The FDA recently issued a notice to warn doctors and patients of the risks associated with off-label uses of devices normally used to destroy abnormal or pre-cancerous cervical or vaginal tissue and genital warts.

The FDA issued its notice July 30, 2018, alerting doctors and patients the agency has concerns about use of energized medical devices being used for vaginal rejuvenation treatment.

The term vaginal rejuvenation is not well-defined, but generally, it refers to non-surgical procedures designed to treat a variety of vaginal changes, including dryness, itching, lack of elasticity, atrophy, or painful sex or painful urination. The FDA says it has not cleared any device for the purpose of vaginal rejuvenation treatment.

Advertising efforts target women who have survived cancer and suffered negative gynecological effects from hormone imbalances. Most marketing is directed at post-menopausal women who contend with dryness, laxity, painful sex, or painful urination.

Vaginal Rejuvenation Treatment Problems

Some device manufacturers and some gynecologists are marketing energy-based devices as ways to treat undesired vaginal changes related to menopause, urinary incontinence, or sexual problems, says the FDA’s warning.

“The safety and effectiveness of energy-based devices for treatment of these conditions has not been established,” the warning says.

The FDA has sent letters to several companies about their marketing of vaginal rejuvenation as a service available to patients using the medical devices normally used to treat pre-cancerous cells and genital warts.

Among the companies who received a letter regarding their alleged marketing of off-label vaginal rejuvenation treatment are:

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

Vaginal rejuvenation treatment by energy-based devices has led to burning, scarring, and painful sex after treatments, the FDA says.

Many companies, such as Cynosure, market the lasers as in-office treatments with “minimal side effects” and “no down time.” Cynosure promotes MonaLisa Touch as a probe that “delivers gentle laser energy to the vaginal wall, stimulating a healing response. The total procedure takes less than five minutes.”

Cynosure recommends three 5-minute treatments at 6-week intervals for “post-menopausal women with gynecologic health concerns.”

Cynosure’s website, smilemonalisa.com, almost makes MonaLisa Touch vaginal rejuvenation treatment sound like a fountain of youth, touting the device as “innovative technology for vaginal and vulvar health.”

Some of the providers who offer vaginal rejuvenation treatment are not licensed physicians. Aestheticians and nurses have started businesses that promote vaginal rejuvenation treatment among their “specialties.”

Lasers that are turned too high or concentrate on delicate tissue for too long can cause permanent scarring, burning, or nerve damage.

A number of celebrities have touted vaginal rejuvenation treatment as a way to recapture their gynecological youth, but off-label uses of medical equipment that has not been tested and proven safe and effective for the delicate vaginal tissue could prove irreversibly damaging.

Does a Vaginal Rejuvenation Treatment Always Involve Lasers?

Many different methods of vaginal rejuvenation have become options in recent years. While many of these devices use radiofrequency or fractionated carbon dioxide lasers to increase blood flow and stimulate the production of collagen within delicate vaginal tissues, other methods involve actual surgery.

Women who have severe cases of pelvic organ prolapse may need surgical intervention. Pelvic organ prolapse is a disorder involving one or more of the pelvic organs, most often the bladder, to drop from its normal position in the abdomen. This may occur due to injuries suffered by the muscles or tissues that support the pelvic organs. Often, pregnancy and childbirth, especially a vaginal birth, can cause stress to the pelvic floor’s structure, resulting in pelvic organ prolapse.

One of the main symptoms of pelvic organ prolapse is a bulge in the vagina caused by pressure from the organ that has become dislodged from its normal place on the pelvic floor.

Healthline interviewed Dr. Cheryl Iglesia, a board-certified gynecologist in Washington who is also the former chair of the Committee on Gynecologic Practice of the American Congress of Obstetricians and Gynecologists (ACOG).

The ACOG published a statement in 2007 and reaffirmed the position in 2017, saying cosmetic procedures of the vagina were potentially harmful down the road. In some cases, women who have vaginal tightening procedures prior to menopause end up facing painful intercourse and tearing of their vaginal tissue, leading to a need for a reversal of such procedures, according to Iglesia.

Have you been injured by a vaginal rejuvenation treatment that involved lasers or other energized devices? If you have suffered burning, scarring, or painful sex after receiving a vaginal rejuvenation treatment, you could be eligible to participate in a vaginal rejuvenation lawsuit investigation.