U.S. Food and Drug Administration (FDA) Clearance of CO2 lasers:
Genitourinary syndrome of menopause (GSM), previously known as vulvovaginal atrophy (VVA), is a condition affecting postmenopausal women, which usually includes vaginal dryness, burning, itching, irritation, urinary incontinence, dysuria (pain with urination) and dyspareunia (pain with sexual activity). Standard therapies include vaginal moisturizers, low dose topical estrogen, and selective estrogen receptor modulators. Patient compliance can be low due to numerous factors: cost, inconvenience, method of application, safety concerns, etc. Topical estrogen is currently considered the gold standard therapy for GSM; however, patients and providers are seeking out more affordable, convenient, durable, effective, non-hormonal management options.
For years the CO2 laser has been broadly used in the field of dermatology for the treatment of skin. The CO2 laser fractional micro-ablative technology has been shown to remodel the vaginal connective tissue with the production of new collagen and elastic fibers without tissue damage, which can improve the symptoms of GSM.
On July 30th, 2018, the FDA sent out a warning against the use of energy devices (laser therapy) to perform “vaginal rejuvenation” because of worries about adverse events. Typically, the term “vaginal rejuvenation” applies to procedures that are primarily for cosmetic purposes. “Vaginal Rejuvenation” procedures are elective without a clearly defined medical purpose.
The FemiLift/Pixel CO2 laser system along with the Focusing and Pixel handpieces are cleared by the FDA under K103501 for laser “ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee).”
CO2 lasers are FDA-cleared as safe to use; however, they are not specifically FDA-cleared for treatment of GSM. Throughout the medical literature, therapy using CO2 lasers has been documented as an appropriate and efficacious treatment for GSM; therefore, this is currently an “off-label” use of a device. Within medicine, there are many drugs and devices that have shown to have medical benefit for “off-label” uses. More than 20% of pharmaceutical prescriptions are filled for “off-label” conditions. In addition, “off-label” use of medications and devices has often led to FDA-approval of new therapies (including the most popular class of erectile dysfunction drugs, which were initially studied as a treatment for high blood pressure and chest pain).
In a large case series by Filippini et al, 386 menopausal women with GSM were treated with 3 sessions of fractional micro-ablative CO2 laser. There was resolution of dryness in 60%, vaginal burning in 56%, dyspareunia in 49%, itching in 56%, soreness in 73%, and vaginal introital pain in 49%. These effects were reported after the first session and continued for 1 year after the final session. Most studies report only “minimal” risks, and the procedure is performed in an outpatient setting. The articles mention that most women report some slight redness, swelling, and/or “some discomfort” that disappears within 1 to 2 days. Currently on RealSelf.com, the FemiLift CO2 Pixel laser has a “Worth It” rating of 93%.
Unlike vaginal estrogen, the CO2 laser has additional benefits such as treating lichen sclerosus, potentially removing the need for chronic high-potency topical steroid use. In addition, the CO2 laser has shown promise in the treatment of overactive bladder symptoms and stress urinary incontinence. CO2 laser could create a low-risk alternative to surgery for women seeking other treatment options.
A few additional factors to consider are the specific laser and the type of provider. CO2 lasers should not be confused with radiofrequency (RF) devices, in which the energy waves are less focused and can cause more collateral damage and potential side effects. Also, seek out treatment by a board-certified physician, who can provide a thorough consultation about the risks, benefits, and side effects of this procedure. Adverse events are more likely to occur if the procedure is done in a non-medical setting by providers without enough experience in laser use.
It is important to note that the criteria for FDA device clearance are much less stringent than for drug approval, and that the clearance for the CO2 laser was as described above and not specifically indicated for use in GSM. FDA device clearance does not require the large, double-blind, randomized, placebo-controlled trials with established efficacy and safety endpoints required for the approval of new drugs. We agree with the FDA that these devices need continuing/longitudinal studies, development of clear indications, appropriately informed patients, and skilled and ethical physicians to be used safely.
This is an important time for women’s health, which has been hindered in the past by hesitance to openly address women’s reproductive and sexual health concerns. We do not want this FDA statement to limit the availability of innovative therapies, which when used correctly may benefit women’s reproductive health.
The FDA should not equate “vaginal rejuvenation” cosmetic procedures with innovative therapies that may improve women’s quality of life. The FDA was right to be looking out for women’s health, but we hope that the warning does not scare or deter women from seeking information about alternative therapies that could potentially help.