Women are being warned that so-called "vaginal rejuvenation" procedures may pose serious risks. "The safety and effectiveness of energy-based medical devices to perform these procedures has not been established". "We are deeply concerned women are being harmed", said Gottlieb.
While these procedures are approved for as remedies for pre-cancerous cervical or vaginal tissue and genital warts, the FDA says they are not approved for use as vaginal rejuvenation treatments-even though some are being marketed as such.
"The treatment of these symptoms or conditions by applying energy-based therapies to the vagina may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain", the FDA stressed.
The seven device makers notified by FDA are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.
But the FDA wants women to look out for their own safety, too.
In a statement Monday, FDA Commissioner Scott Gottlieb said that a growing number of manufacturers are marketing their devices for unapproved uses such a vaginal "rejuvenation", in which tissue typically is destroyed or reshaped.
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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.
In most cases, the treatments are "mostly harmless", says Dr. Gupta, "but yes, they can cause scarring and burns if not operated properly or if someone has an allergic reaction", she explains.
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.
Unfortunately, manufacturers are making these deceptive health claims to women, particularly those who are experiencing early menopause or who just completed breast cancer treatment. Needless to say that the FDA has yet to review, let alone recommend, these procedures. But it has found "numerous cases" of harm in adverse-event reports and published literature, he said. We requested that the manufacturers address our concerns within 30 days. "If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions, are appropriate".
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".
One of the companies that received a letter from FDA is Cynosure, which manufactures a device called MonaLisa Touch.