At Intimate You, the safety and welfare of our patients is our number one priority. Our mission is to provide safe, effective treatments and we always work within the appropriate regulatory frameworks. In response to recent communication from the FDA (U.S Food and Drugs Administration) Cynosure Hologic (who market MonaLisa Touch) and BTL (who market Ultrafemme 360) have released the following statements:-
You may have seen a recent press release from the FDA surrounding intimate rejuvenation treatments and the dangers surrounding them while mentioning BTL Aesthetics and making reference to the BTL Ultra Femme 360. We would like to reiterate the safety and efficacy of our treatments – particularly the Ultra Femme 360.
Our main priority at this time is to reassure you and your patients that the Ultra Femme 360 is safe to use. It is important to recognise that, since its launch and with thousands of treatments performed across the UK, there has never been one reported adverse case from our device, globally.
BTL Industries is a medical device manufacturer with over twenty-five years of experience and over 1200 staff across the world who all must adhere to very strict guidelines before any one of our devices are released. This means that we are able to ensure not only the most innovative of treatments but the safest, most consistent results for your patients.
BTL are currently evaluating the letter and preparing the response. We will work with the FDA within the deadline provided and BTL will comply with all regulatory requirements. The US FDA is an organization responsible for market clearances and approvals in the US and it does not have any jurisdiction over other markets. This letter from the FDA does not address regulatory clearances in countries outside the US. The Exilis Ultra 360 has received medical CE mark in European Union (and thus evaluated for safety and effectiveness) inter alia for the “Treatment of sexual dysfunction after vaginal delivery by means of improvement of vaginal laxity”. In addition to the EU, the device has been cleared for vaginal laxity (or similar clearance) in more than 15 other countries.
Here in the UK this device is medically CE marked in line with European guidelines along with a wealth of clinical studies which show the improvement achieved for ladies suffering from stress urinary incontinence, vaginal laxity and sexual dysfunction. The Ultra Femme 360 treatment can therefore be performed confidently and offered, without concern, to your patients.
We understand that your patients may share a number of concerns relating to the recent news release and, as such, we hope that you are able to use the above information to reassure them that the treatment you offer is medically certified, safe for use and has proven results. Should you wish to access further support with your marketing of the Ultra Femme 360 please do not hesitate to contact our team.
Hologic, Inc. and our medical aesthetics division, Cynosure, are aware that the FDA has issued a letter expressing concerns regarding “vaginal rejuvenation” procedures. As a leader in women’s health, Hologic has a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously. We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements.
There is also comments on this matter from Steve Macmillan (Hologic’s CEO) in the public domain under:https://investors.hologic.com/presentations#past – prepared remarks.