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”

FDA News Release

• For Immediate Release: July 30, 2018

Statement was updated on Aug. 2, 2018 to reflect a correction in the listing of manufacturers that received a letter from the FDA.

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Our most fundamental obligation to the American public is providing patients with access to safe and effective medical products to meet their health care needs as well as protecting them from harmful products and deceptive medical claims. A large part of our work focuses on efforts to bring forth innovative, new products. But we’re equally dedicated to monitoring the landscape to ensure products are delivering on their intended benefits and to ensure that if new health risks arise, we take appropriate action.

Delivering on this complementary mission is a key aim of our Medical Device Safety Action Plan. The plan outlines how the FDA will encourage innovation to improve safety, detect safety risks earlier and keep doctors and patients better informed. Our plan would establish a robust medical device patient safety net in the U.S. We are taking steps to streamline and modernize how we implement post-market actions to address device safety issues to make our response to risks more timely and effective.

Advancing the health of women is a priority for the FDA. As part of our action plan, we’re working to improve evidence generation about the safety and effectiveness of health technologies in clinical areas that are unique to women. And as part of these efforts, we also watch for, and take action against, bad actors who unfortunately take advantage of unsuspecting consumers by marketing unapproved, deceptive products that may pose safety risks and violate the trust of American consumers.

That’s what we’re doing today.

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.

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.

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 Industries, Cynosure, InMode, Sciton, Thermigen and  Venus Concept. 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.