According to a warning released by the U.S. Food and Drug Administration on July 30, 2018, cosmetic vaginal procedures known as vaginal rejuvenation are potentially dangerous and may result in serious side effects.

FDA Safety Warning

The FDA safety warning refers to cosmetic vaginal procedures as well as medical procedures intended to treat vaginal conditions including urinary incontinence and issues related to menopause.

According to the warning, energy-based devices including lasers are often used in non-surgical vaginal treatments. Although lasers and energy devices have been approved for other types of treatments, the safety and efficiency of these lasers and devices for cosmetic vaginal procedures has not been verified, and serious side effects are possible, the FDA says.

What is Vaginal Rejuvenation?

These vaginal rejuvenation procedures are intended to alter the appearance of the vagina, as well as treat many vaginal conditions. These conditions include:

• Pain during urination
• Pain during intercourse
• Vaginal atrophy or dryness
• Itchiness
• Vaginal laxity
• Decreased sensation

According to an article published by the Washington Post in 2018, the laser treatment involves inserting a tube inside of the vagina to heat or laser the tissue. The procedure takes a few minutes to an hour and is described by one company as being “virtually painless.”

Laser and energy-device treatments are not approved by the FDA for the treatment of any of these conditions, the agency says. Despite this lack of regulation or approval, many companies are allegedly marketing vaginal treatments to patients. Some of the companies marketing such treatments include:

• Venus Concept
• BTL Industries
• Cynosure
• Alma Lasers
• Sciton
• Thermigen
• Inmode MD

The FDA has reached out to some of these companies regarding their marketing of these devices for unapproved procedures, expressing concern that the companies’ promotional materials may violate the federal Food, Drug and Cosmetic Act.

Possible Side Effects

As these treatments are not approved by the FDA, little is known about the possible side effects of vaginal rejuvenation. Some patients have reported burning, scarring, and pain following their procedures. Patients who have undergone vaginal treatments and experienced adverse symptoms may report their symptoms and experiences to MedWatch, the FDA’s  adverse event reporting system.

Who is Vaginal Rejuvenation Marketed Towards?

Vaginal treatments are marketed towards many demographics of women, including women in menopause and women who have experienced childbirth.

As hormone levels change with age, many women experience vaginal dryness or discomfort. Rejuvenation is marketed towards menopausal women as a way to increase their quality of life and improve age-related conditions including incontinence.

Similarly, many women who have gone through childbirth later experience issues including vaginal laxity and incontinence.

If you have undergone rejuvenation or another cosmetic vaginal surgery and suffered adverse side effects, you may be eligible to join a vaginal rejuvenation lawsuit investigation at no cost to you and pursue compensation for your injuries.