In December, 1996, the Food and Drug Administration issued the first clearance letter for a microdermabrasion machine, intoducing a new modality for the esthetic industry in the United States. The first machine utilizing this mechanical exfoliation technique was brought into the U.S. in January of 1997. Unfortunately, except for manufactirer's instruction manuals, there has been no documentation published about the effective use of this procedure by estheticians. It is my purpose to provide a generic, yet comprehensive overview of the machines, legal issues, cautions and procedures pertaining to this new device.

Microdermabrasion Background

The European market has been using the microdermabrasion machines since approximately 1986. Originally developed as a safer alternative to open dermabrasion, the devices were quickly adopted by estheticians as an additional means of exfoliation. More than 10 different systems were available in Europe between 1990 and 1992, sold under different names and configurations.

In 1994, Fred DeJacma, owner of ALI, a U.S. laser distributor for Mattioli Engineering, saw one of the Italian-designed machines and partnered with Mattioli to meet the FDA requirements to introduce it to the States. Since then, many manufacturers have followed Mattioli's lead and introduced over a dozen different models of microdermabrasion machines.

The Machines and How They Differ

There are many machines now available to the U.S. market. All operate on the same basic principle: a closed-loop vacuum system that shoots corundum onto the skin and vacuums up the used crystals and exfoliated skin, depositing it into a separate waste jar. Many of the newer generation of machines have reduced the amount of crystal used and muffled the noise made by the vacuum system.

Individual dials lend a wide range of treatment strengths, so that the esthetician may customize each procedure for the client by regulating the flow of crystals and the power of the vacuum. In at least one of the newer models, there are electronically controlled settings that can reproduce safe and predictable treatments. Some manufacturers are providing the crystal in sealed containers, which eliminates the mess that sometimes occurs while filling the new crystal canister. As the canister empties, it can then be switched out to the waste position, and the contaminated crystals and dead skin may then be appropriately disposed of, eliminating the possible exposure to contaminants.

The vacuum action provided by the treatment in and of itself tends to stimulate blood flow and lymphatic movement, which speeds healing and brings a healthy glow. Some manufacturers even suggest using a vacuuming treatment (with crystal flow shut off) and afterward proceeding with the exfoliating itself. Their claim is that this method provides better results. This would be a factor that the esthetician would have to judge for his or herself. many find the exfoliation treatment sufficiently stimulating, and that most clients do not need additional stimulation.

Handpiece Issues

At this time, there are several manufacturers in Europe holding patents on several handpiece configurations for the devices. A particular caution applies to the handpiece patent arguement. Be aware that when researching the machines, if the manufacturer that you are working with has a glass or tungsten carbide handpiece, you need to ask the sales representative for a copy of his manufacturer's patent on the handpiece.

One of the ways that the various manufacturers have avoided patent infringement issues is by maintaining the basic design of the handpiece, but changing the material it is produced from, i.e., stainless steel, titanium, etc. There are other, more innovative manufacturers who have altered the design of the handpiece enough that there is no cause for patent concern. Although there would be no repercussion per se to owners of machines with the patented handpieces being marketed by other than the patent owner, if there were ever a patent-infringement lawsuit filed and won, you may find yourself without a source for new handpieces for your machine. The purchaser must take responsibility and act as an educated consumer when dealing with the representatives of these manufacturers.

Other Issues of Concern

Concerns regarding the invasiveness of the procedure have been addressed by some of the manufacturers, with the production of two devices with distinctly different power levels. As both versions of these machines are not inexpensive, they will not be for everyone. However, no matter whether your practice is within a salon or within a medical setting, adequate training is essential, even if you must seek additional education independent from that which the manufacturer provides.

Some manufacturers have policies regarding sale to non-licensed persons. To ensure that a professional is purchasing the device, the manufacturer should require a copy of your licensure as a condition of sale. The sales representative might also inquire about the amount of advanced training prior to purchase and other possible certifications (such as physician's assistant, medical assistant or CIDESCO diplomate). More importantly, the esthetician should be cautioned that a condition of the sale should not be just that you have the money to pay for it.

The price of a microdermabrasion machine ranges from $9,500 to $12,900 for the esthetician models and upwards of $25,000 for a medical version. This is probably one of the most expensive pieces of equipment an independent esthetician will ever purchase, and you should make sure that the machine you chose would fulfill your requirements for satisfactory client results, in addition to providing an additional source of revenue. The size or price of a machine is not necessarily indicative of the quality of the results produced, nor service concerns.

The best way to make an educated decision is to attend one of the larger skin care conferences, as most of the current manufacturers will have displays. This way you can observe demonstrations, perhaps have a treatment and ask the representatives questions. Don't be afraid to ask questions about support service, training, average cost of treatments, and handpiece concerns. Remember, it is your money!

Corundum

Corundum crystal is also known as aluminum oxide and bauxite. The crystal that has been provided by the manufacturers of the machines is as close to pure as possible, states Mr. Oyvind Berg, of Laser Hair Care, Florida. Aluminum oxide is an inert material; therefore, there can be no specific adverse reaction to it. The crystals are very irregularly shaped (described as being very similar to rock candy crystals), and they are extremely effective for the purpose of exfoliation. The market for the corundum has, of course, increased with the use of the microdermabrasion machines, and the cost per pound ranges anywhere from $7 up to $16. There are many sources for corundum, including, of course, the manufacturer. However, the esthetician must be careful when purchasing from an unknown source. Some practitioners have found, in their attempts to cut costs, that what they thought was a "great deal" on 99% pure corundum was actually an impure product that clogs the machines, possibly causing damage and also contains significant levels of impurities. These sources should be avoided by the conscientious esthetician. If the practitioner has any doubts, they shoul request a copy of the MSDS from the crystal provider.

The recycling of crystal is to be avoided, for both the obvious sanitation and safety purposes and effectiveness. As an example, if you have performed a procedure on an acne client and have unroofed a pustule, bacteria contained within the pustule will be carried into the waste container, along with the used crystal and exfoliated skin. Cross-contamination would then result if you were to reuse that same crystal on a following client, exposing the next client to the bacteria. The efficacy of the recycled crystals is also jeopardized, because studies have shown that as the crystal impacts the skin, its edges become smoother, and therefore the effectiveness of the procedure is diminished significantly.

Excessive exposure to aluminum dust is potentially hazardous, as indicated by Drs. Tsai, et al, in Dermatologic Surgery, June, 1995. "The high levels of aluminum found in the brain tissue of Alzheimer's victims suggest an etiological role of aluminum in Alzheimer's disease." Therefore, routine protection of the eyes and use of surgical masks is recommended for operators.

FDA Issues

There has been some confusion over the requirement of an FDA clearance for microdermabrasion devices. Originally, the FDA placed the new microdermabrasion devices in the same classification as the dermabrasion brush, a Class 1 medical device (a device rendering a non-significant, non-invasive procedure) which required that each manufacturer obtain a 510(k) clearance letter for each machine. However, in February, 1998, the FDA reclassified the machines as Class 1 exempt status, which does not require a 510(k) clearance letter.

because of this change in FDA classification, some machines have 510(k) clearances while others do not. As you consider purchasing a machine, you should be aware that it is only necessary to register the manufacturer and device name with the FDA. A 510(k) is no longer needed and a machine that has a 510(k) clearance is not necessarily of a better quality, or meeting a higher standard, than one that does not.

Do the Claims Have Merit?

While relatively new to the states, European estheticians and physicians have been using the devices for at least a decade with a great deal of success. There have been studies performed by European physicians, documenting their use of the machines for stretch mark and tattoo removal, and scar revision, and each manufacturer has their own set of photographs and written work to bolster their marketing claims. Much of the clinical information regarding treatment of stretch marks or tattoo removal is published in "non-referred" European medical journals, providing anecdotal rather than scientific studies.

A group of physicians in Taiwan performed a study on the treatment of scars, the results of which were published in the June, 1995 issue of Dermatologic Surgery. The study indicates that the depth of the wounds were "barely through the epidermis. Thus the healing process was quick (within 3-5 days)." The physicians found that they obtained good to excellent clinical improvement with the microdermabrasion technique.

Although just this one study has been published in a referred medical journal in the U.S., it must be pointed out that these types of procedures are not appropriate in the esthetic setting, as the successful treatment of these conditions requires the removal of significant amounts of epidermis, down possibly into the dermis. The state boards would also frown upon these treatments, as they necessitate removal of live tissue, and that is not the esthetician's domain (nor would it be covered under esthetic liability insurance).

Mr. Michael Mosk, President of SoundSkin Corporation, states that "Microdermabrasion in the esthetic setting was designed to remove superficial epidermis as part of a course of treatment sessions that are themselves part of a well-organized regimen of skin care. The device was not designed to remove deep wrinkles seated in the dermis."

The Results You Can Expect

The procedure, which is technically referred to as microdermabrasion (the name PowerPeel is a registered trademark of Aesthetic Lasers, Inc), utilizes corundum crystal to gently exfoliate the uppermost layers of the stratum corneum. The use of a closed vacuum loop, in combination with the crystal, provides a very even, controlled exfoliation, allowing the technician to address various perceived defects in the surface of the client's skin, including uneven texture and hyperpigmentation.

One of the unique features about microdermabrasion is the control level of exfoliation. Unlike chemical peels (AHAs, modified jessner peels) which can possibly have significant reactions, including edema, erythema and the resulting hyperpigmentation and/or scarring, in addition to "hot spots" that may be left unprotected until too late, microdermabrasion exfoliation may be so gentle that not the slightest amount of redness is apparent by the time the client leaves the clinic. This allows the client to continue on his/her daily routine without the downtime that a modified jessner peel, or other chemical peel would require. There is no need for a fan, timer, or analgesic with microdermabrasion. The procedure is a progressive, rather than aggressive treatment. The client must be educated during the consultation that this is a treatment in which she may see visible results after the first treatment. Lasting, and more significant results, are obtained during a series of six or more treatments, with follow-up treatments thereafter as deemed necessary by the client and her esthetician.

There are virtually no areas of the body that might not benefit from microdermabrasion. Hyperpigmentation and uneven surface texture are the most successfully addressed concerns for this progressive treatment in the esthetic market. When microdermabrasion is used as an exfoliation modality, it can be performed on the entire face and neck with a redo sweep on any areas of hyperpigmentation or textural irregularities that the client is concerned about. Because this technique provides such control, the practitioner may exfoliate what amounts to up to two weeks' worth of stratum corneum without causing the client undue discomfort or down time.

The melanocytes that create the hyperpigmentation lie approximately 28-34 days below the surface. Thus, in exfoliating the upper layers of stratum corneum, and then applying a hyperpigmentation gel, the client will observe the lightening results much faster. It is important to point out, however, that although some lightening effect may be seen with just the microdermabrasion, the optimal results require use of a skin bleaching agent, whether it is a prescription the client obtains from her physician, or one that she might purchase from the esthetician.

When addressing uneven surface texture, the same procedures can be used, keeping in mind that the progressiveness of the treatment is important. Deeper acne scars cannot be resolved by the esthetician, as even traditional dermabrasion has difficulty obtaining good results on deeper acne scars. Marketing by some manufacturers to the contrary, features treatments that go beyond the scope of an esthetician's license. Traumatic or surgical scars, however, may be improved, because these tend to be elevated. With experience and training, the practitioner may be able to reduce the appearance of these scars.

Cleints wishing to ameliorate either of these conditions should be advised to expect at least six treatments, no farther than 14 days apart. For example, the physicians in Taiwan obtained good results on traumatic or surgical scars with an average of four treatments; the acne scars required an average of more than 15 treatments. Of course, packaging treatments in the skin care clinic with a discount for a prepaid series provides a significant incentive to encourage client compliance. Ronald L. Moy, M.D., Dermatologist and Editor of Dermatologic Surgery, believes that the results seen from a series of microdermabrasion treatments could possibly be able to postpone later resurfacing. "....although it does not remove the deeper wrinkles, it does ameliorate fine lines and blotchiness, going one step beyond AHAs."

Mark G. Rubin, M.D., is in private practice in Beverly Hills, CA, and is Associate Clinical Professor of Dermatology at UCSD. He suggests that although heat may be a hyperpigmentation trigger in some clients, inflammation is the universal trigger (thus the term post-inflammatory hyperpigmentation). For instance, if during the treatment the practitioner creates a superficially pink appearance for an afternoon (a not infrequent result), there should be no subsequent hyperpigmentation. On the other hand, if the esthetician is overly aggressive and creates a more rug-burned appearance, with inflammation lasting for three, four or even five days, this can cause increased pigmentation in the treated area. Obviously then, caution must be exercised if what the client is addressing is hyperpigmentation. Progressive rather than aggressive treatment, once more, is the key.

According to Dr. Rubin, the risk of hyperpigmentation increases with depth of exfoliation; it is acknowledged that the microdermabrasion process can be anything from the most superficial exfoliation to a wound that can equal an erbium laser treatment. Dr. Rubin makes clear that "the practitioner must be prepared to only create an exfoliation at the depth of which they are both licensed for and prepared to care for. Therefore, the only appropriate location for an exfoliation treatment that requires the use of prescription anesthetic or antibiotic would be within the physician's office."

Some sales representatives may attempt to suggest that the purchasing esthetician may be able to remove tattoos, stretch marks or scarring can actually be proven to be removed by this method. The performance of such treatments by an esthetician could result in the revocation of your esthetic license and nullification of your liability insurance.

References

Mahuzier, Francois, M.D. Microdermabrasion in Practice, (English Translation). SOLAL, 1995

Tsai, et al., "Aluminum Oxide Crystal Microdermabrasion." Dermatologic Surgery. Vol. 21, 1995. p.539-542

Article by Laura Root, a CIDESCO Diplomate and editor of the ASEM report.