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Statement - BAAPS response to the FDA warning on vaginal rejuvenation

Paul Banwell, Consultant Plastic Surgeon and member of the British Association of Aesthetic Plastic Surgeons, said: 

"We welcome the comments made by the US Food and Drug Administration (FDA) regarding the exponential rise in vaginal rejuvenation devices globally, the marketing claims associated with them and, most importantly, how the potential benefits are being conveyed to the public.

"The FDA has provided balanced comment encouraging and supporting the introduction of new technology for patient benefit but only in the context of supporting clinical studies and a central theme of patient safety, which can be viewed here  https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615130.htm 

"Like the FDA, many physicians and surgeons worldwide recognise the potential benefits of such devices but have exercised caution in routinely recommending such treatments due to the limited scientific data available. 

"However, there are currently many non-specialist aesthetic practitioners using such machines based upon marketing claims made by the device manufacturer and we would agree with the FDA that these marketing strategies need to be re-evaluated and improved education programmes provided for such practitioners.

"It is even more timely that in a poorly regulated aesthetic medicine industry, we recognise that well-designed (independently funded) peer-reviewed, randomised, controlled trials examining the benefits of all devices in vaginal rejuvenation are long overdue. 

“There has been an exponential rise in the interest in women’s health and sexual well-being and whilst this should be encouraged, it is vital that any educational and treatment initiatives are provided in a sensitive manner free of any misleading or marketing hyperbole.’

 

 

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