The Food and Drug Administration is warning women to be wary of cosmetic gynecological procedures due to the risk of vaginal rejuvenation injuries.

The FDA has approved laser and energy-based devices to treat serious conditions. Approved treatments include the eradication of abnormal or pre-cancerous cervical or vaginal tissue and the destruction of genital warts.

A number of manufacturers of these medical devices, however, have reportedly started marketing their use as ways to cosmetically change the appearance of the vaginal tissue.

According to the Daily Beast, manufacturers are marketing the term “vaginal rejuvenation” to describe non-surgical ways to supposedly recapture a youthful genitalia by resolving issues such as dryness, itching, atrophy or loss of elasticity.

Despite the marketing efforts of these manufacturers, the FDA has not approved any medical devices for vaginal rejuvenation.

False Advertising: Vaginal Rejuvenation

Manufacturers are promoting these devices as treatments for a variety of vaginal issues women face during menopause and to help correct problems such as urinary incontinence and painful sex. Other advertisements allege the laser or radio frequency treatments can improve conditions of the vaginal wall, canal and pelvic floor or help counteract complications after breast cancer treatments.

At least one company markets the use of its laser probes to stimulate the production of cells, collagen and moisture in the vaginal area to recapture a youthful genitalia.

In addition to the promotions by manufacturers, celebrities have been known to tout the praises of their revitalized private parts. Reality television stars who talk about their cosmetic surgery procedures have added vaginal rejuvenation to the list of procedures du jour.

However, the FDA says there is no evidence any of the vaginal rejuvenation therapies work, and while it’s not unusual for medications or medical devices to be used for off-label purposes, the actual promotion or marketing of such products for off-label uses is a direct violation of FDA regulations.

Risks of Vaginal Rejuvenation Injuries

The FDA warns of potential vaginal rejuvenation injuries such as burning of delicate vaginal tissue that can develop scar tissue. As a result, some patients experience painful sex and chronic pain.

The American College of Obstetricians and Gynecologists also says no adequate clinical studies have been published that assess long-term results, safety or complication rates for the procedures and that women may be traumatized by undergoing an unproven procedure and risking vaginal rejuvenation injuries.

Listed among the companies under investigation for allegedly promoting off-label vaginal cosmetic procedures are:

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

Scott Gottlieb, FDA Commissioner said in a press release that women opting for the unauthorized procedures could not only incur vaginal rejuvenation injuries, but also could neglect to seek appropriate help for serious medical issues. He further expressed, “We are deeply concerned women are being harmed.”

One of the target audiences is also among the most vulnerable. Vaginal rejuvenation marketing has targeted women who have undergone chemotherapy for breast cancer and are experiencing early signs of menopause.

Gottlieb said he finds such marketing efforts by the companies “egregious” because there is no proof such treatments are safe for post-chemotherapy patients.

ASLMS Weighs in

According to the American Society for Laser Medicine & Surgery (ASLMS), 45 Manufacturer and User Facility Device Experience (MAUDE) database reports involved vaginal rejuvenation procedures.

The ASLMS analyzed the reported device incidents, and the clinical report was published in Lasers in Surgery and Medicine medical journal in April 2019.

The study found that most of the patients who reported injuries from vaginal rejuvenation procedures went to a doctor because of the complications, which included:

• Long-term pain
• Numbness
• Burning
• Bladder issues
• Infection
• Scarring
• Dyspareunia (pain during sexual intercourse)
• Disfigurement
• Increased symptoms
• Lichen sclerosis, which is a thinning of the skin around the genital area

“These events signify the importance of clinical trials that investigate the efficacy and safety profile of laser and energy-based devices for optimization of sexual function and treatment of genitourinary syndrome of menopause (GSM)-related symptoms,” said Dr. Jusleen Ahluwalia, who led the study.

Ahluwalia is a second-year dermatology resident at UC San Diego, who also serves as a resident/fellow board representative on ASLMS. She concentrates on research involving the use of lasers and similar medical devices used to treat skin cancer and melasma, which is a brown or gray discoloration that appears in patches usually on the face.

Despite the FDA’s notice regarding the fact that vaginal rejuvenation through laser treatments have not been proven safe or effective, many companies continue to market their products for off-label use. In addition, med-spas and some gynecologists continue to promote the laser treatments as a way for older women to recapture the youth of their genitalia.