Vaginal "rejuvenation" devices promising to solve symptoms related to menopause, sexual functions and other conditions are unproven, according to a medical device warning issued by the U.S. Food and Drug Administration on Monday.
Opening up about this issue, a woman who used the "Thermiva" device from ThermiGen to treat her urinary incontinence said, "I was in so much pain. went to my OBGyn and she then informed me that I had bruising and she looked on the FDA website and told me that the product is not approved from FDA".
The term "vaginal rejuvenation" has been used to describe non-surgical procedures meant to treat symptoms and conditions including vaginal laxity, atrophy, dryness or itching, pain during sexual intercourse or urination, and decreased sexual sensation.
"The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", the commissioner said.
The FDA says these companies have not undergone the correct approval process required to show that the treatments they offer work as advertised or even that they're safe to use. 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.
In addition to the deceptive health claims being made about the products, the devices are in some cases being marketed to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause, Gottlieb said.
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Dr Vanessa Mackay, from the UK's Royal College of Obstetricians and Gynaecologists (RCOG), said: "There is no evidence to suggest that non-surgical "vaginal rejuvenation" devices are effective in improving vaginal muscle tone or reshaping vaginal tissue". Cynosure has said in a statement that they are preparing an answer to the letter from the FDA.
"Vaginal rejuvenation procedures claim to tighten the skin and the vaginal tissue beneath the skin by using various forms of energy devices", says Adeeti Gupta, M.D., a board-certified gynecologist and founder of Walk In GYN Care in NY.
They were given 30 days to address the FDA's concerns.
These products are typically not covered by insurance, especially more serious treatment procedures, which are often referred to as "designer vaginoplasty", "revirgination", or "G-spot amplification". But these reports indicate these procedures can cause serious harm. "We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements".
Discuss the benefits and risks of all available treatment options for vaginal symptoms with your health care provider.
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