The Food and Drug Administration has issued a stern warning to several manufacturers and a statement of caution to the public concerning “vaginal rejuvenation,” an umbrella term for a host of procedures to alter vaginal tissue for therapeutic or cosmetic purposes.
Dr. Marie Paraiso
Lasers and other energy-based devices have been approved to treat abnormal or precancerous cervical or vaginal tissue and general warts, but the FDA has not approved any to treat vaginal atrophy, urinary incontinence, or reduced sexual function.
Device manufacturers claim lasers can address these conditions despite limited scientific evidence for their safety or efficacy. Insurers do not reimburse the procedures, considering them to be cosmetic.
In a July 30 statement, FDA Commissioner Scott Gottlieb, MD, slammed “deceptive” marketing practices on the part of manufacturers.
The FDA has reviewed 12 complaints since December 2015 of adverse effects related to vaginal procedures using the devices. Two were from manufacturers reporting pain and bleeding in patients following treatment, FDA spokeswoman Deborah Kotz said in an interview. “The FDA has also received voluntary MedWatch reports from individual patients who experienced significant pain and discomfort from procedures performed with these devices.”
The agency has targeted seven firms: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and ThermiGen, with letters demanding evidence of FDA approval, clearance, or intent to seek clearance for use of their products on female genitalia. They also asked for evidence backing specific claims.
In a July 26 letter to BTL Industries, for example, the FDA demanded to know why the firm was marketing its Exilis laser device, approved for the treatment of facial wrinkles, as “Ultra Femme 360,” which it called “a whole new approach to women’s intimate health.” The device, according to the manufacturer, “provides the shortest noninvasive radio-frequency treatment available for female intimate parts” and “is proven to increase elastin and collagen in the treatment area.”
The FDA asked Cynosure, the maker of the Mona Lisa Touch, a system marketed as an FDA-approved treatment for vaginal atrophy, for evidence to support its claims that Mona Lisa Touch “is the only technology for vaginal and vulvar health with over 18+ published clinical studies” and is clinically proven to treat “painful symptoms of menopause, including intimacy.” They also asked for information about a modification to the originally approved device that was not brought to the FDA’s attention.
In a letter to Alma Lasers, whose Pixel CO2 Laser System was approved for use in a broad use of surgical applications including gynecologic surgery, the FDA noted that the device was being marketed as “FEMILIFT,” a laser procedure designed to “improve vaginal irregularities” and to assist “in vaginal mucosa revitalization.” The FDA demanded evidence for those claims.
The manufacturers have 30 days to respond to the FDA, which has not ruled out seeking enforcement action against firms with unsatisfactory responses.
For more than a decade, researchers have shown that healthy vaginal morphology is exceptionally wide ranging, including a recent study in more than 650 women, the largest to date (BJOG. 2018 Jun 25. doi: 10.1111/1471-0528.15387). Nonetheless, interest in elective vaginal procedures has only increased, with an industry report from the International Society of Aesthetic and Plastic Surgery describing a 45% increase in the use of one surgery, vaginal labiaplasty, between 2014 and 2016. Most procedures were performed in Brazil and the United States.
While plastic surgery societies support vaginal rejuvenation procedures, the American College of Obstetricians and Gynecologists has long frowned on them, with its first critique issued in a 2007 committee opinion. “No adequate studies have been published assessing the long-term satisfaction, safety, and complication rates for these procedures,” the association said last year in its most recent update on the subject.
Gynecologist David M. Jaspan, DO, of the Einstein Healthcare Network in Philadelphia, echoed ACOG’s views and said he welcomed FDA interest in vaginal rejuvenation.
The practice has “never been endorsed by the College or a board. It’s been considered a cosmetic procedure and it’s been under scrutiny for at least a decade,” Dr. Jaspan said. “I have reservations about the clinical outcomes and the training surrounds these procedures and I anxiously await randomized controlled trials to further evaluate them.”
Gynecologists who offer the procedures caution that they may have a role, and that randomized trials are underway to determine which groups of women might be best helped.
Marie Paraiso, MD, professor of obstetrics and gynecology at the Cleveland Clinic, said she uses the Mona Lisa Touch, a CO2 fractionated laser, to treat patients with genitourinary syndrome of menopause (GSM). These patients, Dr. Paraiso said, “complain of vaginal dryness and are unable to have intercourse or experience significant pain during or after intercourse. Some of them also may have irritative voiding, urinary frequency and urgency, or mild stress incontinence.”
Dr. Paraiso’s group has performed some 300 treatments with the laser and “we have fortunately not had patients complaining of persistent vaginal pain or scarring.” About 80%-90% of patients respond, she said, with some 20%-25% seeking retreatment within a year. “I believe for women who have contraindications to hormonal therapy or do not tolerate or cannot afford prolonged hormonal therapy, the CO2 fractional vaginal laser has been effective.”
Dr. Paraiso is also leading a multisite clinical trial randomizing about 200 patients with GSM to the laser treatment or estrogen-based vaginal creams, and following them for 6 months; thus far, she said, 6 of 89 patients, half in the laser arm, have reported mild to moderate adverse events.
Dr. Paraiso said she does not have a financial relationship with the manufacturer of Mona Lisa Touch, and that the trial was funded by the Foundation for Female Health Awareness, which receives unrestricted research grants from some device makers. “Our institute owns the laser and I have never been paid to train anyone to perform these procedures,” Dr. Paraiso added. “Our onus was to study the laser in order to improve the lives of our patients.”
Other trials comparing vaginal lasers with sham treatment are currently underway or in planning.
The North American Menopause Society struck a cautious note in response to the FDA criticism. In a statement issued August 1, JoAnn Pinkerton, MD, the society’s executive director, said the field needed prospective, randomized, sham-controlled trials of the laser and energy therapies. The therapies “may turn out to be an appropriate choice for many women, particularly for those concerned about breast cancer risk” associated with hormonal treatments. But until more robust data are available, doctors should “discuss the benefits and risks of all available treatment options for vaginal symptoms, including over-the-counter lubricants, vaginal moisturizers, and FDA-approved vaginal therapies such as vaginal estrogen and intravaginal dehydroepiandrosterone and oral therapies such as hormone therapy and ospemifene to determine the best treatment for women with GSM.”
Any discussion of vaginal energy-based therapies, should include the disclosure that these have not been approved for the specific indication, Dr. Pinkerton cautioned.