01 Aug FDA warns against Vaginal Rejuvenation…What Does This Really Mean?
More and more women are giving themselves permission to take care of and feel good about their bodies again. Whether due to aging, childbearing, cancer treatment or a host of other issues, women suffer from a collaboration of factors that affect the internal and external genitalia. As a result, vaginal rejuvenation is growing in popularity.
The FDA suddenly has a lot to say about vaginal rejuvenation. In a strongly-worded statement, the FDA has warned doctors and patients alike about the risks associated with “energy-based devices” for “vaginal rejuvenation.” The concerns included the use of such devices off-label, because safety and efficacy haven’t yet been established and because some patients were reporting burns or worse outcomes after certain procedures. In fact, in the statement, the FDA says they “have not cleared or approved any energy-based device to treat…sexual function.”
So why am I telling you this?
Confusion Around “Vaginal Rejuvenation”
As stated by the FDA, vaginal rejuvenation is a vague term. It can be used to describe surgical and nonsurgical treatments alike. Doctors may refer to a treatment as vaginal rejuvenation because it treats one or many problems including, but not limited to, vaginal laxity, vaginal atrophy, dryness, itching, pain with intercourse, decreased sensation, aesthetic changes and labial hypertrophy. Just as there are many symptoms that lead a woman to search for answers, there are a multitude of treatment options on the market for the general category of “vaginal rejuvenation.”
Rightfully, the FDA is concerned with both the safety of these procedures and how well they deliver on promises to the consumer. Enter the confusion. When we, as physicians, make claims in the broad category of “vaginal rejuvenation,” it can lead some doctors to make misleading promises that he or she may not be able to deliver. More specific wording is warranted in our discussion regarding the safety and efficacy of such devices.
Is Votiva Safe?
At AgeWell we use Votiva, an energy-based radiofrequency (RF) treatment, to address common issues in women that lead to sexual dysfunction. We are passionate about helping our patients alleviate their discomfort and feel good about their bodies again, but we are even more passionate about taking care of our patients safely. The FDA has indeed cleared FormaV, the continuous radiofrequency hand-piece of the Votiva machine, for the use of treating sexual dysfunction. From my personal experience as well as from visiting with doctors who’ve performed many more treatments than I have, I can confidently say Votiva is a safe and effective treatment option for women who suffer from vaginal laxity, atrophy, and dryness. These symptoms lead to painful or unpleasant intercourse and cause varying degrees of sexual dysfunction.
And, for most women, comfortably having sex again is truly experiencing “vaginal rejuvenation.”
For more information, schedule a consultation to see if you are a good candidate and if Votiva is right for you by calling our Amarillo office at (806) 683-6813.