The FDA commissioner Scott Gottlieb released a statement Monday, saying they had "recently became aware" of manufacturers selling "vaginal rejuvenation" treatments and devices to treat "conditions and symptoms related to menopause, urinary incontinence or sexual function".
In some cases, women who've gone into early menopause after breast cancer treatments are opting for these interventions, but "the deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said.
It has sent warning letters to seven companies: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen. If its concerns are not addressed, the agency could take enforcement action.More news: Urban Meyer on Leave as Ohio State Investigates New Allegations
The FDA also noted in a safety alert that vaginal rejuvenation is often used to describe nonsurgical procedures that are meant to treat symptoms such as vaginal laxity, atrophy or dryness, and pain during urination, among others.
But, they highlighted the fact that it did not clear the devices for symptoms related to menopause, urinary incontinence or sexual function. The devices are not created to work on large areas or for reshaping procedures such as those performed during vaginal rejuvenation.
Gottlieb also said he was concerned that deceptive marketing of these devices might prevent some patients from getting appropriate therapies for severe medical conditions. However, the FDA is urging women considering treatment for vaginal symptoms to speak with their doctors about available options, as well as their benefits and risks.
"The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said.More news: Treasury Department Sanctions Turkish Officials over Detention of U.S. Pastor
Women are being warned that so-called "vaginal rejuvenation" procedures may pose serious risks.
But their use to treat vaginal dryness, itching and laxity, the FDA said, has not been approved. We've also established the Women's Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders.
"These procedures are not medically indicated, and the safety and effectiveness of these procedures have not been documented", the group said in a 2007 statement.
Over a dozen adverse reports after the use of these treatments have brought this issue to the forefront.More news: Bank of Japan Shift Propels Biggest Bond-Yield Jump in Two Years