Robotic-assisted nipple-sparing mastectomy was first reported in a cadaveric study conducted by Sarfati et al¹ in 2016. Four fresh cadaveric breasts were used, and the authors reported that the procedure was feasible with complete mammary gland removal through a 4-cm axillary line incision.¹ Soon after that initial report, other groups from Europe and Asia reported similar investigations in which patients were undergoing nipple-sparing mastectomy either for breast cancer prevention (in carriers of gene variations) or for treatment of newly diagnosed breast cancer.^2-4 Currently, the use of the robot to assist in mastectomy procedures is not approved by the US Food and Drug Administration. Despite this, there have been isolated reports of robotic-assisted breast surgery in the US in the past 2 years. In response to these reports, the US Food and Drug Administration issued a statement on February 28, 2019, warning that the safety and effectiveness of robotic devices for mastectomy have not been established.

Sarfati等[ ^1]在2016年进行的尸体研究中首次报道了机器人辅助的保留乳头乳房切除术。使用了四个新鲜的尸体乳房，作者报告说该程序可行，可通过4厘米腋窝完全切除乳腺线切口。¹这份初步报告发表后不久，来自欧洲和亚洲的其他小组也进行了类似的研究，其中患者正在接受保留乳头的乳房切除术，以预防乳腺癌（在基因变异的携带者中）或治疗新诊断的乳腺癌。^{2 -4}目前，美国食品药品监督管理局尚未批准使用机器人协助乳房切除术。尽管如此，在过去的2年中，美国仍没有关于机器人辅助乳房手术的报道。针对这些报告，美国食品药品监督管理局于2019年2月28日发表声明，警告尚未确定用于乳房切除术的机器人设备的安全性和有效性。