It’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? Maybe, but not without careful consideration!

A quick history of robotic-assisted surgeries.

Robotic 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. According to robotic surgical device maker da Vinci, surgeons have performed over 7 million procedures with their surgical robots.

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?

There are many potential benefits for the surgeon and the patient, although as you’ll read below, there are concerns as well.

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, research shows that robotic surgeries can reduce scarring, infection, and post-surgical recovery time, as compared to traditional surgical procedures.

What are the dangers of robotic-assisted surgery?

Some experts express concern about patient safety and surgeon experience, evidence, and cost.

For instance, in June 2021, researchers released the results of a retrospective study in which they determined there is currently no clear advantage with existing robotic platforms. Since robotic-assisted surgery tends to be more expensive and and increases the length of surgical procedures, the lack of benefit is certainly worth considering.

Additionally, in August, 2021, the US Food and Drug Administration (FDA) released a safety communication reminding patients and healthcare providers that the safety and effectiveness of robotic-assisted surgeries for mastectomy procedures, or for the prevention or treatment of breast cancer, have not been established.

Importantly, the FDA added they are aware of allegations that clinical studies using robotic-assisted devices to perform mastectomies are being conducted without the required FDA oversight.

What kinds of patient harm can come from robotic-assisted surgery?

Certainly, no surgical procedure, with or without robots, is risk-proof. But are robotic surgeries more dangerous?

Patients harm can results from 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?

Certainly, 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, an evaluation into the death of a patient who had a robotically-assisted heart operation in the UK determined that the patient’s death was directly caused by the operation and the robotic assistance. Sadly, experts determined the patient would have had a 99% chance of survival had the operation been performed conventionally. Moreover, the evaluation noted the lack of standards for training on robotic devices. In fact, alarmingly, the lead surgeon (who was later dismissed) had turned down opportunities to train on the Da Vinci machine.

Additionally, an 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.

Can we trust research results on robotic-assisted surgeries?

If you are trying to evaluate the potential dangers of robotic-assisted surgery, consider that 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, in a 2020 article in British Journal of Surgery, the authors state that although robot‐assisted surgery has many potential surgical benefits, there is a lack of high‐quality evidence to support widespread implementation. Importantly, the researchers found no patterns of harm to patients associated with these surgeries.

Could conflicts of interest skew research results?

Yes! 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!

Before agreeing to any surgery, ask your doctor about the benefits and risk for all available treatment options. Moreover, 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.

Additionally, to determine if the study authors have a potential financial conflict of interest, search the Open Payments database. Importantly, 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, read Financial Conflicts of Interest in Medical Research.

Learn more…

In addition to knowing the dangers of robotic-assisted surgery, 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:

NOTE: I updated this post on 8-1-22.

The Dangers of Robotic-Assisted Surgery