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http://www.shmirshky.com/wp-content/uploads/2014/02/Ellen_Dolgen_Menopause_Monday.jpgFor most of us, when we hear the words Mona Lisa, we think of the portrait of a woman by the Italian artist Leonardo da Vinci. The portrait is of Lisa Gherardini, the wife of Francesco del Giocondo. However, it appears there is a new MonaLisa that is quite the talk now. It is called, the MonaLisa Touch (MLT).

This MonaLisa doesn’t hang in the Louvre Museum in Paris! It is a laser device for the vagina! In the spirit of full disclosure here, I am probably one of a very few 62 year old women who has yet to laser her face, let alone her vagina!

I have been inundated with questions about this new device from women who are experiencing vulvovaginal atrophy (VVA) – atrophic vaginitis or as laypeople call it, dry vagina. VVA is very common for post-menopausal women, many breast cancer survivors, and women who have had a hysterectomy. If you are experiencing vaginal atrophy, you are not alone! VVA is estimated to affect over 50% of post-menopausal women.
Mona Lisa
When it comes to the vagina, thin is out! Finally, a body part that is supposed to be fat and plump! VVA can result in the walls of the vagina becoming thinner, pale, and the natural elasticity and blood supply is reduced. The vagina can lose hydration and thickness causing a loss of lubrication – basically disrupting the natural pH balance of the vagina. The vaginal canal shrinks and becomes inelastic and more prone to trauma. This can result in itching, burning, painful sex, and chronic UTI’s. Oh joy!

I reached out to the following doctors to get their take on the MonaLisa Touch laser:
Dr. Michael Krychman* is the Executive Director of the Southern California Center for Sexual Health and Survivorship Medicine Inc. in Newport Beach, CA. Dr. Krychman co-authored a recent in depth review for North America Menopause Society and subsequently republished by Medscape.
Dr. Steven A. Rabin* owns the MonaLisa Touch laser and is currently performing these treatments in his office in Burbank, CA. In addition, he is a national trainer for the MLT.

Think of me as your laser-focused vagina reporter! Ready……..here we go………

The MonaLisa Touch laser is designed and produced by DEKA (Italy) and was approved by the FDA for non-specific gynecological procedures, December 2014. Dr. Rabin purchased his MLT in December 2014. The machine is estimated to cost, $175,000 in the United States.

Rabin explained how the treatment works, “Fractional CO2 treatment applies tiny laser pulses into the treated area. The columns of laser energy stimulate the surrounding tissues to rush in and heal the areas, bringing in several growth factors, new blood vessels, new collagen, and elastin. Treating vaginal atrophy in this way, we are able to restore pre-menopausal metabolic activity with the new synthesis of collagen, hyaluronic acid, glycosaminoglycans (I looked this up in an English dictionary, but it is still Chinese to me!) and proteoglycans. The evidence shows a hydrated and restored mucosa which then functions as healthy younger tissue. It’s more elastic and resilient. It is less prone to trauma, and irritation.”

Dr. Rabin went thru the steps of this in-office procedure:

  • In preparation, patients refrain from using any lubes or products for at least 3 days before the procedure.
  • There is no need for painkillers or valium, etc.
  • A slender vaginal probe is inserted to the full depth of the vagina. (It does not matter if the patient has had a hysterectomy or not.) The probe is retracted 1 centimeter at a time. At each centimeter level, the probe is rotated and the laser is activated at the 12, 2, 4, 6, 8, and 10 o’clock positions.
  • The whole process takes about 3-5 minutes. Dr. Rabin indicates that none of his patients have complained of pain, and they have never had to stop a treatment due to discomfort.
  • The recovery is brief – no hot baths, no strenuous activity and no sex for 2-3 days.
  • Although rare, there can be a brief healing discharge which may last for a few days.
  • The prescription is for three treatments, six weeks apart and then a single maintenance treatment once a year.

Dr. Rabin treated his first patient, January 2015. He explained that she was a 50 year old breast cancer survivor who had taken breast cancer protocol medications to shut down her estrogen and, subsequently, she had her ovaries removed. Not surprisingly, she developed severe vaginal atrophy, dryness, pain tenderness and vagina narrowing. She was unable to be comfortable just sitting or walking… and sex was impossible. Even the small probe was a little tight on the first treatment. After her second MLT treatment (6 weeks later), she reported that she was able to engage with her husband just 9 days after her first treatment. Sex was comfortable and enjoyable. It was their first time having intercourse in over 5 years.

Krychman’s review points out that although laser companies claim on their websites that the CO2 fractional laser may be a treatment for a variety of postpartum/lactational incontinence, and dyspareunia in women with breast cancer, there is no published data on these unique patient populations, nor are there any high-quality clinical trials to support these claims. He, also, noted that the criteria for device clearance are much less stringent than for drug approval. Device clearance does not require the large, double-blind, randomized, placebo-controlled trials with established efficacy and safety endpoints required for approval of new drugs.

Many health care professionals remain skeptical of the FDA approval process altogether, so I asked Dr. Rabin to give me his take on the established regulations on how this new technology was cleared for use.

He replied, “The safety of the fractional CO2 laser has been long established in the medical literature and for procedures on the face, neck and other parts of the body. In this case, this specific fractional CO2 laser machine was already approved and has been in use here in the United States for other uses for years. It has a great track record of safety. Showing that it is also safe and effective to treat the vaginal sidewalls for atrophy was done convincingly and the FDA approved it.”

Again, it is important to note that the MLT is not approved specifically for the treatment of VVA but rather for non-specific gynecological conditions. Many doctors feel that although it has been studied in other bodily areas, it still has limited data when used on the vulvovaginal tissues. Of course, the vagina is not the face. You may want wrinkles in your vagina or ridges and folds whereas on the face……not so much.

Rabin stresses that while the MLT laser is new here in the USA, there are tens of thousands of women worldwide who have already safely benefited from the procedure.

Krychman cited the following published studies:

  • An abstract presented at the 2011 International Continence Society in Glasgow, where they reported that an analysis of eight vaginal specimens from four women who underwent Co2
    fractional laser treatment. Light and electron microscopic evaluation demonstrated remodeling of vaginal connective tissue without damage to surrounding tissues.
  • There was a follow-up pilot study performed on 50 postmenopausal women with symptoms related to VVA (vulvovaginal atrophy) who were dissatisfied with their previous local estrogen
    therapies. A three-laser application improved the most bothersome vulvovaginal symptoms in this 12 week study. However, changes in pH and what they call the “vaginal maturation index
    are not specifically mentioned. The study had a small size and short duration, without any long term follow-up of the patients.
  • Another study of 15 patients with a 12 week follow-up demonstrated improved dyspareunia related to VVA.

The data cautions that these short-term studies do not address the potential long term complications that could be possible in the vagina, such as scaring. The studies certainly have some short comings including lack of monitoring for concurrent use of vaginal hormonal or non-hormonal products or systemic medications that could have contributed to the observed improvement with laser treatment.

Most health care professionals agree that larger powered studies, with more patients who are followed for longer periods of time are needed with newer very expensive technology.

When asked about the short and long term risks of scarring or damage to the vagina tissue, Dr. Rabin responded, “Fractional CO2 laser used on vaginal tissues has proven to be safe. Since its first use in 2008 there have been no problems identified with it. When used with the recommended settings and techniques, we do not expect nor have we seen any damage. Laser stimulates a natural healing process that wakes up these cells and gets them back to work creating more moisture, elasticity and vitality. There is less risk and no apparent scarring with fractional CO2 laser as compared to the way CO2 laser used in the past for cutting and vaporizing tissues. With many years of experience using fractional CO2 laser on the face, neck and other areas, this is a safe and proven technology.”

Contrary to our shoe budget, most of us don’t have unlimited $’s budgeted for our vaginas, so I asked Dr. Rabin about the cost/benefit of this procedure over using LET (local estrogen therapy). Dr. Rabin charges $2400 for the series of three laser procedures. He mentioned that he does offer some payment plans when circumstances make that necessary. He did note that the initial series costs may range from $1800 – $3000+ depending on the practitioner.

Like Dr. Rabin, many laser practitioners are advocating a repeat procedure “tune-up” (for an additional fee) at the one year mark. Dr. Rabin explained that this single once a year maintenance can vary from $600 – $1,000 for a year. He is charging $800.

Krychman states that there is not data to support that this repeat procedure is medically warranted, necessary or even safe. Currently, this procedure is not covered by insurance and remains a very expensive fee for a service procedure.

I reached out to Rite Aid Pharmacy to get some specific comparative pricing for LET (Local Estrogen Therapy):
Cream -1 tube is $174.54 (some women need one a month- some less) = $2,094.48 per year
Tablets -1 box is $166.59 (usually lasts a month) = $1,999.08 per year
Ring – 1 ring is $317.89 (usually lasts 3 months) = $1, 271, 56 per year

Dr. Rabin pointed out that it is often not a simple choice of LET vs. MLT. The four circumstances where MLT should be considered to solve the symptoms of vaginal atrophy are:

  1. Women who are advised to avoid all estrogens.
  2. Women who prefer not to use any hormones at all.
  3. Women who are using systemic and/or local vaginal estrogen (LET) and are not getting relief of their vaginal atrophy symptoms.
  4. Those women who are not happy with the need to use vaginal products week after week, and find the creams to be messy or irritating.

Dr. Krychman continues to stress that the laser technology holds excellent promise for the future of VVA treatment, however, further long-term efficacy and safety data should be collected before fully embracing this expensive, uncovered by health insurance, new technology. In addition, I chatted with two menopause specialists, one in San Francisco and one in New York who told me that they were not yet ready to recommend the laser, but rather they were taking a wait and see approach.

I have always been curious about that look in the Mona Lisa’s eyes. Now I understand, it is because they are so laser!

Click here to download my free eBook, MENOPAUSE MONDAYS: The Girlfriend’s Guide to Surviving and Thriving During Perimenopause and Menopause.

Suffering in silence is OUT! Reaching out is IN!

*Disclosures:
Dr. Krychman reports: Consultant/Advisory Board: Palatin, Pfizer, Shionogi, Sprout, Noven, Viveve Medical Materna.
Dr. Rabin reports: Speaker’s Bureau: Ascend, Cynosure

 

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