Experts Say Vaginal Rejuvenation Devices Are Necessary for Women’s Health, Despite FDA Warning

Experts Say Vaginal Rejuvenation Devices Are Necessary for Women’s Health, Despite FDA Warning featured image
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If we worked in Silicon Valley or were part of the gaming community, we would be referencing “virtual reality,” but because we’re beauty-obsessed, “VR” means one thing: vaginal rejuvenation. “For a long time, the focus has been on men’s sexual health, but people are now paying attention to what can be done for women,” says New York plastic surgeon B. Aviva Preminger, MD. “The conversation is finally changing.” 

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The term vaginal rejuvenation has been called into question by some doctors who suggest it only encompasses aesthetic procedures, but we spoke to many experts who disagree. “Women come to us with functional and medical issues such as laxity, dryness, lack of sensation or inability to climax, and stress urinary incontinence (SUI), and our arsenal of tools can help correct them,” says Cindy Barshop, founder of VSpot, a female wellness spa in New York, which she runs with her business partner and obgyn Carolyn DeLucia, MD. “Whether we’re treating the area internally or externally, we’re rejuvenating it in some way to help improve a woman’s life and self-esteem.”

In order to understand the need for VR devices and how they work, there are a few anatomical facts to consider: Although the two often get conflated, the vagina is the interior path that connects to the cervix, and all of the external parts are known as the vulva. Inside the vagina, there are three key layers of tissue: mucosa, smooth muscle and fibrous tissue, which is where collagen and elastin live. “The mucosa is the layer on the surface that can be touched. It has a similar texture to the lining of the mouth, and it heals just as fast, too,” says Dr. Preminger. “As we age and our estrogen levels drop, particularly during menopause, this tissue can experience atrophy and a decline in moisture, which can cause it to become very irritated and painful, especially during sex.” The most recent U.S. Census revealed that nearly 50 percent of post-menopausal women experience these symptoms.

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Another common concern is a decrease in vaginal muscle tone, which can occur as the result of childbirth, the normal aging process and menopause. “Reduced collagen and elastin lead to lax vaginal tissue that can cause a lack of sensation during sex, an inability to orgasm and urinary leakage, which is when a little bit of urine seeps out during actions like coughing, sneezing or running,” says Dr. DeLucia. “Urinary incontinence alone affects millions of women, but no one really talks about it.”

Energy Healing
Over the last decade, scientific breakthroughs have given rise to a menu of options designed to treat—and in some cases, prevent—these issues. The two main categories of VR devices, lasers and radio frequency (RF), are based on nonsurgical technologies that have been proven to tighten and resurface skin on the face and body. Duxbury, MA plastic surgeon Christine Hamori, MD says that although the majority of doctors still consider the VR space new and long-term clinical studies on many of these treatments are still underway, peer-reviewed data published in the Aesthetic Surgery Journal suggests promising results. (Note: This data does not apply to the new crop of at-home laser and RF devices, which make similar claims, but lack the requisite clinical evidence to back them up.)

When vaginal dryness is the issue, lasers such as diVa and MonaLisa Touch—the original VR device that launched stateside in 2014—employ either erbium:YAG, hybrid energy or fractional CO2 (different wavelengths of light) to help enhance lubrication in the vagina by reactivating collagen production in the tissue. Rochester, NY dermatologist Lesley C. Loss, MD uses the diVa laser at her practice, and says most patients describe the treatment as feeling like mild pressure and/or a dull, tapping sensation with little discomfort. “Three treatments spaced out over 12–18 weeks and one maintenance treatment each year afterward are generally recommended for the best possible results.”

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For vaginal tightening, radiofrequency devices—popular options include the Viveve System, Votiva and ThermiVa—are the best bet. (Some can also be used to tighten the labia as well.) During a treatment, waves of RF energy heat the mucosa to between 104 and 116 degrees Fahrenheit, causing tissue contraction that produces a tightening effect. Some RF technologies offer the benefit of rejuvenating the mucosa and building collagen, too. “The treatments feel like warmth and are comfortable for the patient,” Dr. Preminger says. The number of treatments needed is device-dependent—some only require one; others require two or three and then one treatment per year following to maintain the results.

The length of both laser and RF treatments also depends on the specific tool used, but typically ranges between five and 30 minutes, and there’s very little downtime. “Side effects include mild spotting, swelling and warmth in the area for up to 24 hours, and sexual intercourse and submersion in a tub should be avoided for about 48 hours,” says Dr. Loss. “Patients can return to exercise when they feel ready.”

Dr. Hamori says that data points to the improvement of urinary incontinence with both CO2 lasers and radio frequency. “However, RF is able to penetrate deeper than CO2, so it is thought that the supportive structures of the vagina may be targeted more easily with RF technologies,” she adds. Ultimately, a consultation with a qualified, board-certified dermatologist, plastic surgeon or gynecologist will determine the best approach for each patient.

FDA Advisory
Last week, the U.S. Food and Drug Administration (FDA) released a statement saying these treatments have been cleared for destroying abnormal or precancerous cervical or vaginal tissue, as well as condylomas (genital warts) and other serious genitourinary (GU) conditions—but not for disorders and symptoms related to menopause, urinary incontinence or sexual function. Furthermore, the Administration claims these treatments “have serious risks and don’t have adequate evidence to support their use for these purposes.”

FDA commissioner Dr. Scott Gottlieb says he is aware of “numerous” reports of vaginal burns, scarring, pain during sexual intercourse and recurring or chronic pain following these procedures and as a result, is asking the manufacturers of the devices in question to address their concerns and reevaluate the marketing of their products.

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In light of the statement, NewBeauty reached out to several physicians who use these devices regularly to get their opinions. New York dermatologist Macrene Alexiades, MD, says, “Lasers and devices have been used in GU treatment for more than 40 years and have a large accumulating body of evidence showing unequivocal benefit to genitourinary health. There have been very few and rare reports of burns or complications. However, these devices are not supposed to be marketed for indications they are not FDA-cleared for until they receive approval, and this is where some companies have gone awry, leading to warning letters.”

That being said, these devices do work for many people and it’s important that the FDA is finally discussing women’s health issues after all these years. “The important take home messages are that women need treatments for conditions such as pain with intercourse, urinary leakage and infections, which can result in a poor quality of life,” says Dr. Alexiades. “Approximately 50 percent of postmenopausal women suffer from these conditions, and this new generation of devices offers significant efficacy and excellent safety profiles.”

Reston, VA urogynecologist Maria Canter, MD agrees. “Although I agree with the FDA that the safety and effectiveness of a device should be established prior to it being marketed a certain way, some patients have failed multiple ‘approved’ treatment options and have had significant improvement with energy-based devices. For example, a radio-frequency device I work with, Viveve System, has studies demonstrating safety and efficacy when used to treat vaginal laxity that can lead to decreased sensation during intercourse and urinary incontinence. There is also a prospective randomized controlled trial that was blinded and demonstrated significant improvement in symptoms. This device also currently has 2 FDA IDE trials. To date, there have been no serious adverse events and the benefits have outweighed any risk.”

Moreover, Dr. Preminger is currently in the midst of a multisite, institutional review, board-approved, controlled study to look at the efficacy of Votiva, one of the laser devices in question, and has not experienced any major adverse events with it so far.

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“Certainly there is marketing hype and excitement surrounding these treatments. This is an aspect of women’s healthcare that has not had much attention in the past—the main reason being the lack of options,” says Dr. Canter. “As a woman’s healthcare specialist, I think it is time for women’s intimate health issues to be in the spotlight. Women have struggled for years.”

“Time’s up in women’s health,” adds Dr. Alexiades. “Those of us in the medical sciences will continue to forge ahead with properly designed FDA trials seeking regulatory clearances through the appropriate channels, but women need to speak up for the development of treatments for conditions they alone are afflicted with rather than suffering in silence.”

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