'Vaginal rejuvenation' devices 'have serious risks,' warn FDA

"Vaginal rejuvenation" is a much-contested expression referring to the treatment of various physiological changes affecting a woman's vaginal canal, vaginal wall, or pelvic floor — often following a vaginal birth or menopause.

 

Many women who have gone through a vaginal birth, or through menopause, may experience laxity of the vaginal canal, damage to their pelvic floor, vaginal dryness, or impaired firmness of the vaginal wall.

These physiological changes can lead to other conditions, such as urinary incontinence, and they can affect a person's sex life, as well as their general sense of well-being.

One practice that promises to address these issues, and which has been gaining popularity over the past few years, is that of so-called vaginal rejuvenation, in which energy-based devices — employing laser or radiofrequency — are used to stimulate vaginal tissue and allegedly help it to regain firmness, elasticity, and lubrication.

But the effectiveness and safety of such procedures have been questioned by researchers. Now, the United States Food and Drug Administration (FDA) have issued a warning stating that energy-based devices for "vaginal rejuvenation" can be unsafe and their use should be avoided.

"Our most fundamental obligation to the American public is providing patients with access to safe and effective medical products to meet their health care needs as well as protecting them from harmful products and deceptive medical claims," asserts FDA Commissioner Dr. Scott Gottlieb in an official statement.

"Advancing the health of women is a priority for the FDA. [...] And as part of [our] efforts, we also watch for, and take action against, bad actors who unfortunately take advantage of unsuspecting consumers by marketing unapproved, deceptive products that may pose safety risks and violate the trust of American consumers."

-FDA Commissioner Dr. Scott Gottlieb