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News: FDA Warns About Use of Certain Devices for “Vaginal Rejuvenation”

News: FDA Warns About Use of Certain Devices for “Vaginal Rejuvenation”

Experts caution that energy-based devices are not approved for “vaginal rejuvenation” and may cause harm.

In late July 2018, the U.S. Food & Drug Administration (FDA) released a statement warning women considering having “vaginal rejuvenation” or cosmetic procedures using lasers or radiofrequency devices to be aware of the potential for serious side effects. The FDA also sought to put health care providers who use such “energy-based devices” to perform these procedures on notice as well.

While these nonsurgical devices have been approved by the FDA for treating certain gynecological conditions (such as pre-cancerous cervical or vaginal tissue and genital warts), the safety and effectiveness of these devices for “vaginal rejuvenation” has not been studied or confirmed.

According to the FDA, certain manufacturers may be promoting their devices for “vaginal rejuvenation” to help treat conditions including:

  • Vaginal stretching and looseness
  • Vaginal atrophy, dryness or itching
  • Painful sex
  • Trouble urinating
  • Decreased sexual sensation

Each device works differently, but in general, laser devices involve inserting vaginal probes that deliver laser energy to the vaginal wall. Some companies claim this can stimulate healing of vaginal tissue. Similarly, devices that use radiofrequency energy are said to help tighten vaginal tissue.

Women who have symptoms related to menopause—including vaginal dryness, urinary incontinence or sexual dysfunction—may find these sorts of claims compelling. But the FDA wants physicians and patients to know that these devices are not approved as treatment options for symptoms like these.

Understand the risk of side effects
According to the FDA, not only do these devices lack FDA approval for treatments related to “vaginal rejuvenation,” but their use in this way may lead to vaginal burning, scarring and pain shortly after treatment, and recurring or chronic pain.

If you’re considering treatment options for symptoms related to menopause, urinary incontinence or sexual dysfunction, talk with your OBGYN about the best options for you.

Meanwhile, it’s worth noting that the FDA’s statement doesn’t apply to surgical procedures that are also referred to as “vaginal rejuvenation.” These surgeries may be done to tighten the vagina or for cosmetic reasons. However, those are controversial, too. The American College of Obstetricians and Gynecologists has warned in the past that there’s usually no medical reason to do them.

If you’ve heard about “vaginal rejuvenation” procedures using laser or radiofrequency devices and are tempted to try them, the FDA says to think twice.

And if you have had a “vaginal rejuvenation” at your doctor’s office using a laser or radiofrequency device and are experiencing any problems, the FDA recommends filing a report through MedWatch, also known as the FDA Safety Information and Adverse Event Reporting Program.

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