Novus Medical supports FDA statement on ‘vaginal rejuvenation’ devices
A UK medical device company has today welcomed the warning issued by the FDA on what are known as ‘vaginal rejuvenation’ treatments.
Novus Medical – the UK supplier of The Juliet for gynaecological use by medical professionals only – has echoed the concerns of the U.S. Food and Drug Administration, which is urging women to resist the pressure to undergo ‘designer vagina’ rejuvenation procedures.
The organisation yesterday said it was ‘deeply concerned’ about the rise of cosmetic vaginal rejuvenation treatments, which are often mis-sold to women.
Many treatments promise to increase sexual pleasure, ‘shrink’ the labia, and tighten the vagina but come with little evidence to support the claims. In some reported cases the treatments are even injuring patients.
Novus Medical supports the FDA’s instruction that to keep offering these treatments, suppliers and medical professionals will need to provide the FDA with evidence to back up those claims.
Novus gynaecologists have reviewed the clinical evidence for the Juliet and are satisfied with the application of the Juliet treatment for vaginal atrophy, dyspareunia, vaginal itching, burning and urinary incontinence.
It is not a cosmetic platform; its purpose is to alleviate distressing medical symptoms of vaginal atrophy including vaginal dryness and itching, and can offer a reduction in urinary urgency.
It’s not a ‘fix’ for all women, and suitability must be confirmed before any procedure may take place.
Jim Westwood, Director of Novus Medical, welcomes the industry shakeup. He saysit’s time that medical procedures and cosmetic treatments were separated entirely to avoid patient confusion.
“Only medically approved devices should be used for gynaecological procedures, and some companies have been mis-selling the benefits of platforms to make a profit from vulnerable patients. We welcome the FDA’s comments and urge patients to only seek appropriate treatments from regulated medical professionals,” Jim says
“Reports of misuse have left women with burns and internal damage as a result of vaginal ‘rejuvenation’ treatments gone wrong. This jeopardises the faith in medical treatments of a similar nature, such as The Juliet, that DO have the FDA approval and scientific data to support them.
“There haven’t yet been the same warnings in the UK specifically yet, but it’s surely a matter of time. Our advice for patients considering undergoing medical treatments for vaginal atrophy is to do your research and speak to a GP andreputable gynaecologist before making any decisions.”
In the U.S Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen have all been warned to change their marketing to make clear that they have not been approved for cosmetic vaginal rejuvenation.
“Raising awareness about these false claims and unsupported science should be a top priority for us here in the UK too. These cosmetic treatments and misleading marketing tricks are putting women at risk, and distracting patients from treatments that can actually change their lives,” concludes Jim.
All clinical data/evidence for the Juliet is published and available readily upon request from Novus Medical.