Update on Aesthetic Medical Devices

It never ceases to amaze me how many medical products are marketed for use to the non-medical market. There are so many skin care products making outrageous claims and product manufacturers making claims about their devices and all the while, marketing them to people who cannot legally perform services with the device. This problem is more prevalent today than ever before and this is counter intuitive since there has never been more regulation in the health industry and the FDA has stepped up compliance.

I have previously written about skin care products that claim to alter and repair DNA (this is really funny because it is so outrageous); other products that claim to treat rosacea (even though when you read the package insert it refers to treating “redness”) and devices that are marketed to the aesthetic market when they are being offered to treat medical conditions. Sometimes the problem is that the device is a medical device being offered to non-medical markets. Other times the problem is that the device is treating medical conditions or the use of the device is such that it constitutes the practice of medicine.

I was reading Day Spa magazine today and I ran across an advertisement that I have seen for MANY years. It was for the Lamprobe. Interestingly enough, I met the owner about ten years ago and asked how he is marketing the device to the non-medical market. He had an unsatisfactory answer. It is not my intention to malign any particular product, but this one typifies the problem.

The Lamprobe advertises that it treats skin tags, broken capillaries, cholesterol deposits, cherry angiomas, fibromas, spider nevi, clogged pores and milia. Very interesting. An esthetician can treat NONE of these proposed uses. How can this product be ethically marketed to the non-medical aesthetic market when the user cannot legally perform the treatments? Virtually all of these proposed uses are outside the scope of license of an esthetician and they are clearly and squarely within the parameters of medicine.

Paddy Deighan JD PhD
http://www.medicalandspaconsulting.com

AGGGHHHHH More Esthecians Trying to Inject Botox and Dermal Fillers

This topic just will NOT go away!!! Where is this coming from all of a sudden. Today, I was minding my own business (admittedly a rarity). I was receiving a far infra red body wrap at a Las Vegas facility. I brought the July issue of Dermascope - a reputable medical aesthetic magazine. I noted an article written by a "medical aesthetician" so that immediately caught my attention because the law does not make the distinction between and esthetician and a medical esthetician. I have blogged about this frequently. In fact, calling yourself that can violate FTC guidelines and state board of cosmetology and medicine mandates. Arguably you are deceiving the public by calling your self that since it is not a higher license and does not allow you to perform additional services.

Then my knickers really got into a bunch when I read the article! The author incorrectly asserts that estheticians can perform ablative laser, dermal filler (Restylane, Collagen, Juvederm) and Botox injections! Hey, folks, I taught at a premier cosmetology school and I can tell you that the depth of knowledge and experience of the vast majority of estheticians is NOT appropriate for these types of treatments. In any event, it is NOT legally supportable for them to do these procedures!! They cannot practice medicine. They cannot dispense prescription drugs or provide medical devices and they cannot operate a laser (except in limited situations). I actually pioneered the ability of esteticians to perform laser hair removal in New Jersey many years ago.

I am actually taking the time and trouble to send Dermascopes editors a letter about this. If enough people read things like this, they will believe that it is acceptable for estheticians to practice medicine.

I do not know where all of this is coming from nor do I know why it is suddenly so prevalent. As I mentioned in an earlier blog, in the past two weeks, I received calls from doctors in Texas, Nevada and Colorado about this. Now, I read this article that would have many believe that estehticians can inject Botox, dermal fillers such as Restylane and Juvederm and perform laser treatments.

Folks, Estheticians Cannot Inject Botox and Dermal Fillers!!!

There seems to be a massive increase in the number of non-medical personnel injecting Botox® Cosmetic, dermal fillers such as JuveDerm, Collagen, Perlane, Hylaform and Restylane. There is a correspondingly huge increase in the arrogance with which such providers are maintaining that they are allowed to do this. In the past two weeks, I received contacts from physicians in New Jersey, Texas, Colorado, California and Nevada about the issue of estheticians injecting Botox® Cosmetic.
The argument that they are allowed to do this is that they are doing so under supervision of a physician. IF this is legally supportable, the non-medical personnel would have to be DIRECTLY employed by the physician and properly supervised by the physician. Remember that I stated “IF” this is legally supportable. Other times they are stating that the physician can DELEGATE this to the non-medical personnel. Again, “IF” this is legally supportable (and it isn’t), the injector would have to be directly employed by the physician and supervised by the physician. Additionally, it would be far more preferable if the injector was NOT and Independent Contractor of the physician. He or she should be an employee.
Realize that there are many issues presented here- not the least of which is insurance coverage. If an esthetician injects Botox® Cosmetic , Collagen, Restylane, Perlane, Hylaform, Juvederm etc., there is NO insurance coverage for this procedure!!
Another issue is that the esthetician license is frequently not recognized in the medical office. Accordingly, the esthetician is an unlicensed non-medical person performing medical treatments. Even in situations in which the esthetician license is recognized in a medical office, the scope of their license NEVER allows them to inject Botox® Cosmetic or dermal fillers.
So, let’s sum this up…non-medical personnel are injecting prescription drugs and medical devices through a syringe and there is no professional negligence coverage; and they are doing so outside the scope of their license. This is OK??? Really?? Guess what…it isn’t OK….for the simple reason that they are engaged in the “UNAUTHORIZED PRACTICE OF MEDICINE”!!!!! EVERY state prohibits this! EVERY STATE! The state Attorney General can prosecute such cases..wanna go there??? 

Non-Physician Owned Medical Spas

It is really frustrating to see soooo many medical spas violating basic state and federal laws. I had occasion to visit a medspa in Las Vegas this week. I was SHOCKED at the number of state and federal violations I noticed. Medical assistants injecting Botox® cosmetic, non-licensed individuals operating a laser, equipment not available in the USA, and a “supervising” physician that has never been on the site!! In fact, a medical assistant should not be employed in that capacity by a non-physician owned medical spa!! It amazes me that there is so much clear violation of so many laws and the arrogance of those that defend the un-defendable when approached with the issues.
Compliance is on the rise and states, the FDA and other federal agencies are becoming more aware of the issues. Physicians are more aware of the duties and responsibilities of being a medical director or in medically supervising another facility.
Folks, it is time to wake up and appreciate that a non-physician owned medical spa is a huge concern, It is very difficult for such facilities to operate in any manner of compliance. They are called “medical” spas for a reason. I am not saying that it is impossible; but it is problematic!! Websites frequently provide so much information of violations that regulators would not even have to visit the site! Websites and advertising are the biggest source of compliance triggers. The facility that I visited this week had CLEAR indication that the physician was the owner of the medical spa!! AS I mentioned, the physician had never even been on the site!! Peer complaints are next – many of your peers will complain to the boards of cosmetology or medicine. The boards, by charter, must investigate EVERY complaint – no matter how deficient on its face. The cost of defending a compliance audit is HUGE and the fines and penalties are high. There is even criminal prosecution and loss of professional license possibilities. Yes, this does happen!!