FDA is concerned that vaginal ‘rejuvenation’ may hurt more than help

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Many women who go through menopause or have undergone a vaginal birth experience symptoms that are often uncomfortable. Vaginal laxity, pelvic floor damage, vaginal dryness or an impaired firmness in the vaginal wall are some of the experiences that lead them to consider vaginal rejuvenation.

Many medical practitioners claim that ‘vaginal rejuvenation’ is a treatment that can alleviate the discomfort of those problems. But the U.S. Food and Drug Administration has an alternative opinion you should strongly consider before going under the knife (or the laser).

FDA Commissioner, Dr. Scott Gottlieb, said in an official statement recently that women are at risk of deceptive marketing practices that put their intimate health at risk.

The FDA said it is committed to improving women’s health. Part of that commitment means calling out gynecologists and plastic surgeons who use off-label devices in an attempt to make you [and your vagina] feel healthier and stronger.

“Advancing the health of women is a priority for the FDA. […] And as part of [our] efforts, we also watch for, and take action against, bad actors who unfortunately take advantage of unsuspecting consumers by marketing unapproved, deceptive products that may pose safety risks and violate the trust of American consumers.”

One study cites an increased cultural pressure on female aesthetics has led them to increased persuasion to consider the path of vaginal rejuvenation. Think billboards, fashion magazines, and cultural standards of what “beauty” looks like.

Women seek vaginal rejuvenation to strengthen their vaginal wall or increase hydration of the vaginal mucosa to make sex more pleasurable and decrease discomfort. That’s great but what if the pain you experience is worse than before?

Vaginal rejuvenation is an umbrella term for practices that claim to improve functions of the vagina and surrounding tissue. Medical practitioners can use non-invasive surgery for improving dryness or vaginal atrophy. Gynecologic or plastic surgeons can perform labiaplasty (reconstructing labia minora or majora) or vaginoplasty (pelvic floor surgery).

Of course, you want to look and feel good, especially in the most tender of areas, but at what expense?

“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” Gottlieb said. “We are deeply concerned women are being harmed.”

The FDA questions the effectiveness of these kinds of surgeries and said their use should be avoided until further research is available for women to make informed decisions, not just a spur-of-the-moment quick fix.

Though the FDA allows a specific clinical use of vaginal rejuvenation for serious medical conditions, as a cosmetic procedure it can cause “serious adverse events” such as vaginal burns, scarring, pain during sex and recurring pain.

Furthermore, the FDA has sent letters to companies that promote cosmetic vaginal rejuvenation urging them to cease deceptive marketing.

The FDA sent the warning letters to companies Inmode, Sciton, Alma Lasers, Thermigen, BTL Aesthetics, BTL Industries, Venus Concept and Cynosure. They were asked to give detailed information about what approval process their techniques are being used.

The agency has also informed health care providers of the risks associated with vaginal rejuvenation, reminding them the FDA has not approved of energy-based devices for those practices.

Talk to your doctor about alternative remedies to fix your situation before you rejuvenate.

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