Many of you have contacted me wondering what is going on with Derma Pen, LLC. If you are their customer, you have no doubt received an email from them stating that they are closed for business as far as needling devices and needling tips are concerned. It begins as follows:
“Please be advised that Derma Pen, LLC is no longer selling its micro-needling devices or micro-needling tips effective April 17, 2015.”
The letter goes on to state:
“Micro-needling devices, such as the Dermapen, require a different method of registration than the industry has been using up to this point.”
“…the FDA stated that under 21 CFR § 878.4820, powered dermabrasion devices “have abrasion substrates which are brushes, rasps and burrs that are intended to abrade and remove layers of skin via shear force.” Because the Dermapen and similar micro-needling devices use needles to penetrate the skin rather than shearing away layers of skin, a micro-needling device like the Dermapen “…exceeds the limitation of 21 CFR § 878.9 and therefore, is not exempt from premarket notification.” In other words, claims for micro-needling and the scientific technology behind micro-needling are currently outside the scope of the 21 C.F.R § 878.4820 for surgical dermabrasion devices and, therefore, the micro-needling devices are not exempt Class 1 devices.”
“Consequently, we have accepted the FDA’s position that the underlying scientific technology of micro-needling differs from its current registration for “dermabrasion” and therefore is not an exempt Class 1 device. Accordingly, Derma Pen agreed to stop selling micro-needling devices and tips.”
In essence, most needling device companies used a loophole in the system to have their devices registered as “microdermabrasion” devices. This served to get them to market sooner without the expense it takes to have new technology approved with required accompanying studies. I have suspected pen companies have known for years that they were building their house on sand, but nobody wanted to be first to play by the stricter rules that apply to a totally new device, as it is a more costly path. The first company to get things properly classified might be, in a sense, “penalized” because they immediately lose advantage when all the other companies jump on the bandwagon as a “me too” without that initial spend. The pioneering company is not given time to recoup their investment before competitors swarm the market.
So where does this leave you? If you are a Derma Pen customer this will impact your business significantly. While there are other pen companies from which you can still purchase devices and needle cartridges, you may worry that their device sales will be shut down as well, along with Derma Pen. There is that risk, although I am aware of several companies who are in the process of submitting applications to the FDA device division. Because the process demands more in terms of design control, as well as safety and efficacy, this could turn out to be a good thing all around. A new generation of higher quality pens may be the result. Companies who were exploiting the market with cheap knock-off devices, offering little or no training or support, may be forced to the sidelines.
Another positive thing that this may also incite is a period of reconstitution during which all the key elements of needling safety and efficacy can be sorted out, not just pen design. This would not be a bad outcome if you concur with me that microneedling art and science has come to resemble the “Wild West”. By this I mean it is offered by a wide range of practitioners, often incorrectly…sometimes egregiously so.
Many of the worst problems I have seen with needling are not pen-induced, but are rather allergic and toxic reactions to substances being needled into skin, or applied to recently needled and vulnerable skin, that simply do not belong there. These include a lot of things in common cosmeceuticals that are benign to “intact” skin, but also substances which any first year medical student will tell you is taunting nature. (Think about it. How are allergy tests performed? Scratch the skin and apply a substance.) Some pen companies have contributed to the plethora of nasty skin problems by recommending or selling these chemicals to be used with needling treatments. Practitioners who have not been adequately trained continue to use these with abandon.
The good that may come from all of this is that it will allow regulatory bodies to catch up with the sudden explosion that has occurred with microneedling world-wide. Protocols and “scope of practice” (based on levels of competency) need to be clearly defined. Classification of devices is presently based on “length of needles”. For example, people are allowed to purchase a 0.5 mm device which is classified as a “cosmetic” instrument, yet “medical” conditions are treated with this length as well. “SCOPE OF PRACTICE” HAS TO BE BASED ON “CONDITIONS BEING TREATED”, NOT NEEDLE LENGTH.
I mentioned level of competency — a presumption of microneedling competency based on a “degree” or a “diploma” is dangerous. Microneedling was not taught at medical school, and has only recently been added to cosmetic school courses, so one cannot extrapolate competency on the basis of having a degree or a diploma. Numerous needling device companies may offer certification in microneedling, but it is often just a course on how to “use the device”, NOT “how”, “when”, “why”, or “which” skin conditions to treat. It may seem a simple procedure, but one cannot view this in isolation. The nuances of treating varying conditions, as well as exceptions to the rules, makes this much more complex. Many of you have paid for this certification thinking that you now know all you need to know in order to do treatments competently and safely. You should check with your malpractice insurance company as to whether your insurance is valid if such training forms the basis for your level of competency. (I have heard that some insurance companies did not recognize the Derma Pen certification. Now that they are out of business it would be especially prudent to revisit this with your insurance provider.)
Virtually all the complications that are referred to me from around the world result from: 1) inappropriate use of ancillary topical products, 2) inappropriate patient selection, 3) inappropriate device and depth selection, 4) inappropriate frequency of treatment, and 5) treating outside scope of practice. All of these relate to inadequate training and an industry that has not yet learned to regulate itself (hence the FDA has now entered to do the job for them).
The good news? Needling is here to stay. To shut it down would lead to civil unrest among the many patients who have tasted its success, (as would taking tattoos away from motorcycle clubs).
What form will it take in the future? In addition to the needling carpetbaggers, there are some very high quality, ethical companies involved in creating devices, and rational topical solutions, for microneedling. These companies also support adequate training and continuing education, as well as the introduction of standards of practice and other indices of a maturing industry that recognizes the value of doing things right, not just making a fast buck.
What should you do in the interim? You should, as with other procedures you perform, (lasers especially), seek proper training — not just the bare minimum or a “rubber stamp” in order to purchase a device. Training should include a clear understanding of skin anatomy, skin physiology, pathophysiology of the various skin conditions being treated (such as melasma or scarring), etc. You should learn what topicals to use and, even more importantly, what NOT to use. You should know how your device interacts with skin and how it treats each particular condition. Do not risk your reputation and business with an inferior foundation. Empower yourself with the knowledge you need to be the best and, in so doing, avoid the complications that would require more FDA involvement.