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.
“The MonaLisa Touch [Cynosure/Hologic] has over 40 published studies and most of them focus on atrophy symptoms, so things like vaginal dryness, itching, pain with intercourse. I think the challenge is when people start touting all vaginal rejuvenation devices for overactive bladder and sexual symptoms like arousal and improving orgasms,” Dr. Ingber says.
Dr. Ingber uses the MonaLisa off-label for treating lichen sclerosus. He says it works well in his experience and there are a couple studies that have shown treatment success for patients with lichen sclerosis.
“So, if the patient with lichens sclerosus has tried the creams, we can present them with the data and say it’s not officially approved for that condition but it may help them. I think that’s reasonable,” Dr. Ingber says. “It is reasonable to tell a patient that a device might help improve stress incontinence. What would be unreasonable is to tell a patient that a device will help SUI, or that a device will improve things that have no data to support the claim.”
Yet, even Dr. Ingber says he has noticed that patients treated with the Votiva (Inmode) for vaginal laxity or mild prolapse after childbirth seem to also experience improved symptoms of mild stress incontinence. To give what he sees in practice some research clout, he has launched an investigator initiated trial funded by Inmode looking at patients with stress incontinence.
Rebecca Dunsmoor-Su, M.D., MSCE, owner and lead physician of RenuvaGyn, in Seattle, Wash., says she purchases and uses devices based on research. Dr. Dunsmoor-Su, an OB/GYN who promotes her practice as offering medical vaginal rejuvenation services, says she uses the MonaLisa Touch laser, but not for aesthetics. Rather, she uses it to treat the indications for which the device has been studied: menopausal symptoms and genitourinary syndrome of menopause.
Making claims that the MonaLisa or any other energy-based device will tighten vaginal tissue or increase sexual pleasure is selling patients a bill of goods and patients’ safety could be at risk, she says.
“I think part of the problem is that now all of these devices are not only sold to gynecologists or urologists. So people use them in practices when they’re not familiar with how to use something like this in the vagina. They may not be familiar with vaginal physiology. Each of these devices are [sic] different. I think most of them are probably harmless when done correctly. But especially when you’re dealing with a laser, you could go too deep if you don’t know how to use it correctly,” Dr. Dunsmoor-Su says.
There are those who say promoting the term vaginal rejuvenation is a sham. Gynecologist and female genital plastic and cosmetic surgeon Michael P. Goodman, M.D., in Davis, Calif., writes in an email to The Aesthetic Channel that he’s not at all surprised by the FDA’s alert.
“There is virtually no evidence-based research on outcome and risk in any area other than usage for post-menopausal atrophic [vaginitis], where there does happen to be a modest amount of data,” Dr. Goodman writes. “There is also anecdotal data on short-term improvement for urinary incontinence. There is decent data on usage for lichen sclerosus. But for ‘vaginal Rejuvenation,’ zip, zilch!”
Dr. Goodman writes that he applauds the FDA for taking a closer look, but suggests FDA’s warning about dangers from these devices might be over-exaggerated.
“… basically these devices are safe, overall, but not necessarily effective,” according to Dr. Goodman. “I personally feel the term ‘vaginal rejuvenation’ is so vague and non-directive as to warrant removal from the lexicon.”
The FDA’s Recommendations, Warnings
FDA has contacted Alma Lasers, BTL Industries, Cynosure, InMode, Sciton, Thermigen and Venus Concept about its concerns and requested the manufacturers address those concerns within 30 days.
Among the companies to acknowledge the FDA’s recent move, Cynosure issued a statement August 2 to its customers. Cynosure suggests the FDA’s letters to each company vary in content, depending on the agency’s specific concerns.
“The letter received by Hologic did not question the safety of the device but did question some of the claims located on our website and whether our existing 510(k) clearances adequately include those claims,” according to the letter. “We are evaluating the concerns raised in the letter and we intend to work collaboratively with the agency to respond to their questions.”
The FDA warns women and providers about what it calls serious concerns about deceptive marketing of unproven treatments. The agency makes it clear that it has not established that energy-based devices are safe for vaginal rejuvenation or cosmetic vaginal procedures, and consumers should understand this means the devices haven’t been cleared or approved for treatment of vaginal symptoms related to menopause, urinary incontinence or sexual function.
The FDA encourages people who have had complications after undergoing vaginal rejuvenation treatment to file reports through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
The government agency recommends the same to providers, and advises those who offer such procedures to talk with patients about the benefits and risks of all available treatment options.
“As part of our Medical Device Safety Action Plan and our ongoing commitment to advancing women’s health, we’ve begun building out important device safety registries. We’ve also established the Women’s Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders,” according to an FDA press release.