The US Food and Drug Administration (FDA) has highlighted concerns about using robotically assisted surgical devices for mastectomies and other cancer surgeries, citing a lack of evidence for safety and effectiveness.
Robotically assisted surgical devices can be used to perform different surgical procedures through small incisions.
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This approach is known to reduce pain, blood loss, scarring, infection and boost recovery time post-surgery compared to procedures that do not leverage surgical robots.
Surgeons regulate the surgical instruments attached to mechanical arms using computer and software while viewing the surgical site in 3D.
However, the safety and effectiveness of robotically assisted surgical devices in cancer-related surgeries have yet to be established.
The FDA warned that these devices do not have marketing authorisation and the survival benefits of patients in comparison with conventional surgery have not been determined.
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By GlobalDataFDA Center for Devices and Radiological Health, assistant director for health of women Terri Cornelison said: “In the case of robotically assisted surgical devices and cancer-related uses such as mastectomy, we are aware of scientific literature reporting that surgeons have been using the device for uses not granted marketing authorisation by the FDA.
“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.”
The regulatory authority issued a safety notification after a review of scientific literature and media publications that reported poor patient outcomes with surgical robots.
One of the reports indicated a lower long-term survival rate for cervical cancer patients. The FDA also received some reports of patient injury.
