Advancements in surgical technology present the potential to improve surgical error rates, reduce recovery times, limit patient scarring and other lasting effects of surgery.
In recent years, hospitals and surgery centers have increased their use of surgical robots for a variety of surgeries including prostate and other urology surgeries, gynecological, cardiothoracic, general surgery, head and neck, abdominal, and cancer procedures.
Intuitive Surgical, the manufacturer of the Da Vinci surgical robot, which is the only surgical robot approved by the Food and Drug Administration for commercial use in the United States, makes persuasive promises that the use of their products improve surgical outcomes and optimize patient recoveries.
Intuitive’s public relations campaign has worked. The number of robotic surgical procedures has increased dramatically in recent years. According to Intuitive’s corporate Web site, tens of thousands of robotic procedures have been performed using the Da Vinci robot technology alone. More than 300 hospitals across the United States currently use surgical robots in their procedures.
However, growing concerns are emerging regarding the effectiveness of the equipment as questions are growing regarding whether the robot improves surgical outcomes and the long-term health of patients.
Recent incidents where patients have been seriously injured or killed during robotic surgery as a result of defective robotic equipment or inadequately trained surgeons performing robotic surgery without necessary oversight or preparation highlight the need for patients and medical professionals to further research and understand the existing risks and dangers of robotic surgery.
How it Works
The surgical robots, which weigh more than 1000 pounds and are approximately 6 feet tall with three spider like arms, are positioned next to the patient while the physician looks at computer images of the patient through binocular like lenses. The surgeon, often located 10 or more feet from the patient, maneuvers the robotic arms by moving hand and foot levers.
The use of surgical robots by doctors and hospitals is big business. Indeed, the cost of robotic surgical procedures is substantially higher than traditional procedures. For instance, robot-assisted prostate surgery can cost about $1,500 to $2,000 more per operation.
With purchase costs of the robot between $1.5 million and $2.5 million depending on the model and annual service fees of $140,000 or more, hospitals have an added incentive to advertise and recommend robotic surgical procedures for their patients to ensure that the equipment is a money-maker for the hospital. Studies of hospitals who are the first to obtain robotic surgery technology indicate that hospitals experience a significant increase in surgery volume and profits.
A report by Dartmouth University concluded that medical centers too often advertise and promote unproven and experimental treatments and technologies as a way to promote business. This trend is evident in some hospitals’ marketing and use of the Da Vinci robot.
Additionally, numerous physicians have expressed concern that surgical robots are unnecessarily used by doctors in simple procedures due to patient interest in the technology and as a way to increase hospital profits.
Dramatic Increases in Use Don’t Match Ongoing Concerns
With advertising by hospitals and Intuitive Surgical arguing that robotic surgery reduces recovery times and minimizes scarring, the popularity of robotic surgeries has grown dramatically.
For instance, one in six men develop prostate cancer at some point in their life time. Statistically, most prostate cancer patients select to have surgery performed. As of 2009, eighty- six percent of the 85,000 men who had prostate cancer surgery were robotically performed, according to Intuitive Surgical, the maker of the Da Vinci robot.
Despite representations made by Intuitive that thousands of peer-reviewed studies demonstrate the effectiveness of robotic surgery, there is little conclusive evidence that the robotic technology improves the efficiency of operations or enhances short or long-term medical outcomes in any measurable way.
Additionally, robotic surgical procedures take up to twice as long to perform and physicians must routinely prepare traditional medical equipment for surgical use in the event that the robot malfunctions or limits the procedure in some fashion.
Physicians have expressed frustrations with the lack of technological advancement with the robots, due in part to Intuitive Surgical’s monopoly on the industry in the United States, which has enabled the company to maintain high price levels with little technological advancement in the equipment.
Other doctors have criticized the lack of tactile feedback as being potentially detrimental to patient safety when surgeons operate in sensitive areas of the body, such as arteries.
A recent Duke University study revealed that very similar side effects were experienced by men who received a laparoscopic surgery robotically in comparison to a traditional surgical procedure. However, men who had the procedure performed using a surgical robot experienced feelings of dissatisfaction or regret three to four times higher than men who had the surgery using traditional techniques.
A 2009 study in the Journal of the American Medical Association, which is the only national study to compare outcomes in robotic and non-robotic prostate operations, found that patients who underwent a minimally invasive robotic prostatectomy were almost two times more likely to experience incontinence, erectile dysfunction or other postoperative genitourinary complications.
These findings raise serious questions about Intuitive Surgical’s representations regarding the effectiveness of the robot in improving patient outcomes.
Potential Safety Threats to Patients by Defective Robots
The public is learning that the use of robotic technologies also present numerous risks of serious bodily injury or death.
Patients may be exposed to doctors with a lack of training on the robotic instruments. For instance, experienced surgeons report that it takes 200 to 300 robot-assisted operations to become highly proficient. Yet, to become eligible to use a surgical robot in an operation, a physician is reportedly only required by the manufacturer to complete a 2 to 3 day training course and observe a minimal number of robotic surgeries with a mentor.
Intuitive Surgical and the doctors who use the robots have known of the risks associated with the equipment for more than a decade. In 2002, a Florida man bled to death over the course of 24 hours after two of his main arteries were sliced by a doctor using Da Vinci while performing a kidney removal procedure.
In April 2012, a lawsuit was filed against Da Vinci after a 24 year old woman died in 2010 two weeks after a doctor performed a hysterectomy surgery using the Da Vinci robot. During the surgery, an electrical current from the machine severely burned the victim’s artery and intestines, which caused her fatal internal injuries.
In 2011, allegations emerged that Da Vinci technicians and equipment repair personnel were not available to assist a surgical team when the robot malfunctioned during a surgery on a Louisiana woman, causing injury to the patient.
A separate lawsuit in Alabama was also filed in spring 2012 alleging that Da Vinci fraudulently misrepresents that effectiveness and safety of the robot in the surgeries it performs and that it does not adequately train medical personnel in learning to use the technology prior to allowing surgeons to perform surgeries on the machine.
There are numerous other reports of the machine cutting internal organs due to robot malfunctions and doctor error due to lack of training on the robot.
With the continuing increase in the use of Da Vinci surgical robots for a larger variety of complicated surgeries, the number of patients injured by defective surgical robots or mistakes made by inadequately trained doctors performing surgeries with the robots is expected to grow.
What If I am Injured in a Da Vinci Operation?
Patients injured in operations where Da Vinci surgical robots were used may have legal claims against a number of parties. Potential defendants may include:
- Intuitive Surgical, the manufacturer of the defective Da Vinci robot, for designing or manufacturing a defective product or failing to properly train users of the surgical robot;
- The hospital or surgery center where the operation was performed for failing to ensure the proper operation of the surgical robot equipment;
- The physician for failing to ensure he or she was properly trained on the equipment;
If you or a loved one sustain injuries in a Da Vinci operation, you should seek immediate medical attention and consult with an attorney as soon as feasible.
Make every attempt to document your injuries and conversations you may have had with medical personnel who have first-hand knowledge of the situation when the injuries were sustained.
If you or a family member have been seriously injured in an operation by a doctor using a Da Vinci Surgical Robot, please contact us to explore your product defect and medical malpractice legal options.