Gottlieb is concerned that these procedures are aimed at women who had cancer treatment that caused early menopause, a fact he considers to be egregious and, adding that the manufacturers use "deceptive marketing of a unsafe procedure with no proven benefit".
Paul Banwell, consultant plastic surgeon and member of the British Association of Aesthetic Plastic Surgeons, shared the FDA's concerns: "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".
Scott Gottlieb, a commissioner of the FDA, recently stated that a growing number of manufacturers are marketing their devices for unapproved uses such a vaginal rejuvenation.
According to the FDA, numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain have been reported and documented. The devices have also not been FDA approved for use in treating sexual dysfunction, such as decreased sexual sensation or pain during intercourse or urination.
Understand that the FDA has not cleared or approved any energy-based medical device for vaginal "rejuvenation" or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function. Answers from the companies have been sought within the next 30 days. The agency is requesting the companies to address their concerns within one month.
The FDA is warning consumers against serious risks of some "vaginal rejuvenation" devices, and a lack of evidence to support their uses for this goal. The FDA commissioner added that these "unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions".
Over a dozen adverse reports after the use of these treatments have brought this issue to the forefront.
Hologic, Inc., owner of Cynosure, replied to this with an email saying they have "a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously".
The FDA says it's received complaints about burns and other damage.
These products are vigorously advertised online and in most visual and print media citing "better feminine life", "better intimate health" and other false claims.
The FDA is encouraging women to stop using these devices and report any issues to the FDA's adverse event reporting program, called MedWatch.