FDA Warning July 30 2018
Update: Effective September 2018, after careful consideration and review of the community standard, we will resume offering the Valayza vaginal laser procedure using the Mona Lisa Touch laser, but only after the patient reviews and signs a new version of our informed consent document. Here is the entire informed consent document in pdf format. The FDA has not banned the procedure. They have issued a warning to laser manufacturers and doctors to present the facts to the patients and then let them use their own judgment. We completely agree. Click here for our full statement.
What is the Valayza™ Procedure?
The Valayza™ Procedure uses the MonaLisa Touch™ laser to improve the health and thickness of the vaginal mucosa (the mucous membrane) that lines the vaginal walls. The Valayza™ is not a cosmetic procedure. It is a medical treatment that can renew and restore vaginal health and function resulting in increased vaginal lubrication and sensation, decreased pain and burning, and a revived sex life.
What type of results can I expect?
The great majority of treated patients report a significant reduction in vaginal dryness, vaginal burning and pain during intercourse, which contributes to a substantial improvement in their quality of life.
These results are possible due to the stimulation of the vaginal mucosa, which renews and regenerates. There is actual growth of new cells and tissues which takes place for weeks after each treatment. Results are most noticeable one and a half months after a treatment session and optimal results are seen after the third treatment session.
How long will these results last?
Studies done in Italy and Australia show that positive results can last up to one year after completion of the initial treatment course. They recommend a single annual treatment afterwards to maintain the beneficial effects.
What are the benefits of this treatment?
The Valayza™ vaginal laser treatment causes a functional restoration of the vaginal mucosa, which helps to greatly reduce or even eliminate the symptoms of vaginal atrophy, a widespread problem among pre and postmenopausal women (and women who have lost estrogen due to other conditions such as chemotherapy). Thanks to its action on factors that lead to vaginal dryness, fragility and loss of mucosal elasticity, this treatment can eliminate troublesome itching, irritation and pain, which become particularly acute during intercourse. The interaction with the laser stimulates the collagen contained in the vaginal walls, and helps the lining to grow and thicken. This results in vaginal rehydration and functional tissue restoration, which in turn can contribute to improved self-confidence and sexual sensation.
Is anesthesia required?
No, usually no anesthesia is required. However, if a patient prefers, a topical anesthetic gel can be applied inside the vagina prior to the procedure. Some women report a brief "tingling" sensation vaginally when the laser is activated.
How is the recovery?
Most women report slight localized discomfort following the Valayza™ Procedure and during the first few days after the session. Nearly all patients resume their normal routine after one to three days. During the initial healing period, it may be recommended to avoid lifting weights or certain activities, such as taking a hot bath, vigorous physical exercise or sexual activity. Your doctor will give you instructions for a speedy recovery.
Am I a candidate?
The Valayza™ Procedure is most suitable for any woman with symptomatic vaginal atrophy due to loss of estrogen. In particular, Valayza™ is the ideal treatment for those who are looking for a less invasive procedure, compared to traditional surgical, pharmaceutical or hormonal treatments. Remember, no one can advise you better about what is the best way for you to achieve optimal results than your doctor.
Appropriate candidates for this procedure include pre and post-menopausal women, breast cancer survivors of any age and breastfeeding women with vaginal burning due to low estrogen. Basically, if there is symptomatic vaginal atrophy due to low estrogen, Valayza™ can help.
Are there any risks?
The risks are minimal. This 5-minute treatment is performed in the doctor’s office. There might be temporary side effects such slight redness or swelling of the external vaginal area, and some discomfort that usually disappears in one or two days. In one clinic in Australia, over 1,000 patients have been treated without a single complication.
What is the cost?
Please call our “hotline” at 844-VALAYZA for more information about cost or if you have any questions. That’s 844-825-2992.
Over a five year time frame, the cost of three initial sessions with a yearly maintenance procedure afterwards is less than most daily pharmaceutical treatments. Financing is available through CareCredit. To our knowledge, the Valayza™ procedure is not covered by any medical insurance provider.
Tell me more about the laser itself
The MonaLisa Touch laser is a patented CO2 fractional laser, specifically designed for an intravaginal application. It received FDA clearance for safe use vaginally in September 2014. The procedure is carried out in a medical office and normally does not require any anesthesia and does not involve any cutting or stitching. The procedure is not approved by the FDA for this specific medical indication. Please see our web page for comments.
A consultation and examination with a Gyn physician is required before the procedure is done for the first time; this could take 10-15 minutes, and the treatment itself takes about 5 to 10 minutes. These can be two separate appointments or with advance planning can be combined into a single office visit.
Can MonaLisa Touch be used to treat vaginal laxity?
Vaginal laxity, sometimes referred to as a "loose vagina," is a condition where the diameter of the vagina has increased causing less sensation during sex. This is often due to natural yet traumatic events, such as giving birth or tissue relaxation due to the aging process. In these cases, it is essential to evaluate the cause and the state of the vagina to exclude vaginal prolapse or an involvement of the vaginal muscles. If a thorough exam determines that the problem is a loose vaginal wall rather than true prolapse, the Valayza™ Procedure can provide significant improvement for this condition as well.
The information herein is intended solely to provide a general introduction to the Valayza™ Procedure, which involves the use of a vaginal laser for the treatment of vaginal atrophy. This information is not to be used to determine the appropriateness of this procedure for a given individual, nor provide any guarantee of the final outcome or results of the treatment. Further details regarding the Valayza™ Procedure and whether or not it is right for you should be discussed with your Gyn physician.