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.
Today, 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.
We recently notified seven device manufacturers of our concerns about inappropriate marketing of their devices for “vaginal rejuvenation” procedures. They are: Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton and Thermigen. 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.
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. Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options. FDA is committed to helping advance the development of safe, effective treatment options for these conditions.
We’ve been focused on advancing new policies to improve our oversight of device safety. As part of our Medical Device Safety Action Plan and our ongoing commitment to advancing women’s health, we’ve begun building out important device safety registries. We’ve also established the 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.
As part of this critical work, we remain dedicated to closely monitoring reports of adverse events associated with “vaginal rejuvenation” procedures. We will keep the public informed if significant new information becomes available. We’d also like to learn more about patients’ experiences with these procedures. We encourage those who’ve had an adverse event associated with the use of these devices to report their problem to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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