Medicine

FDA warns about vaginal 'rejuvenation' device claims

FDA warns about vaginal 'rejuvenation' device claims

Monday, the FDA issued a statement warning that some of the "vaginal rejuvenation" treatments on the market can come with unsafe side effects, like vaginal burns, scarring, and pain.

There has been a growing number of dubious claims about vaginal rejuvenation treatments, which supposedly can cure incontinence or painful sex for older women.

However, it is usually recommended for small-scale situations such as "destroying abnormal, pre-cancerous cervical or vaginal tissue as well as genital warts". "We are deeply concerned women are being harmed", said Gottlieb.

As per CNN, FDA in a statement said, "We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal "rejuvenation" and/or cosmetic vaginal procedures". He said the agency doesn't know the extent of the risks because it hasn't reviewed the devices for such procedures.

The FDA will closely monitor reports of problems associated with "vaginal rejuvenation" procedures, and will keep the public informed, Gottlieb said. It's sent warning letters to seven companies, including Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen.

If the FDA's concerns are not addressed, the agency said that they will consider potential enforcement actions.

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"Deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb fumed in one tweet.

In addition to the deceptive health claims being made about the products, the devices are in some cases being marketed to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause, Gottlieb said.

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.

The benefits and risks of all available treatment options for vaginal symptoms should be discussed with patients. FDA is committed to helping advance the development of safe, effective treatment options for these conditions. As part of our Medical Device Safety Action Plan and our ongoing commitment to advancing women's health, we've begun building out important device safety registries.

Two reports have been received by the FDA from manufacturers as well as dozens of reports from patients in relation to adverse effects as a result of vaginal rejuvenation procedures.

"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". Dr. Cheryl B. Iglesia, director of the section of female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, said the laser technology held promise but more study was needed to understand the safety as well as which patients the devices might help.


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