FDA issues vaginal rejuvenation devices warning
The US Food & Drug Administration (FDA) commissioner Scott Gottlieb, MD, released a statement 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.
It said: “We’ve recently become aware of a growing number of manufacturers marketing ‘vaginal rejuvenation’ devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function. The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.”
The news made international headlines and sent shockwaves through the aesthetics industry, which has been spearheading promotion of energy-based devices as a new and innovative method of non-invasive vaginal rejuvenation.
The news also left many women feeling anxious about the safety and efficacy of these treatments as well as causing concern to those providing them in-clinic.
In explaining its actions, the FDA claimed that, while a large part of its work focuses on efforts to bring forth "innovative and new products", it is equally dedicated to monitoring the landscape to ensure products are "delivering on their intended benefits" and to ensure that if "new health risks arise", appropriate action is taken. This is a key aim of its Medical Device Safety Action Plan, which outlines how the FDA will encourage innovation to improve safety, detect safety risks earlier and keep doctors and patients better informed. The body has also established a Women’s Health Technologies Strategically Coordinated Registry Network (CRN) to provide more complete evidence in clinical areas that are unique to women, such as uterine fibroids and pelvic floor disorders.
The statement went on to say, “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 condylomas (genital warts). But the safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA 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.
“In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain. We haven’t reviewed or approved these devices for use in such procedures. Thus, the full extent of the risks is unknown. But these reports indicate these procedures can cause serious harm.
“We’re warning women and their healthcare providers that the FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared.”
The FDA notified seven device manufacturers of its concerns about inappropriate marketing of their devices and requested that the manufacturers address these concerns within 30 days. If these concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions.
Consultant plastic surgeon and member of the British Association of Aesthetic Plastic Surgeons Mr Paul Banwell was quoted in the press when the story broke. He is now calling for a task force to be set up to safeguard practitioners and patients. He said, "There has been an exponential rise in the interest in women's health and sexual well-being and whilst this should be encouraged, it is vital that any educational and treatment initiatives are provided in a sensitive manner free of any misleading or marketing.
“I think we need to convene an urgent task force to produce recommendations and guidelines for patients and practitioners to show the UK is responding positively to these FDA claims.”
See the September issue of Aesthetic Medicine for our special report on how the industry has responded to the news.
