Restore Blog

The FDA and the sensationalized frenzy with regards to vaginal laser therapy

Having treated many patients with diVa vaginal laser for close to two years, it is exasperating to see what the media has done to create fear in the public over a treatment that has helped thousands of North American women.  Yes, I was an early adopter of this technology, but prior to obtaining the diVa, I had done about a hundred treatments with the same hybrid fractional laser technology by Sciton known as the Halo for skin of the face and body.  I was impressed with both the efficacy and very low downtime associated with the treatment.  I did my research as to the validity of using this technology for the vagina and how it would benefit my patients.  

In my practice of providing non-surgical aesthetic treatments, the diVa is the one technology that I have no concerns as to the efficacy.  My experience is reflected in the Realself consumer-based website which allows patients to openly discuss their treatment and give their views. DiVa has a 98%  “Worth It “ rating on this website.  

In a practice where my main demographic is women in menopause, it is clear that there is a need for more effective treatment.  The use of traditional “medically approved” treatments for the symptoms of menopause, including vaginal moisturizers, lubricants, and vaginal estrogen preparations are not effective for many women. DiVa offers a safe and effective option for women where all else has failed.  Out of 10,000 procedures, Sciton self-reported one adverse effect to the FDA.  It was unrelated to an internal diVa treatment or a device malfunction.  The clinical review board for diVa consists of 10 urogynecologists/urologists.

DiVa is FDA approved for use on soft tissue.  The FDA’s statement that created the frenzy was to ensure that the marketing claims of vaginal devices are within compliance and making sure that the term “vaginal rejuvenation” is not misleading to patients.  Their letter to individual companies was not a warning letter, but rather requesting information regarding clearances and marketing practices. In the
FDA’s assessment, the term “vaginal rejuvenation” does not have a clear meaning and feels the public could be misled in their expectations.  Right now, it appears that they are making decisions about which devices did not adhere and those that simply need to provide clarification.  DiVa falls into the clarification category, and has not used the term “vaginal rejuvenation” in any marketing practices in its history.  Additionally, the letter did not address or include questions of safety of treatments, efficacy or outcome dialogue.

Indeed there are product manufacturers that make exaggerated claims and those that sell knock-off devices to non-discriminating practitioners, but this is a problem in the whole aesthetic industry, not just in regards to vaginal rejuvenation. The most important message that media should be making to the public is to find a licensed and reputable physician that has expertise in whatever treatment they might be contemplating. But that wouldn’t be nearly as exciting to read, now would it?