Dr. Larkin Discusses Vaginal “Rejuvenation”
Watch Dr. Larkin’s interview with CH 12 Morning News discussing the issue of vaginal “rejuvenation” treatments, and read more in our Q+A below.
- In July, the FDA issued a warning letter about the use of fractional CO2 lasers for “vaginal rejuvenation” and cosmetic vaginal procedures.
- The letter noted that the FDA has not approved these devices for “vaginal rejuvenation” or vaginal cosmetic procedures due to lack of supporting data and cited serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain.
- It’s confusing for patients – it’s not clear when laser treatment might be useful and when it might be harmful.
FIRST, WHAT IS ‘VAGINAL REJUVENATION’?
- Vaginal rejuvenation is not a medical term nor does it address a medical condition.
- It is a marketing term being touted to make women more self-conscious about the appearance of their labia and to promote procedures to address appearance or other claims, such as improving bladder control, sexual function and laxity – all with no data to support these claims.
WHAT IS VAGINAL ATROPHY OR GSM?
- Vaginal atrophy – also known as genitourinary syndrome of menopause (GSM) – IS a real medical condition that warrants medical treatment.
- It includes symptoms such as pain during sex, vaginal dryness, burning and irritation that stem from a loss of estrogen due to menopause.
- There are many OTC products and many FDA-approved therapies that are safe and effective for treating VA/GSM– including low-dose estrogen — that should be first line for the vast majority of women.
WHY SHOULD WOMEN BE CONCERNED?
- Most primary care clinicians are uncomfortable evaluating and treating vaginal atrophy or addressing sexual health- which is one of the reason that only 7% of women with this condition receive treatment.
- These devices do not receive the same regulation from the FDA as medications (medications require randomized placebo controlled trials showing efficacy and safety, compared to devices which have very minimal requirements)
- And, these devices have been marketed and sold to clinicians in various specialties that have nothing to do with women’s health – and clinicians without women’s health training are using them. Women are having these procedures performed by clinicians not trained in examining women or evaluating their women’s health complaints, often without a physical exam, and without adequate information about the lack of data to support the claims or to confirm safety, and possible risks with the procedures.
HOW SHOULD VAGINAL ATROPHY BE TREATED?
- The GOOD NEWS for women is that, after a 10-year gap (post the women’s health initiative data in 2002), in the last 2 years, there are now 3 new FDA-approved products for vaginal atrophy on the market- Intrarosa (intravaginal DHEA), Imvexxy (the new lowest dose soft estradiol gel cap), and Osphena and oral daily medication.
- CO2 laser treatment of vaginal atrophy MIGHT be appropriate for some select women but women must be informed about the limitations in data.
THE BOTTOM LINE?
- We must raise the standard of care for women.
- There are large gaps in care, and unmet medical needs — particularly in areas of menopause management and vaginal health and sexual health.
- Statistics show that despite the availability of safe and effective treatments for vaginal atrophy after menopause, only 7% of women receive treatment.
- Women should be educated and informed. Women should understand that they must have a physical exam by a trained clinician prior to these procedures. If they are not given an exam, they should be concerned. They should also ask questions about the specialty and training of the person performing the procedure. And women should ask if there are other options they could consider that might also be effective and covered by their insurance.