Vaginal 'rejuvenation' devices have serious side effects, might be unsafe, FDA says

Think Twice Before you Consider ‘Vaginal Rejuvenation’ Procedures

Think Twice Before you Consider ‘Vaginal Rejuvenation’ Procedures

The Food and Drug Administration warned against the use of energy-based devices for the procedure or other cosmetic interventions, saying that such treatments could lead to vaginal burns, scarring, and chronic pain.

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". "We are deeply concerned women are being harmed", Gottlieb said. The agency is requesting the companies to address their concerns within one month.

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.

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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 procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue", Gottlieb wrote in the statement. Gottlieb added that "The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious".

So, for women who are experiencing incontinence or painful sex as a result of menopause, the best advice is to speak to your doctor about possible procedures which do work and to avoid vaginal rejuvenation procedures until more serious testing has been done. The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious. He said the agency doesn't know the extent of the risks because it hasn't reviewed the devices for such procedures. "But these reports indicate these procedures can cause serious harm", the FDA said. We've also established the Women's Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders. "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 agency has received 14 reports of adverse events related to the treatments, including burning sensations and significant pain.

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