The “safety and effectiveness” of procedures promising to treat vaginal conditions related to menopause is unclear, the U.S. Food and Drug Administration warned Monday.
Health care providers using lasers and similar devices for vaginal dryness, and pain during sex or urination are not using those medical devices for their intended use, the FDA says. Since December of 2015, Deborah Kotz, a press officer with the FDA, said the agency has received a dozen reports of complications related to these procedures. At least two reports cited pain and bleeding.
“The FDA has not cleared or approved any energy-based medical device for vaginal ‘rejuvenation’ or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function,” said the agency in a statement.
One example of such device is the MonoLisa Touch laser procedure by Cynosure, advertised as a “long-lasting solution” for menopausal side effects. Parent company Hologic, Inc. said it is aware of the FDA warning. The company is one of several that was issued a letter from the agency prompting device manufacturers to respond within 30 days or face potential enforcement actions.
“As a leader in women’s health, Hologic has a strong track record of rooting our products in science and clinical evidence, so we take the contents of this letter seriously,” Jane Mazur, a spokesperson for Hologic, Inc., said in a statement. “We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements.”
The FDA urges anyone who suffered a complication linked to a vaginal “rejuvenation” treatment to report it through MedWatch.
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