FDA rejects ban on pelvic mesh, supports reclassification

FDA medtech regulators decline a citizen petition to ban transvaginal mesh implants in the U.S., but "tentatively" that a reclassification may be in order to put the devices under more regulatory scrutiny.

FDA regulators refused this week to ban U.S. sales of pelvic mesh implants, rejecting in large part a petition filed by consumer advocacy group Public Citizen, but offered some consolation in a potential reclassification of the devices to a higher-risk category.

Food & Drug Administration (FDA), Public Citizen

News Well, Personal Injury, Food & Drug Administration (FDA), Implants, Recalls, Women's Health

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