"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", reads the statement issued by FDA commissioner Scott Gottlieb, M.D. These products have serious risks and don't have adequate evidence to support their use for these purposes. He also said that officials have found "numerous cases" of serious harm.
In a safety communication, the FDA told patients and doctors that laser and radiofrequency devices approved to treat abnormal tissue have been improperly promoted to address sexual discomfort and vaginal dryness. What's more, vaginal rejuvenation procedures have been tied to serious side effects, including vaginal burns, scarring, pain during sexual intercourse and recurring or chronic pain.
FDA is warning women and their healthcare providers of potential risks from the unapproved use of energy-based devices for "vaginal rejuvenation" or cosmetic procedures, and has notified seven device manufacturers of its concerns.
Not only is vaginal rejuvenation likely ineffective when comes to its claims on sex drive, the FDA warns that the procedures come with other risky are downright unsafe.
If you're dealing with painful sex or other sexual dysfunction issues-or if you're just into the idea of having a more enjoyable sex life-the recent trendiness of vaginal laser rejuvenation might have seemed like a magic wand.
Gottlieb is concerned that these procedures are aimed at women who had cancer treatment that caused early menopause, a fact he considers to be egregious and, adding that the manufacturers use "deceptive marketing of a unsafe procedure with no proven benefit".
We haven't reviewed or approved these devices for use in such procedures. Answers from the companies have been sought within the next 30 days.
"The deceptive marketing of unproven treatments may not only cause injuries, but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions", said Gottlieb, in a statement.
One such company that received a letter from FDA is Cynosure, which manufactures a device called MonaLisa Touch. We encourage those who've had an adverse event associated with the use of these devices to report their problem to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Hologic, Inc., owner of Cynosure, replied to this with an email saying they have "a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously".
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