"The use of energy-based devices to perform vaginal 'rejuvenation, ' cosmetic vaginal procedures, or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events", the warning said.
"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", FDA Commissioner Scott Gottlieb, MD, said in a statement.
The FDA said it was "deeply concerned" people were being injured with these procedures.
If the FDA's concerns are not addressed, the agency said that they will consider potential enforcement actions.
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The agency said that it has approved such devices, which commonly use laser beams or radiofrequencies, for specific gynecologic uses, including the destruction of precancerous cervical or vaginal tissue and the removal of genital warts. But the safety and effectiveness of these devices hasn't been evaluated or confirmed by the FDA for 'vaginal rejuvenation'.
The FDA noted in a safety alert issued Monday that vaginal "rejuvenation" often is used to describe nonsurgical procedures meant to treat symptoms such as vaginal laxity, atrophy or dryness, and pain during intercourse or urination.
In fact, the FDA recently notified seven device manufacturers about inappropriate marketing of their devices for "vaginal rejuvenation" procedures, he pointed out.
During the procedure, the tissue is destroyed or reshaped. The FDA commissioner added that these "unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions".
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More and more women undergo vaginal rejuvenation procedure without being aware of the risks involved when unapproved devices are used.
The benefits and risks of all available treatment options for vaginal symptoms should be discussed with patients. The FDA disagrees. But even though the agency originally approved the devices for certain treatments, it is legal for doctors to use them for off-label conditions. 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. "The FDA wants to make it clear that all these devices do not have any evidence that they help enhance sexual desire", she says.
The FDA is encouraging women to stop using these devices and report any issues to the FDA's adverse event reporting program, called MedWatch.
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