The FDA Cautions Robotically-Assisted Surgical Devices in Mastectomy and Other Cancer-Related Surgeries

Posted on February 28, 2019 by Medtech[y] Staff

Today, the FDA issued a safety communication to patients and health care providers urging caution when using robotically-assisted surgical devices for mastectomy and other cancer related surgeries.

According to the FDA release, 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.

“Certain patients with cancer may require surgical procedures to treat or prevent the spread of cancer in their body. These procedures are often associated with improved survival outcomes for these patients. However, 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.

While robotic surgery has grown and become more accepted by patients and their physicians, the FDA has not granted marketing authorization for any robotically-assisted surgical devices for use in mastectomy or for the treatment or prevention of cancer.

The most successful company in the space is Intuitive Surgical, who sells the da Vinci surgical robot. Since the da Vinci was FDA cleared, there have been over 6,000,000 procedures performed and the company expects over 1,250,000 performed in 2019.

However, with acceptance typically comes expanded use outside the guidelines in which a device was approved. Recently, robotic-assisted surgery has been used for breast reconstruction or preventive mastectomy, which are outside the clearance for the da Vinci.

While there are surgeons using the device for these procedures, the FDA is reiterating that safety and effectiveness of robotically-assisted surgical devices for mastectomy and any cancer-related surgery has not been established.

“Our surveillance using multiple tools—medical device reports, patient registries, scientific literature—helps us monitor and identify potential problems with medical devices as they arise. In the case of robotically-assisted surgical devices and cancer-related uses such as mastectomy, we are aware of scientific literature reporting that surgeons have been using the device for uses not granted marketing authorization by the FDA. We want doctors and patients to be aware of the lack of evidence of safety and effectiveness for these uses so they can make better informed decisions about their cancer treatment and care. This safety communication issued today reflects the agency’s commitment to enhancing our oversight of device safety as part of our Medical Device Safety Action Plan, as well as the agency’s ongoing commitment to advancing women’s health.”

However, the FDA is aware of scientific literature and media publications reporting poor outcomes for patients, including one limited report that describes a potentially lower rate of long-term survival when surgeons and hospital systems use robotically-assisted surgical devices instead of traditional surgery for hysterectomy in cases of cervical cancer. In addition, the FDA has received a small number of medical device reports of patient injury when these devices are used in cancer-related procedures.

As with every surgical indication, including those with robotic assisted devices, more data and safety information should be understood before a wider audience utilizes these devices in in mastectomy or for the treatment or prevention of cancer.