PracticalDermatology

When shopping at your local drugstore, you probably have noticed that you can buy an array of home grooming equipment there. These are consumer-grade versions of the products you’d normally see at a salon and, although one might reasonably think that haircuts are the sort of things you should leave to the professionals, these products must sell well enough to warrant their continued presence on store shelves.

In recent years, certain medical aesthetic devices have also become available to the public, although they are, generally speaking, a bit less widely available than those clippers at the drugstore. However, it’s certainly conceivable that at some point in the near future, you’ll be able to walk into a Target or Walmart and walk out with an FDA-approved microneedling device. But today, most consumer-grade medical aesthetic devices are manufactured in China and sold online, and they tend to be of somewhat suspect quality, so here are some things you and your patients should know about these products.

Why Can You Buy These Products?

I’ve spoken and written a lot about how only certain medical professionals are legally allowed to administer certain treatments in a medical setting, but generally speaking, people are free to do whatever they want to themselves. In the case of microneedling, for example, you do not necessarily need a medical professional to run a roller over your forehead. Since the treatment doesn’t require any sort of prescription medication, it’s easy to understand why microneedling devices are among the medical aesthetic devices most commonly sold to consumers.

As is typically the case, these consumer-grade products fall below the standard of quality of the equipment used at medical spas or physicians’ offices. In fact, most of the microneedling devices that have flooded the market in recent years come from China and are sold to consumers for laughably low prices. Walmart’s website sells one roller for $4, for example. As you can probably imagine, you get what you pay for in situations such as these, but that’s not going to stop consumers from laying their money down and hoping for the best.

What Are the Risks?

As in the haircutting example mentioned above, just because people can perform treatments on themselves doesn’t mean that they should. Microneedling is not a terribly complicated treatment, certainly, but in its most simple incarnation, you’re still using a roller with dozens of tiny needles and, as such, you could still injure yourself with it. However, the needles on consumer-grade microneedling devices are so small that they only provide superficial benefits—they don’t penetrate deeply enough to induce collagen production. Professional-grade products, on the other hand, penetrate more deeply and can use heat to stimulate production of not only collagen, but also hyaluronic acid and elastin. The consumer-grade products hardly seem worth the risk, by comparison.

What’s more, the products medical spas and physicians’ practices utilize typically are approved by the FDA, which normally indicates a certain standard of reliability and quality; consumer-grade equipment typically does not offer the same assurances. These products generally are made of much cheaper material and are sold by third parties on consumer websites, such as Amazon. This is broadly legal, as long as the products in question aren’t being explicitly marketed for medical use. For example, the listing for one microneedling roller that is sold on Amazon contains two disclaimers. One states, “This cosmetic instrument is used for exfoliation purposes only.” A much longer one says the manufacturer’s statements have not been evaluated by the FDA and that Amazon is not responsible if the product should create any sort of health issue. This can be viewed as a sign that Amazon knows it is selling a medical product under the guise of an exfoliator, and a quick scroll through the user reviews confirms that customers understand exactly what it is intended for.

Regardless, if the FDA or a state regulatory agency were to receive a complaint about one of these products from a customer, it would seek legal redress against the product manufacturer (and perhaps the retailer, if it has not been properly indemnified), so the only real risk to the consumer is his or her well-being.

What Products Are Available?

As previously stated, microneedling devices are among the most commonly sold medical aesthetic devices, and it’s because their manufacturers can plausibly deny that they are designed to administer medical treatments. Even among some medical aesthetic professionals, the medical nature of microneedling is a controversial subject, as some believe that using short needles that are only designed to pierce the outermost layers of skin should not be viewed as a medical procedure. However, all the state regulatory agencies that have ruled on the matter have concluded that microneedling that pierces the outermost layer of skin is, in fact, a medical treatment, and we at the American Medical Spa Association (AmSpa) recommend that medical spas approach it as such, with proper delegation and oversight protocols in place. However, there has been no crackdown on consumer-grade microneedling devices as of yet.

Energy-based hair removal is another popular at-home treatment; however, it’s important to note that what is available to consumers is much different than what is available to medical aesthetic professionals. Most medical spas and practices that offer hair removal treatments use lasers, which are, thus far, strictly professional grade, and it’s difficult to envision a scenario in which regulatory agencies are going to be okay with untrained people running around with consumer-grade lasers, so it’s unlikely they will be available anytime soon.

However, intense pulsed light (IPL) hair removal devices are widely available to consumers, and are even marketed by well-known, reputable manufacturers, such as Remington and Gillette. These devices are not as powerful or precise as lasers, and their utility is generally limited to a fairly narrow range of users. Typically, they work best on people with light skin and dark hair, as they will often burn darker skin because it reacts to the light in the same way the hair does. However, some consumers find these devices to be effective, relatively inexpensive alternatives to laser treatments. IPL devices from reputable manufacturers tend to cost around $300 – 500, although as you can probably imagine, there also are cheaper alternatives made by companies whose names are not quite as familiar.

Hyaluron pens also are gaining traction as at-home medical aesthetic devices. These products are typically used to inject fillers—generally hyaluronic acid—but do so without using traditional needles or syringes. This technology is new enough that there is no legislation that addresses it directly, but because it does not utilize needles—instead creating a high-pressure “jet” that penetrates the skin—one could conceivably make the case that the pens are not medical equipment. This is why there are several hyaluron pens available to purchase from retailers such as Amazon, albeit from no-name manufacturers. You also can purchase hyaluronic acid on Amazon, although in many cases it is highly diluted.

Unfortunately for those who believe that these products are not medical in nature, recent reports indicate that the Texas Medical Board has sent a letter to at least one medical aesthetic provider stating that it views hyaluron pens as medical devices. This is consistent with most medical boards’ contentions that any treatment that penetrates the skin is intrinsically medical in nature, so it’s likely that more medical boards will issue similar proclamations as the issue gains prominence.

What Should My Patients Be Aware Of?

People purchasing these products need to understand the risks involved in performing these treatments outside of a professional medical environment. It might seem simple to roll a microneedling device across your forehead, but without the expertise of a trained provider and high-quality equipment, you might not get the same results as you would at a medical spa. Furthermore, consumers are much more likely to injure themselves using these products than they are to be injured at the medical spa—again, because of lack of training and inferior equipment.

If your patients insist on purchasing at-home medical aesthetics devices, encourage them to buy warrantied products from trusted manufacturers whenever possible. This might not be feasible with most of these products, but when it is, prospective customers should definitely let brand recognition be a part of their decision-making process. Consult with them to make the best decision for their skin and, ideally, help guide them to products that will complement the professional treatments they are receiving professionally.

It’s one thing to buy an inexpensive cell phone cover or mouse pad from a company you’ve never heard of before—it’s quite another to go with an unknown when purchasing something that designed to penetrate your skin. It might not seem that the stakes are particularly high, but if you’re cut by a poorly manufactured microneedling device or burned by a shoddy IPL device, you’ll certainly feel differently.

Some of your patients won’t be swayed by this advice, but deep down they know it’s true—if an offer seems too good to be true, it probably is. Your patients will get what they pay for; make sure to help them understand why it’s always better to go professional when it comes to medical aesthetics than performing DIY aesthetics.