Article: The buzz around MonaLisa Touch
|alert||Questions for your doctor|
|What does MonaLisa Touch do?||Clinical trials|
The issued this alert in July, 2018 noting that laser or radiofrequency or laser devices that have received 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 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.
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.
The author also emphasizes that lasers undergo a much less regimented process for 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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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.
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.
This article is relevant for:
Women experiencing vaginal symptoms from menopause
This article is also relevant for:
Breast cancer survivors
Ovarian cancer survivors
People with a genetic mutation linked to cancer risk
Women under 45
Women over 45
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The National Comprehensive Cancer Network (NCCN) has survivorship guidelines. Their guidelines on sexuality and intimacy include the following strategies for addressing sexual function concerns for cancer survivors.
- Discuss available drugs including bupropion, flibanserin or hormone replacement
- Topical vaginal therapies
- Discuss options for clitoral stimulation
- Referral to a sexuality specialist
- Pelvic physical therapy
The American College of Obstetricians and Gynecologists recommends the following:
- The first options for women with ER-positive breast cancer who are experiencing vaginal issues and urinary tract problems should be nonhormonal approaches such as lubricants, moisturizers, or oils.
- If symptoms are not relieved by nonhormonal approaches, then low dose vaginal estrogen (i.e. estrogen applied directly to the vagina) can be used.
- The decision to use vaginal estrogen “should be preceded by an informed decision-making and consent process in which the woman has the information and resources to consider the benefits and potential risks of low-dose vaginal estrogen.”
The National Comprehensive Cancer Network (NCCN) provides cancer risk management guidelines for people with inherited mutations linked to cancer. In their guidelines on risk management for women at high risk for ovarian cancer, the NCCN panel states:
- Some research has shown that in women who have , hormone replacement does not negate the reduction in breast cancer risk associated with the surgery. However they caution those considering hormone replacement to consider the limitations of the existing research when making this decision.
- Individuals who undergo hysterectomy at the time of are candidates for estrogen-only hormone replacement therapy, which has been associated with a lower risk for breast cancer compared with combination estrogen + progesterone therapy. Individuals with an intact uterus are not candidates for estrogen-only therapy due to the increased risk for endometrial cancer.
The North American Menopause Society is a professional society of experts in the field of menopause.
- In 2017 they released a position statement on hormone replacement therapy, which includes the following:
- Menopause symptoms and a variety of diseases are more likely to occur in women who have surgical menopause from ovary removal. These symptoms can have a major effect on quality of life and potential adverse effects on the cardiovascular system, bone, mood, sexual health and cognition, which have been shown in observational studies to be lessened by estrogen therapy.
- Unless contraindications are present, estrogen therapy is indicated for women who have removed both ovaries, to reduce their risk of sexual side effects, bone loss, heart disease and decline. For women who retain their uterus, endometrial protection (progesterone) is indicated.
- Specific to women with or mutations who have removed their ovaries to lower their risk for cancer:
- For women with or mutations who have not been diagnosed with breast there is some evidence suggesting that that hormone therapy use after does not increase the risk for breast cancer any further.
- Considerations should be made about the benefits of estrogen to prevent health risks caused by surgical menopause.
- Considerations should be made (based on a limited amount of data) about hormone therapy until age 52 with discussions about longer use based on the individual patient.
- In 2018, they released a joint position statement with the International Society for the Study of Women's Sexual Health on management of genitourinary syndrome of menopause (GSM) in women with or at high risk for breast cancer, which included the following:
- People with, or at high risk for breast cancer should discuss treatment options for GSM with their healthcare providers using a shared decision-making approach.
- For women diagnosed with breast cancer:
- Vaginal moisturizers and lubricants are recommended as initial treatment options.
- Local (vaginal) hormone treatment may be considered for women for whom nonhormonal options do not work. Local therapy should be individualized, taking into account the risks of disease recurrence and severity of vaginal symptoms.
- Intravaginal estrogens in women on tamoxifen may be less of a concern than intravaginal estrogens in women on aromatase inhibitors.
- For high risk women without breast cancer who have undergone , vaginal hormone therapy is likely to be safe.
- I have vaginal dryness, pain or other side effects from menopause. What treatments might help me?
- Am I a candidate for hormone replacement therapy?
- Am I a candidate for vaginal estrogen?
- Do I qualify for any clinical trials for treatment of vaginal atrophy?
- Can you refer me to a menopause expert?
The following research studies related to sexual health are enrolling patients.
- NCT04806724: Opening the Conversation Study. This study will look at a program designed to help young couples dealing with breast or gynecologic cancer cope with and communicate about cancer-related reproductive and sexual health concerns.
- NCT04049331: Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone. The overall goal of this study is to evaluate the effect of a testosterone drug called Depo-Testosterone (or 'testosterone cypionate'), an FDA-approved drug for improving fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity in young cancer survivors who report fatigue and have low testosterone. This study is not open to men who have been diagnosed with hormone related cancers, including or breast cancer.
- NCT04025372: INTREPId (INTermediate Risk Erection PreservatIon Trial). This study is comparing the use of a new form of hormonal therapy used with radiation as a possible treatment for intermediate risk and whether this new form of hormonal therapy is as effective as the standard hormone therapy while also preserving erectile function.
- NCT05636943: Couples' QOL in Breast Cancer (C-QOL). The goal of this study is to measure the effect of a sexual quality of life intervention in women with breast cancer and their partners.
- NCT01788839: Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and . The purpose of this study is to see how cancer treatment affects sexual and reproductive function. The patient will also be asked to participate in blood draws to see if and how cancer treatment affects the ovaries and the ability to have children (fertility).
- NCT03257670: Fractional CO2 Laser Therapy Versus 4% Topical Lidocaine Gel for Dyspareunia in Breast Cancer Survivors. This study is looking at whether therapy with a CO2 laser to the vagina is more effective than lidocaine to the opening of the vagina before intercourse to reduce painful intercourse in women who are breast cancer survivors and whether or not the CO2 laser improves pelvic floor function, bowel and bladder function, and sexual function before and after treatment.
- NCT03707340: A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors. The purpose of this study is to determine if flibanserin improves or has any effect on hyposexual desire disorder/HSDD in women who are taking tamoxifen for breast cancer.
- NCT04812912: Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer. The purpose of this study is to find out how cancer treatments (chemotherapy and/or radiation therapy) affect reproductive and sexual health in people with early onset colorectal cancer.
- NCT02706561: Helping Men Adhere to Sexual Rehabilitation Following Cancer Surgery The purpose of this study is to test two different ways to help men with sexual rehabilitation.
- NCT03525262: Oncologic Therapy While Ensuring Neurovascular Conservation (POTEN-C) (POTEN-C). Reduction of dose to or 'sparing' of nerves during radiation for localized cancer may improve sexual health without changing cancer outcomes.
- NCT03716739: Improving Quality of Life of Cancer Survivors With Androgen Deficiency. The goal is to learn if testosterone replacement therapy (TRT) is safe and effective in improving the symptoms of androgen deficiency (sexual symptoms, low energy, and physical dysfunction) and overall health-related quality of life in men with cancer who have undergone radical prostatectomy.
The following are studies on menopause and menopause management for survivors and previvors:
- NCT03815929: , Estrogen Therapy and Cardiovascular Disease Risk in Young Women. Researchers are trying to assess the best dose of estrogen for decreasing heart disease in women who have removed their ovaries before the age of 46.
- NCT05042362: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Hot Flashes Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-1). he study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. Researchers will study how well 26 weeks of elinzanetant works compared to a in women who have been through the menopause and have hot flashes.
- NCT05099159: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Hot Flashes Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through Menopause (OASIS-2). The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. Researchers will study how well 26 weeks of elinzanetant works compared to a in women who have been through the menopause and have hot flashes.
- NCT05030584: A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Hot Flashes Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through Menopause (OASIS-3). The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. Researchers will study how well 52 weeks of elinzanetant works compared to a in women who have been through the menopause and have hot flashes.
- NCT04251052: A Study to Compare Two Surgical Procedures in Women with Mutations to Assess Reduced Risk of Ovarian Cancer (SOROCk). Women with a mutation ages 35 – 50 at risk for ovarian cancer are eligible. SOROCk will determine if removal of alone can reduce the risk of ovarian cancer nearly as much as removing the ovaries and .
- NCT04439370: Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women. This study will look at the effects of early menopause on blood pressure.
- NCT03572153: A Mind-Body Intervention for Hot Flash Management. The main goal of this study is to test whether self-administered hypnosis can be used to reduce hot flashes more than self-administered white noise hypnosis over 6 weeks of home practice.
- NCT05086705: EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer. This trial studies how well a personal heating and cooling device worn on the wrist (called EMBr Wave) may help reduce hot flash severity in women with a history of breast cancer.
- NCT04821141: Phase IIB Trial of Bazedoxifene Plus Conjugated Estrogens. Women at increased risk for breast cancer experiencing hot flashes will receive bazedoxifene plus conjugated estrogens (similar to the drug Duavee) for 6 months or a control (no drug). Researchers will measure breast density on and needle biopsy looking at biomarkers.
FORCE offers many peer support programs for people with inherited mutations.
- Our Message Boards allow people to connect with others who share their situation. Once registered, you can post on the Diagnosed With Cancer board to connect with other people who have been diagnosed.
- Our Peer Navigation Program will match you with a volunteer who shares your mutation and situation.
- Our moderated, private Facebook group allows you to connect with other community members 24/7.
- Check out our virtual and in-person support meeting calendar.
- Join one of our Zoom community group meetings.
- The American Association of Sexuality Educators, Counselors and Therapists (AASECT) is a professional organization for sexual health experts. They maintain a tool to help people find a sexual health expert near them.
- Register for the FORCE Message Boards to get referrals from other members. Once you register, you can post on the Find a Specialist board to connect with other people who share your situation.
The following resources can help you find experts who specialize in managing symptoms related to menopause:
- The North American Menopause Society has a tool to help you find a qualified menopause expert in your area.
- The National Certification Commission for Acupuncture and Oriental Medicine has a searchable directory of licensed acupuncturists.
- The American Academy of Sleep Medicine maintains the public-facing website SleepEducation.org that includes a section on finding a sleep center by location.
- The National Institutes of Health () and Related Bone Diseases National Resource Center has a page on finding an expert.
- Register for the FORCE Message Boards to get referrals from other members. Once you register, you can post on the Find a Specialist board to connect with other people who share your situation.