FDA head Dr. Scott Gottlieb today released a statement warning about “vaginal rejuvenation” procedures intended to treat conditions related to menopause, urinary incontinence or sexual function, saying that the products used in the procedures “don’t have adequate evidence to support their use for this purpose.”
Gottliebb said that the procedures use lasers or energy-based devices to destroy or reshape vaginal tissue, and while the FDA has approved such devices for treating serious conditions such as the destruction of abnormal or precancerous cervical or vaginal tissues, the devices and procedures have not been evaluated for “vaginal rejuvenation.”
“In addition to the deceptive health claims being made with respect to these uses, the “vaginal rejuvenation” procedures have serious risks. 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,” Gottlieb said in a press release.
Upon reviewing adverse event reports and published studies, Gottlieb said the FDA found numerous cases of vaginal burns, scarring, pain during sexual intercourse and recurring or chronic pain, according to the release. He added that as the devices haven’t been reviewed for ‘vaginal rejuvenation’ purposes, the true extent of the risk is unknown, but that reports seem to indicate that the procedures can cause serious harm.
The FDA warned women and healthcare providers of the serious risks associated with the devices, and said it has notified seven device makers about their concerns. The makers include Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen, according to the release.
“We requested that the manufacturers address our concerns within 30 days. If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions, are appropriate. This matter has the full attention of our professional staff,” Gottlieb said in his release.
Gottlieb said that the “deceptive marketing” may not only cause injuries, but also keeps individuals from accessing appropriate care for their conditions. He suggested that women seeking non-hormonal options for issues such as vaginal dryness speak to their doctor about risks and benefits of suggested treatment options.
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