FDA Issues Warning About Robotically Assisted Surgical Devices

Apr. 8, 2019

The US Food and Drug Administration (FDA) has issued a warning about the use of robotically-assisted surgical devices in patients who are undergoing surgery to prevent or treat cancer. In its warning, the FDA notes that the safety and effectiveness of the devices have not been established in certain procedures and may even negatively affect the patient’s long-term survival.

Robotically Assisted Surgical Devices Used for Cancer Procedures

According to the FDA, robot-assisted surgery has become more widely used because physicians and patients believe the devices may improve the patient’s recovery time while also enhancing surgical precision. The robotically assisted devices allow surgeons to perform procedures through small incisions in the patient’s body, which may lessen the pain, blood loss, and scarring, as well as decrease the risk of infection.

The surgeon uses a computer and software technology to control the surgical instruments via mechanical arms. The system typically has four arms, three of which hold surgical tools while the fourth holds a camera that transmits images to a monitor overseen by the surgeon.

Robot assisted surgery is used for mastectomy in women with breast cancer or who are at high risk of breast cancer, and for the prevention or treatment of other cancers. The FDA, however, notes that the safety and effectiveness of robotically assisted surgical devices in preventing or treating cancer has not yet been scientifically established.

“There is limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival,” the FDA writes.

Despite the lack of scientific evidence of the safety or effectiveness of robotically assisted surgical devices, there are reportedly surgeons and hospital systems that use them. The FDA has so far not issued any authorization for such devices to be marketed as preventing or treating cancer. Any marketing regarding cancer treatment for the devices must state that cancer treatment outcomes linked to the device have not received an FDA evaluation.

Study Finds Lower Rates of Disease-Free Survival

One study cited by the FDA found that the survival rate following radical hysterectomy for cervical cancer was lower when that surgery was laparoscopic or involved robotically assisted surgical devices.

That study was published in The New England Journal of Medicine and involved 319 patients who received minimally invasive surgery and 312 who received open surgery. Of those who received minimally invasive surgery, almost 85 percent underwent laparoscopic surgery while the remained had robot-assisted surgery. The majority of patients had stage 1B1 cervical cancer.

The disease-free survival rate at 4.5 year post-surgery was 86 percent with minimally invasive surgery, compared with 96.5 percent with open surgery. On the whole, minimally invasive surgery was associated with a lower rate of disease-free survival and a lower rate of overall survival than open surgery.

A second study, conducted by the National Institutes of Health, found that of 2,461 women who had cervical cancer, 9.1 percent of those who had minimally invasive surgery died within four years of the operation, while only 5.3 percent of those who had open surgery died in the same time frame.

Two possible explanations for the decreased survival rates are that the tools used in the surgeries could spread the cancer cells or that the carbon dioxide used in the patient’s abdomen during minimally invasive procedures could increase the risk of cancer cells becoming implanted.

FDA: Health Care Providers Should Have Specialized Training

Though the FDA has not approved marketing for surgical devices regarding their use in breast cancer treatment or prevention, the agency recommends that health care providers who use robotically assisted surgical devices to receive specialized training and practice using the equipment. The FDA further recommends patients ask their surgeons about any training, experience and patient outcomes they dealt with as well as possible complications.

Meanwhile, the FDA is evaluating literature regarding robotically assisted surgical devices and monitoring for adverse events linked to the devices. While it is illegal to market devices for off-label uses it is not illegal for doctors to use a device for unapproved use.

Doctors may continue to perform robot-assisted surgeries for unapproved uses, but if patients are not warned about the risks, those physicians could face legal troubles.

Among the robotic surgery devices in use are the da Vinci Surgical System and the Senhance Surgical System.

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