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What are the Dangers of Robotic-Assisted Surgery?

photo operating roomIt’s easy to imagine robots performing surgery on patients in the 1960s TV shows The Jetsons or Star Trek. But what if your surgeon wants to use a robot during your surgery? Do you know about the potential dangers of robotic-assisted surgery? In many ways, this is the wild, wild west of medicine.  Although some claim these robotic devices could help standardize surgical procedures and enable minimally invasive surgery, others remain concerned about the ever-increasing use of an unproven technology. Would surgeons and hospitals use robotic-assisted surgery without proof of its safety and benefits? It seems so. Should you choose this option the next time you or a loved one needs surgery? Not without careful consideration!

A quick history of robotic-assisted surgeries.

photo surgeon using robot for surgeryRobotic surgical technology was first developed in the 1990s by the US Department of Defense for battlefield use. In 2000, the US Food and Drug Administration approved the da Vinci Surgical System by Intuitive Surgical Incorporated for laparoscopic surgeries. For many years, the da Vinci system enjoyed a monopoly in the field, but now more than a dozen medical technology companies sell robotic surgical devices, including Stryker, Accuray and Smith & Nephew. In 2019, 1/4 of US hospitals use at least one surgical robot.

How does this work?

The computer and software technology allow a surgeon to precisely control surgical instruments attached to mechanical arms – all while seated at a console near the patient. A 3D high definition screen allows the surgeons to clearly see a magnified view of the surgical area.

How common are robotic-assisted surgeries?

These surgeries are increasingly common. A press release by Intuitive Surgical Incorporated states that in 2018, surgeons performed over 1 million procedures using da Vinci worldwide, an 18% increase over 2017. In the US alone, surgeons performed 753,000 procedures using da Vinci in 2018.

Keep in mind that these numbers only represent procedures using the da Vinci system and do not include statistics for the many other robotic surgical systems made by other companies.

Why are these surgeries increasing in popularity?

Despite its high price tag, surgeons and patients are increasingly interested in robotic-assisted surgeries. Why? Certainly, the ability to improve minimally invasive surgery has sparked interest. But, aggressive marketing by Intuitive Surgical Incorporated, and other companies, has also played a role. Additionally, I’m guessing that our collective desire for the newest technologies, for products ranging from our toasters to our TVs and cars, makes us believe that robotic surgeries must be better.

What kinds of surgeries use robotic devices?

Surgeons use these devices for many types of minimally invasive procedures, including general surgery and procedures in the following specialties:

  • Cardiac
  • Non-cardiac thoracic
  • Colorectal
  • Head and neck
  • Urologic
  • Gynecologic

What are the benefits of robotic-assisted surgery?

photo man holding sign saying advantage & disadvantage - Dangers of Robotic-Assisted SurgeryThere are many potential benefits for the surgeon and the patient, although the scope of the benefits and safety remains a concern to many patient safety experts. (See below for more information on these concerns.)

Robot manufacturers, as well as many researchers, claim robotic surgical systems provide many benefits for the surgeon, including:

  • 3D magnified vision
  • Enhanced surgical dexterity, from
    • Eliminating surgeon’s hand tremors
    • Motion scaling (converting the surgeon’s large hand movements into smaller movements of the surgical instrument)
  • Greater surgical precision
  • Increased range of motion
  • Improve access to the surgical site
  • Enhanced ergonomic design which improves surgeon comfort

Similarly, robot manufacturers and some researchers report that robotic-assisted surgery can benefit patients by:

  • Reducing length of hospital stay
  • Improving postoperative recovery time
  • Decreasing postoperative pain
  • Decreasing blood loss

Additionally, the FDA states that these surgeries may also reduce scarring, infection, and post-surgical recovery time in comparison to traditional surgical procedures.

Is robotic-assisted surgery safe?

safety first sign - Dangers of Robotic-Assisted SurgeryCertainly, no surgical procedure, with or without robots, is risk-proof. But are robotic surgeries more dangerous?

On February 28, 2019, the US Food and Drug Administration (FDA) released a safety communication warning patients, surgeons, and health care organizations about using robotic-assisted surgical systems for the prevention and treatment of cancers, including mastectomies. The communication states that the safety and effectiveness of using robotic devices in mastectomies or in the prevention or treatment of cancer has not been established. Furthermore, the FDA states there is limited, preliminary evidence that robotic-assisted surgeries for treatment or prevention of cancers that affect women may be associated with diminished long-term survival.

The FDA is not the only organization concerned about these robotic systems. For the last 20 years, ECRI, a patient safety organization, has expressed concern about patient safety and surgeon experience, evidence, and cost.

What are the potential dangers of robotic-assisted surgery?

Patients can be harmed due to surgeon error and/or device malfunction. ECRI collaborated with the Pennsylvania Patient Safety Authority to analyze adverse events from robotic surgeries in Pennsylvania hospitals over a 10-year period. Of the 544 reported adverse events related to robotic surgery, almost 25% were “Serious Events” that led to patient harm. In addition to 10 tragic patient deaths, they found that the majority of patient harms from robotic-assisted surgeries involved:

  • Unintended lacerations and/or punctures
  • Blood loss
  • Complications from patient positioning during the procedure
  • Retained foreign bodies
  • Infections

Does surgeon experience impact safety?

photo surgeon in the OR - Dangers of Robotic-Assisted SurgeryCertainly, surgeons need specialized training to use these devices. But how much training is needed to safely and effectively use these tools? Unfortunately, no one has a clear answer to that critical question.

For example, ECRI’s investigations found that patients may be harmed during these procedures when performed by both experienced and less experienced surgeons. Furthermore, they state that learning to use these devices is a long process, with an unknown number of procedures needed to attain and maintain skills and proficiency. Moreover, their analysis found that even surgeons who are well experienced in robotic surgery can have serious patient-safety events.

However, a recent analysis of adverse events related to robotic-assisted urologic surgery suggests that better surgeon coaching (along with improved technology to prevent device malfunction) could improve the safety and quality of robotic-assisted surgery.

What is certain is the lack of clear and proven guidance regarding the benefits and dangers of robotic-assisted surgery.

Can we trust research results?

Many patient safety experts believe the quality of the research on the safety and benefits of these robotic devices is below par. For example, a 2018 article in American Journal of Surgery states the “integrity of the medical literature about robotic surgery remains unclear despite wide-spread adoption“.

Additionally, ECRI states that the “quality of most of the published robotic surgery studies is low to very low“. Furthermore, they report that for most types of procedures, there is no conclusive evidence to prove the effectiveness of robotic surgeries as compared to traditional methods. Although there have been more than 15,000 peer-reviewed articles published on robotic-assisted surgeries, ECRI believes these studies have not improved the strength or quality of the evidence.

Could conflicts of interest skew research results?

photo of briefcase filled with $100 bills - Dangers of Robotic-Assisted SurgeryYes! As usual, money talks. And influences.

Researchers analyzed clinical literature to determine if payments made to surgeons by Intuitive Surgical Incorporated (ISI) impacted the quality of research. As reported in the 2018 American Journal of Surgery article, their findings highlight a potential bias as the studies published by those receiving payments were of low quality and contained highly positive conclusions regarding the robot. Interestingly, in 2015, the median payments by ISI to its top 20 earners was $141,959.

Can we trust these potentially biased studies to determine the safety and effectiveness of these robotic devices?

Need surgery? Do your research!

photo doctor speaking with older female patient - Dangers of Robotic-Assisted SurgeryBefore agreeing to any surgery, discuss the benefits and risk for all available treatment options. If you’re considering robotic-assisted surgery, learn as much as you can about the dangers of robotic-assisted surgery for the procedure you need. Ask potential surgeons these questions:

  • What kind of training and experience do you have with the same device you would use for my procedure?
  • What are the outcomes for your patients for this procedure?
  • How many robotically-assisted surgical procedures like mine have you performed in the past year and in your career?
  • What are the possible complications and how often they happen?
Want to conduct your own research?

You can read published papers evaluating the safety and benefits of robotic-assisted surgery for the procedure you are considering. To determine if the study authors have a potential financial conflict of interest, search the Open Payments database. If you find a history of payments to the researcher(s) from a robotic surgical system maker, discuss your concerns with your doctor.

To learn more on these issues, read:

Learn more…

Additionally, it’s important to understand that all surgical procedures carry risk. For more information on reducing your risk of surgical problems, read these blog posts:

 

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