Feminine rejuvenation comprises a number of differing issues and symptoms, which can vary according to a patient’s stage of life and circumstance, and can present singularly or as a combination of indications. Nonsurgical feminine rejuvenation using energy-based technologies is one of the fastest growing in-office procedures. While this market is still in its relative infancy, due to excellent clinical outcomes, along with minimal discomfort and downtime for the patient, these new modalities are replacing surgical feminine rejuvenation procedures at a rapid pace.
This complex indication is described by a variety of names. Treatments encompass remodeling of the external genitalia for medical or cosmetic reasons such as labial reduction/augmentation or labial color restoration due to dyschromia; vaginal atrophy, which typically occurs in the hypoestrogenic state of menopause, but can also occur with hysterectomy, lactation or with the use of anti-estrogen medications such as those used during breast cancer treatments; laxity caused by vaginal child birth or associated with menopause; reducing dyspareunia (pain during intercourse) for improved sexual health; and stress urinary incontinence (SUI), a common issue after childbirth or with menopause.
Atrophic vaginitis or vaginal atrophy is one of the most characteristic consequences of menopause. The estrogen decline initiated by the ending of the menstrual cycle leads to thinning of the vagina walls and changes in the vulvovaginal mucosa that manifest as a number of clinical symptoms such as itching, dryness, burning, dysuria and dyspareunia.
As reported by the American Association of Family Physicians, vaginal atrophy is a chronic and progressive medical condition estimated to affect an estimated 10% to 40% of postmenopausal women and this rate is expected to increase with the rise in life expectancy. Notably, despite this significant prevalence of symptoms, it is believed that only 20% to 25% of symptomatic women seek medical attention.
Vaginal atrophy may also occur in pre-menopausal or perimenopausal women who have taken anti-estrogenic medications or who have medical or surgical conditions that result in decreased levels of estrogen such as hysterectomies, radiation or tamoxifen treatment for breast cancer.
While there are a number of symptoms associated with vaginal atrophy, one of the earliest is decreased vaginal lubrication. This is followed by other symptoms such as SUI or urinary tract infections. A reduction in estrogen results in a number of cytological changes in the vaginal tissue including decreased elasticity associated with the loss of collagen and elastin, and proliferation of connective tissue. This leads to a shortening and narrowing of the vagina. Thinning vaginal surfaces become fragile, which can cause vaginal bleeding, and a lack of lubrication can lead to dyspareunia, itching, burning and discharge.
Vaginal laxity can occur for many reasons, such as aging, genetic factors, lifestyle and/or trauma and is not limited to women that have given birth vaginally. Up to 76% of women may experience decreased vaginal sensation due to laxity during their lifetimes. During vaginal childbirth tissues of the introitus are loosened to accommodate the fetal head and this can be worsened by subsequent births. Additionally, with aging can come a loss of vaginal tissue due to changes in cellular renewal. Diminished collagen and elastin can lead to decreased elasticity of the vagina and introitus.
According to statistics reported in the BJOG: An International Journal of Obstetrics & Gynecology, the prevalence of vaginal laxity was reported more commonly by younger women (15–44 years) at 8.0% than by older women (≥ 45 years) at 2.9%. While traditional treatments do not address vaginal laxity and the loss of elasticity, energy-based devices can help in the restoration of vaginal tissue tightness by inducing collagen remodeling in the vaginal wall and the introitus.
Correction of SUI is a huge unmet need of many women as there are no pharmacological agents specifically for this condition. It is usually treated with surgical procedures or Kegel exercises to strengthen the surrounding structure of the bladder. Notably, improvement in SUI is not currently a prime indication for most available energy-based technologies, but could become a major additional opportunity in the future.
Dissatisfaction with the appearance of the external genitalia can also lead to low self-esteem, lack of confidence and reduced sexual satisfaction. Labial remodeling is commonly seen as a cosmetic procedure, nonetheless there can also be medical reasons for treatment. Until recently the only option was surgical labiaplasty, which can be painful and invasive.
According to Shelena Lalji, M.D., a board certified OB/GYN in Houston, Texas, most women believe these issues are a natural part of aging and feel hopeless about it. “It is such an intimate issue that many women are hesitant to discuss their symptoms with anyone so it is incumbent on physicians to begin these conversations with their patients,” she shared. “We need to realize that these are serious concerns for many of our patients and we now have effective ways to help them. Additionally, if male physicians are uncomfortable discussing these issues, this may be an easy role for mid-level female providers to assist patients with these esteem building and life-changing treatments. Too many women are suffering in silence, but we can now truly impact their sexual well-being.”
As all women eventually enter menopause, the potential opportunity for this cash-pay sector is huge. In the U.S. alone there are nearly 46 million women between the ages of 50 and 80, along with more than 2.8 million breast cancer survivors. Due to population size and the number of presenting symptoms post-menopausal women offer the largest treatment group. Furthermore, the U.S. Census Bureau’s Current Population Survey shows that 52.4% of women between the ages of 15 and 44 have had children, so the pool of post-partum women with vaginal laxity offers great potential as well.
Generally, menopause and its associated symptoms, along with vaginal laxity are treated by primary care physicians. Other indications such as SUI may also be treated by urogynecologists. In many cases aesthetic issues of the external genitalia are also being addressed by cosmetic surgeons and other aesthetic physicians.
According to Medical Insight’s January 2017 Annual Aesthetic Practice Survey of U.S. aesthetic physicians, approximately 21% of practices responding to the survey currently offer feminine rejuvenation treatments. Of those practices offering treatment, the majority are treating 1-5 patients per week, and charge around $800-$1,500 per treatment.
For OB/GYN physicians that also provide aesthetic services, energy-based technologies for feminine rejuvenation are a natural addition to their practices. These physicians seem more comfortable with adding capital equipment. However, they differ from aesthetic practitioners in that they generally want more clinical data to understand the true effects of the technologies and devices indicated specifically for their use. This contrasts with aesthetic physicians that are generally comfortable with their own clinical practice as many cosmetic procedures are technique driven.
Energy-based devices for feminine rejuvenation could potentially bridge both the aesthetic and medical provider, thus allowing the market to expand significantly in terms of the provider base. In addition, many patients seeking these treatments are new to physician offices so feminine rejuvenation could act as a gateway procedure bringing in patients across a wide age range, similar to neurotoxins and non-invasive body shaping.
Due to the needs of these differing specialties, companies are focusing their efforts accordingly. Manufacturers are generally developing systems that can treat all feminine rejuvenation conditions. In 2008 the first non-surgical, energy-based system dedicated to feminine rejuvenation became available in Europe and today there are at least 19 different systems available globally, which utilize a variety of energy sources, including CO2, Er:YAG, radiofrequency (RF) and high-intensity focused ultrasound (HIFU).
Ablative CO2 lasers have been utilized for some time to treat the vulva and perineum with the purpose of improving cosmetic concerns, such as additional unwanted skin, dyschromia and skin tags. Various studies have shown that treatment with fractional CO2 lasers helps return the vaginal mucosa to a pre-menopausal state by restoring epidermal thickness and inducing a rich dermal vascular supply. Alma Lasers (Buffalo Grove, Ill.) currently offers FemiLift, an FDA approved CO2 based system for internal resurfacing of the vagina. Other CO2 based technologies being used for feminine rejuvenation include MonaLisa Touch (manufactured by Deka and distributed in the U.S. by Cynosure), the patented GynoLaser applicator from Ilooda (Gyeonggi-do, South Korea), FemTouch from Lumenis (San Jose, Calif.), DivaTight from Quanta System S.p.A. (Samarate, VA, Italy), which is only available outside of the U.S., and CO2RE Intima from Syneron (Irvine, Calif.).
Non-ablative 2940 nm Er:YAG-based systems utilize laser pulses to heat tissue to a depth of 100 microns, leading to contraction of these irradiated tissues and ultimately neocollagenesis, providing improvement in vaginal laxity. Top devices featuring Er:YAG technology include IntimaLase, RenovaLase and IncontiLase from Fotona (Europe & U.S.), one of the most established laser companies in the aesthetic industry. However in the U.S., Fotona currently does not offer these specific gynecologic options. Lutronic (Fremont, Calif.) has CE Mark clearance for their Action II Petit Lady, which runs on the multi-purpose Action II fractional Er:YAG laser. Currently it is only available outside of the U.S.
The diVa™ hybrid fractional laser from Sciton (Palo Alto, Calif.) uniquely combines the 2940 ablative Er:YAG wavelength and 1470 nm to provide customizable treatments with tunable ablation and coagulation, varying densities and automated precision that rotates, retracts and delivers pulses automatically in 3 to 5 minutes. Choices of 90°, 180° and 360° angles are software driven. diVa rotates within the single-use quartz dilator (SQD), for uniform, uninterrupted energy delivery, and when used in combination with diVaTyte™, it is an easy, no downtime, external approach that offers a fast, comfortable and consistent solution for vaginal therapy, all from the JOULE™ platform.
Monopolar RF has been utilized for rejuvenation of the skin as it allows for the safe delivery of thermal energy to the deep dermis to achieve lifting and tightening while avoiding epidermal and neurovascular damage. Treatment with RF initially produces immediate collagen fibril contraction and resultant tissue tightening to initiate a wound healing response that produces long-term neocollagenesis and tissue contraction. Examples of RF-based feminine rejuvenation systems include ThermiVa from Thermi, an Almirall Company (Irving, Texas), the Viveve system from Viveve, Inc. (Sunnyvale, Calif.), and the ULTRA Femme 360 system from BTL Aesthetics (Framingham, Mass.), which is the newest product to hit the market.
BTL Ultra Femme 360 reportedly offers the shortest RF treatment time available for women’s intimate health and wellness procedures. Utilizing 360° volumetric heating and novel EFC™ technology with integrated impedance intelligence, this device ensures the most effective and uniform tissue heating, allowing physicians to treat at high energy levels without compromising patient comfort.
Currently Hironic is the only manufacturer to offer a HIFU device to treat vaginal laxity and atrophy and has five patents pending for this technology related to gynecologic treatment. At this time the device is only available outside of the U.S.
In 2016, there were an estimated 5,900 systems installed globally for feminine rejuvenation indications. These devices were used to perform over half a million procedures, generating about $512 million in fees for practitioners, according to the recently released Energy-Based Feminine Rejuvenation market study from Medical Insight, Inc. (Irvine, Calif.).
Also, in 2016, total global sales of feminine rejuvenation devices exceeded $100 million, as reported by Medical Insight. Through 2021, sales are estimated to rise by 26% per year. On a regional basis, North America will be the largest market for energy-based feminine rejuvenation with growth expected to expand by 30% per year, followed by Asia at 24%, Europe at 20% and Latin America at approximately 16%.
It is obvious that energy-based feminine rejuvenation services represent one of the most attractive and fastest growing new market sectors, and Patricia Scheller CEO at Viveve, Inc., believes the market for feminine rejuvenation, “Could easily surpass these current estimates as more and more women and physicians see the benefits of these procedures.”
