Mona Lisa Touch and the FDA


 

Comment on recent FDA paper about *vaginal rejuvenation*

Given the recent news about the FDA “letter” to the vaginal rejuvenation companies, Cynosure included, I want to address the FDA paper directly, and what I think it reflects. The FDA sent different letters to each company, and the one to Cynosure (who make MonaLisa Touch) was specific about making sure they can back up effectiveness claims on their website. It was not a warning about the safety of MonaLisa Touch, though some of the other companies that make other devices did receive safety questions.

I would like to explain why I still have confidence in treating my patients with the MonaLisa Touch laser:

There are many devices on the market for “vaginal rejuvenation”, most of them being marketed to pre-menopausal women for tightening and sexual pleasure enhancement. Some are also used by providers in post-menopausal women. Of all the devices marketed, the only one with FDA approval for vaginal use is Mona Lisa Touch. This means that the FDA has reviewed available peer-reviewed data and deemed it safe. The FDA does not generally assess these devices for effectiveness; rather they focus on safety in order to give approval. In terms of effectiveness, they monitor marketing and request proof of claims, but do not include this in their approval process.

Many of these other devices are adaptations of pre-existing lasers or radio-frequency ablation devices that had previous FDA approval for other procedures (usually for surface skin dermatology procedures). However they did not seek specific vaginal application approval. One of the other devices has a very deep penetration, specifically to cause scarring and tightening. These devices may be associated with some bad outcomes, depending on who uses them. They are often marketed to plastic surgeons and dermatologists, not gynecologists. This is not true for MonaLisa Touch. The FDA is finally noting that there is much “off label” use of these devices, and that women should be cautious about these other device uses. They do not have specific safety concerns about MonaLisa Touch, and are not recommending removal from the market.

The reason I use MonaLisa Touch, and did not choose any of the other devices marketed is that it is the only device with a long history of safety and efficacy studies published in peer-reviewed journals. These studies directly address its use in post menopausal women. These outcomes studies give me a realistic idea of true success rates, and show a 10 year safety record. Additionally there was recently a good, independent, comparative study published showing that MonaLisa Touch performed well compared to estrogen for vaginal symptoms. Another very large (4 academic medical centers) comparative study is finishing up and will hopefully be published early next year.

I have been doing Mona Lisa touch at Renuvagyn since 2016. I have seen over 100 women there. In my experience the success rates from the studies are accurate (88-92% of women are satisfied or very satisfied with treatment). I have seen no serious bad outcomes. While there is some discomfort surrounding the treatment, that is expected and can be managed. I have had no patients experience long term discomfort due to the laser.

I will continue to offer this therapy in my office with confidence, and will continue to address the needs of peri- and post-menopausal women to the best of my ability.

Sincerely,

Rebecca Dunsmoor-Su, MD MSCE FACOG

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