Laser Vaginal Rejuvenation with the Mona Lisa Laser

Vaginal Rejuvenation

Used here, the term refers to making the vaginal and vulvar tissues healthy again to help with vaginal dryness and painful intercourse, vaginal laxity due to loss of tone of the vaginal mucosa, and restoration of the functionality of urogenital structures. Many women will suffer from painful intercourse after menopause due to thinning of the vaginal tissues. Through restoration and creation of healthier vaginal tissues, sexual health can be vastly improved. Restoration of the tissues to health can also help with vaginal laxity, incontinence, and frequent vaginal and urinary tract infections.

Vaginal Atrophy: The Statistics

75 % of women have reported that vaginal atrophy negatively impacts their lives

63 % of women failed to recognize vaginal atrophy as a chronic condition

44 % of women reported that they did not consult a gynecologist for finding a solution

4 % only recognized the common symptoms of vaginal atrophy

Vaginal Atrophy

Vaginal atrophy is a very common condition, especially among women in menopause. The vulvo vaginal region is very sensitive to estrogen decline, with a series of consequences that impact directly on the quality of a woman’s life: weakness and laxity of the vaginal mucosa, dryness, itching and burning, pain during sexual intercourse (dyspareunia) During menopause, the mucosa presents a particular condition with metabolically quiescent fibrocytes as opposed to fibroblasts, unable to actively produce collagen, hyaluronic acid and other molecules needed for an adequate glycoprotein ground matrix. This can result in dry mucosa because it is dehydrated and less well nourished meaning it is fragile and more prone to infections.

The Mona Lisa Laser

The Mona Lisa Laser is a CO2 laser which creates a gentle burn to this tissues where it is applied. This brings in healing fibroblasts and causes a remolding of the tissues through increased collagen production. Vaginal biopsies have proven that the vaginal wall grows thicker with stronger and more elastic tissue and new blood vessels.

The Mona Lisa Laser uses the technology of the SmartXide2 fractional CO2 laser used in DOT Therapy, and applies laser energy to the vaginal walls in a non-continuous mode, in small 200 micron dots. This means that only a small percentage of vaginal tissue is directly affected by the laser. This is critical to achieving the right mechanism of stimulation and tissue regeneration with neither side effects nor pain for the patient during and after treatment.

The MonaLisa Touch is the only technology for vaginal and vulvar health with over 18+ published clinical studies. It is embraced by hundreds of experts in female pelvic health and premier academic institutions. It is the only treatment with proprietary stacking technology that enables deeper penetration and helps achieve maximum results. While other lasers have now entered into the market, this laser has been the most extensively studied.

The Mona Lisa Laser and the FDA

The Mona Lisa Touch Laser system has been FDA cleared as safe to use, however it has not been specifically FDA approved for treatment of atrophy, laxity,or incontinence. Therapy using the Mona Lisa Touch laser has been documented as an appropriate and efficacious treatment for vaginal symptoms due to menopause in the medical literature. This is an "off-label" use of a device which has been used in a medical setting in thousands of women. In September 2014, the SmartXide2 CO2 laser from the Italian company DEKA, along with a CO2 laser from the American company Cynosure, were cleared by the US Food and Drug Administration (FDA) for "incision, excision, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing." Subsequently, a laser system called the MonaLisa Touch for the treatment of vulvovaginal atrophy (VVA) and other symptoms of the genitourinary syndrome of menopause (GSM) has been marketed using this device. It's important to understand that the criteria for device clearance are much less stringent than for drug approval and that the clearance for the device was as described above and not specifically indicated for use in VVA. Device clearance does not require the large, double-blind, randomized, placebo-controlled trials with established efficacy and safety endpoints required for the approval of new drugs.

The Mona Lisa Laser Procedure

This is an office procedure. During a treatment, a vaginal probe is inserted into the vagina, and delivers gentle, virtually painless laser energy to the vaginal wall, stimulating a healing response. The surrounding vulvar tissues are also treated. The total procedure takes less than five minutes, and a typical course of treatment is three procedures over 18 weeks. Many women report symptom relief after the very first treatment, and even greater improvement after treatments 2 and 3. Annual follow up is generally recommended with one treatment per year.

The Statistics

Symptom Improvement % after three Mona Lisa Touch treatments:

Burning 84% report improvement
Itching 85% report improvement
Dryness 76% report improvement
Painful intercourse 74% report improvement
Laxity 90% report improvement

Fees

Established patients: 600.00 USD per treatment

New patients: Initial consultation fee to evaluate overall health 500.00 USD + 600.00 USD per treatment

Cost of Mona Lisa Touch Laser (exclusive of other overhead) 185,000.00 USD

Addendum:

Fractional Laser Treatment of Vulvovaginal Atrophy and U.S. Food and Drug Administration Clearance Position Statement The American College of Obstetricians and Gynecologists and The American Congress of Obstetricians and Gynecologists

Several media outlets have described fractional carbon dioxide (CO2) laser as “approved” or “cleared” by the U.S. Food and Drug Administration (FDA) for the treatment of vulvovaginal atrophy (http://www.medicaldaily.com/fda-approves-monalisa-touch-laser-vaginal-dryness-caused-vaginal-atrophy-313184, http://www.realself.com/question/seattle-wa-the-monalisa-touch- and-work, and http://blogs.webmd.com/womens-health/2015/07/how-to-treat-vaginal-dryness-inmenopause.html). The purpose of this Position Statement is to advise obstetrician– gynecologists and patients that this technology is, in fact, neither approved nor cleared by the FDA for the specific indication of treating vulvovaginal atrophy. Under its 510(k) process, the FDA has cleared a fractional CO2 laser (DEKA SmartXide2 CO2 laser) for the indications of “incision, excision, ablation, vaporization, and coagulation of body soft tissues in medical specialties, including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery”1. In addition, another laser system (Cynosure, ______________________________ 1 U.S. Food and Drug Administration. Re: trade/device name: DEKA SmartXide2 Laser System [letter]. Silver Spring (MD): FDA; 2014. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf13/k133895.pdf. Retrieved May 19, 2016. The American College of Obstetricians and Gynecologists The American Congress of Obstetricians and Gynecologists 409 12th Street, SW • PO Box 96920 • Washington, DC 20090-6920 • Telephone 202-638-5577 Fractional Laser Treatment of Vulvovaginal Atrophy and U.S. Food and Drug Administration Clearance Page 2 Inc., RevLite Q-Switched Nd: YAG Laser System) has been cleared by the FDA for “incision, excision, ablation, vaporization of soft tissue for General Dermatology, Dermatologic and General Surgical procedures for coagulation and hemostasis” 2 . It is important to note that although there are a number of indications enumerated for this technology, the specific indication for the treatment of vulvo vaginal atrophy is not listed. Preliminary observational data have shown some potential benefits with the use of this technology in treating patients with vulvo vaginal atrophy 3–5 . However, these observational trials do not evaluate the use of concomitant treatments, and they lack long-term follow-up (trials assessed follow-up at 12 weeks). No randomized trials or comparative effectiveness studies have been published (www.medscape.com/viewarticle/846960). Although initial data indicate potential utility, additional data clearly are needed to further assess the efficacy and safety of this procedure in treating vulvo vaginal atrophy, particularly for long-term benefit. Obstetrician–gynecologists should be cognizant of the evidence regarding innovative practices, and should be wary of adopting new or innovative approaches on the basis of promotions or marketing 6. It is critical that patients are provided with accurate information regarding the efficacy and safety of treatment options, particularly when considering emerging technology. One component of this information is an accurate description of the FDA’s clearance or approval terminology. Obstetrician–gynecologists have an ethical responsibility to provide accurate and current information to patients in order for them to be fully engaged in the informed decision-making process. Approved by the Executive Board: May 2016.