By Bill Kress
These days, you just can’t believe everything you read, especially when it comes to your health and well-being – and even more so when it’s about questionable medical procedures in the field of cosmetic gynecology.
So when Urogynecologist Dr. Jaime Sepulveda learned that energy-based medical devices were being falsely touted as FDA-approved for use in so-called vaginal “rejuvenation,” he took it as a call to action – to stress the importance of open and honest dialog with patients considering vaginal cosmetic surgery.
Bogus media reports began surfacing last year describing fractional carbon dioxide laser as “approved” by the U.S. Food & Drug Administration for the treatment of vulvovaginal atrophy. Immediately, the FDA spoke up. The agency issued a stern alert to the medical community in July 2018 that such clams were entirely untrue.
“They came on stronger and swifter that I have ever seen,” says Dr. Sepulveda, “in their warning against the use of lasers in the vagina, under the heading of vaginal rejuvenation.”
The root of the problem, he says, is that marketing terms like rejuvenation, designer-vaginoplasty, and revirgination are giving room to a whole host of procedures that have not been scientifically proven to be beneficial.
A pioneer in his field, Dr. Sepulveda has been conducting cosmetic gynecological for 25 years. He is devoted to providing only evidence based procedures – a principal of his practice that he regularly conveys to his patients.
“At every opportunity, I explain to them what the evidence shows and why evidence is so important. That is what the referring physicians have come to expect,” he says. “And that is why my practice is so successful.”
With a sub-specialty in urogynecology and pelvic reconstructive surgery, Dr. Sepulveda’s practice is located in the heart of South Miami’s medical district at 6200 Sunset Drive.
So not only are women being lulled by marketing lingo into undergoing potentially unsafe procedures, he says rejuvenation is actually a myth!
“There really is no such thing as vaginal rejuvenation and revirgination. What we are really doing, or what we should be doing, is treating conditions that affect the appearance and conditions that affect urogenital function.”
However, based on evidence from other areas of cosmetic surgery, energy based procedures such as laser and radio frequency have been used as a substitute for surgical repairs and established vaginal therapies. But not so fast, said the FDA. Because women with vaginal dryness or prolapse “should not be treated with a lasers under the heading of vaginal rejuvenation.”
Not to say that certain laser systems have not been cleared by the FDA for indications in unrelated medical specialties and dermatology procedures. But the specific indication for the treatment of vulvovaginal atrophy, urinary incontinence or prolapse is not one of them.
Also, to be fair, preliminary observational data have shown some potential benefits with the use of this technology in treating patients with vulvovaginal atrophy, incontinence and prolapse. Anecdotal reports may even seem promising. However, these reports lack long-term follow-up, scientific design with professional scrutiny and do not evaluate the use of concomitant treatments, that is, treatments that take place one after the other.
Additionally, no randomized trials or comparative effectiveness studies have been published in a peer reviewed publication.
The FDA’s conclusion was clear: additional evidence is needed to assess the efficacy and safety of this procedure, particularly for long-term benefit.
What’s the Problem
So the problem isn’t with the idea of vaginal cosmetic surgery. After all, there’s no question women deserve the opportunity to explore options to make themselves look better and feel better.
Instead, it’s the reality that marketing procedures that are not yet proven in the field of gynecological cosmetics exposes women to undisclosed complications.
For Dr. Sepulveda, what stood out most in the report was the specific warning that physicians “should be cognizant of the evidence regarding innovative practices, and should be wary of adopting new or innovative approaches on the basis of promotions or marketing.”
He has long believed gynecologists have an ethical responsibility to provide accurate and current information to patients regarding the efficacy and safety of treatment options in order for them to be fully engaged in the informed decision-making process.
“Suffice to say, my practice does not deal in unproven techniques,” he states. “Notwithstanding, there is going to be space for energy-based devices in gynecological cosmetics, but first we need the studies to support their use.
What a Woman Wants
So what are the top conditions women want to address?
We as a surgical specialty do many reconstructive procedures for women who have a prolapse, that is, a feeling of a vaginal bulge. In fact, one out of 11 women will require a procedure for prolapse in their lifetime. We have also been very good at clearing up urinary incontinence – and in the process, giving self-assurance back to our patients with evidence based procedures.
So what comes next? After all that work, what women often wants next is a cosmetic procedure in the vulva and the vagina. In fact, reduction of the vulva represents about 40 percent of all cases.
“Many patients request a cosmetic procedure to look better once prolapse and incontinence has been treated. It is something that they will share with their partners, something that will make them more like ‘themselves’ again,” says Dr. Sepulveda.
One area that can be fixed is the labia. While it may seem that a redundant labia is a trivial issue, he says noting could be further form the truth. Such issues can seriously impede a woman’s sense of freedom and confidence.
“Simple things like getting onto a spinning bike or going horseback riding – even wearing a swimsuit – makes them uncomfortable in the way they look.”
Reduction labiaplasty, however, is not without risk, he notes. There is risk of disfigurement, bleeding, cutting too much, cutting too little and it has been approached in all different ways, lasers, sutures.
Adherence to sound surgical principles translates into the best results. “Experience makes a difference.”
So before pursuing a vaginal cosmetic procedure, Dr. Sepulveda suggests educated consumers take the following steps:
Do a search to determine the qualifications of doctors. You will want to go with to someone who is board certified, preferably in gynecology
Visit the website of American Board of Obstetrics and Gynecology to see who is certified in the subspecialty of Female Pelvic Medicine and Reconstructive Surgery.
Find out how many cosmetic procedures they do in a month.
Determine what kind of technique the doctor uses. Do they use microsurgical technique? Ask about healing expectations and establish realistic goals.
Find a doctor that best lines up with your goals and expectations.
“Our objective is to provide procedures that have a reasonable level of evidence, reduce the risks and improve the life of women through empowerment in the decision for surgery” says Dr. Sepulveda. “That is why I often say, “in God we trust, all the rest is evidence.’’
Dr. Jaime Sepulveda’s practice is located at 6200 Sunset Drive, Suite 504, in South Miami. For more information, call 305-669-6267 or visit www.miamiurogynecologycenter.com.