On 30 June, FDA Commissioner Scott Gottlieb, M.D. warned against laser treatment for “vaginal rejuvenation” or other procedure with a cosmetic purpose. He explains that these treatments can cause vaginal burns, pain, and scarring.
In the press release, the agency says that the devices were approved for other purposes: removal of genital warts or destruction of precancerous cervical or vaginal tissue. The agency explains that the devices have not been proved to work in treating symptoms of menopause or other issues like urinary incontinence or sexual function:
“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,” stated the safety alert released on the agency’s website.
According to Scott Gottlieb, many manufacturers have marketed their devices as being useful in “vaginal rejuvenation” (a procedure that usually destroys or reshapes the tissue).
A Dangerous Procedure With No Proven Benefit
While officials reviewed the adverse-event reports and other data, they found many cases of serious harm:
“We haven’t reviewed or approved these devices for use in such procedures. Thus, the full extent of the risks is unknown. But these reports indicate these procedures can cause serious harm.”
This is why the agency has released the warning, adding that they have notified seven manufacturers about the “inappropriate marketing,” asking for a response within 30 days. Gottlieb explains that if the manufacturers don’t rectify these concerns, “the FDA will consider what next actions, including potential enforcement actions, are appropriate.”
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 dangerous procedure with no proven benefit.” 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.”
Rex Austinwas born and raised in Thunder Bay Ontario on the shores of Lake Superior. Apart from running his own podcast (Ice Fishing And Other “Cool” Things), he spends his time canoeing and backpacking in Northern Ontario.. As a journalist Rex has published stories for Global News (Thunder Bay) we well as Buzz Feed and Joystiq. As a contributor to Great Lakes Ledger, Rex most covers science and health stories. Contact Rexhere