FDA Warning has been released. The FDA has not established the survival advantages and risks compared to traditional procedures — and educated providers and patients that it has not yet accepted any system for operations — specifically mastectomies.
The bureau’s security communication is in response to reports in the science journals and elsewhere, such as in the media and promotional materials, that describe physicians and hospital programs which use robotically assisted surgical devices for mastectomy.
Specifically, the FDA Warning said that it had been conscious of some peer-reviewed journals reporting bad patient outcomes, including one restricted report printed in the New England Journal of Medicine last November describing lower long-term disease-free survival in robot-assisted hysterectomies for cervical cancer. The bureau also said it has received a few medical device accident reports after cancer-related procedures.
“Our surveillance utilizing multiple tools–medical device reports, patient registries, scientific research –helps us monitor and identify possible issues with medical devices as they arise,” Terri Cornelison, M.D., Ph.D., assistant director for the health of women from the FDA Warning Center for Devices and Radiological Health, said in an agency announcement . “We want doctors and patients to be aware of the dearth of proof of safety and effectiveness for these uses in order that they could make better-informed decisions about their cancer treatment and care.”
The NEJM study, financed by Medtronic and MD Anderson Cancer Center, compared the noninferiority of laparoscopic and robot-assisted hysterectomy to start surgery, monitoring cervical cancer patients for four-and-a-half years. It found that the speed of disease-free survival was 86.0% with minimally invasive surgery, compared to 96.5% with open surgery.
Thus far, the product evaluations of the FDA Warning have mostly focused on tracking the 30 days after a robotic process for complication rates and comparing them to alternative surgical methods. A fuller evaluation of surgery apparatus for therapy or the prevention of cancer would need to include analyses of clinical outcomes like disease-free survival local tumor recurrence or overall survival across a much longer timeframe, the agency said.
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