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The FDA is warning consumers against serious risks of some â€˜vaginal rejuvenationâ€™ devices, and a lack of evidence to support their uses for this purpose.
The FDA is warning consumers against serious risks of some ‘vaginal rejuvenation’ devices, and a lack of evidence to support their uses for this purpose. In a statement, FDA Commissioner Scott Gottlieb, MD, said the agency has recently become aware of a growing number of manufacturers marketing devices that claim to treat conditions and symptoms related to menopause, urinary incontinence and sexual function. These devices perform procedures that utilize lasers, and other energy-based elements to destroy or reshape vaginal tissue.
Officials with the FDA have notified 7 device manufacturers of their concerns about inappropriate marketing of these products for ‘vaginal rejuvenation’ procedures. The notified manufacturers include: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen.
“We are deeply concerned women are being harmed,” said Gottlieb, in a press release. “As part of our efforts to promote women’s health, the FDA has cleared or approved laser and energy-based devices for the treatment of serious conditions, like the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as genital warts. But the safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for ‘vaginal rejuvenation.’
Women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and who are seeking alternative nonhormonal options, may be particularly drawn to ‘vaginal rejuvenation’ devices,’ according to the agency. However, the FDA is urging women considering treatment for vaginal symptoms to speak with their doctors about available options, as well as their benefits and risks.
“In addition to the deceptive health claims being made with respect to these uses, the ‘vaginal rejuvenation’ procedures have serious risks,” Gottlieb added. “In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause. The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.”
According to the FDA, numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain have been reported and documented. In these cases, the FDA had not reviewed or approved the used devices for the purpose of ‘vaginal rejuvenation.’
“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,” said Gottlieb, in a statement.
The FDA has requested that the manufacturers address the concerns within 30 days. If the concerns are not addressed, the FDA has vowed to consider further appropriate actions, which may include potential enforcement actions.
Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation” [news release]. Silver Spring, MD; July 30, 2018: FDA website. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm615130.htm. Accessed July 30, 2018.