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”
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.