Note: Vaginal rejuvenation links are NSFW.
In late July, the U.S. Food and Drug Administration published a statement about laser-based vaginal rejuvenation procedures. These nonsurgical procedures use laser and energy technology to treat a variety of symptoms, including painful sex, urinary incontinence and dryness, as well as vaginal laxity or stretching. The FDA cites a lack of clinical evidence supporting the procedures’ benefits, while calling attention to negative side effects in a small number of reported cases.
“The FDA has reviewed evidence from a total of 29 studies and found a modest rate of adverse events related to these procedures for the relief of menopausal symptoms and stress urinary incontinence,” says Deborah Kotz, a spokesperson for the FDA. They have received 12 reports of “adverse events,” according to Kotz.
What do doctors say about vaginal rejuvenation?
Most laser and energy-based vaginal therapy devices are being used off-label (in other words, not yet FDA-approved to treat conditions they’re being marketed as addressing). These procedures, as with all new treatments, are deserving of more research.
But the doctors we spoke to still consider the treatments to be safe and valid options for addressing vaginal concerns that stem from childbirth, menopause and other changes — including painful sex, urinary incontinence, dryness, and vaginal laxity.
“The laser and energy vaginal devices in question have not been FDA approved for the claims that are frequently made about them, but they work well anecdotally and in clinical practice,” says New York City-based plastic surgeon and RealSelf Chief Medical Officer, Dr. Lara Devgan.
Many cosmetic procedures, which are now FDA-approved — including Botox — began with off-label use and gained popularity before being approved. Doctors seem to be viewing vaginal rejuvenation the same way.
“Vaginal rejuvenation is an off-label use of lasers and energy devices, and formal FDA investigation is needed before the companies can make the marketing claims they are making,” says Dr. Devgan. “But this does not restrict what physicians are able to do, within the parameters of good clinical judgment and respect for patient safety.”
Dr. Jeff Healy, who performs vaginal rejuvenation treatments in his Oahu practice using the ThemiVa, told us “I think the FDA is simply saying they don’t have enough data to confirm the benefits of vaginal rejuvenation. There are not a lot of scientific studies to verify the benefits of treatment, but anecdotally, in my practice, we have had outstanding results with no complications.”
What do the RealSelf reviews say?
On RealSelf, vaginal rejuvenation has a 95% “Worth It” Rating, and some devices have even higher satisfaction. However, the reviews from patients are quite mixed.
One RealSelf user shared a very positive experience with diVa Vaginal Therapy. “I had accepted this idea that sex will be uncomfortable forever and I will pee my pants if I cough, laugh, or sneeze too hard…. I’ve had 2 of 3 treatments. One with numbing cream and one with nothing. EASY PEASY! I now have no discomfort/pain with intimacy, I don’t pee when laughing or sneezing.”
Another user raved about her ThermiVa experience, saying “I had a excellent experience with this procedure. It has changed my life; I highly recommend it. The procedure was a non-painful experience; no complications or side effects. I really didn’t know what to expect with this procedure; I am so thankful I did this.”
Not every experience is so positive, though. Another RealSelf reviewer writes, “I was interested in ThermiVa for minor bladder leakage during coughing or sneezing and to increase sensitivity. I completed my last treatment of three a few days ago. Unless there are results still to be seen and felt, the treatment was a total waste of time and money. The treatments were also somewhat uncomfortable.”
This reviewer was also let down by her procedure, “I am so disheartened! I have had 3 treatments and my symptoms are WORSE than when I started. My husband and I cannot make love at all…it is so painful. This has not helped me and I am extremely disappointed.”
RealSelf isn’t the only place talking about the results of vaginal rejuvenation. Both NPR and Mother Jones have reported on vaginal laser therapy success stories from consumers who were experiencing painful sex and vaginal discomfort.
As with all cosmetic procedures, it’s crucial to do your research. “Women should ask a lot of questions before having any procedure,” says Dr. Healy. “They should do their homework and make sure their physician is board-certified and has a lot of experience performing the procedure.”