Article: The buzz around MonaLisa Touch

Contents

FDA Alert

The FDA issued this alert in July, 2018 noting that laser or radiofrequency or laser devices that have received FDA clearance are ONLY cleared for treating abnormal or pre-cancerous cervical or vaginal tissue and genital warts and have NOT been approved for vaginal rejuvenation. The FDA issued warnings to companies marketing their devices to treat vaginal atrophy or other vaginal symptoms of menopause. 

Why is this relevant for cancer survivors?

Many young cancer survivors are at increased risk for premature menopause following treatment for cancer. Women at high risk for cancer undergo early menopause as a result of risk-reducing surgical removal of their ovaries. While the research suggests that hormone replacement is safe for most young previvors after risk-reducing surgery, some may be reluctant to take hormones. Systemic hormone replacement is not recommended for breast cancer survivors.

Women may feel uncomfortable bringing up sexual concerns with doctors and may be unaware that of medical options for treating sexual side effects from cancer treatment or prevention exist. These women may suffer from a medical condition known as genitourinary syndrome of menopause, or GSM, brought on by a decrease in sex hormones and a change in the vaginal pH (acidity). GSM symptoms include vaginal dryness, shrinking of tissues, and itching and burning, which can make intercourse painful. GSM affects up to half of post-menopausal women, and can contribute to bladder and urinary tract infections as well as incontinence.

Normally, doctors recommend lubricants and vaginal creams to reduce symptoms related to GSM as the first treatment for women who have medical reasons to avoid systemic hormones. For those whose symptoms persist, vaginal estrogen therapy is often recommended. Indeed, several societies, including the American College of Obstetricians and Gynecologists suggest that vaginal estrogen can be used, even for women treated for breast cancer. Still, women with, or at high risk for breast cancer may be worried about taking any form of estrogen, especially if they were diagnosed with a hormone receptor-positive breast cancer. For these patients, interest in the MonaLisa Touch has blossomed.

What does MonaLisa Touch do?

The MonaLisa Touch is a carbon dioxide laser specifically designed to treat vaginal tissue. Similar to laser facial treatments, the procedure uses lasers to make micro-abrasions or tiny scratches in the vaginal wall, which stimulate growth of new blood vessels. The treatment is reported by the manufacturer to be nearly painless and takes about five minutes. It requires several sessions and a "booster" session every 18 months or so. MonaLisa Touch is a medical treatment, not a “vaginal rejuvenation” procedure, which would instead promote tightening and be considered a cosmetic procedure. The Food and Drug Administration approved MonaLisa Touch as a medical treatment in 2004.

In the 2017 FOX News article "Is Laser Treatment for Vaginal Atrophy Safe?" the author outlines some of the benefits, costs, side effects and long-term implications associated with the procedure.

The author notes one of the major benefits of MonaLisa Touch is the procedure requires no anesthesia, and most patients can resume normal activity after undergoing a treatment. There are side effects reported for women who undergo the laser treatment. These are mostly minor and may include itching, burning, redness, or swelling immediately following the procedure.

A big concern for anyone considering this procedure is that most insurance companies do not cover the MonaLisa Touch procedure and patients must pay an average $2,400 out of pocket to receive treatment.

Limitations and long-term implications

The author also emphasizes that lasers undergo a much less regimented process for FDA clearance than do drugs. In addition, he reports most of the research for MonaLisa Touch rests in relatively recent, small trials with no control groups. Also, researchers did not follow women long-term to see how soon symptoms recur or if any other resulting health problems occur. Clinical trials enrolling patients are open and others will be opening soon.

The author concludes, “Laser treatment for vaginal atrophy has shown promise in helping women manage crippling post-menopausal symptoms. However, women should consider that there might be unknown risks for them long-term, although none have come up thus far. They should make the decision carefully with the help of a health care professional and choose the best option for their situation.”

A patient’s perspective

FORCE spoke with Ashely R., a young breast cancer survivor about her journey after breast cancer treatment. Ashley is currently enrolled in a Mona Lisa Touch clinical trial based at The Ohio State University, in Columbus, Ohio:

“At a recent appointment with my oncologist, I mentioned what impacts me the most, in my new normal, almost 3 years out from diagnosis, with no signs of cancer.  Three years of menopause through ovarian suppression  has had some not so pleasant effects on my body, and my sex life.  She mentioned the clinical trial and I was immediately on board.  One week later I met with the doctors and researchers, filled out a ton of paperwork, had a baseline exam. The next day received my first of three laser treatments.  It truly was almost painless. I am a very outgoing person, and not too modest, so I had been vocal on a number of occasions, to my doctors about my vagina atrophy.  I have an excellent care team, and they did refer me to a specialist in sexual behavioral health, and that was extremely helpful.  But I needed something more physically regenerative.  I’m so glad I kept pressing the issue because it finally got me somewhere.  I think too often women are either too embarrassed to talk about this, or maybe they feel like “I’m alive, and this is just something I have to live with now”.  So many things change after a cancer diagnosis, for young women especially.  Many of us have lost our breasts, which we identify so strongly with our sexuality.  We have to learn new ways to feel sexy and intimate.”

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Posted 01/19/18
 

References

FOX News Is laser treatment for vaginal atrophy safe?

Holmberg, L, Iversen OE et al. J Natl Cancer Inst. 2008 Apr 2;100(7):475-82. doi: 10.1093/jnci/djn058. Epub 2008 Mar 25.Increased risk of recurrence after hormone replacement therapy in breast cancer survivors. HABITS Study Group.  

ACOG Committee Opinion No. 659: The Use of Vaginal Estrogen in Women With a History of Estrogen-Dependent Breast Cancer. American College of Obstetricians and Gynecologists’ Committee on Gynecologic Practice, Farrell R. Obstet Gynecol. 2016 Mar;127(3):e93-6. 
 

Disclosure

FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.