This mostly data-free story is by a self-described (on her website) OB-GYN and lifestyle “entrepreneur,” and reads much like a promotional piece for one brand of a growing number of laser-based devices used to treat vulvo-vaginal atrophy.
By some estimates, a majority of women experience vulvo-vaginal atrophy during and after menopause, childbirth, or cancer treatment, and for many, the symptoms can include burning, itching, irritation and pain during sexual intercourse. A host of of medicinal therapies, including the gold standard of low-dose local estrogen, hormone creams, and topical lubricants are available.
Although the article notes the availability of other laser-based device and medicinal options, it makes unsupported claims for the superiority of the Mona Lisa Touch Laser (MLTL), stating “there has not been a successful non-medication alternative treatment option for vaginal dryness.” The rationale offered for such praise is that the other vaginal lasers “don’t have the same track record,” but in fact all of the devices marketed in the U.S. have U.S. Food and Drug approval.
The overall issue for women who want to treat vaginal dryness is that the bar is set very low for FDA approval of devices (in contrast to studies needed to approved medicines), and although the article touts the MLTL as having undergone “long term studies,” the literature suggests that the longest follow up in studies of it and its shelf mates is closer to 12 weeks.
Overall, the device highlighted here has been tested in only a few studies involving a few hundred women worldwide, and long-term effects of using this or any laser to essentially “remodel” the vagina by removing layers of built-up dry skin are unknown.
The “medicalization” of natural aging, particularly for women, is reflected in the tsunami of products, plastic surgery procedures, and diets designed to lure half the population into a forever-young buying frenzy. To be sure, vaginal atrophy can be serious and can interfere with the pleasures of sex and other pursuits, but as the history of estrogen replacement therapy suggests, efforts to beat back the aging process that go beyond healthy diets, exercise, and good hygiene often have unintended negative consequences. Therefore, stories in major news media have a responsibility to proceed with caution about devices like the Mona Lisa Touch Laser, and to make sure that their reporting is evidence-based and promotion-free.
We’ll give the benefit of the doubt here and say that cost was at least mentioned — it said the “unit cost” of a session with the laser of $1,000.
In reality, the overall cost is closer to $2,000-$4,000, and annual follow-up therapies are recommended by practitioners. Moreover, there is no discussion of the cost of the laser in question compared to other laser-based devices, or compared to hormone therapies and lubricants.
There are no actual clinical data cited, even for the two or three modest clinical studies undertaken with the MLLT. All readers are told is that “many women report positive changes after just the first 4-minute treatment,” whatever that means, going on to say “the end result is a vagina makeover.” The only data sets reported are all about the percentages of women who allegedly report vaginal atrophy’s negative impact on their lives (75 percent); who “failed” to recognize vulvar vaginal atrophy as a chronic condition (63 percent) and so on. And none of these percentages is attributed.
Any laser treatment has the potential for additional harm, such as scarring or perforation, but this was not mentioned. Also longer term follow-up for benefits and safety have not been clinically documented nor reported.
The story is very weak on this criterion: What was the clinical evidence? How many patients were studied? Was there a control group? What were the limitations? Nothing is said on the matter.
Several reviews have been done (Medscape has a pretty good one) and the two clinical trials that were reported in the literature were reasonably careful to note that the studies were weakly controlled.
The story could leave the naive reader with the impression that vaginal dryness is a major medical epidemic. It’s important to note that not every women with vaginal dryness has vulvo-vaginal atrophy. We also object to the abbreviation of symptoms that add to the medicalization, in this case “VVA.”
There were no independent sources. We also think the story should have specified if the the author of the story–a self-described entrepreneur–has any commercial relationships with the company, or not.
The article duly notes the alternatives. But this is a barely passing satisfactory, because the story implies that none of these match the value of the MLTL device, which the story describes as a “game changer.”
There are a number of local estrogen delivery methods (cream, suppository, estrogen ring) that are acceptable to women and result in measurable benefit, at a fraction of the cost. Some of these may be safe for some cancer survivors because they result in little increase in circulating estrogen.
Although not explicitly stated, the story suggests the treatment device is widely available.
We’re not sure why this device is being written about now, based on what was included in the story.
We could not locate a news release on the topic, so we’ll rate this N/A. However, the tone of the story is promotional and written in a manner similar to what a company might put out for media attention.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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