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



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
Over the last decade,
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.”


https://www.newbeauty.com/blog/dailybeauty/12393-vaginal-rejuvenation-devices/

By | 2018-08-07T20:06:11+00:00 August 7th, 2018|Categories: Plastic Surgery|0 Comments

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