FDA Issues Warning on Laser Treatment for Vaginal Atrophy and Other Menopausal Symptoms

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Vaginal laser treatments have been marketed as a treatment for vaginal atrophy and other symptoms related to menopause and sexual function. The manufacturers of these energy-based devices say the procedure helps blood flow return to the vagina, promoting healthy tissue growth.

On July 30, 2018, the U.S. Food and Drug Administration (FDA) issued a warning about energy-based devices used to treat vaginal conditions and symptoms related to menopause, urinary incontinence, or sexual function. Currently, no vaginal laser device or procedure is cleared or approved by the FDA for any of these vaginal issues.

The FDA is concerned that the safety and effectiveness of these devices hasn’t been proven in scientific studies and that using the devices could lead to serious side effects, including vaginal scarring and burns.

“We’ve recently become aware of a growing number of manufacturers marketing ‘vaginal rejuvenation’ devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function,” said FDA Commissioner Scott Gottlieb, M.D., in a statement. “The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.

“In addition to the deceptive health claims being made with respect to these uses, the ‘vaginal rejuvenation’ procedures have serious risks,” he continued. “In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause. The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.”

Much more research with long-term follow-up is needed to further understand how safe and beneficial this technology might be.

Stay tuned to Breastcancer.org Research News for the latest information on laser treatment for vaginal symptoms related to menopause and sexual function.

To discuss the intimate side effects of breast cancer treatment with others, join the Breastcancer.org Discussion Board forum Sex and Relationship Matters.


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