FDA Cautions That Robotic Devices Are Not Approved for Mastectomy or Other Women’s Cancer Surgeries
Because of limited preliminary evidence that the use of robotic-assisted surgical devices for treatment or prevention of women’s cancers may be associated with diminished long-term survival, the U.S. Food and Drug Administration (FDA) issued a reminder warning to healthcare providers and the public (https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm632142.htm) in February 2019 that the technique has not been FDA approved for this purpose.
Robotic-assisted surgery may allow surgeons to operate more precisely and patients to have faster recovery times because incisions are more minimal. However, the benefits and risks in cancer surgery have not been established, and limited reports, including one released in November 2018 investigating the use in cervical cancer, have linked the technique to poorer long-term outcomes.
To date, FDA has not granted marketing authorization for any robotic-assisted surgical devices for use in the United States for the prevention or treatment of cancer, including breast cancer. FDA is monitoring the literature, as well as reports of adverse events to its MedWatch program, to understand the benefits and risks as they evolve.
Oncology nurses are well positioned to recognize and report any adverse events from surgery, including with robotic-assisted devices. Learn more about institutional or FDA reporting at ONS’s Recognize It; Report It webpage (https://www.ons.org/toolkits/recognize-it-report-it).