By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)
The recent warning by the U.S. Food and Drug Administration (FDA) to manufacturers of vaginal rejuvenation devices has caused quite a stir. And for some, the reaction has been closer to an all-out panic. Already, I’m hearing from concerned members threatening lawsuits, trying to return their devices, and demanding immediate refunds from manufacturers.
Believe me, I understand. Had I purchased a device for several hundreds of thousands dollars, I would be alarmed by the warning, too. But as with many things in this industry, the reaction to the FDA warning may end up being more damaging than the warning itself. The ensuing panic and reaction could end up threatening a procedure that, by all accounts, is very safe, very effective, and enjoys unprecedented patient satisfaction.
So, I’m here to reassure everyone and, hopefully, calm the waters a little bit. DONT PANIC! Keep calm and carry on as normal. This is not the end of the world, and I doubt very much that any medical spa or provider has anything to worry about, including those who continue to offer these procedures.
The bottom line is this: vaginal rejuvenation is 100% legal for medical spas, and any physician can recommend and delegate the procedure using any of the devices at issue. This is called “off label” use of a medical device—using a medical device for a procedure other than what it is approved for by the FDA. This is done ALL the time. Botox, for instance, is not FDA approved for many, if not most, of the treatments it is used for. Indeed, most medical spas, surgeons and cosmetic derms are offering Botox injections off-label every single day. So long as the physician determines that, in his or her medical judgment, the treatment is appropriate and safe, these procedures can and should continue. There is no danger for medical spas here. The FDA doesn’t even have jurisdiction over medical spas or providers, so even if it wanted to do something (which it doesn’t), it couldn’t. There truly is no need to panic.
As AmSpa and the law firm of ByrdAdatto indicated in our joint statement on the matter:
“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… 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.“
AmSpa members with additional questions about the warning can take advantage of their annual compliance consultation call with ByrdAdatto.
There are some things that all medical spas and providers should do, however. This warning is much more about marketing and advertising than it is about the actual treatment. All the FDA is saying is that manufacturers need to ensure that they are not marketing these machines for anything other than that which they are formally approved for. That’s it, nothing else. The FDA wants to ensure that the public, including medical spas, is aware that they have not approved these devices for things like tightening, dryness, or incontinence. That doesn’t mean you can’t use them for those conditions; it only means that the manufacturer cannot market their devices for those conditions.
I don’t recommend that anyone try to return their devices. What you should do is:
- Make sure that your consent forms are up to date and explain that the procedure is not FDA approved for vaginal rejuvenation; and
- Keep a close eye on your marketing material so that you are clearly explaining what you are offering is an “off label” treatment. Just be honest with your patients. Education is key. Like with Botox, medical professionals who are within their state’s legal scope of practice to perform these procedures are still OK to do so. Thus far, this practice has proved to be quite safe.
In some ways, I wish the FDA had taken a less alarming approach to this issue, but, at the same time, I understand their position. Their job is to protect the public, and the manufacturers of vaginal rejuvenation devices are responsible for marketing their products legally. But this, like most things in this industry, will work itself out. There will be a device approved by the FDA for these conditions in the near future. Until then, do as the Brits do: Keep Calm and Carry On
I highly recommend that you listen below to the recent podcast we hosted with attorney Jay Reyero of ByrdAdatto Law Firm as he gives some great perspective—and advice—on this issue. Also, stay tuned for more as we’ve reached out to the FDA and are trying to get them on a podcast as well. Remember: AmSpa is here for you!