The US Food and Drug Administration (FDA) issued a safety communication to healthcare providers about the use of robotically assisted surgical devices for mastectomy and other cancer-related surgeries that are not already FDA approved.
Robotically assisted surgical devices currently enable surgeons to perform a variety of procedures in a minimally invasive manner through small incisions, which may reduce pain, blood loss, and scarring. However, studies have suggested that these minimally invasive procedures for cancer-related surgeries are more likely to result in recurrence of the disease and/or death than standard, large-incision surgeries. Additionally, research has questioned robot-assisted surgeries for increasing patients’ risks by requiring them to stay longer on the table and under anesthesia.
Concerns are growing that robots and minimally invasive procedures may, in fact, spread cancer during the procedure because the robot fails to visualize and fully remove diseased tissue and spreads cancer cells around the operation site. In the case of a traditional open mastectomy which optimally results in the removal of the tumor in one whole piece to avoid fragmenting the cancerous tissue and possibly leaving residual disease behind, robotic mastectomy may be especially susceptible to tissue fragmentation precisely because it uses a small incision which may disallow the en bloc removal of the tumor.
Interestingly, robotic-assisted mastectomies have been pioneered in Europe and are becoming more popular there because surgeons assert that they have cosmetic and convenience attributes. A Danish study recently published indicated that the risk of severe complications among early-stage endometrial cancer patients who underwent surgery after the national introduction of minimally invasive robotic surgery was significantly reduced.
This caution from the FDA follows the November 2018 publication of a study in the New England Journal of Medicine that reported robot-assisted cervical cancer surgeries had reduced long-term survival when compared with open abdominal radical hysterectomies among women with early-stage cervical cancer; however, the article did note that other researchers have reported no statistically significant difference in long term survival when these types of surgical procedures are compared.
Further, critics of robotic-assisted surgeries for cancer-related procedures also claim that their use unnecessarily increases the patient's cost of treatment; in response, hospitals maintain that utilizing these devices provides them a quality edge in patient care and treatment. Surely, decrease of pain, blood loss and scarring experienced by a patient is a positive result. However, hospitals and providers would be prudent to comprehensively weigh the benefits and temper the desire to keep up with robotic innovation against the unknowns and potential risks before utilizing robotic-assisted procedures in cancer treatments.
Advice for Medical Providers to Minimize Legal Liability:
Understand that the FDA has not cleared or approved any robotically assisted surgical device based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.
Be aware that robotically-assisted surgical devices have been evaluated by the FDA and cleared for use in certain types of surgical procedures, but not for mastectomy.
Undergo, pursuant to FDA recommendation, training for the specific robotically assisted surgical device procedures you perform.
Talk to your patients about your experience and training, and the clinical outcomes expected with the use of robotically assisted surgical devices. Discuss the benefits, risks, and alternatives of all available treatment options with your patients to help them make informed treatment decisions.
Be aware that clinical studies conducted in the United States involving a legally marketed device investigating a new intended use are subject to FDA oversight.
Work with your local hospital/clinic to establish patient registries to gather data on the use of robotically assisted surgical devices for all uses, including the prevention and treatment of cancer. Patient registries may help characterize surgeon's learning curves, assess long-term clinical outcomes, and identify problems early to help enhance patient safety.