Robotic Surgery for Mastectomies, Other Cancer Treatments May Not Be Safe or Effective, FDA Warns

Federal health officials are warning against the use of robotic surgery for women with breast cancer, those at high risk for breast cancer, or individuals considering the procedure for prevention or treatment of other cancers.

In a Safety Communication issued on February 28, the FDA indicates that individuals who under go robot surgery for mastectomies or other cancer treatments may have reduced long-term survival rates. In addition, the agency indicates that undergoing robotically-assisted surgery as part of cancer treatment is not proven to be safe or effective.

The warning urges doctors to exercise caution when using robotically-assisted surgical devices, and indicates that patients should discuss the benefits, risks and alternative treatment options to make an informed treatment decision.

Robotic surgery involves the use of complex, computerized machines that allow doctors to perform surgical procedures through small incisions to the patient’s body. They often can help reduce surgical pain, blood loss, scarring, infection, and limit recovery time after surgery when compared to traditional surgical procedures.

During these robotic surgeries, computers help guide the surgeon to precisely control surgical instruments attached to mechanical arms. The surgeon can create small incisions while viewing the surgical site in three-dimensional high definition.

Robotically-assisted surgery is often touted as a breakthrough and revolutionary treatment option, with hospitals and medical facilities touting a myriad of advantages. However, concerns have emerged among some consumer advocates in recent years that facilities may push wider use of robot surgery, as part of an effort to recoup costs associated with the expensive devices.

In the statement issued this week, the FDA warns that the safety and effectiveness robotically-assisted surgery for mastectomy procedures or prevention or treatment of cancer has not been established. The agency also indicates that it has not approved any of the devices for the prevention or treatment of any cancer, including breast or cervical cancer.

The agency points to a study published last year in the New England Journal of Medicine, which found that patients who had robotically-assisted surgery or other forms of minimally invasive surgery had lower survival rates compared to patients who underwent traditional surgery.

Robotic-assisted hysterectomy for cervical cancer had reduced disease free survival rates of 86% compared to nearly 97% for traditional surgery and lower overall survival rates at near 94% compared to more than 99% for traditional hysterectomy.

The agency warned, that the evidence is limited and more research must be conducted; however, this study indicates robotic surgery may be associated with diminished long-term survival in some cases. Furthermore, research to date has focused mainly on complication rates and not longterm survival.

The FDA warning calls on patients to consider the benefits and risks fully before choosing robotically-assisted surgeries. More so, any alternatives, like traditional surgery, should be considered as well. Patients should ask doctors about their training and experience using theses devices and potential complications.

“Today we are warning patients and providers that the use of robotically-assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency, and therefore the survival benefits to patients when compared to traditional surgery have not been established,” said Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health.