See us for Mona Lisa Touch or an O shot in Philadelphia, Pennsylvania, New Jersey, Bala Cynwyd, Pennsylvania, and the surrounding areas. The Falcone Center for Functional, Cosmetic and Regenerative Medicine offers advanced treatments for women seeking to look and feel more youthful.
If you are suffering from vaginal dryness, itching, or painful intercourse related to decreased estrogen production or lichen sclerosis, the MonaLisa Touch laser treatment may be your solution. Loss or decrease in estrogen can dramatically change a women’s vaginal and sexual health. Hormone replacement therapy can help but many women do not want the risks or side effects of hormones and seek alternative treatments.
You no longer have to suffer the discomfort and loss of sexual function that occurs with aging. There are options!
MonaLisa Touch™ is a painless and minimally invasive CO2 laser treatment for women experiencing changes in vaginal health. Whether estrogen loss it is due to hysterectomy, menopause, cancer treatment, nutrient deficiency or pregnancy, MonaLisa Touch treatment can help to relieve the related itching, irritation and pain restoring comfort and sexual health.
How does it work?
MonaLisa Touch is a simple and comfortable office based Co2 laser treatment. A topical numbing cream will be placed into the vagina for 20 minutes prior to treatment making the procedure feel like a light vibration. You are awake for the treatment and it takes less then 10 minutes.
What results can I expect?
MonaLisa Touch helps to restore collagen in the vaginal walls improving the elasticity of the tissue and aiding in rehydration of the area. Most women have a reduction in dryness, decreased pain during sex, improvement in urinary symptoms and less burning sensation almost immediately.
We recommend a series of three treatments spaced over twelve weeks. Some women notice improvement in one session but for best results, a three treatment regimen should be followed.
We can also combine your MonaLisa Touch laser treatments with an O-shot to further help with mild urinary incontinence, sexual arousal, increase sexual pleasure and treatment of conditions such as lichen sclerosis. Click Here to learn more about O-Shot treatment.
Long Lasting Relief
After your series of three treatments, you may want to return every 6-12 months for one session to maintain your results. Individual maintenance intervals will vary depending on the severity of your symptoms. Most women enjoy improvement in their condition for 6 months or longer.
Results may also be further improved by combining MonaLisa Touch treatment with an O-shot. Click here for more information on the O-shot.
Some mild discomfort and swelling can occur after treatment for approximately one to three days. In order to minimize symptoms, we recommend that you avoid hot baths, sauna, physical exercise and sexual intercourse during the healing period of about three to four days.
What are the Risks of Treatment?
Overall, Philadelphia and Bala Cynwyd Mona Lisa Touch patients tolerate the treatment very well. Some temporary side effects can be mild redness, swelling and discomfort. Risks and benefits of treatment will be discussed at your initial appointment. An evaluation will be performed at your consultation to determine if MonaLisa Touch treatment is appropriate. Please bring a copy of your last pap smear to your appointment. If you have not seen your gynecologist for routine care, we require that it is completed prior to scheduling MonaLisa Touch treatment.
What is the Cost of Treatment?
Cost of treatment can vary depending on whether or not you are scheduling one or three treatments. For your convenience, we accept Visa, Mastercard, cash, bank check, Flexible Spending Account payment or financing through Care Credit. Visit www.CareCredit.com should you need financing assistance to pay for your MonaLisa Touch procedure.
Is the Mona Lisa Touch, ThermiVa or Tempsure Vitalia FDA cleared/approved for Vaginal Rejuvenation?
On July 30, 2018, the FDA issued a statement expressing concerns regarding “vaginal rejuvenation” procedures using energy-based devices. The FDA submitted letters to 7 medical device companies including Cynosure Inc , the manufacturers of MonaLisa Touch and Tempsure Vitalia and Thermigen LLC, the manufacturer of the ThermiVa treatment.
The letter received by Cynosure Inc. (Hologic), did not question the safety of the device but did question some of the claims located on the company’s website and whether the 510 (k) FDA clearance adequately includes the treatment claims of Vaginal Rejuvenation. A similar letter was issued to Thermigen for the ThermiVa treatment. Even though the ThermiVa device was cleared for use in dermatological and general surgical procedures, it was not specifically FDA cleared for the “vaginal rejuvenation” claims located on the website www.ThermiVa.com.
MonaLisa Touch (the SMARTXIDE2 Laser system) received FDA 510(k) clearance on September 5, 2014 for indications that included gynecology applications such as incisions, excisions, ablations, vaporization and coagulation of body soft tissues in medical specialties including aesthetics and gynecology. The MonaLisa Touch treatment could be considered an “off label” use of the technology when using it for “vaginal rejuvenation” purposes as the FDA 510(k) clearance did not specifically stipulate “vaginal rejuvenation” as part of the clearance.
Similarly, the use of radiofrequency energy delivered by ThermiVa and Tempsure Vitalia for “vaginal rejuvenation” would be considered “off-label” uses of the technology.
There are many examples of “off label” use of technology and treatments in medicine. One would be the use of Botox. Botox is an FDA approved treatment for frown lines between the eyebrows yet Botox is often used on numerous areas of the face that are not FDA approved to reduce lines of facial expression. Areas of treatment such as the chin or lip lines would be considered “off label” uses of Botox. It is the treating physician that must exercise good judgement and be adequately trained and comfortable with performing “off label” treatment areas.
As a patient, you should know the risks and benefits of treatment. This information is being provided to keep our patients up-to-date with the latest issues regarding Tempsure Vitalia, MonaLIsa Touch and ThermiVa treatments. Even though we have had many successful, uncomplicated treatments using these technologies at the Falcone Center, we want you to be fully informed with any treatment decision and know the latest concerns of the FDA.
The role of the FDA is to safeguard patient safety. Even though thousands of women have had positive outcomes from MonaLisa Touch and ThermiVa treatment, complications have been reported to the FDA which has likely been the motivation behind this report.
If you have concerns regarding undergoing MonaLIsa Touch, ThermiVa or Tempsure Vitalia treatment, please discuss your concerns with Dr. Falcone prior to undergoing treatment. You should also discuss the treatment with you gynecologist.
You can learn more about the current status of the recent FDA report by visiting the Cynosure website at www.Cynosure.com or www. ThermiVa.com.