Is Vaginal Rejuvenation Safe?

By: Dr. Kathleen Welsh

12/15/2018

As a cosmetic dermatology practice, we talk about collagen and the loss of it a LOT. How collagen breaks down as we get older, how sun damage expedites the process, how losing it leads to fine lines, deep wrinkles and laxity. Most of us are fairly familiar with this concept and while collagen loss is a normal part of aging, we’ve found some pretty incredible solutions haven’t we? Fillers, topical products, laser and radio frequency treatments can all help to restore lost collagen resulting in tighter, firmer, more vibrant skin.

Just like the rest of the body and due to genetics as well as life events such as childbirth, the collagen of the vaginal walls also age. Distressingly for some, this specific type of collagen loss can manifest in uncomfortable side effects including dryness, urinary incontinence, pain during intercourse and vaginal laxity.

WHAT IS URINARY INCONTINENCE?
In fact, it’s reported that stress urinary incontinence affects an estimated 15 million women in the US.

For many years, I’ve had patients come to me asking if there was anything they could do for these symptoms. And for many years I haven’t had an answer. However, the industry is finally catching up to the need we’ve recognized for so long and we’re beginning to see real results.

After a comprehensive period of review and research, I brought on the Geneveve by Viveve. There are a number of reasons why we chose Geneveve over other non-surgical devices:

  • Geneveve requires only a single treatment versus other devices that require a series.
  • It is non-ablative, which means no pain and no downtime for our patients.
  • It is safe. After large-scale clinical trials, no serious adverse reactions were reported.
  • It is the ONLY device currently seeking FDA approval for treatment of sexual function.

The last bullet point is especially important in light of news coming out this past summer. In July of 2018, the FDA sent a warning letter to seven medical device companies describing complications patients have experienced when undergoing vaginal rejuvenation therapies. You can read the full warning letter here. The FDA outlines some pretty scary stuff including vaginal burns and lasting, chronic pain. When it comes to our most sensitive bits, this information is especially disconcerting.

Various press coverage of this letter from the FDA has understandably resulted in a lot of confusion among patients who may be considering vaginal rejuvenation options. We take FDA recommendations and warnings seriously and they help us to make educated decisions for ourselves and our patients.

We are also a woman owned and operated business. As such we are uniquely committed to exploring and vetting treatments - that when used correctly - specifically benefit women’s reproductive health concerns.

We also believe we don’t see near enough research or development in this area and are excited when new treatments become possible. We mitigate this enthusiasm for new treatments (which believe us, there have been many including ablative vaginal treatments that we’ve never brought into our practice) with the tried and true methods of extensive research.

So are vaginal rejuvenation therapies safe?
The answer is like any laser or RF (radio frequency) device, many are safe, and safer yet when in the hands of a trained professional who knows exactly how to administer the energy. I personally researched all of the vaginal rejuvenation technologies currently available. I underwent a procedure myself feel confident in the safety and efficacy of the device we now offer our patients, the Geneveve Vivive.

Geneveve Vivive was not included in the mailing of the FDA’s warning letter. The specific technology the Viveve uses is cryogen-cooled monopolar radiofrequency (CMRF) that uniformly delivers gentle heating while simultaneously cooling delicate surface tissue. Although radio frequency is a heat based treatment it is non-ablative and is not a laser. Radio Frequency is a technology we are intimately familiar with as we have used RF devices for tightening skin on the face and body for well over a decade.

At Bay Area Cosmetic Dermatology, our expert provider is Garrett Forrest, PA-C. She has trained extensively with the Geneveve device and has performed many Geneveve treatments since we brought the technology on last year. For most patients, the Vivive is a comfortable, single in-office treatment and does not require local or topical numbing medication. There is no down time and patients are seeing some truly inspiring results including reduced dryness, reduced incontinence during exercise (or even just laughing too hard!), increased sexual pleasure and more.

If you have questions about vaginal rejuvenation, concerns about the FDA warning letters or would like to set up a consult with Garrett to determine if you are a candidate for Geneveve, please contact us. We have a team of women waiting to help.

* All information subject to change. Images may contain models. Individual results are not guaranteed and may vary.