The FDA cautions against energy-based procedures
In July 2018, the FDA released a statement of concern reiterating the need for research and randomized clinical trials before energy-based device treatments can be widely accepted, and that they are currently cleared only for general gynecologic indications and not for disorders and symptoms related to menopause, urinary incontinence, or sexual function.18
The FDA stated that “we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions [vaginal laxity; vaginal atrophy, dryness, or itching; pain during sexual intercourse; pain during urination; decreased sexual sensation], or any symptoms related to menopause, urinary incontinence, or sexual function.” The FDA noted that serious complications have been reported, including vaginal burns, scarring, pain during sexual intercourse, and recurring, chronic pain. The FDA issued letters to 7 companies regarding concerns about the marketing of their devices for off-label use and promotion.
Several societies have responded. ACOG reaffirmed its 2016 position statement on fractional laser treatment of vulvovaginal atrophy.19 JoAnn Pinkerton, MD, Executive Director of The North American Menopause Society (NAMS), and Sheryl Kingsberg, PhD, President of NAMS, alerted their members that both health care professionals and consumers should tread cautiously, and they encouraged scrutiny of existing evidence as all energy-based treatments are not created equal.20 They noted that some research does exist and cited 2 randomized, sham-controlled clinical trials that have been published.
Various novel technologic therapies are entering the gynecologic market. ObGyns must critically evaluate these emerging technologies with a keen understanding of their underlying mechanism of action, the level of scientific evidence, and the treatment’s proposed therapeutic value.
Radiofrequency energy devices appear to be better positioned to treat urinary incontinence and vaginal relaxation syndrome because of their capability for deep tissue penetration. Current data show that laser technology has excellent promise for the treatment and management of GSM. Both technologies warrant further investigation in long-term randomized, sham-controlled trials that assess efficacy and safety with validated instruments over an extended period. In addition, should these technologies prove useful in the overall treatment armamentarium for gynecologic conditions, the question of affordability and insurance coverage needs to be addressed.
ObGyns must advocate for female sexual wellness and encourage a comprehensive multidisciplinary team approach for offering various therapies. Ultimately, responsible use of evidence-based innovative technology should be incorporated into the treatment paradigm.
Despite recent technologic advancements and applications in gynecologic care, minimally absorbed local vaginal hormonal products (creams, rings, intravaginal tablets) and estrogen agonists/antagonists remain the mainstay and frontline treatment for moderate to severe dyspareunia, a symptom of vulvovaginal atrophy due to menopause. Newer medications, such as intravaginal steroids1 and the recently approved bioidentical estradiol nonapplicator vaginal inserts,2 also offer excellent efficacy and safety in the treatment of this condition. These medications now are included under expanded insurance coverage, and they offer safe, simple, and cost-effective treatments for this underdiagnosed condition.
- Intrarosa [package insert]. Waltham, MA: AMAG Pharmaceuticals Inc; February 2018.
- Imvexxy [package insert]. Boca Raton, FL: TherapeuticsMD; 2018.
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