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FDA Urges Caution With Robotically Assisted Surgical Devices
The Food and Drug Administration (FDA) has warned against the use of robotically assisted devices for mastectomies and other cancer surgeries, stating that the products may pose safety risks and result in poor outcomes for patients.
The agency said it decided to issue its warning after reviewing studies suggesting that robotically assisted devices were being used to perform cancer procedures for which there is limited data on their safety and effectiveness.
One recent study in the New England Journal of Medicine reported that use of the devices in radical hysterectomies in women with cervical cancer was associated with lower rates of disease-free survival and overall survival than traditional surgery.
The FDA also urges patients to discuss the risks, benefits, and alternative procedure options with their doctors before making treatment decisions, and to ask their doctors about their training, experience, and outcomes of patients they have treated with robotically assisted surgery.
Source: FDA, February 28, 2019