Industry reacts to FDA warning over vaginal rejuvenation devices
There have been mixed reactions from the aesthetics industry following a staetment by US federal agency the Food & Drug Administration (FDA) on efforts to safeguard women’s health regarding vaginal rejuvenation.
The statment said there were “deceptive health claims” and “significant risks” related to devices marketed for use in medical procedures for vaginal rejuvenation.
It added: “We’ve recently become aware of a growing number of manufacturers marketing ‘vaginal rejuvenation’ devices to women…The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.”
The news shocked the aesthetics industry, which has been spearheading the promotion of energy-based devices as a new and innovative method of non-invasive vaginal rejuvenation.
Both manufacturers and practitioners came out in defense of the procedures, saying that the devices are safe when used by properly trained providers at the correct settings for the clinical conditions they were designed for.
However, consultant plastic surgeon and member of the British Association of Aesthetic Plastic Surgeons Paul Banwell is now calling for action to safeguard practitioners and patients. He said: “I think we need to convene an urgent task force to produce recommendations and guidelines for patients and practitioners to show the UK is responding positively to these FDA claims.”