General: Mona Lisa Touch (MLT) fractionated CO2 laser treatments have been approved and available in Europe since 2008, and available in the US as experimental since 2013 and FDA approved and available in US since 2014. The technology is an adaptation of the fractionated CO2 laser treatments used in dermatology to treat wrinkles and rejuvenate surface skin. The MLT laser is actually the only such laser or device on the market currently with the specific indication for treating vaginal atrophy, incontinence and lichen sclerosis in menopause (although there are other devices marketed for these indications, they have not been specifically tested or approved for vaginal indications.) The MLT treatment makes a pattern of microinjuries that penetrate the vaginal mucosa to the level of the basement membrane and ground substance. The subsequent inflammation causes the fibrocytes to “reawaken” and become functional fibroblasts, elaborating proteoglycans and collagen. The tissue re-hydrates because of the hydrophyllic proteoglycans. The cells also return to making hyaluronic acid, lowering the pH to normal range. The normal pH and sloughing of glycogen at the surface cause the vaginal flora to normalize, with a predominance of lactobacilli.
Histology: This slide is taken at 2 months, after 2 of the 3 treatments have been done. Reference Zerbinati N, et al.
Outcomes: The most dramatic effects are seen when women are asked about improvements in sexual function and decreases in pain with intercourse. These effects are durable over 1 year if the correct series of treatments (3 treatments, spaced at 6 weeks) is undertaken, and requires only a 1 time “touch up” yearly. No exogenous hormones are needed to support these changes or maintain effect. For this reason this has been an increasing popular treatment among women with a history of breast or uterine cancers.
Over the course of 10 years of studies, no significant side effects have been reported. Women report temporary discomfort with treatment (typically 2/10) and some report discharge or spotting for up to 48 hours post-treatment. Contraindications to treatment include women with mesh reconstruction of the vagina, those with significant uterine prolapse, active Herpes lesions (can treat women who are HSV positive) and any cancer or precancerous lesions of the vulva or cervix that have gone untreated.
Most of the current published data is from studies designed for approval in Europe and for the FDA, and are short term (3-6 month) outcomes data. These data show significant improvements in sexual function, incontinence symptoms and decreased irritation in the vulvar area.
The following charts are from Perino et al, a 3 month follow up study:
Dr Sokol and colleagues recently presented 12 month follow up data at AUGS national meeting (the paper is currently in press) with the following results:
Procedure: The in office procedure requires no sedation or pre-treatment. The treatment takes approximately 5 minutes to complete. There is no discomfort from the internal laser treatment, if vulvar laser is planned the patient is provided with numbing cream to use immediately before the procedure in the office. The patient is treated 3 times, at 6 week intervals. We then recommend a single treatment yearly as maintenance.
Cost: At present there is no CPT code available for this treatment and insurance companies are not providing reimbursement. As such, I generally recommend that, if appropriate, patients exhaust their covered options (hormone treatments) before moving to laser treatment. That being said, the average cost for treatment (Approx $2400 for the 3 treatment series) can be comparable to copays for estrogen therapies (Estrogen cream copays range from $10-300 per month, Estring up to $300 every 3 months). We do provide a receipt so that reimbursement from Health Savings Accounts by the patients can be taken.
Zerbinati N, et al. Microscopic and ultrastructural modifications of postmenopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatment; Lasers Med Sci 2014 (pub. on-line)
Athanasiou, S et al. The effect of microablative CO2 laser on the microflora of postmenopausal women. Climacteric 2016: Oct 19(5) 512-8.
Perino A, et al. “Is vaginal fractional CO2 laser treatment effective in improving overactive bladder symptoms in post menopausal women? Preliminary results. Eur Rev Med Pharm Sci 2016 Jun20(12) 2491-7
Poster presentation AUGS meeting 2016, Sokol et al. ”Use of a Novel fractionated CO2 laser for the treatment of the genitourinary symptoms of menopause” in press
Pieralli A, et al. Fractional CO2 laser for vulvovaginal atrophy (VVA) and dysparunia relief in breast cancer survivors. Arch Gynecol Obstet 2016 Oct 294 (4) 841-6.