The United States Food and Drug Administration issued a warning Thursday about the use of surgical robots in breast cancer surgery. FDA says that use of the robotic medical devices in mastectomy, lumpectomy, and related surgery because of "preliminary" evidence that it may be linked to lower long-term survival.
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The warning was specifically directed at use of the devices for cancers that affect women, specifically breast and cervical cancer.
Robotic surgery with devices like the da Vinci Surgical robot is also now increasingly used for cancers that affect men, like prostate cancer.
The study doesn't appear to address this.
From reporting by Emily R. Siegel and Andrew W. Lehren at NBC News:
The FDA's official safety communication said that while robotic "surgery may help reduce pain, blood loss, scarring, infection, and recovery time," there is "limited, preliminary evidence" that using the devices for cancers that affect women, specifically breast and cervical cancer, may be associated with diminished long-term survival.
In a statement, Dr. Terri Cornelison, assistant director for the health of women in the FDA's Center for Devices and Radiological Health, said the FDA is "warning patients and providers that the use of robotically assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency, and therefore the survival benefits to patients when compared to traditional surgery have not been established."
Prior related reporting at NBC: "New Robot Surgeon Works on Its Own"
IMAGE: Da Vinci Surgical Robot, courtesy davincisurgery.com
