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Cancer Risk From Fibroid-Removal Tool Still Too High, FDA Says

A new review of recent studies confirms its previous estimates of the risk of spreading uterine cancer after laparoscopic power morcellation to have uterine growths (fibroids) removed, the U.S. Food and Drug Administration says.

The new review found that about 1 in 225 to 1 in 580 women who undergo this procedure have undetected uterine cancer. This is generally consistent with the 1 in 350 incidence estimated in a 2014 FDA review.

“We recognize that some health organizations have reported a lower estimate of risk and that some groups continue to request that we scale back our recommendations,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an agency news release.

“However, after looking at all the relevant data, we believe our estimates remain accurate, and our recommendation against the use of this device to remove fibroids in the vast majority of women is appropriate and critical to better protecting these women. We are committed to continuing to review new relevant data to assure patient safe,” Shuren said.

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