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Press Release/Announcement

FDA Safety Communication: update--robotically-assisted surgical devices in mastectomy.

MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; August 20, 2021.

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August 20, 2021
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.