ECWMG’s response letter to the FDA concern regarding the MonaLisa Touch

 

August 7, 2018

 

To our valued patients,

 

At the end of 2015, Dr. Teng and I began researching the various options available for non-hormonal treatment for the genitourinary syndrome of menopause (GSM).   The genitourinary syndrome of menopause (GSM) is a new term that describes various menopausal symptoms and signs including not only genital symptoms (dryness, burning, and irritation), and sexual symptoms (lack of lubrication, discomfort or pain, and impaired function, but also urinary symptoms (urgency, dysuria, and recurrent urinary tract infections)1.  The impact of untreated GSM on a woman’s quality of life is significant and requires adequate treatment options.

 

There are many technologies that have been long used on other parts of the body that are now being used to treat GSM.   The option of an effective, hormone-free treatment for GSM has a lot of value.  Many women cannot safely take hormonal medications and many others chose not to due to side effects and risks.  

 

After detailed review of the available options, their published efficacy data and safety profiles2-9, we decided to purchase the MonaLisa Touch laser to provide fractional CO2 treatment for GSM to our patients in the comfort of our office.  The MonaLisa Touch laser was not the cheapest or smallest device available, but it was by far the device with the most successful results2-9, the least intrusive treatment and the least side effects.   While it’s not 100% successful for every patient, it also has no long term adverse reactions. 

 


Our experience over the last two and a half years with nearly 100 patients has been overwhelmingly positive.   Many women have had complete resolution of their symptoms, most have been able to discontinue hormone therapy, and others have had significant enough improvement to consider the treatment successful.   There are patients who’ve found the treatment not that helpful, or not helpful at all, but there have been no permanent or long-standing adverse reactions.   The most common side effect is irritation of the vulva and the worst case was no longer than 2 weeks. 

 

The recent FDA statement expressing concern regarding “vaginal rejuvenation” has clearly come to us as a surprise.   We highly value the safety that FDA oversight brings to the US market for medical treatments.   It is our understanding that this statement arose out of reported, severe complications from a different device, based on a completely different technology.  The letter received by Cynosure, the division of Hologic, that makes the MonaLisa Touch, from the FDA did not question the safety of the device, but some of it’s marketing material10.  

 

We are excited to live in a time with so many treatment options for women who suffer from GSM.  Each woman is unique and each woman deserves access to a variety of treatments that may best fit her needs, both hormonal and non-hormonal.   Our office stands by the option of the MonaLisa Touch CO2 laser as the most effective, longest-lasting non-hormonal option for the treatment of GSM.

 

We welcome questions and concerns from our patients, but hope this letter helps to reassure concerns related to the FDA statement released last week.

 

Thank you,

 

 

Sarah Azad, MD

 

 

  1. Hyun-Kyung Kim et al. Aug 2015. The Recent Review of the Genitourinary Syndrome of Menopause. J Menopausal Med. 2015 Aug; 21(2): 65–71. 
  2. Salvatore, S et al. Apr 2015. Sexual function after fractional microablative CO₂ laser in women with vulvovaginal atrophy.  18(2):219-25. 
  3. Salvatore, S et al. Aug 2017. A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study.  17(4):363-9. 
  4. Sokol, ER et al. Oct 2016. An assessment of the safety and efficacy of a fractional CO2 laser system for the treatment of vulvovaginal atrophy. Menopause. 23(10):1102-7.
  5. Pieralli, A. Oct 2016. Fractional CO2 laser for vulvovaginal atrophy (VVA) dyspareunia relief in breast cancer survivors.  Arch Gynecol Obstet. 294(4):841-6.
  6. Cruz, VL et cal. Jan 2018.  Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women.  25(1):21-28.
  7. Gonzalez Isaza, P et al. Feb 2018.  Long-term effect of thermoablative fractional CO2 laser treatment as a novel approach to urinary incontinence management in women with genitourinary syndrome of menopause. Int Urogynecol J. 29(2):211-215.
  8. Siliquini, GP et al. Aug 2017. Fractional CO2 laser therapy: a new challenge for vulvovaginal atrophy in postmenopausal women.  20(4):379-384.
  9. Sokol, ER. Et al. Jul 2017. Use of a novel fractional CO2 laser for the treatment of genitourinary syndrome of menopause: 1-year outcomes. Menopause. 24(7):810-814.
  10. https://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM615120.pdf

 


El Camino Women’s Medical Group offers the latest Minimally Invasive Solutions for gynecologic problems.   Drs. Amy TengErika Balassiano, and Pooja Gupta, all members of AAGL (American Association of Gynecologic Laparoscopy) are highly trained and experienced in the field of Minimally Invasive Gynecgologic Surgery.   Dr. Erika Balassiano is also a graduate of the Minimally Invasive Gynecologic Surgery Fellowship, under the supervision of world-renowned Dr. Camran Nezhat.

 

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