “on the high side.” It further warned that such standards could result in “unintended consequences.”
Another practice involved linking company sales staff bonuses to medical facilities meeting a quarterly quota of robotic operations. These reps were urged to “scrub” doctors’ schedules. Once the schedule was scrubbed, procedures would be moved up by a few days so that the company could meet its goals. In other instances, such as in the case of a prostatectomy performed on a 300-pound man, surgical risk factors and other characteristics — such as weight – that would not make a patient a good candidate for robotic surgery were not disclosed to doctors. One email from a sales director told staff to, “Be proactive in finding cases to convert. Be prepared to challenge each trained surgeon every time you see a [laparoscopic procedure] or open case. Be unsatisfied with the thought of ending a day without a converted case.” Concerns other than medical efficacy and patient outcomes were likely at the forefront in these situations.
Studies Have Found Da Vinci Injuries and Deaths are Underreported
While there is a federal rule that requires reporting within 30 days of surgical incidents, it appears that this rule is not strictly being followed. A study published in the Journal for Healthcare Quality identified a number of incidents involving the da Vinci system that went unreported. The study focused on a 12 year period from January 2000 to August 2012. During that period 71 deaths and 174 injuries were reported for a total of 245 incidents. By cross-referencing the FDA device database known as MAUDE, LexisNexis, and federal court records via PACER an additional 5 unreported incidents and 3 incidents where reporting was problematic were uncovered. One of the study’s authors believes that these 8 cases represent a sampling of a much larger number of unreported or misreported da Vinci incidents. He states that the number identified incidents “seems very low, given the discussion of these events in the surgical community.”
A 2010 web-based survey seems to square with the data and suspicions provided by the 12-year study. The survey was sent to practicing urologists who have performed a robot-assisted radical prostatectomy (RARP). The study revealed that almost 60% of surgeons had experienced at least one device failure prior to the beginning of the procedure. Perhaps even more troubling, just over half of respondents indicated that they had experienced an irrecoverable system error while performing a medical procedure.
What Types of Da Vinci Injuries Have Occurred?
Consider the injuries and medical ordeal suffered by Erin Izumi after she underwent robotic surgery to correct an endometriosis condition. During the operation that lasted for nearly 11 hours, MS. Izumi suffered severe injuries that were not discovered until 10 days later when she was rushed to the emergency room. She had suffered damage to both her colon and rectum during the procedure. She underwent a series of procedures to correct the damage that resulted in a 5-week hospitalization. However many other injuries can occur as a result of robotic surgery. These injuries include:
- Neuropathy or nerve damage
- Breakdown and release of muscle fiber into the patient’s bloodstream
- Cut, torn or punctured spleen
- Cut torn or punctured bladder
- Cut, torn or punctured blood vessels
- Excessive blood loss
- Collapsed lung or pneumonia
- Kidney damage
- Kidney failure
Robotic surgery is rife with risks. There are complications that can occur in any surgical procedure along with those that are unique to robot-assisted procedures. This risk was always offset by the promise of improved medical outcomes. However, according to Allison Okamura, an associate professor of mechanical engineering at Stanford and the director of the Collaborative Haptics and Robotics in Medicine Lab, believes that the jury is still out whether robotic procedures are always worth the extra time and expense they require. Until these studies can be completed, candidates for robotic surgery should ask their doctors about how the medical benefits the procedure provides to them specifically.