Experts discuss the place for female rejuvenation

Dr. KatzFemale rejuvenation includes a range of  functional and aesthetic procedures in the female genital region. Therapies are aimed at correcting and restoring the vagina’s structural form and surrounding tissues and improving the vaginal mucosa’s hydration and elasticity, says Bruce Katz, M.D., director of JUVA Skin and Laser Center, New York, N.Y., a proponent of these procedures and whose practice offers them.

It’s estimated that more than 50% of the female population over age 50 has some degree of uterine prolapse or pelvic organ prolapse.1 Almost all post-menopausal women have vaginal atrophy, dryness, and dyspareunia and other symptoms associated with menopause. An estimated 15 million women suffer from stress urinary incontinence.2 Almost all women have some degree of vaginal laxity after bearing children.

“All of these women could potentially benefit from non-invasive vaginal rejuvenation procedures,” says Min-Wei Christine Lee, M.D., M.P.H., dermatologic surgeon and director, The Skin and Laser Treatment Institute, Walnut Creek, Calif.

According to an unpublished pilot study at Dr. Katz’s institution, of the women who are getting female rejuvenation procedures, 56% are aged 50 to 59, 22% are aged 40 to 49, 11% are aged 30 to 39, and 11% are aged 20 to 29.

Pointing out that 22% of the women getting the procedure are under age 40, Dr. Katz notes that it’s not just a treatment for pre- and post- menopausal women.

“It’s often used after childbirth when tissues become stretched,” he says. “This can result in loss of self-confidence, reduced participation in exercise, loss of sexual interest or desire, and disturbed interpersonal relationships.”

A logical therapeutic addition

Dr. Katz’s large laser center is equipped with 45 lasers, so adding female rejuvenation procedures to its menu was a logical decision.

“We already used laser technology for other areas of the body, such as eliminating wrinkles and rejuvenating the face, neck, chest, and hands and are very comfortable using it,” he says. “We mostly treat women in our practice, performing cosmetic dermatology and cosmetic laser surgery, and this was another facet to help women make improvements functionally and aesthetically.

The scope of the procedures performed at JUVA Skin and Laser Center include using the FemiLift (Alma Lasers) to treat tissues internally to improve atrophy, tighten vaginal skin, improve vaginal lubrication, and treat stress urinary incontinence.

The ThermiVa (Thermi) radio frequency device is used to treat tissues internally as well, and also externally for vulva laxity, tightening of vaginal tissue for aesthetic purposes, and increased hydration in the vaginal mucosa. 

Dr. Katz says the procedure improves lubrication because it improves blood supply to the tissues. Combined with improving the elasticity of the vaginal muscles, women who have had the procedure report having intensified orgasms.

Dr. Katz is a proponent of female rejuvenation procedures because they are minimally invasive, safe, and have no downtime.

“We can help women with these issues that in the past could only be addressed with surgery, Kegel exercises, or electric stimulation, with the latter two not helping much,” he says.

Regarding malpractice, he doesn’t see any potential risks as there have been no significant side effects from the procedures.

“Learning to use the FemiLift laser is fairly easy,” Dr. Katz says. In fact, he doesn’t actually perform the procedures, rather a nurse practitioner trained in gynecology does them.

Next: A good fit for some

A good fit for some

Dr. LeeAs a physician who had education in obstetrics and gynecology (Ob/Gyn) prior to switching to the dermatology specialty, Dr. Lee believes she is in an ideal position to perform female rejuvenation procedures. Dr. Lee is also a laser expert with more than 40 lasers in her practice.

“Since the mid-2000s, there has been a noticeable need for non-invasive procedures to help with vaginal laxity,” she says. “The first device for tightening of the vaginal canal -IntimaLase (Fotona) - became available internationally several years ago. I was the first U.S. doctor to start performing procedures with it in 2014.”

She also performs Fotona’s IncontiLase therapy, which helps with stress urinary incontinence.

Prior to these laser procedures, Dr. Lee believes the surgical solutions for these gynecologic conditions have been unacceptable.

“They are extremely painful, have long recovery times, and have a high risk of complications,” she says. “There was a great need for non-invasive and safer options for women. Even if they only had modest improvement, women suffering from these gynecologic conditions are very grateful for any improvement. I have treated hundreds of women who all experienced improvement in their gynecologic conditions with no side effects or complications.”

Laser experts

Another reason why Dr. Lee believes dermatologists are the ideal specialist to perform female rejuvenation procedures is because Ob/Gyn physicians are not comfortable with lasers and have not embraced this new area of research.

“While dermatologists are very comfortable with adopting new laser technology in terms of applications to the skin, many feel the use of the new lasers for gynecologic applications is outside their comfort level,” she says.

In addition, dermatologists treat all parts of the skin and have traditionally been the pioneers and experts in all laser procedures applied to the skin.

“The vaginal mucosa is a continuation of the skin - dermatologists are very experienced and adept at treating the mucocutaneous juncture (which includes oral mucosa, vaginal mucosa, and rectal mucosa),” Dr. Lee says. “Because dermatologist thought leaders also are the leading experts at dealing with lasers and complications from lasers, it was natural for laser companies to seek their advice in terms of how to assess and evaluate tissue interaction and clinical application of laser wavelengths as it applies to any skin surface, including vaginal mucosa.”

Dr. Lee’s primary concern about any physician entering this field is that most doctors don’t understand the vast difference between the different lasers. Fotona was the first and so far the only nonablative fractional Erbium laser developed for treatment of the vaginal mucosa.

Other lasers have tried to copy the concept, but have used more invasive modalities such as fractional CO2 or ablative fractional Erbium, she says. Besides the Fotona IntimaLase and IncontiLase therapies, the only noninvasive options on the market are the radiofrequency devices. These include the Ultra Femme (BTL), Geneve (Viveve), and ThermiVa (Thermi).

Considerations

Dr. Lee cautions that if a dermatologist or Ob/Gyn wants to introduce vaginal rejuvenation to their practice, they should only consider a noninvasive option in order to minimize side effects and complications.

She recommends the specialties work together.

Dermatologists can partner with Ob/Gyns who may not feel comfortable learning and investing in expensive laser equipment nor want to invest time and effort to offer these procedures in their practices. They may prefer to work with or refer patients to dermatologists to treat these patients after they’ve performed an initial examination.

Further, Dr. Lee would caution dermatologists from treating patients with uterine prolapse because they could encounter problems such as causing uterine perforation with certain lasers. (Uterine perforation is not known to happen with Fotona’s IntimaLase/IncontiLase therapies, but it could potentially happen with a device that relies on manual back and forth thrusts). Also, dermatologists may not adequately be able to assess if a patient has uterine or pelvic prolapse. Therefore, Dr. Lee recommends that patients have a complete examination and clearance by an Ob/Gyn before performing a laser vaginal rejuvenation procedure.

Next: Another point of view

Another point of view

Dr. GendlerEllen Gendler, M.D., clinical associate professor of dermatology, NYU Langone Medical Center, New York, N.Y., has different sentiments from Drs. Katz and Lee.

“Dermatologists are not in the best position to make accurate diagnoses regarding the causes of a female patient’s complaint of genitourinary syndrome of menopause [basically vaginal atrophy, dryness, and laxity],” she says. “While it could be due to age or from having children, there are many other causes, and a gynecologist should be the one handling it.”

Because she is not a gynecologist, Dr. Gendler says only the external genitalia are visible to her without a speculum exam, and she does not feel that dermatologists without additional training in obstetrics and gynecology are experts at this. An internal exam is not part of her standard skin examination.

“If I did do a vaginal procedure and the patient had a problem, then I would have to send her to a gynecologist to diagnose it. I would remove growths that are on the external genitalia, but not remove things that are actually inside the vagina,” she says.

What’s more, dermatologists are not equipped to handle problems that occur from laser resurfacing inside the vagina.

“With any procedure I perform, I need to be able to handle the complications,” she says.

Dr. Gendler goes on to say that bringing up the topic of “female rejuvenation” doesn’t fit into her discussion in a routine dermatology exam.

“When a patient has an appointment, I do a thorough [external] skin exam, looking for both benign and malignant skin lesions, identifying inflammatory skin conditions, and discussing cosmetic procedures if a patient is interested. But how would I broach the topic of female rejuvenation? Normally, a patient would not mention to her dermatologist that she has vaginal dryness during intercourse or that her vagina is not as tight as it used to be,” she says.

“The only way for that to come up in the conversation would be if the patient saw an advertisement in the office which alerted the patient that the dermatologist deals with this issue, or if another staff member broached the subject with the patient. If a patient mentioned the subject of vaginal dryness, I would refer her to a gynecologist,” she says.

Dr. Gendler points out that The American Congress of Obstetricians and Gynecologists [ACOG] is not a proponent of female rejuvenation procedures, and has stated: “Vaginal rejuvenation procedures are not medically indicated, nor is there documentation of their safety and effectiveness. Moreover, it is deceptive to give the impression that any of these procedures are accepted and routine surgical practices. ACOG recommends that women considering cosmetic vaginal procedures should be informed about the lack of data supporting the effectiveness of these procedures as well as their potential complications, including infection, altered sensation, dyspareunia [pain], adhesions, and scarring.”3

“I feel that this speaks forcefully to the notion that dermatologists should be even more leery of doing procedures outside their area of expertise, especially when these procedures are not generally accepted by the primary specialty’s medical organization and have not been studied in a thorough enough manner yet to establish their effectiveness,” Dr. Gendler says. “ACOG has stated that real controlled studies need to be done and doesn’t endorse it at this time.”  

According to an ACOG statement: “It is imperative that studies on these procedures be conducted and published in peer-reviewed publications so that the evidence and clinical outcomes can be reviewed. Until that time, the absence of data supporting the safety and efficacy of these procedures makes their recommendation untenable.”3

Dr. Katz notes that, “What we are referring to in terms of vaginal rejuvenation is resurfacing using lasers and radio frequency. These procedures are basically non-invasive and have no significant side effects.” His institution’s pilot study of FemiLift’s laser procedure showed significant benefits including improvements in vaginal laxity, lubrication, and stress incontinence in the long run. Others’ studies have found similar benefits.4,5,6

“So I strongly disagree with ACOG’s stance,” the dermatologist says.

But Dr. Gendler goes on to say that she has doubts that studies will prove that laser resurfacing of the vagina will prove to be effective in the long run.

“Perhaps there will be some role for radiofrequency for vaginal laxity in the future, at least to improve it temporarily. And if a gynecologist wants to perform these procedures - even though the benefits might be only temporary, that’s fine. It is analogous to a dermatologist injecting Botox, the effects of which only last a few months. But even if scientific studies would show that laser resurfacing of the vagina has long-term effects, I still feel that dermatologists don’t have any business doing it.”

Dr. Gendler believes the biggest motivator for dermatologists to perform female rejuvenation is financial gain.

“But dermatologists already have enough opportunities to have lucrative practices, particularly by doing cosmetic procedures, which insurance companies don’t cover,” she says.

She also notes that the largest malpractice carrier in New York State doesn’t generally cover these procedures, and each physician should check with his or her malpractice carrier before assuming that it offers coverage. 

“I think it is disingenuous for dermatologists to say they are doing vaginal laser rejuvenation for altruistic reasons because their patients are suffering,” she concludes. “If that is indeed the case, true altruism would dictate a referral to a gynecologist.”

The bottom line is, “Female rejuvenation is very new area and quite controversial, so it’s difficult for many physicians in the dermatology and Ob/Gyn specialties to know how to deal with it,” Dr. Lee says.

“There is also great variability in laser devices and most practitioners are unable to discern the differences among various offerings. The ability of a practitioner to perform these procedures needs to be looked at on an individual basis - generalizations can’t be made at this point,” she says. ƒ

Disclosures: Drs. Katz and Gendler report no relevant disclosures. Dr. Lee reports no financial interests (ie: stock options) to disclose but she is a consultant for Fotona and is on the advisory panel for BTL and many other laser companies.

References

1. Barber MD, Maher C. Epidemiology and outcome assessment of pelvic organ prolapse. Int Urogynecol J. (2013) 24:1783–1790. DOI 10.1007/s00192-013-2169-9. http://dev-test.glup.it/wp-content/uploads/2013/11/ABS2_ottobre_13.pdf. Accessed December 8, 2016.

2. Luber KM. The definition, prevalence, and risk factors for stress urinary incontinence. Rev Urol. 2004; 6(Suppl 3):S3–S9. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1472862/. Accessed December 7, 2016.

3. ACOG advises against cosmetic vaginal procedures due to lack of safety and efficacy data. ACOG website. August 31, 2007. http://www.acog.org/About-ACOG/News-Room/News-Releases/2007/ACOG-Advises-Against-Cosmetic-Vaginal-Procedures. Accessed December 2, 2016.

4. Menachem A, Alexander B, Martinec KS, Gutman G. The effect of vaginal CO2 laser treatment on stress urinary incontinence symptoms. ALMA SURGICAL FemiLift. April 2016.

5. Femopase G, Femopase S, Alonso Salas SM. Vaginal application of fractional CO2 laser (FemiLift) and improvement of female sexual response. WAMS - IV Congress of Medical Sexology. October 9,10, 2015. Córdoba, Argentina.

6. Tadir Y. Fractional/pixel co2 laser therapy (Femilift) for genitourinary syndrome of menopause (GSM): round table discussion. ALMA SURGICAL FemiLift. June 2016.