The technology is being marketed as a treatment for urinary incontinence, sexual dysfunction, and menopause–without being proven safe or effective.
Government health officials have a message for anyone considering “vaginal rejuvenation” procedures or other types of vaginal cosmetic surgery: Buyer beware. These procedures have not been proven safe or effective, the U.S. Food and Drug Administration said in a statement issued Monday—and in fact, they could pose serious risks to women’s health.
The FDA’s statement, along with its accompanying safety communication, focuses on radiofrequency or laser devices used to destroy and reshape vaginal tissue. These devices have been FDA-approved for the treatment of a few specific conditions, like the removal of pre-cancerous growths, ovarian cysts, and genital warts. But the technology is now being marketed for other uses, the agency says, with no science to back up those claims.
Specifically, manufacturers are touting these procedures for the treatment of symptoms related to menopause, urinary incontinence, and problems with sexual function. The procedures are also being marketed to women who have had treatment for breast cancer and are experiencing early menopause due to chemotherapy, radiation, or removal of the ovaries.
“Think about how your hands get dry and thin in the winter; that’s kind of what happens to the vagina if you’re not producing enough estrogen—and that can hurt during sex,” says Christine Greves, MD, an ob-gyn at Orlando Health Hospital in Florida who was not involved in the FDA’s warning. In theory, she says, medical devices that reshape vaginal tissue may help relieve some of that pain and tightness for some women—even if they’re not approved specifically for that purpose.
But according to the FDA’s statement from Commissioner Scott Gottlieb, MD, these products “have serious risks, and don’t have adequate evidence to support their use for these purposes.” Dr. Gottlieb added, “We are deeply concerned women are being harmed.”
The FDA says it has reviewed numerous reports of vaginal burns, scarring, pain during sex, and recurring or chronic pain as a result of these procedures being used for off-label purposes. And because these devices haven’t been extensively studied for use in these contexts, the agency says there’s no way to really know the full extent of these risks.
On top of that, the FDA also takes issue with device manufacturers engaging in false advertising about their products. “The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious,” Dr. Gottlieb said. These practices may not only cause injuries, he added, “but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions.”
Take women who are suffering from menopause-related vaginal dryness, for example. Some may not want to (or may not be able to) use hormonal treatments, explains Dr. Greves, and may be looking for alternatives. But before these women decide to undergo an unproven vaginal rejuvenation procedure, she says, they should make sure they’ve considered all of their options.
“If the problem is pain with sex, let’s discuss other options: How about trying to use a dilator first, gently, or try vaginal estrogen if you can take hormones,” she says. “If all that fails, and if your life is still negatively affected and you feel that your relationship is suffering because you can’t have intercourse without pain, then maybe you are willing to accept the risks of a procedure like this.”
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For patients who are in that situation, she encourages them to find an experienced physician to perform the procedure, and to speak with them first about its potential dangers. (Dr. Greves does not perform vaginal rejuvenation procedures herself, but she does know other doctors who do—mostly in boutique practices and specialty clinics.)
“It is risky, and it’s important to discuss your concerns and know that there’s no guarantee about what you’re going to get,” she says. “This a situation where it’s important to know the risks, benefits, and alternatives—and just because a doctor offers it, that doesn’t mean it’s proven to be safe.”
The same advice goes for any woman considering vaginal rejuvenation for aesthetic or cosmetic reasons, she says. “By trying to make your vagina look 'better,' you’ll be risking chronic pain for life,” she says. “There’s always a chance you’ll create a new problem by trying to fix the old one.”
Essentially, that’s the FDA’s bottom line, as well. “Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options,” Dr. Gottleib said in his statement.
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The FDA will continue to monitor reports of adverse effects associated with vaginal rejuvenation procedures, and it encourages patients who have had problems to report them through the agency’s MedWatch website. The agency also called out seven device manufacturers for what it called “inappropriate” marketing of their devices, and requested that those companies address its concerns within 30 days or face potential enforcement actions.
“Any website or news article that claims these devices are approved or cleared by the FDA for vaginal therapy, relief of menopausal symptoms/vaginal dryness, or improvement in sexual function are incorrect,” an FDA spokesperson tells Health in an email. “There are insufficient safety data on energy-based devices for these uses, particularly in cases where women undergo repeat procedures.”