See us for Thermiva or other Women Health Services in Philadelphia, Pennsylvania, New Jersey, Bala Cynwyd, Pennsylvania, and the surrounding areas. The Falcone Center for Functional and Cosmetic Medicine serves women seeking treatments to achieve a more youthful look and feel.
THERMIva is an exciting new treatment with positive results. It is a non-invasive, non-surgical, and non-hormonal approach to rejuvenating the vaginal and outer labial tissues with the power of advanced radiofrequency heat technology. THERMIva may be used to improve the appearance, elasticity, and lubrication of the vagina and surrounding tissues. As this treatment regenerates nervous tissues and enhances orgasmic function, it may also reduce minor urinary incontinence.
THERMIva’s wand is smaller than a finger, and it gently delivers radiofrequency (RF) energy to the inner and outer areas of the vagina with the careful hand of a qualified practitioner. There is no pain associated with the procedure, and most see and feel results immediately. THERMIva treatments require no downtime, and patients may resume sexual and physical activities immediately.
THERMIva vs. MonaLisa Touch
Below is a comparison of the two most popular feminine rejuvenation technologies, THERMIva and MonaLisa Touch. Let us help you discover the procedure or combination of procedures that is right for you.
The similarities of THERMIva and MonaLisa Touch
- Treating incontinence, lubrication, laxity.
- Minimally or non-invasive
- Performed in a brief office based procedure.
- Stimulate the body’s natural collagen production.
- Non-hormonal treatments.
- Similar price range
- Require a series of 3 treatments separate by 4-6 weeks.
- ThermiVa utilizes RF energy; MonaLisa Touch is a Co2 laser.
- MonaLisa Touch recommends 1-3 days of downtime and light physical activity, while ThermiVa has no downtime or physical restrictions.
- The ThermiVa wand is thinner than a finger, while the MonaLisa Touch laser device is approximately an inch in diameter.
- MonaLisa Touch may include side effects like temporary redness, swelling and discomfort;ThermiVa offers no side effects.
- ThermiVa treatments address the labia and the clitoral area to promote external tightening; MonaLisa Touch only treats the internal tissues of the vagina.
What is the cost of THERMIva treatment?
The cost of THERMIva treatment will vary depending on whether or not you are combining it with other women’s sexual health procedures.
You can save up to 25% when combining THERMIva with another same day treatement.
A THERMIva treatment when purchased individually is $1000 per treatment. Because we know it requires three treatments for optimal results, we recommend you purchase a 3-treatment package for $2500.
We believe that our treatment combinations work best and encourage you to discuss all of your options with our staff prior to making your treatment decisions.
Is the Mona Lisa Touch, ThermiVa or Tempsure Vitalia FDA cleared/approved for Vaginal Rejuvenation?
On July 30, 2018, the FDA issued a statement with concerns about “vaginal rejuvenation” procedures utilizing energy-based devices. The FDA submitted statement letters to 7 medical device companies, including the company 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. However, it did question some of the claims on the company’s website and if 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.
Call Us Today For a Free Consultation
Our goal is information and communication. During your one-on-one consultation, we will discuss your concerns and develop a treatment plan designed specifically for you.
Dr. Victoria Falcone, director of The Falcone Center for Functional and Cosmetic Medicine, is board certified in Family Medicine. She is licensed in Pennsylvania and New Jersey and is a member of The Institute of Functional Medicine, The American Academy of Family Practice, and The American Academy of Cosmetic Surgery (AACS). Dr. Falcone offers a unique approach to health, wellness, and rejuvenation, helping men, women and children look and feel better both inside and out. Please call today to schedule your initial consultation!
Scheduling and Cancellation Policy
A $250 deposit is required at the time of scheduling your procedure. You have 48 hours after making the deposit to cancel the appointment and receive a