The FDA says vaginal rejuvenation devices have not gone through the correct approval process required to show they're effective, or let alone safe to use.
There are only a handful of cases that call for letting a laser anywhere near your vagina, according to the FDA-namely, "serious conditions like the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as [the treatment of] genital warts".
According to the FDA, numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain have been reported and documented.
But the FDA wants women to look out for their own safety, too.
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Scott Gottlieb, a commissioner of the FDA, recently stated that a growing number of manufacturers are marketing their devices for unapproved uses such a vaginal rejuvenation.
The FDA warned against "vaginal rejuventation" treatments.
The bottom line: Some nonsurgical "vaginal rejuvenation" treatments aren't approved by the FDA to treat symptoms like vaginal dryness-and could even come with unsafe consequences like burns-so talk to your ob-gyn about alternative options if you're considering one of them.
Monday, the FDA issued a statement warning that some of the "vaginal rejuvenation" treatments on the market can come with risky side effects, like vaginal burns, scarring, and pain. Gottlieb added that "The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious". The devices have also not been FDA approved for use in treating sexual dysfunction, such as decreased sexual sensation or pain during intercourse or urination. However these devices are also being increasingly used for treatment of vaginal laxity, itching and dryness said the FDA. FDA did not take enforcement actions against the companies, but requested that they address the agency's concerns within 30 days.
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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.
Over a dozen adverse reports after the use of these treatments have brought this issue to the forefront.
In a statement, Jane Mazur, Hologic's vice president of global divisional communications, said that "Hologic has a strong track record of rooting our products in science and clinical evidence" and that it is "evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements".
BTL and Cynosure, a division of Hologic, said they were reviewing the warning letters.
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Women who've experienced adverse side effects tied to vaginal rejuvenation devices are encouraged to report their problem to MedWatch, the FDA's adverse-event-reporting program, the agency said.