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.
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Margenthaler JA. Robotic Mastectomy—Program Malfunction? JAMA Surg. 2020;155(6):461–462. doi:10.1001/jamasurg.2019.6361
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