By Alex R. Thiersch
Microneedling (also known as collagen induction therapy) is a simple form of skin treatment where needles penetrate the skin to create superficial wounds that stimulate the production of collagen and other growth factors in response. It produces visible results with few possible complications, and it is popular with both patients and medical aesthetic professionals because it is easy and quick. A patient can undergo a basic microneedling procedure in a matter of minutes.
Although these procedures are simple, the legal issues surrounding them are not. Are they considered medical treatments? Why or why not? Who can perform them? If your practice offers microneedling treatments or is considering offering them, it’s imperative you understand the debate surrounding this matter.
Generally speaking, any treatment that breaks the outer layer of the patient’s skin is considered a medical treatment. It might stand to reason, any procedure using a needle also involves breaking the skin, but the distinction of whether or not the skin is being broken is very difficult to make when you are dealing with tiny needles that can be mere fractions of a millimeter long.
At what depth is the skin broken? Unfortunately, there is no legal standard. It depends on the patient, the part of the body being treated, and the amount of pressure applied.
This uncertainty can create problems for a medical aesthetic practice. If a microneedling procedure is not medical in nature, an esthetician can perform it and the patient can be on his or her way a short time later. However, if it is medical in nature, a patient history must be taken, a medical professional must see the patient prior to any treatment, and proper supervision and/or delegation procedures must be observed while the treatment is taking place. This makes the procedure far less profitable for the medical spa and far less convenient for the patient.
I believe, with limited exceptions, most state boards would consider microneedling a medical treatment. The fact that needles are involved and that the skin can be broken—even if it won’t always be broken—will be enough for state investigators to consider microneedling more like typical injectables and less like ordinary facials. As such, the safe practice is to treat microneedling as a medical procedure—ie, a prior good faith exam by doctor or mid-level practitioner, proper protocols and supervision, and performance by medically licensed practitioners (ie, no aestheticians). Enforcement is currently almost nonexistent—I recently had a conversation with a nursing board investigator, and he had no idea what microneedling even was—but at some point there will be a bad outcome that will cause lawmakers to take action.
It is best for those who own and operate medical aesthetic practices to come to terms with this reality as soon as possible in order to limit the exposure of their facilities and employees to legal action. It may hurt your bottom line at first, but you will likely find that conforming to this standard will improve your practice’s services and prevent issues when laws regarding microneedling arrive.
Alex R. Thiersch is the founder and director of the American Med Spa Association (AmSpa) and AmSpaMD, which provides legal and regulatory counsel for medical aesthetics practices. Reach out to Alex at [email protected].