Da Vinci Surgical Robot lawyers at Pintas & Mullins Law Firm report that the robot’s manufacturer, Intuitive Surgical, recently fell 18%, ending the largest intraday drop since October 2008. Analysts and experts are downgrading Intuitive shares and speculating why da Vinci’s sales are slowing, asserting that it may be due to the recent instrumental issues and patient injuries.
In May 2013, Intuitive Surgical sent out an ‘urgent medical device notification’ alerting hospitals that there was a potential issue with one of the system’s instruments, which could cause internal burns in patients. The notification detailed the presence of micro-cracks in some models of the da Vinci monopolar curved scissors, which could cause leaks and create a pathway for electrosurgical energy to leak into tissue during surgery, potentially causing burn injuries. In bold type, the notification clarified that these micro-cracks may be invisible to physicians.
About two months before this notification, CNBC published a story on the growing concerns surrounding the da Vinci Surgical Robots. The system was initially touted as a revolutionary advancement, transforming traditional surgery with less blood loss and faster recovery times. Despite selling thousands of robots worldwide, the reality of the new technology turned out to be much grimmer.
As the popularity and presence of the da Vinci has grown, as has the questions and concerns about its safety, training methods, and aggressive marketing. All three of these issues are in fact at the center of the recent litigation brought against Intuitive Solutions.
Many surgeons agree that, in the right hands, the da Vinci system is generally safe. However, Intuitive does not alter the way they train surgeons, despite their prior knowledge or ability before using the robitc system. They are all trained in the same way, however, it is not reasonable to believe that every surgeon in the U.S. can be adequately trained in the same way. Compounding this, the training is actually extremely limited, which is disconcerting when you consider the massive responsibility of, say, performing surgery to remove cancerous tumors.
The da Vinci system allows surgeons to sit behind a 3-D monitor, with video game-like controllers that dictate the movements of the robot’s four arms. Surgeons are able to use the da Vinci only after completing several steps, including one hour of training, four hours of watching procedures online, seven hours operating on a pig, and two surgeries overseen by a more seasoned robotic surgeon (although this last requirement varies between hospitals).
Many of the surgeries the robot is recommended for, however, have not been proved to be more successful when performed with the da Vinci. One of these common procedures performed by robots is a hysterectomy, which the Journal of the American Medical Association concluded has not been shown to be more effective than traditional laparoscopy.
Earlier in 2013, the president of the American Congress of Gynecologists and Obstetricians said that, due to aggressive advertising and marketing, many women are hearing about the “claimed advantages” of robotic hysterectomies. She noted that the robotic surgery is not the most minimally invasive nor is it the most cost-effective, and that it is important for women to recognize the difference between marketing hype and reality.
Partly in response to the aggressive marketing, there has been a sharp
increase in lawsuits and complaints about injuries sustained during robotic
procedures, including deaths. At least 10 have been filed since 2011,
most of which are headed toward mediation. One gynecologist stated that
the sophisticated technology comes with its own set of issues which can
inadvertently cause serious injuries, such as burns and heat-related damage
to intestines, bowels and other organs.
The FDA database shows at least 245 serious injuries and 85 deaths related to the da Vinci system to date, along with another 4,600 adverse events filed. Many critics believe these numbers are vastly underreported, however, as filing events with the FDA is not required by law. Dr. Marty Makary of Johns Hopkins University Hospital stated that the industry does a poor job of monitoring the safety profile of new technologies, and the da Vinci is a classic example.
Da Vinci Surgical Robot lawyers at Pintas & Mullins Law Firm are currently investigating claims of injuries caused by this system, which may include bowel, bladder, and vascular injuries, or other internal punctures, burns and tears. If you or a loved one was seriously injured by the da Vinci Surgical Robot, you may be entitled to significant compensation through a lawsuit against Intuitive Solutions, and should contact a skilled attorney as soon as possible.