FDA warns about 'deceptive' vaginal rejuvenation claims, dangers

  • FDA warns about 'deceptive' vaginal rejuvenation claims, dangers

FDA warns about 'deceptive' vaginal rejuvenation claims, dangers

In an official statement issued by the agency, Scott Gottlieb, FDA commissioner, says they are recently aware of an increasing number of companies claiming that their products provide vaginal rejuvenation to women. "We are deeply concerned women are being harmed".

As a further step, the FDA has sent notifications to Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Cynosure, ThermiGen and Sciton.

They were given 30 days to address the FDA's concerns.

FDA has approved laser and energy-based devices for the treatment of serious conditions such as the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as genital warts.

The U.S. Food & Drug Administration warned against "vaginal rejuvenation" treatments due to potential health and safety risks, including burns and scarring.

Vaginal rejuvenation is often used to describe a non-surgical procedure meant to relieve symptoms such as vaginal laxity, vaginal atrophy, dryness or itching, pain during sexual intercourse, pain during urination and decreased sexual sensation. Some of these issues are symptoms related to menopause, urinary incontinence, or sexual function issues. The devices are not created to work on large areas or for reshaping procedures such as those performed during vaginal rejuvenation. They FDA has noted that these treatments are sold to women who have been treated for breast cancer early and experience menopausal symptoms.

"The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb added.

"These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options", he explained. The devices have not been approved for such use in sexual dysfunction.

"The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said.

A company called BTL promised "a whole new approach to women's intimate health" using "a noninvasive, no downtime procedure with minimal risk". In addition, there are many reports of women being injured by these procedures.

The FDA will closely monitor reports of problems associated with "vaginal rejuvenation" procedures, and will keep the public informed, Gottlieb said. "The FDA wants to make it clear that all these devices do not have any evidence that they help enhance sexual desire", she says.