The Emergence of Robotic-Assisted Breast Surgery: Proceed With Caution

Rosa F. Hwang, MD; Kelly K. Hunt, MD


Annals of Surgery. 2020;271(6):1013-1015. 

In This Article

Abstract and Introduction


The use of robotic-assisted surgery has grown exponentially with >1 million procedures performed globally in 2018 with the da Vinci system (Intuitive Surgical Inc., Sunnyvale CA) for general and oncologic surgeries. This represents an increase of >7-fold in 10 years. Breast surgery was not one of the initial disease sites to incorporate robotic-assisted surgery into practice; however, with the increased use of nipple-sparing mastectomies several groups have begun to explore the approach and have published results with their early experience. In this issue of the Annals of Surgery, Lai et al publish a consensus statement on robotic mastectomy which was intended to provide standardized guidelines for those surgeons utilizing the procedure in their clinical practice.[1] They convened a group of international surgeons with experience in robotic mastectomy and vetted 52 statements through an electronic voting process for several rounds to be followed by an in-person meeting in May, 2019. On February 28, 2019 the US Food and Drug Administration (FDA) issued a statement urging caution when using robotically-assisted surgical devices in women's health, including mastectomy.[2] The FDA issued the communication in order for patients and physicians to know that the FDA was aware of the use of robotic-assisted devices in patients for prevention or treatment of cancer but that the agency had not granted marketing authorization for these indications. In light of the concern regarding the lack of cancer-related outcomes with the use of robotic-assisted mastectomy in the prevention or treatment of breast cancer, and the publication of the international consensus guidelines by Lai et al, we ask: why would a robot be advantageous in the surgical approach; what the consensus statement guidelines provide to the community; and what is the regulatory process for this procedure in the United States?