AmSpa and ByrdAdatto Joint Statement on FDA Vaginal Rejuvenation Warning

Posted By Eric Atienza, Monday, August 13, 2018

AmSpa


The American Med Spa Association

224 N Desplaines St, Suite 600

Chicago, IL 60661



ByrdAdatto

8150 N Central Expy #930

Dallas, TX 75206



The US Food and Drug Administration recently issued a warning to several device manufacturers regarding the marketing associated with "vaginal rejuvenation," and the American Med Spa Association and the law firm of ByrdAdatto want med spa practices to understand how this relates to their day-to-day operations.

Med spas and other health care professionals should not panic as the FDA will not be raiding their businesses. The FDA does not have any control over a physician's ability to prescribe "off-label" which in this case would be when physicians are using the energy-based devices to perform vaginal rejuvenation procedures. 

Although the particular devices are approved by the FDA, they are approved for a very specific use which is not the performance of vaginal rejuvenation procedures. What is important for med spas and other health care professionals to understand is that such "off-label use" is subject to the oversight of their medical boards.

Therefore, med spas and their medical directors that are performing vaginal rejuvenation or are interested in providing vaginal rejuvenation should take this opportunity to review how they are or will be performing these procedures.

Not only should the physicians or medical directors responsible for performance of the procedure be properly trained and qualified for it specifically, but they should also have a good understanding of any available scientific and clinical data relating to the procedure in order to, in their professional judgment, determine it safe for patients.

In addition, they also need to confirm they are meeting the supervision required of those health care practitioners providing the medical services.

Finally, they need to ensure patients are being fully informed and understand the risks about the procedure and that all information communicated satisfy state medical board rules and laws, including those relating to advertising.

For more information on this topic listen to the episode of AmSpa's Medical Spa Insider podcast detailing the issue.


Alex Thiersch, JD,

Founder/Director

The American Med Spa Association


Michael Byrd, JD,

Partner

ByrdAdatto


Brad Adatto, JD,

Partner

ByrdAdatto

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