A recently published article in JAMA (Journal of the American Medical Association) cast doubt on the efficacy of laser treatment for genital syndrome of menopause (GSM), and specifically the symptoms of atrophy.
This well designed study was done in Australia, and involved a comparison between patients treated with CO2 laser, sham (fake) laser treatment, and estrogen. Although this would naturally raise concern amongst women who have chosen this treatment, I would like to put the matter in some context. On the other hand, two recent studies show that the Fotona Erb Yag laser is highly effective for the treatment of urinary incontinence.
Vaginal estrogen is a well-established treatment for urogenital atrophy, and until about ten years ago, was the only available treatment for this condition, and it is still the most common treatment. This is in spite of the fact that we have little high quality evidence of its efficacy. Stating this is not at all the same as saying it doesn't work, but there is little hard science backing up its use. More on this later in this essay.
Atrophy is a condition that develop in almost every postmenopausal woman, whether menopause is natural, or caused by surgical removal of ovaries, or ovarian failure from other causes for instance chemotherapy. One of the main problems with estrogen is that not everyone can safely use it. Most breast cancer survivors, or women who have a high risk for thrombotic events, cannot use estrogen. Also, using vaginal estrogen is sometimes messy, and is always a bit of a proverbial pain. No wonder one large study found that only ten percent (TEN percent!) of women continue with the treatment after one year, despite the negative effects of discontinuing the treatment.
As a result of the problems, inconvenience and inability or unwillingness of large numbers of woman to use estrogen, there was a great need for a new treatment modality for vaginal atrophy.
Enter the Fotona company. Fotona is the oldest and largest laser company in the world, with lasers used in every conceivable industry (industrial, military, telecommunications, medical). The company has large research facilities, with their main medical research facilities in Italy. In the early 2000s, they started researching the effect of Erbium laser on human tissue. This led to the development of clinical applications in a variety of medical fields including Women’s Health and cosmetics. Eventual approval was received almost globally, for use of their Erbium Yag laser for cosmetic procedures, as well as for treatment of vaginal atrophy, stress urinary incontinence, and vaginal tightening. Treatments were launched after extensive laboratory and initial confirmatory human clinical trials of safety and efficacy. Since then a relatively large body of evidence has confirmed these initial findings.
To date, there is overwhelming clinical and trial evidence of efficacy in cases of stress incontinence, with large studies out of Japan showing that this laser (Fotona Er Yag) is equally effective than sling (mesh) surgery, but without any of the risks of the surgery. (Okui N, Miyazaki H, Takahashi W, Miyauchi T, Ito C, Okui M, Shigemori K, Miyazaki Y, Vizintin Z, Lukac M. Comparison of urethral sling surgery and non-ablative vaginal Erbium:YAG laser treatment in 327 patients with stress urinary incontinence: a case-matching analysis. Lasers Med Sci. 2021 Apr 22. doi: 10.1007/s10103-021-03317-x. Epub ahead of print. PMID: 33886071). Here is another recent research article showing high efficacy for the treatment of urinary incontinence: (https://www.ics.org/2021/abstract/218)
There is also evidence for the treatment of atrophy and tightening, with applications for these conditions, including for mild to moderate prolapse. I personally have hundreds of satisfied patients, some of whom have been coming for their maintenance follow up treatments for years. Their testimonies leave me with absolutely no doubt that it works.
Enter CO2 laser:
Fotona has patents on Erbium laser. They were the first to study and develop laser solutions for gynecological issues. In time, other, competing (and generally much smaller) companies who only had access to other types of lasers, but not Erbium, recognized that the market demand for these treatments were huge, and they developed a serious case of FOMO (fear or missing out). Since most of them could not develop Erbium lasers, they tried to make a square peg fit a round hole, by computer control of the much more dangerous and much older technology CO2 lasers. Basically, what happens in these lasers (for instance Mona Lisa Touch), is that a computer cuts the beam off before it manages to burn too deeply. But the fact is that CO2 needs to burn into the tissue to reach a deeper level. Erbium laser, in contrast, can go right through the surface layers (like radio waves), reaching the required deeper layers usually WITHOUT damage to the surface. Erbium also has a proven effect of causing contraction of the collagen fibers, whereas CO2 beams basically just burn through.
A few years ago already, the FDA warned about the fact that lasers are dangerous, and complications are more common than appreciated. As far as vaginal treatments were concerned however, it is extremely important to realize that they were talking specifically about CO2 laser. Erbium laser was not even mentioned. The recent popular press articles mentioned these FDA warnings but did not clarify this important fact.
As far as the current controversy is concerned: The Australian study throws doubt on the clinical efficacy of CO2 laser (like Mona Lisa Touch) for vaginal atrophy. ONE study, ONE specific laser and ONE specific indication.
It has NOTHING to say about the use of laser for any other indication. And if we are fair and use a scientific approach, we must admit that the study cannot, and does not even say ANYTHING about whether Erbium laser may or may not be effective for atrophy specifically, and is completely irrelevant to use of Erbium for other indications. It is like butter vs margarine; one may be better, but we just don’t know for sure, since the results of many studies are often contrary to every other previous study. We just received a study showing butter is no-good. That doesn't mean the same is true for margarine, and fortunately I like and use margarine (proverbially).
I will admit that this study results are disappointing, but on the other hand, it does make me again appreciate my original decision to invest in Fotona Erbium technology, and NOT in a CO2 laser. CO2 lasers have their place. It is however perhaps just not the best tool for these indications.
We must keep in mind that this is how science generally progresses. One study shows this, the next shows that. Eventually, over a long period of time, the truth emerges. I cannot even tell you HOW MANY studies have found commonly performed surgical procedures to be of no value whatsoever. This is true even in, and I’d say, ESPECIALLY, in urogynecology for things like prolapse, incontinence etc. What is in no doubt, however, is that many of these surgical procedures have risks, sometimes serious risks. Are we thus to stop doing most surgical procedures for prolapse, incontinence etc. every time a new study shows that it is not effective? That is not how the world of medicine works. If we must change everything after each contrary published study, we will all be psychotic and there will be no options for patients. Furthermore, there is also little quality evidence even for the use of vaginal estrogen for atrophy, but we have used estrogen for decades. There is also little quality evidence for physiotherapy, including especially pelvic floor physiotherapy, for many of the indications that we routinely recommend physiotherapy for. I am a big proponent of physiotherapy, but this just again proves that clinical practice is often not the same as research. Medicine is an art, as well as a science, after all.
We build the case for knowledge over time, evaluating new evidence considering what we know from previous evidence, personal experience and patient reports and outcomes. Randomized controlled trials, though considered the ‘gold standard’ in the world of scientific inquiry in medicine, do have their problems and are not always relevant to clinical practice. Their truth is one type of truth, not always considering all factors. One simple fact is that it does not answer the question: If not that, then WHAT? What are the alternatives? In some cases, the alternatives are worse, or completely unacceptable, or abcent altogether. Do we just stop everything because of questions? Of course not.
Having said that, we certainly must question our prejudices and beliefs, and be prepared to change our opinions and practices according to emerging evidence, wherever that eventually leads us to.