August 3, 2018

FDA warns against devices marketed for 'vaginal rejuvenation'

Daily Briefing

    FDA Commissioner Scott Gottlieb on Monday announced the agency has warned seven companies to cease marketing their devices for procedures called "vaginal rejuvenation," saying the treatments are dangerous and deceptively marketed.

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    FDA warns women, health care providers of deceptive health claims for 'vaginal rejuvenation'

    Gottlieb in a statement said FDA has approved laser and other "energy-based" devices that destroy or reshape vaginal tissue for the treatment of serious conditions, including the destruction of genital warts and abnormal or pre-cancer cervical or vaginal tissue.

    However, he said FDA has not confirmed the effectiveness or safety of such devices for procedures marketed as "vaginal rejuvenation," which claim to treat conditions and symptoms related to menopause, sexual function, or urinary incontinence. Gottlieb said the devices "have serious risks and don't have adequate evidence to support their use for these purposes."

    Further, Gottlieb said the agency is "deeply concerned women are being harmed" from vaginal rejuvenation procedures. The agency reviewed both adverse event reports—and published literature on vaginal rejuvenation and found such procedures had resulted in a number of cases of vaginal:

    • Burns;
    • Pain during sexual intercourse;
    • Scarring; and
    • Recurring or chronic pain.

    FDA spokesperson Deborah Kotz said the agency has received dozens of reports about complications related to the procedure since December 2015.

    Gottlieb said FDA is warning women and their health care providers against using laser and energy-based devices to treat gynecological conditions that FDA has not cleared the devices to treat.

    According to Gottlieb, FDA recently issued warning letters to seven device manufacturers—Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen—over the inappropriate marketing of their devices for vaginal rejuvenation. FDA in the letters told the manufacturers to no longer promote their devices for vaginal rejuvenation.

    Gottlieb said the manufacturers have 30 days to address the concerns FDA raised in the letter. If the manufacturers do not address FDA's concerns, the agency will consider potential enforcement actions if needed, Gottlieb said.

    Gottlieb said, "The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions. These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options."

    Gottlieb recommended, "Women considering treatment for vaginal symptoms … speak to their doctor about the potential and known benefits and risks of all available treatment options."

    FDA urged women who suffer from complications related to vaginal rejuvenation procedures to report any adverse events through MedWatch.

    Comments

    Jane Mazur, a spokesperson for Hologic, the parent company of Cynosure, said the company is aware of the warning letter Cynosure received for its MonoLisa Touch laser. Mazur said, "As a leader in women’s health, Hologic has a strong track record of rooting our products in science and clinical evidence, so we take the contents of this letter seriously. We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements."

    The American College of Obstetricians and Gynecologists (ACOG) said, "Obstetrician-gynecologists should be cognizant of the evidence regarding innovative practices" and they should be wary "of adopting new or innovative approaches on the basis of promotions or marketing." ACOG said it has issued a number of statements saying FDA has not cleared or approved devices, such as MonaLisa Touch, to treat menopausal symptoms.

    Cheryl Iglesia, director of the section of female pelvic medicine and reconstructive surgery at MedStar Washington Hospital Center, said devices are promising, but additional research is needed to determine whether the devices are safe and which patients might benefit from the device. She said, "I think the FDA is trying to be conservative. They do not want the marketing to be ahead of the science on this"(May, USA Today, 7/31; Kaplan, New York Times, 7/30; McGinley, "To Your Health," Washington Post, 7/30; Gottlieb statement, 7/30).

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