Abstract and Introduction
Objective: The treatment of genitourinary syndrome of menopause (GSM) includes prescription hormone therapy, nonhormonal over-the-counter products, and most recently, laser treatment. Although the Food and Drug Administration has cleared fractional carbon dioxide (CO2) laser for a variety of dermatologic and gynecologic indications, lasers have not to date, been approved for use for vulvar/vaginal atrophy, or sexual dysfunction.
Methods: Four case studies that were referred to a tertiary sexual medicine center regarding laser treatment complications for GSM are reported. Patient data were Health Insurance Portability and Accountability Act of 1996 protected and informed consent was obtained by all patients.
Results: Four cases are presented, which demonstrate complications after completion of three consecutive laser treatments for GSM. Case 1 is a 65-year-old woman with GSM and moderate vaginal stenosis who had two vaginal wall lacerations after resumption of intercourse. Case 2 is a 61-year-old woman who had persistent dyspareunia following vaginal laser treatments. Case 3 is a 68-year-old woman who reported worsening dyspareunia and had a fibrous band mid vagina that impinged on the canal. Case 4 is a 55-year-old woman who complained of dyspareunia and insertional pain, after her laser. Assessment and follow-up treatment are presented.
Conclusions: Laser therapy for the vagina shows excellent promise for the treatment of GSM in some women; however, complications such as fibrosis, scarring, agglutination, and penetration injury have been documented. Food and Drug Administration–approved products for GSM should be considered frontline treatments until long-term, prospective, randomized, sham-controlled trials are conducted that confirm efficacy and safety for device treatments.
Genitourinary syndrome of menopause (GSM) is the novel term, which encompasses a constellation of vaginal, vulvar, and clitoral symptoms including the historical term vulvovaginal atrophy (VVA). The decline of estrogen affects many genital tissues including the clitoris, vulva, vagina, and the trigone of the bladder and this process is characterized as a chronic and progressive condition that many women endure. Although menopause is heralded as the most common underlying etiology for hypoestrogenic state, women who are lactating or taking a variety of medications can also suffer from a progressive estrogen-deprived condition characterized by thinning of the vaginal epithelium, decreased vascularity and elasticity, and reduced genital lubrication. These physiological changes can lead to symptoms of vaginal dryness, pruritus, pain, irritation, dyspareunia, decreased sexual pleasure, and decline in overall function.[2,3]
Approximately, 40% to 80% of postmenopausal women endure GSM symptoms. Currently there are many available treatment approaches for this medical condition, including hormonal medications, nonhormonal pharmacologic treatments, and behavioral modifications. From a regulatory perspective, there are a plethora of Food and Drug Administration (FDA)-approved options including: minimally absorbed local estrogen creams, rings, intravaginal tablets, and ultralow teardrop vaginal inserts. Oral selective estrogen receptor agonist/antagonists and the steroid intravaginal prasterone have also been approved for moderate to severe dyspareunia a symptom of VVA due to menopause. The use of laser treatment for the management of GSM has, however, gained physician popularity.
Multiple media outlets having highlighted vaginal laser treatment as "the next best thing" in treatment of vaginal and vulvar atrophy.[6,7] The FDA cleared the fractional CO2 lasers for a variety of dermatologic and gynecologic indications in 2014 and health care providers began embracing and utilizing CO2 or Erbium-YAG laser for the management and treatment of GSM and painful intercourse.[8,9] Most published literature indicates no adverse events and/or no complications. However, prospective, randomized sham-controlled data remain sparse. Although this technology shows wide utilization and excellent promise for the treatment of VVA and other conditions, proper trials which follow patients to confirm safety and efficacy of this new technology are needed before rapidly embracing it into medical practice.
No advancement in science is without a learning curve and as advocates for women's health, providers must critically examine the evidence for efficacy safety and adverse events. This report summarizes four separate cases of observations following laser treatment which have been seen in a tertiary referral sexual medicine center. These medical complications have been linked to their laser treatment.
Menopause. 2019;26(4):423-427. © 2019 The North American Menopause Society