The federal agency issued the warning after reviewing scientific literature that detailed poor patient outcomes associated with the surgical devices. The FDA also said it’s received a few reports of patient injuries linked to use of these devices for cancer-related procedures.
In the safety notice, the FDA noted it has not cleared robotically-assisted surgical devices for use in mastectomies or other surgeries to treat or prevent cancer.
“We want doctors and patients to be aware of the lack of evidence of safety and effectiveness for these uses so they can make better informed decisions about their cancer treatment and care,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, told STAT.
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