The American Food and Drug Administration (FDA) which is responsible for regulating health devices and medicines in the US has issued a statement expressing concerns over the unregulated use of “vaginal rejuvenation” devices which have increased in use in both the US and UK and which promises, amongst other things, treatment for the menopause, urinary incontinence and improvements in sexual intercourse.
The statement dated 30 July 2018 goes on to say:
“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.
In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.”
The UK has seen a number of clinics offering this treatment with high profile marketing campaigns to promote it’s use. Cosmetic vaginal procedures such as labiaplasty and vaginaplasty have been steadily rising in recent years and anecdotal reports have suggested young girls as young as 9 have been seeking out the procedure.
The regulation of health devices in the UK is the responsibility of the Medicines Healthcare Regulatory Authority, however they are yet make any comment on these procedures.
With the ever advancing availability of high street cosmetic procedures and the lack of close regulation, it is vital that they remain proactive in considering emerging treatments and ensuring that there are effective checks and balances in place to ensure patient safety.
Whilst there has always been a market for cosmetic procedures that promise much but deliver little, the serious adverse conditions associated with devices marketed for vaginal rejuvenation merit careful consideration and the closer regulation of their use.