Apparently, the companies are claiming that the procedure, the destruction and/or reshaping of vaginal tissue, is an effective treatment for menopause symptoms, urinary incontinence and sexual function.
The bottom line: Some nonsurgical "vaginal rejuvenation" treatments aren't approved by the FDA to treat symptoms like vaginal dryness-and could even come with unsafe consequences like burns-so talk to your ob-gyn about alternative options if you're considering one of them.
Scott Gottlieb, commissioner of the Food and Drug Administration, said several device makers are marketing their products for uses that have not been approved by the agency. "We are deeply concerned women are being harmed", said Gottlieb.
"To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence, or sexual function", the statement explained. In these cases, the FDA had not reviewed or approved the used devices for the objective of 'vaginal rejuvenation'. Thus, the full extent of the risks is unknown.
If you suffered any adverse effects associated with these procedures, the FDA wants you to file a report through MedWatch.
As part of Monday's warning, the FDA announced it had notified seven companies about the "inappropriate marketing of their devices for "vaginal rejuvenation" procedures" including: Alama Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen. FDA did not take enforcement actions against the companies, but requested that they address the agency's concerns within 30 days. "The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious".
International News Chelsea boss unhappy with Willian 4 hours ago
Lacazette was guilty of the worst miss, misjudging his angles after slipping the ball through Andreas Christensen's legs. Both sides converted all five of their penalties in the shootout before England midfielder Loftus-Cheek was thwarted.
Everton sign Lucas Digne from Barcelona
The 25-year-old will be part of the Toffees' squad until June 2023 at least, after putting pen to paper on a five-year deal. The player has been criticised by some on social media regarding the tattoo, while Liverpool fans have joked about it.
Form Kohli 'a unsafe customer' for England: Gooch
I have played with Hardik Pandya at Mumbai so you are open to having a chat. "It will be highly competitive", he said. There is a lot more familiarity between the sides than there ever has been before".
The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions. Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options. They have been permitted by the US FDA earlier for treatment of abnormal and precancerous vaginal and cervical tissues and remove genital warts.
In a move to improve their oversight of such devices, the FDA has also started building device safety registries.
For instance, Alma Lasers promoted one of its devices as offering "a better feminine life". In addition, there are many reports of women being injured by these procedures.
Women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and who are seeking alternative nonhormonal options, may be particularly drawn to "vaginal rejuvenation" devices, ' according to the agency.
"It is deceptive to give the impression that vaginal rejuvenation, designer vaginoplasty, revirgination, G-spot amplification, or any such procedures are accepted and routine surgical practices".