On July 30, 2018 the Food and Drug Administration (FDA) issued a statement to patients and healthcare providers expressing concerns regarding "vaginal rejuvenation" procedures using energy-based devices. The FDA submitted letters to seven companies who manufacture vaginal laser devices, including Cynosure Inc., a division of Hologic, the manufacturer of the Mona Lisa Touch. The Mona Lisa Touch (SMARTXIDE2) Laser System that we use here at Urology of Indiana was cleared on September 5, 2014 by the FDA for the treatment of several gynecologic conditions, and numerous published research studies have found this therapy to be highly effective in the treatment of painful intercourse related to vaginal dryness resulting from a lack of estrogen. All 7 of the companies who received letters make different laser products, and the letters each expressed different concerns. The letter submitted to Hologic did not include any concerns about the safety of the Mona Lisa Touch device, but rather questioned some of the claims located on the company’s website.
It is important to realize that the Mona Lisa Touch therapy is a safe, usually painless procedure designed to treat symptoms of painful intercourse related to vaginal dryness resulting from a lack of estrogen. It is not designed or intended for “tightening” the vagina, enhancing sexual pleasure, or treating urinary incontinence or other conditions. It is also important to remember that many other treatments are available for vaginal dryness and painful intercourse, including over-the-counter lubricants, vaginal moisturizers, vaginal estrogen and dehydroepiandrosterone therapies, and oral medications.
Conditions affecting women’s pelvic health are important, and unfortunately in the past many of these have not been well-recognized or treated. Newer therapies have shown a great deal of promise, and more research in this area is certainly on the horizon. The physicians and advanced practice providers at Urology of Indiana are here and available to help you understand the safety and effectiveness of all available treatments and select the one that is best for you. Please do not hesitate to contact us with any questions you may have. 877.362.2778