FDA Commissioners Warnings for “vaginal rejuvenation” raises significant concerns

FDA Commissioner’s warning regarding deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation” raises significant concerns.

Seems like another medical device litigation is brewing. We noted the FDA’s recent warnings about vaginal rejuvenation when FDA released its statements on July 30. Today we dive a little deeper into the FDA Commissioner’s statements.

The Food and Drug Administration recently noted that it had “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 FDA noted that “the procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue” and that the “products have serious risks and don’t have adequate evidence to support their use for these purposes.” The FDA Commissioner explained that the FDA has cleared or approved energy-based devices. Such devices were intended “for the treatment of serious conditions like the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts).” The FDA notes, however, that “the safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for ‘vaginal rejuvenation.’”

This is significant. This means the companies promoting these products may be engaged in off-label marketing. Before selling certain products, companies must go to the FDA and provide information about the product. The FDA then reviews it and allows the company to sell the product for specific intended uses. Sometimes companies promote the product beyond those uses and that can raise significant issues. Additionally, one could read the Commissioner’s statements to suggest some companies are misbranding these devices. This conduct could give rise to several claims in a product liability or personal injury case involving women injured by vaginal rejuvenation devices.

With respect to the deceptive claims, the FDA notes that “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.” These are specific representations patients’ should be looking out for and if such representations were made, patients should investigate further.

In its warning, FDA recommended the following for patients:

• Be aware that the safety and effectiveness of energy-based devices to perform vaginal “rejuvenation” or cosmetic vaginal procedures has not been established.
• Understand that the FDA has not cleared or approved any energy-based medical device for vaginal “rejuvenation” or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function.
• Discuss the benefits and risks of all available treatment options for vaginal symptoms with your health care provider.
• If you have undergone treatment for vaginal “rejuvenation” and experienced a complication, you are encouraged to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

FDA recommended Health Care Providers as follows:

• Be aware that the safety and effectiveness of energy-based devices to perform vaginal “rejuvenation” or cosmetic vaginal procedures has not been established.
• Understand that the FDA has not cleared or approved any energy-based medical device for vaginal “rejuvenation” or vaginal cosmetic procedures, or for the treatment of vaginal symptoms related to menopause, urinary incontinence, or sexual function.
• Discuss the benefits and risks of all available treatment options for vaginal symptoms with your patients.
• If any patients experience adverse effects from procedures that involved the use of energy-based devices to perform vaginal “rejuvenation”, cosmetic procedures, or treat genitourinary symptoms of menopause, sexual dysfunction, or urinary incontinence, please file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

If you have undergone a vaginal rejuvenation procedure using lasers, and have suffered adverse side effects from these procedures, it is important to file a report through MedWatch. If you have any questions, or if you believe you have a case, contact us at KBA Attorneys.