BlueCross BlueShield of Tennessee Medical Policy Manual

Fractional Laser Treatment of Vulvovaginal Atrophy

DESCRIPTION

Vulvovaginal atrophy, also known as vaginal atrophy, atrophic vaginitis, and/or urogenital atrophy, is a condition that causes the vagina and tissue near the vagina to become dry, thin and inflamed. Vaginal atrophy is often caused by lack of a woman’s ability to produce estrogen due to any of the following:

Fractional carbon dioxide (CO2) lasers (e.g., MonaLisa Touch®, CO2RE Intima) are traditionally used to treat skin wrinkles or acne scarring and are being marketed as a non-surgical treatment for vulvovaginal atrophy. The safety and effectiveness of this procedure has not been documented. This micro-ablative procedure is performed in the physician’s office with local anesthetic.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

There is a lack of randomized controlled trials and comparative effectiveness studies. Long-term follow-up is also lacking.

SOURCES

American College of Obstetricians and Gynecologists. (2007, reaffirmed in 2017). Committee opinion (#378). Vaginal ‘rejuvenation’ and cosmetic vaginal procedures. Retrieved September 18, 2017 from https://www.acog.org.

Arroyo, C. (2017). Fractional CO2 laser treatment for vulvovaginal atrophy symptoms and vaginal rejuvenation in perimenopausal women. International Journal of Women’s Health, (9), 591-595. (Level 4 evidence)

Behnia-Willison, F., Sarraf, S., Miller, J., Mohamadi, B., Care, A.S., am, A., et al. (2017). Safety and long-term efficacy of fractional CO2 laser treatment in women suffering from genitourinary syndrome of menopause. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 213, 39-44. Abstract retrieved September 26, 2018 from PubMed database.

Perino, A., Calligaro, A., Forlani, F., Tiberio, C., Cucinella, G., Svelato, A., et al. (2015). Vulvo-vaginal atrophy: a new treatment modality using thermo-ablative fractional CO2 laser. Maturitas. 80 (3), 296-301. Abstract retrieved August 26, 2016 from PubMed database.

Salvatore. S., Nappi, R., Zerbinati, N., Calligaro, A., Ferrero, S., Origoni. M., et al. (2014). A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric, 17 (4), 363-369. Abstract retrieved August 26, 2016 from PubMed database.

Sokol, E.R. & Karram, M.M. (2016). An assessment of the safety and efficacy of a fractional CO2 laser system for the treatment of vulvovaginal atrophy. Menopause, 23 (10), 1102-1107. Abstract retrieved September 26, 2018 from PubMed database.

U.S. Food and Drug Administration. (2011, January). Center for Devices and Radiologic Health. 510(k) Premarket Notification Database K103288. Retrieved August 26, 2016 from http://www.fda.gov.

U.S. Food and Drug Administration. (2013, December). Center for Devices and Radiologic Health. 510(k) Premarket Notification Database K133895. Retrieved August 26, 2016 from http://www.fda.gov.

American College of Obstetricians and Gynecologists. (2016, May). Position Statement: Fractional laser treatment of vulvovaginal atrophy and U.S. Food and Drug Administration clearance. Retrieved August 26, 2016 from https://www.acog.org. 

Winifred S. Hayes, Inc. Health Technology Brief. (2018, March). Laser therapy using MonaLisa Touch (Cynosure Inc.) for vulvovaginal atrophy. Retrieved September 25, 2018 from www.Hayesinc.com/subscribers  (20 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  1/14/2017

MOST RECENT REVIEW DATE:  11/8/2018  

ID_BT

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