FDA statement and diVa Quote from
Dr. Michael J. Coyle DO, FACOOG, FPMRS
Board Certified Female Pelvic Medicine and Reconstructive Surgeon
I appreciate and applaud the FDA for continuing to make sure patients are not misled, misinformed or deceived. I would, however, like to clarify some information that has been reported in the media. In order to fully understand the FDA’s recent letter, it is critical to understand the intent and purpose of their communication. The FDA’s letters were not WARNING letters, but rather letters addressing the concerns about marketing “vaginal rejuvenation” procedures.
As a board certified Urogynecologist, I specialize in treating female patients with many different conditions that massively affect their quality of life. For example, I have treated women for years who suffer from Genitourinary Syndrome of Menopause. This is a horrible condition that leads to very painful, dry, cracked, irritated vaginas, as well as, urinary symptoms, recurrent urinary tract infections, persistent vaginal infections and in most cases, the inability to have normal relations. The treatments that have been available for many years are options such as vaginal moisturizers, vaginal hormones, or systemic hormones. These treatment options are of course always offered, and some patients do well with them, however, what happens when they don’t do well with them? Or what happens when they have been told that they cannot take hormones because of cancer risks? What do we do with these patients?
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That is the question that leads me to search for other ways that I can try and improve these patients’ lives by improving their vaginal health. I started researching lasers, specifically vaginal lasers. I started my research in 2014 but did not purchase a laser until December 2016. Once I learned that specialists have been using this same laser technology to treat the faces of patients safely for years, I knew that it would be safe to use the same technology in the vagina. We have been using the diVa attachment to the Joule system now since 2016, and it is truly amazing to see how these women’s lives have been restored!!!!
This laser technology is the same technology that has been used safely and effectively for many years to improve the health of body tissue and has been FDA approved for use in Gynecology. The vagina is no different, it is a body tissue that often times, when not optimal, will cause severe symptoms and a significant strain on one’s life. In my practice, the diVa vaginal therapy has given my patients hope and in many, many cases restored their lives.