Vaginal Rejuvenation Devices Are Not Approved as Safe, FDA Warns: 'We Are Deeply Concerned'



‘Vaginal Rejuvenation’ May Pose Serious Health Risks, Says FDA

Consumers and companies are warned about safety concerns of laser and radiofrequency devices.

By Becky Upham

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Laser devices may not be safe for vaginal rejuvenation treatments, warns the FDA.
Laser devices may not be safe for vaginal rejuvenation treatments, warns the FDA.
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July 31, 2019

The U.S. Food and Drug Administration (FDA) issued a warning yesterday to patients and healthcare providers regarding the safety and efficacy of vaginal “rejuvenation” and cosmetic vaginal procedures. Not only are these procedures unproven, but according to the FDA they may result in serious adverse events, such as vaginal burns, scarring, and chronic pain.

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“These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed,” said the FDA's commissioner, Scott Gottlieb, MD, according to the FDA statement.

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Laser Devices Have Been Promoted for Medical Symptoms Without Proof, Say Critics

The energy-based devices, commonly radio frequency or laser, have been cleared by the FDA for procedures such as removing abnormal or precancerous tissue or genital warts, and “general gynecologic indications.”

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Many manufacturers are marketing procedures for symptoms that the devices haven’t been tested or approved for, such as vaginal dryness, menopause symptoms, urinary incontinence and sexual function, and that’s a problem, says Stephanie S. Faubion, MD, the director of the Women’s Health Clinic and Office of Women’s Health at the Mayo Clinic in Rochester, Minnesota.

Where Is the Datato Support the Use of These Devices in Treating Menopausal Symptoms?

“There’s a sad lack of data here to support a number of these procedures that are being done,” she says. “It’s a little like the Wild West out there. These devices have been extrapolated for all kinds of different uses which we don’t have a lot of data for,” says Dr. Faubion. “The government is taking a very good step to put some boundaries around this.”

What Women Need to Know About Cosmetic Procedures for the Vagina

The public needs to be aware that there is a lack of science for energy-based devices in treating symptoms of menopause, says Faubion. “We have lots of proven treatments for women for treatment of vaginal dryness and sexual pain,” she says. “There are emerging data about the laser for those conditions, but there are still studies that need be done.” This would include long-term studies, as well as studies that compare the treatments with “sham” laser treatment (doing nothing) and the gold standard, low-dose standard estrogen treatments, she says.

Since December 2015, the FDA has received a total of 12 adverse event reports involving energy-based devices for vaginal rejuvenation and cosmetic vaginal procedures, says FDA spokeswoman Deborah Kotz. “Two medical device reports from manufacturers describe pain and bleeding in patients who have had these procedures,” she says. In addition to this information, the FDA has also received voluntary med watch reports from individual patients who experienced significant pain and discomfort from procedures performed with these devices, says Kotz.

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What the FDA Told Device Makers

In addition to warning consumers and healthcare providers, the FDA notified seven device manufacturers that they may be marketing the devices in a manner that violates the Federal Food, Drug, and Cosmetic Act, sending them what is known as a “It Has Come to Our Attention” letter, considered less serious than a “Warning” letter. According to Kotz, this sort of communication is used to begin a dialogue with a firm in order to gather more information. Depending on the company’s response, the FDA may or may not pursue further action.

What Is Meant by Vaginal Rejuvenation?

In addition to marketing the devices for menopause-type symptoms, many firms promote lasers as a way to improve the appearance or “youthfulness” of the vulva and vagina. The website of one company that received an FDA letter advertised claims that a laser-assisted procedure was “designed to improve vaginal irregularities,” and “assist in vaginal mucosa revitalization.” Another website promotes the procedure as a way to address patient concerns such as “not feeling the same or as youthful as they once did,” or wanting to “feel good about their appearance.”

Procedures on the Vagina Differ From Procedures on the Face

Is this procedure different from other sorts of laser treatments that a woman might have on her face to appear more youthful? “This is on a totally different body part,” says Faubion. “The tissues are going to behave differently on the face versus inside the vagina, and I don’t think we know what those effects are,” she says.

Anti-Aging Therapies for the Vagina and Vulva?

Many of these companies are marketing to doctors and consumers the idea that the vagina somehow needs anti-aging therapy and that this is the end-all-be-all for that, says Faubion. “There is absolutely no scientific data for that. Why are we telling women that their vaginas and vulvas need anti-aging therapy?” she says. “We don’t have the data that it’s going to be effective in that, not to mention any potential safety issues from the procedures.”

“Women need to feel empowered to demand the science behind medical procedures and medications,” says Faubion. “There’s a history of a lack of vetting of drugs and testing in women; now we’re randomly doing a scientific procedure on women without any data behind it?” she says.






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Vaginal Rejuvenation’ May Pose Serious Health Risks, Says FDA
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Date: 11.12.2018, 03:25 / Views: 85484