MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; August 20, 2021.
This announcement seeks to raise awareness of the potential risks associated with the use of robotic-assisted surgical devices in mastectomies or cancer-related care. Recommendations for patients who may seek to have robotically assisted surgery include asking about their surgeon's experience with these procedures and discussing benefits, risks, and alternatives regarding available treatment options with their health care provider. Suggestions for health care providers include completing specialized training on procedures they perform. A WebM&M commentary described the challenges and benefits associated with robotic surgery.
Alemzadeh H, Raman J, Leveson N, et al. PLoS One. 2016;11:e0151470.
Using an automated natural language processing tool, this retrospective study evaluated adverse events related to robotic surgery reported between 2000 and 2013. Device malfunctions contributed to many incidents, thus understanding these technical difficulties will be important for avoiding future harms.
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