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Who Can Perform Aquagold Fine Touch Procedures?

Posted By Administration, Tuesday, December 11, 2018

By Alex R. Thiersch, CEO of the American Med Spa Association (AmSpa)

Aquagold Fine Touch is a channeling device offered for sale by Aquavit Pharmaceuticals that has become extremely popular in the medical aesthetics industry. It delivers micro-droplets of a variety of drugs—typically including Botox and other toxins, as well as fillers—into the skin. What’s more, its manufacturer claims the treatments it provides are pain-free.

Unlike a typical Botox treatment, in which the drug is directly injected and paralyzes the muscle, an Aquagold Fine Touch treatment is essentially microneedling. It delivers tiny amounts of the drug with which it is loaded over a wide area—much wider than a Botox treatment can manage. It is suitable for sensitive areas where Botox is impractical or impossible, such as the neck, and because the doses are much smaller than typical toxin treatments, it tends to result in skin that looks more natural and vibrant. Patients who wish to avoid the “frozen” look that Botox and other toxins often produce are embracing this technology.

As is typically the case when such a product emerges, we at AmSpa are getting a ton of questions about who can actually perform Aquagold Fine Touch procedures. The treatment appears to be very straightforward—a provider simply applies the device to the skin like a stamp. Its simplicity raises an obvious question: Can an esthetician or licensed vocational nurse (LVN) perform this procedure?

It’s good that we’re getting these questions because it shows that medical spa owners and operators care about remaining compliant, but because technology moves faster than the law, it’s sometimes difficult to determine what the answers are when new technology emerges. However, we can use what we know about similar treatments and technologies to determine the most prudent course of action until government agencies make their rulings.

Simply put, the Aquagold Fine Touch is essentially a microneedling device, so a lot of the issues we’ve addressed in recent years regarding microneedling are likely also going to apply to it. Every state that has looked into microneedling has found it to be a medical treatment, so a good-faith exam must be performed before the procedure, and if a doctor is not administering the treatment him- or herself, it must be properly delegated.

Unfortunately for practices that would like to use unlicensed practitioners to perform Aquagold Fine Touch procedures, this takes them out of the scopes of practice for estheticians and LVNs. In addition, the fact that Botox and fillers are being administered raises the question of whether or not this represents an injection and, therefore, if it can be administered only by a registered nurse or, in some cases, a nurse practitioner, physician assistant or physician.

The only conclusion we can draw with any sort of certainty is that Aquagold Fine Touch will be regulated in much the same way as microneedling, both in terms of medical board rulings and FDA approval, which has become a bit of a sticking point for microneedling products recently. Additionally, mixing different drugs together, as many doctors do with the Aquagold Fine Touch device, may represent a violation of pharmaceutical regulations, as many IV bars are finding out. Does a practice need to be registered as a pharmacy and have pharmaceutical oversight? Can nurses do it? Can LPNs? Who is qualified, capable and allowed to do this under the law?

Unfortunately, I don’t have all these answers at the moment, but I am going to find out, so stay tuned to AmSpa for more about Aquagold Fine Touch treatments. Thus far, it has been very safe and very well received, but the industry needs to have a firmer grasp on the regulatory issues surrounding it.

Tags:  Med Spa Law  Med Spa Ownership  Med Spa Trends 

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Microblading Training Offered at The Medical Spa Show 2019

Posted By Administration, Friday, December 7, 2018

By Alex R. Thiersch, CEO of the American Med Spa Association (AmSpa)

Microblading is here to stay. A semi-permanent beautification technique that is typically used to improve the perceived thickness of patients’ eyebrows, microblading is a treatment in which technicians create superficial cuts near the surface of the skin and fill them with pigment, creating the illusion of fuller hair. It is an exciting treatment that is becoming quite popular—in fact, according to the 2017 State of the Medical Spa Industry Report conducted by AmSpa, microblading is the fastest-growing new treatment in the industry, with revenue produced by it increasing approximately 40% from year to year. 

However, it is also worth noting that AmSpa’s study found that only around 25% of medical spas offer microblading. That number seems to be rising, but the market for this service is also growing, and enterprising practices stand to make a great deal of money with it, since it is absurdly inexpensive to the practice—all it requires is a disposable device that costs around $5. What’s more, in many states a practice typically does not need a doctor or a medically licensed practitioner to perform these treatments, thus keeping their practical costs low. However, medical spas can charge upwards of $500 for microblading services, so practices can reap very high profit margins when it is administered. Patients like it because it is simple and semi-permanent, making it a much more palatable solution than tattooing, which has been used in the past for the same purpose; microblading also tends to look a bit more natural.

I’ve been told by medical aesthetic professionals that eyebrows are the new lips, so microblading is something that medical spa owners who want to advance their practices should definitely consider exploring.

Educate yourself

Because microblading is so potentially lucrative, AmSpa is offering a one-day microblading training course at The Medical Spa Show 2019 in Las Vegas, which takes place on February 7, 2019. It is presented by Maegen Kennedy from Fleek Brows Microblading in Orlando, FL, who has been training people to perform this technique for several years. She is a board-certified physician assistant and licensed tattoo artist whose experience in the field can help newcomers understand the ins and outs of the microblading process. Visit medicalspashow.com or americanmedspa.org to learn more about this opportunity.

The micro print

If you are considering joining AmSpa and Maegen for this course, you should probably be aware ahead of time that because the microblading process is so similar to that of tattooing, most states that have issued rulings on the matter of who can legally perform these treatments have declared that a tattooing or body art license is required to perform it. 

If your practice is located in one of these states, you and your employees would need to obtain these licenses (if you don’t already have them) in order to perform microblading treatments in a medical spa. This might sound like a bit of a hassle, but earning a tattooing license is often surprisingly simple. Consult a local health care attorney to learn how you and your employees can get tattooing licenses in your state or city. (Author’s note: The American Med Spa Association (AmSpa) works with a national law firm that focuses on medical aesthetic legalities and, as a member, along with a number of other great benefits, you receive a discount off of your initial consultation. To learn more, log on to www.americanmedspa.org.)

If you need to know anything else about this topic, you can learn more about microblading at AmSpa’s consumer treatment website

Microblading training is highly sought after, and this is a great chance to learn about a type of treatment that could make a big difference for a practice’s bottom line. Join AmSpa and Maegen Kennedy in Las Vegas to learn how your medical spa can hit the jackpot with microblading.

Tags:  Med Spa Trends  The Medical Spa Show 2019 

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The Rise of Non-Core Physicians

Posted By Administration, Tuesday, November 27, 2018

By Alex R. Thiersch, CEO  of the American Med Spa Association (AmSpa)

During its early years, the medical aesthetics industry was dominated by the physicians who are referred to as “core doctors”—plastic surgeons, facial plastic surgeons, oculoplastic surgeons, and dermatologists. This makes sense, since these physicians are well-suited to oversee and provide medical aesthetic services. However, in recent years, more and more non-core doctors have entered the marketplace. They are looking for ways to boost their compensation, define their brands and be their own bosses, and they are taking over the industry, much to core doctors’ chagrin.

Today, approximately 60% of all medical directors at medical spas are non-core physicians, and it’s likely that percentage will only increase in coming years. An incredible influx of non-core doctors is coming into the marketplace, and it is very likely that their ranks will expand as the popularity of medical spas increases and the public becomes more aware of these businesses.

Core doctors tend to presume that they are best-equipped to deal with the intricacies of the non-surgical medical aesthetic industry, because it is roughly adjacent to their fields of expertise. However, many often try to run their medical spas as parts of their surgical and dermatological practices without realizing that a medical spa requires a much different business model and perspective.

Non-core doctors, meanwhile, are aware that they don’t know about the medical aesthetic industry and are willing to work to learn about it. They tend to place their primary focus on their medical aesthetic practices, and they become part of the industry by fully participating in it and committing to it. They perform the treatments, build their brands, undergo business training—in other words, they experience all the aspects of running a medical spa. Whether through education or trial and error, they try to learn how to run medical spas effectively. They know they need to have patients in order to survive, which is something many core doctors tend to overlook—if a medical spa associated with a surgical practice doesn’t make money, it’s not a major problem because the surgical practice is where the real money is. If a medical spa is a physician’s primary focus, though, he or she must learn to adapt quickly, and that’s why non-core doctors have experienced significant success in the medical aesthetic industry in recent years.

Of the top 10 medical spas that I know of in the country, none are run by core doctors—they’re run by either non-core doctors or entrepreneurs, most of whom partner with non-core doctors as their medical directors.

In the face of this, core doctors have begun to express concern about the quality of the treatments provided by non-core doctors and, honestly, they have a point. After all, you probably wouldn’t want to be one of the early patients at a medical spa that’s run by a non-core doctor who is new to the industry. However, at the same time, why would you want to go to a core doctor’s medical spa that’s connected to a surgical practice, where your treatment is viewed as an afterthought?

Non-core doctors are affecting the industry in ways that few could have foreseen. When I speak to core doctors at conferences such as Vegas Cosmetic Surgery, I tell them that they’ve fallen behind when it comes to medical spas, and that they need to start considering their medical spas as discrete businesses or else they’re going to be pushed out of the industry. Some core doctors understand this, and when they implement this philosophy into their medical spas, they’ll likely be surprised by how much more money they make.

However, as of now, the medical aesthetic industry belongs to the non-core doctors, and it’s up to the core doctors to catch up and reclaim what was once theirs.

If you would like to learn more about the legal issues surrounding your medical spa, attend The Medical Spa Show this coming February in Las Vegas, NV. 

Tags:  Business and Financials  Med Spa Trends 

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Can an Esthetician Do It?

Posted By Administration, Tuesday, November 20, 2018

By Patrick O’Brien, J.D., Legal Coordinator for the American Med Spa Association

The services that medical spas offer can range between traditional spa beauty treatments to cosmetic medical procedures. Just as medical practitioners have developed less invasive procedures to offer in their practices, so too have cosmetologists and estheticians adopted more invasive procedures. As discussed previously (and here), this can create issues when these procedures fall into the practice of medicine without a license or without proper delegation an oversight. 

The traditional scope of esthetician practice is usually limited to beautifying procedures and applications that do not invade the living tissue. Typically, living tissue ends up being defined as the stratum corneum, the very top most layer of skin. This is the case in South Dakota, where estheticians are limited to only “non-invasive” procedures that are confined to the non-living cells of the stratum corneum. Similarly, North Dakota forbids estheticians from performing any invasive procedures. This limitation to the stratum corneum allows estheticians to perform many of the services offered in traditional spas, but many of the services a medical spa offers will be outside of their scope of practice. (For individual states, AmSpa Members can refer to your state’s summary here.)

The North Dakota Cosmetology Board mentioned above offers a guidance document you can access here which specifically prohibits their practitioners from performing laser use, CoolSculpting, any sort of injecting, microneedling that invades the live tissue, and chemical peels over a certain strength. These cover many of the most popular procedures that medical spas offer. And since estheticians are the most commonly employed licensee in many medical spas, this can create a temptation to practice beyond their scope. In response to this, many states have passed rules and regulations that provide a legal way for estheticians to extend the scope of their services. This process has taken multiple forms which broadly fall into two categories: 1) expanding their scope or practice or 2) providing rules allowing estheticians to perform medical procedures under physician guidance. However these changes can bring their own risks.

In Minnesota, the legislature passed a law creating an “advanced practice esthetics” license that allows licensees to perform procedures that effect the epidermis. This seems like a minor change, as the epidermis is made of primarily of the stratum corneum. The other two layers of the epidermis are significantly thinner. However, it is enough of a change that many formerly prohibited dermatologic procedures would be permitted within this new scope of practice. In this case, the adopted rules for Minnesota’s advanced practice esthetic license allow practitioners to perform dermaplaning, microdermabrasion, and to use electrical- and light-based skin care treatments. These advanced practice licensees are still prohibited from using lasers, but the other procedures encompass a significant percentage of medical spa offerings. Oregon also has an advanced practice esthetician license that allows license holders to perform “advanced non-ablative esthetic procedures” including, among others, laser-based skin rejuvenation and cellulite reduction. After earning this license the advanced practice esthetician is able to perform services without physician oversight. However, they do need to maintain a collaborative agreement with a medical professional if patients need to be referred. Although both the Oregon and Minnesota advanced licenses prohibit injections, they would still be a versatile licensee to have as part of a medical spa’s team. 

Other states have recognized that, although estheticians may have skills that complement more invasive medical procedures, they still need guidance and oversight of a medical licensee. States such as Wisconsin provide detailed rules for estheticians performing services that are medical procedures under physician supervision. A person licensed by the Wisconsin Board of Cosmetology may provide laser hair removal, microdermabrasion, and certain chemical exfoliation procedures; however, this can only take place in a licensed salon and under the delegation, supervision, and written protocols from a licensed physician. Similarly, Kentucky forbids estheticians from performing common medical spa procedures, such as Botox injections, laser treatments and microblading unless under the direct supervision of a physician. Here, direct supervision means within immediate distance to be able to respond to the patient if needed. These states and others like them attempt to strike a balance between expanding esthetician and cosmetologist’s scope of services and providing sufficient medical oversight.

Many states do not have the formalized rules or roles that allow estheticians expand their scope or perform more invasive procedures offered Minnesota, Wisconsin, or Kentucky. In some of these states, physicians may still be able to delegate procedures to other unlicensed individuals known as medical assistants. This may include people who hold esthetician licenses, but usually requires that they not hold themselves out as practicing under their license. Texas is one such state: Estheticians and cosmetologists may only provide their services in a licensed salon. Furthermore, physicians are unable to delegate cosmetology procedures to those licensees. However Texas law and its medical board do allow physicians to delegate certain procedures to others, including medical assistants. Since these procedures are not within an esthetician’s scope of practice, they could only perform them as an unlicensed medical assistant under the supervision of a physician.

Estheticians can be very valuable and versatile employees to a medical spa. They offer a wide variety of services that complement and enhance the other cosmetic medical procedures offered by licensed health care professionals. And in the states that offer expanded scopes of practice or advanced practice licenses, estheticians can even perform some of the more invasive procedures offered. It is, however, critical that medical spas operate well within the rules for delegation and licensees’ scope of practice. Even where the laws and rules are seemingly clear in allowing a procedure to be done by an esthetician, caution should still be exercised. When a physician’s supervision is required, there is always a requirement that the physician confirm that, in their professional judgment, the person has the appropriate training, skills, and experience to perform the procedures. Clearly this is a subjective standard, and the physician’s judgement in regard to what constituted sufficient training and skill would come under close scrutiny by the medical board if there were ever a complaint or adverse patient outcome reported. The physician’s license would depend on the board agreeing with the physician’s prior assessment and, when a patient has been harmed, the board may be less inclined to agree. On the other end of the relationship, if the physician is not providing sufficient oversight or is allowing the esthetician too much free reign, the esthetician could be made vulnerable to discipline from their own board for exceeding their scope of practice or subject to charges of practicing medicine without a license.

It is critical to every medical spa’s success and to the continued success of our industry as a whole that medical procedures are performed by properly trained and licensed people under appropriate supervision well within the rules and regulations of each state. If you would like to learn more about the legal issues surrounding your medical spa you may want to consider attending The Medical Spa Show this coming February in Las Vegas, NV. 

Tags:  Med Spa Law  Med Spa Trends 

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Understanding CoolSculpting and Your Med Spa

Posted By Administration, Monday, November 19, 2018

By Brad Adatto, JD, Partner, ByrdAdatto

Whether you’re an entrepreneur or a veteran business owner of a med spa, you know that business tends to run hot and cold. But does it really matter that business is hot when lifestyle preferences are cooling down? Literally. CoolSculpting is the growing phenomenon that is shifting a culture that was once obsessed with burning fat to freezing it.

CoolSculpting offers a fat reduction alternative to liposuction and a lifestyle alternative to diet and exercise by freezing and eliminating targeted fat cells using a process called cryolipolysis. The process is noninvasive, nonsurgical, and FDA approved. But make no mistake, there are still plenty of legal considerations to navigate before entering into one of the fastest growing practices in the country.

While the procedure is commonly referred to as a “cosmetic” treatment, CoolSculpting, or cryolipolysis, is considered the practice of medicine and a medical treatment in many states. Therefore, businesses must be extremely careful when navigating state laws regulating the practice of medicine, including the ownership and staffing of a CoolSculpting business.

Here’s what you need to know:

Ownership. You should develop your business and ownership model according to the laws of the state(s) in which you plan to practice. Because these laws vary from state to state, you need to know how to legally structure your CoolSculpting business and the type of liability that may be associated with the structure you choose.

You also need to know if there are any licensing restrictions on owning a business that renders medical services in the state(s). California, for example, limits the ownership of businesses that provide medical treatments to California-licensed physicians, but also allows partial ownership by a list of other non-physician health care providers, subject to strict and narrow business and ownership structure requirements.

The Practice of Medicine. What constitutes the practice of medicine or medical treatment varies from state to state, and these laws can be specific and nuanced to varying degrees. Therefore, you need to know whether CoolSculpting is considered the practice of medicine, and consequently a medical treatment, in your state. For example, Texas considers diagnosing a person as an appropriate candidate for a cosmetic medical procedure and giving orders for their treatment to be the practice of medicine.

Staffing. Medical professional scopes of practice not only vary from state to state, but also vary depending on the training, experience, and skill of a medical professional. Therefore, you need to know who can legally perform the treatment in your facility. It critical that state laws governing who can legally perform medical treatments, such as cryolipolysis, are not confused since many states only permit state-licensed physicians, physician assistants, nurse practitioners, and certain other licensed healthcare professionals to perform cryolipolysis, subject to state laws governing delegation and supervision.

Brad Adatto, JD, is a partner at ByrdAdatto, a business, healthcare, and aesthetic law firm that practices across the country. He has worked with physicians, physician groups, and other medical service providers in developing ambulatory surgical centers, in-office and freestanding ancillary service facilities, and other medical joint ventures. He regularly counsels clients with respect to federal and state health care regulations that impact investments, transactions, and contract terms, including Medicare fraud and abuse, anti-trust, anti-kickback, anti-referral, and private securities laws.

Tags:  Business and Financials  Med Spa Law  Med Spa Trends 

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How Skin Care Products Benefit Medical Spa Patients

Posted By Administration, Thursday, November 8, 2018

By Alex R. Thiersch, CEO  of the American Med Spa Association (AmSpa)

The most effective and marketable services offered by a medical spa will almost always be the treatments provided, running the gamut from microneedling, to laser skin resurfacing, to anti-aging treatments, such as Botox. Although these procedures draw patients in, offering skin care products can put your patients on the path to the best long-term results.

Skin Care Supporting Treatments

It should be no surprise that medical spa treatments designed to revitalize the skin can benefit from proper after-care.

“You’re doing your practice an injustice if you’re not sending the clients home with a product that’s going augment the results of the treatments they just came in for,” said Candace Noonan of Environ Skin Care.

After laser skin resurfacing, for example, doctors on RealSelf.com universally recommend emollients for the days immediately following treatment, with some also suggesting home-care treatments containing retinoids to aid in skin healing. After microneedling, RealSelf.com doctors recommend topicals that include a growth factor for improved results and faster healing.

Do your research and ask your skin care sales representatives what home care products will work best with your menu of services.

Skin Care as an Anti-Aging Treatment

Medical spa-based skin care is not limited to after-care. For patients concerned with procedures relating to skin health and/or anti-aging, medical-grade skin care products can be a treatment on their own. Although moisturizers and other skin products are widely available from drug stores and retail boutiques, these products are often very different than what medical spas are able to offer.

According to the FDA, with retail products, patients should be able to select and safely use the product using only the information available on the label. This means that off-the-shelf products need to be safe enough for a customer to self-diagnose and administer without the advice of a trained professional. As a result—although retail products may say they include similar ingredients the concentration of active ingredients—the ingredient concentration is often far lower, in order to ensure it can serve the widest population of people.

“Generally, brands that are sold in drugstores and department stores contain lower amounts of active ingredients so they’re irritation-free for a broad consumer base,” said Lucy Papa, executive vice-president of Canderm Pharma Inc., which sells both medical-grade and retail-grade skin care products.

Since a medical spa will select products specifically based on a patient’s unique needs and train the patient on proper use, these products will contain a higher concentration of active ingredients with clinically tested formulations that can deliver faster and better results.

“We have to look at things like bioavailability, how is it delivered to the skin, is the skin even able to absorb these ingredients,” said Noonan. “When choosing a skin care line … you have to be able to back it up with science as far as what’s actually going to work.”

The onus is on medical spa professionals to educate patients on the benefits of medical-grade skin care, not only with respect to supplementing procedures, but also as a treatment in itself. Selling skin care in your medical spa will not only lead to better results for your patients, but also for your business, as well.

Tags:  Med Spa Ownership  Med Spa Trends 

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FTC Announces Enforcement Action Against IV Therapy Clinic for Misleading Advertising

Posted By Administration, Monday, October 1, 2018

By Patrick O’Brien, J.D., Legal Coordinator for the American Med Spa Association

The Federal Trade Commission (FTC) recently announced their first ever enforcement action against a provider of intravenous therapy (IV therapy) for making unsupported claims about the health benefits of their IV treatments. You can read the complaint and press release by clicking here. But in brief the FTC alleges that iV Bar’s website contained multiple false, and unsubstantiated representations as to the clinical or scientific effectiveness of the treatments. Setting aside the merit of the FTC’s claims, this case does highlight a hidden danger of medical spa and IV bar ownership: advertising.

Advertising is a critical part of a successful med spa or IV therapy clinic. Effective advertising is vitally important in attracting new patients and informing existing patients of other services you offer. You want to let consumers know of your expertise, the benefits you can provide, and to distinguish your practice above your competitors. However, med spa and IV therapy clinic advertisements, as with other medical practices, fall under several layers of rules and regulations. Since advertising by its very nature is easily accessible out in the public sphere it makes it a simple matter for regulatory bodies to locate advertisements that violate the laws. Therefore it is beneficial for med spa and IV bar owners to have at least some familiarity with the limitations of what they can say in ads.

Read more about legal issues in medical spa advertising here.

Deceptive Practices Acts

In addition to the Federal Trade Commission Act, many states have adopted some form of a deceptive trade practices act designed to protect consumers from fraudulent and deceptive advertising and statements. These are usually enforced by the State’s attorney general and many provide private rights of action allowing the consumer to sue the business directly. For example the Texas Deceptive Trade Practices Act makes it a deceptive practice to represent that goods or services have approval, uses, benefits which they do not. Damages in the Texas statute can include compensation for economic and mental anguish and if the court finds that the conduct was “knowing” and “intentional” it can result in three times the economic and mental anguish damages being awarded to the consumer. 

Medical Licensing Boards

Med spas and IV therapy clinics are medical practices and as such will fall under their state’s rules for physician advertising and professional conduct. Many state Medical Practice Acts, including Florida’s, prohibit physicians from using false, deceptive, or misleading advertising or as is the case in New Hampshire claiming professional superiority. Even if not explicitly in the statutes, state medical board’s ethics rules and opinions often contain similar prohibitions. For a good general overview there are the American Medical Association’s ethics opinions such as this one which states, in part:

Because the public can sometimes be deceived by the use of medical terms or illustrations that are difficult to understand, physicians should design the form of communication to communicate the information contained therein to the public in a readily comprehensible manner. Aggressive, high pressure advertising and publicity should be avoided if they create unjustified medical expectations or are accompanied by deceptive claims. The key issue, however, is whether advertising or publicity, regardless of format or content, is true and not materially misleading.

Often, state medical disciplinary boards are influenced or adopt guidelines similar to the AMA’s.  
The business name you advertise under can also be subject to various rules. Several states, one such being California, prohibit a physician from doing business under a name different than their own unless they obtain a fictitious or assumed name registration. Still other states limit the use of words such as “spa”, “clinic”, or “medical” unless certain requirements are met or procedures offered.

AmSpa members can utilize their annual compliance consultation call with the law firm of ByrdAdatto to understand the medical advertising requirements in their particular state.

Conclusion

False, misleading, and deceptive. If you feel like you are seeing a trend you are right. Generally these laws and boards use similar language to protect consumers and patients. However the specific interpretation and implementation of these terms is not identical and one type of ad or commercial may be acceptable in one state and not in another. So before you launch a “too good to be true” campaign you would do well have it reviewed by your counsel or to read up on your jurisdiction’s advertising rules.  

Attend an AmSpa Medical Spa & Aesthetic Boot Camp to learn how to build and run a profitable, efficient, and legally compliant medical spa practice.

Patrick O'Brien grew up in west Texas loving the outdoors and Scouting, earning the rank of Eagle Scout. After attending Southwestern University, he worked in Margin trading with a major investment brokerage. There, he saw how yesterday’s decisions affect tomorrow, and learned how to proactively navigate situations to give clients the best possible outcome. This problem solving inspired his return to school and pursuit of a law degree from Southern Methodist University. He brings his legal training and business acumen to AmSpa to get ahead of legislative changes which affect our members. When he is not in the office he enjoys reading the same book to his toddler for literally the twentieth time today. But he laughs every time so it is worth it. He also loves cooking and spending time outdoors with his wife, son, and loyal hound.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Med Spa Law  Med Spa Trends 

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SkinPen® Remains the Only FDA-Cleared Device for Microneedling

Posted By Administration, Monday, September 10, 2018
Sponsored Content: Bellus Medical

Aesthetic medical providers beware: The FDA codified its classification order for microneedling, likely putting practices using non-cleared devices at greater risk.

“In many medical device liability cases, a doctor is shielded from liability when properly using a cleared and compliant device, since the FDA review and clearance would ensure all likely hazards are controlled,” said Marc C. Sanchez, an FDA attorney who worked on Bellus Medical’s microneedling De Novo submission. “That defense is totally washed away when using an unapproved medical device.”

As of March 1, there is only one FDA-cleared microneedling device: SkinPen® by Bellus Medical. According to Sanchez, the classification order makes all non-cleared microneedling devices of any kind subject to enforcement actions, such as refusing entry for imported derma rollers and pens as well as issuing warning letters to non-compliant manufacturers.

Read Sanchez’s post on FDA Atty to learn more about the classification order and the new risks for doctors and aestheticians.

Click here for more information on Bellus Medical, and click here to read more about the SkinPen® in AmSpa’s medical spa treatment directory.
 

Tags:  Med Spa Trends  Sponsored Content 

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Which Procedures Count As the Practice of Medicine in a Medical Spa?

Posted By Administration, Thursday, August 30, 2018

By Alex R. Thiersch, Founder and Director of the American Med Spa Association

Determining the distinction between medical and non-medical treatments is perhaps the defining issue of the medical aesthetic industry and, in many cases, that distinction is not as clear-cut as all involved would like it to be—what’s legal in one state might not be in another, for example. (AmSpa members can check their medical aesthetic legal summary to find this information.)

Medical spas, unlike most plastic surgeons’ offices and traditional doctors’ offices, make a lot of their money from offering non-medical treatments—such as facials, chemical peels, and aesthetician services—in addition to medical services. In fact, aesthetician services typically are among the top three treatments offered by most medical spas according to the AmSpa 2017 Medical Spa State of the Industry Survey. Many people begin their experience with a medical spa by partaking of these non-medical treatments before moving on to more invasive solutions so, needless to say, these services can be extremely valuable to a medical aesthetic business.

It is extremely important for employees of a medical spa to understand which procedures they perform are medical in nature so that they can approach them accordingly. If an aesthetician can perform a procedure by him- or herself, costs are much lower and margins are likely much higher; when you move into the medical realm, however, you must involve a physician, nurse practitioner, or physician assistant, and you must follow medical protocol and regulations. Costs go up, record-keeping requirements are far greater, patient privacy becomes an issue, and on and on.

For more information on proper medical spa procedures see AmSpa’s webinars on supervision and delegation, patient-charting requirements, and much more.

Some general guidelines can help determine what is and is not a medical procedure.

Baseline Rule

The baseline rule is that anything that impacts living tissue is considered medical. Generally speaking, if you’re doing something that goes beneath the outer dead layers of skin—known as the stratum corneum—you can assume that you are engaging in the practice of medicine. 

Exceptions

However, there are some exceptions to this rule. In several states, laser hair removal is the subject of certifications and rules that place it at least adjacent to the medical realm, despite the fact that it does not penetrate the skin. 

Additionally, microneedling, one of the trendiest procedures in the business, has been determined to be medical in nature by all the regulatory agencies that have looked at it, despite the fact that in many cases, the needles are set to a depth that does not actually penetrate the stratum corneum. Regardless, the fact that metal needles are the tools being used makes this a medical procedure in the eyes of the law in many cases.

Finally, subdermal fat-removing treatments, such as SculpSure and CoolSculpting, which don’t involve any sort of conventional laser use or invasiveness, still should be considered medical, even though the matter hasn’t as yet been widely investigated by state boards. There is very little doubt in my mind that as soon as an influential state board looks at them, it will determine these treatments to be medical in nature because they affect living tissue; therefore, you must observe medical protocol when performing them.

Beyond these general guidelines, AmSpa can help you determine what is and is not considered a medical procedure in your state. Use our website to keep up with the latest regulatory updates and, join us for an upcoming Medical Spa & Aesthetic Boot Camp (Boston in September, Nashville in October, and Orlando in November), to learn everything you need to know to keep your medical spa compliant and successful.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Business and Financials  Med Spa Trends 

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Fillers For Your Other Lips?

Posted By Administration, Wednesday, August 29, 2018

By Emerald Gutierrez, RN, Certified First Assist in Cosmetic Surgery & Aesthetics

What may surprise you is that more women have problems when it comes to sex than men. Some 43% of women say they’ve experienced sexual dysfunction at some stage of their lives compared to 31% of men.

Sexual dysfunction in both men and women can result in a reduction in sexual intimacy in a relationship, which may then negatively affect family life and self-esteem. We need to keep in mind that female sexual arousal is multifactorial, often with psychological and emotional as well as physical factors, so there is no one ‘magic bullet’ treatment.

When sex becomes more painful than pleasure, don’t lose hope. Explore the below treatments and turn up the heat between the sheets.

The Challenge: Vaginal thinning & dryness; painful sex
The Treatment: Filler or PRP Injection
(Plasma-rich Protein) also nicknamed as the “O” or “O-Shot”

Recommended Treatments: Three every 4 weeks
Down time: None
Pain: None


Regeneration of this area leads to increased sensitivity and better orgasms. It is very safe as we use your own body products with minimal risks of bruising and infection.
-Emerald Gutierrez, R.N
Certified First Assist in Cosmetic Surgery & Aesthetics.

Platelet-rich plasma (PRP), where your platelets are separated from blood and then injected back into the body is traditionally given to stimulate collagen in the face but in recent years this treatment has been found to have benefits for genital areas too. It’s been nicknamed the ‘O shot’ as it’s said to improve sensitivity and the ability to orgasm. PRP tricks the body into believing it has been injured so it releases stem cells which regenerate tissue and we find it can help with everything from the skin condition sclerosis to stress incontinence and sexual dysfunction such as inability to climax.





The Challenge: Vaginal looseness
The Treatment: The Votiva, Radio Frequency by InMode

Recommended Treatments: Three every 4 weeks
Down time: None
Pain: None



Votiva is beneficial for therapeutic use in the treatment of sexual dysfunction or as an adjunct to Kegel exercises (tightening of the muscles of the pelvic floor to increase muscle tone). This treatment delivers gentle, thermal internal tissue remodeling of the genitals that is safe, effective, and in-demand. This is a comfortable treatment that provides uniform radio frequency heating of the internal vaginal tissue and external vulvar laxity or labial hypertrophy.

Labiaplasty
If time, genetics or childbirth has resulted in embarrassment, discomfort or intimacy issues due to the size and shape of your labia, labiaplasty procedure may be a good option for you.

Labiaplasty is a one to two hour surgical procedure designed to sculpt the external vaginal structures by reducing and/or reshaping long or uneven labia. Childbirth, the aging process and the effects of gravity may all erode the beauty of the female genitalia including the labia minora, labia majora, clitoral hood and perineum.
  • Experience a more youthful look in the vaginal area
  • Feel Improved sexual gratification and Increased friction during intercourse
  • Enhance vaginal muscle tone, strength, and control
  • Quick recovery- risks in surgery are extremely rare, and are seen in less than 1% of cases

Emerald Gutierrez has been a Registered Nurse for 18 years. Her experience includes Emergency Dept., In-and Out-Patient Operating Room/Recovery Room, Plastics, Oncology, Women’s Health, GI, Nurse Educator, and Director of Nursing. She began her role as a Beverly Hills Cosmetic Nurse/Nurse consultant when she moved to Los Angeles to obtain her RNFA degree (Registered Nurse First Assist), and her CNOR (Certified Nurse Operating Room) from UCLA. Since then, she has received training from some of the top prestigious and world renowned Cosmetic Surgeons, with most of them appearing on “Dr. Oz”, “The Doctor’s,” “Botched”, and “E Entertainment”.

Tags:  Glam RN Beverly Hills  Med Spa Trends 

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