In late July, the FDA released a safety communication warning against the use of energy-based devices to treat a host of vaginal conditions and symptoms that fall under vaginal “rejuvenation.” The purpose of the FDA communication was to “Alert patients and healthcare providers that the use of energy-based devices to perform vaginal ‘rejuvenation,’ cosmetic vaginal procedures, or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events. The safety and effectiveness of energy-based devices for treatment of these conditions has not been established.”
The FDA’s focus is on nonsurgical procedures providers perform to treat vaginal laxity; vaginal atrophy, dryness or itchiness; pain during sexual intercourse; pain during urination; decreased sexual sensation; and more.
In fact, there are no energy-based devices FDA cleared or approved to treat these or any symptoms related to menopause, urinary incontinence or sexual function. What’s worse, using energy-based therapies to treat these symptoms or conditions could lead to serious burns, scarring and pain, according to FDA.
While the government communication might seem scary, providers shouldn’t worry about the FDA raiding their practices. But they should take note of one thing, according to Jay D. Reyero, an attorney with ByrdAdatto, a firm in Dallas and Chicago that specializes in healthcare law.
“The FDA does not have any control over a physician’s ability to prescribe ‘off-label,’ which in this case would be when physicians are using the energy-based devices to perform vaginal rejuvenation procedures,” Reyero writes in an email to The Aesthetic Channel. “Although the particular devices are approved by the FDA, they are approved for a very specific use, which is not the performance of vaginal rejuvenation procedures. What is important for med spas and other healthcare professionals to understand is that such ‘off-label use’ is subjected to the oversight of their medical boards.”
Reyero writes that, at this point, it’s important for med spas and providers that provide vaginal rejuvenation options or are thinking about adding these services to practice to review how they are or will be performing these procedures.
“Not only should the physicians or medical directors responsible for performance of the procedure be properly trained and qualified for it specifically, but they should also have a good understanding of any available scientific and clinical data relating to the procedure in order to, in their professional judgment, determine it safe for patients,” Reyero writes. “In addition, they also need to confirm they are meeting the supervision required of those healthcare practitioners providing the medical services. Finally, they need to ensure patients are being fully informed and understand the risks about the procedure and that all information communicated satisfy state medical board rules and laws, including those relating to advertising.”
What’s Next for ‘Vaginal Rejuvenation’?
Jason Emer, M.D., a cosmetic dermatologist who offers vaginal rejuvenation services at his West Hollywood, Calif., practice isn’t planning to change practice but encourages more research, patients’ reporting of any harm from the procedures and being upfront and honest with patients about the lack of research.
“The issue here is that everyone knows [radio frequency] technologies and lasers help tighten skin, improve function/blood flow and overall quality. It makes sense it would help genital areas, and for years I have been doing this treatment despite claims. I don’t think it should change what we are already doing because patients are happy and getting amazing results,” Dr. Emer writes in an email to The Aesthetic Channel.
There are reasonable and unreasonable ways to promote off-label uses of devices, according to Michael Ingber, M.D., a urologic and female pelvic medicine and reconstructive surgeon practicing in Denville, NJ.
It’s important that providers tell patients when there is and isn’t data to support a specific indication.
Dr. Ingber is a speaker for Hologic.
Dr. Emer has ties with Cutera, BTL Aesthetics, Inmode, Bovie, Solta/Valeant, Eclipse, Aerolase and Venus.
Dr. Dunsmoor-Su: none.