FDA warns companies about 'deceptive' vaginal rejuvenation claim

FDA warns companies about 'deceptive' vaginal rejuvenation claim

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 FDA has even sent warning letters to seven companies that make these devices-including Cynosure Inc's MonaLisa Touch and Thermigen, Inc's THERMIva-asking the companies to either remove statements linked to nonsurgical vaginal rejuvenation or provide them with backup for those claims.

In particular, the FDA was concerned about laser treatments as they have been known to potentially cause "serious adverse events, including vaginal burns [and] scarring". "The deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", he said.

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.

However these devices are also being increasingly used for treatment of vaginal laxity, itching and dryness said the FDA.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

In some cases, women who've gone into early menopause after breast cancer treatments are opting for these interventions, but "the deceptive marketing of a risky procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb said.

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Meanwhile, FDA requested women to stop using these devices and encouraged them to discuss any of their sexual dysfunction problems and their treatments with their doctors.

The FDA is warning consumers against serious risks of some "vaginal rejuvenation" devices, and a lack of evidence to support their uses for this objective. But the FDA noted the devices haven't been evaluated or approved for vaginal rejuvenation.

Over a dozen adverse reports after the use of these treatments have brought this issue to the forefront.

Not only is vaginal rejuvenation likely ineffective when comes to its claims on sex drive, the FDA warns that the procedures come with other risky are downright unsafe. There is little scientific basis for the use of these methods state the FDA.

"[We have] a strong track record of rooting our products in science and clinical evidence so, we take the contents of this letter seriously", Hologic, Inc.

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 urges anyone who suffered a complication linked to a vaginal "rejuvenation" treatment to report it through MedWatch.

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