Microneedling—also known as collagen induction therapy (CIT)—is a skin treatment in which tiny needles penetrate the skin in order to stimulate the production of collagen and other growth factors. It is relatively inexpensive, produces visible results with little chance of complications, and is easy to perform, so it appeals to both medical aesthetic and medical spa professionals and patients. However, although this treatment is simple, the legal issues surrounding it are not, so it is important that you understand why microneedling is such a controversial topic and how the legal view of it is evolving.
Treatments that break the outer layer of the patient’s skin are typically considered to be medical in nature. You might think that this automatically makes microneedling a medical procedure, but it is actually very difficult to judge if the skin is being broken when you are dealing with needles of this size. It can vary from patient to patient and depend on the part of the body being treated and the amount of pressure being applied.
If microneedling is not medical, it can be performed by an esthetician without a prior physician examination. However, if it is medical, a patient history must be taken, a physician or mid-level practitioner must administer a pre-treatment exam, and proper supervision or delegation procedures must be observed during treatment. Put simply, if microneedling is a medical procedure, it is far less profitable.
The legalities of microneedling and similar procedures have not typically been explicitly addressed in state rules and regulations, so medical aesthetic practices and medical spas have been more or less free to treat it as a non-medical procedure. However, that view may not be congruent with legal realities for much longer. Recently, both the Illinois Department of Financial and Professional Regulation and the California Department of Consumer Affairs Board of Barbering and Cosmetology have issued statements that confirm both bodies view microneedling as an invasive—and thus medical—procedure. “This isn’t new—estheticians cannot penetrate the skin,” said Kristy Underwood, executive director of the California Board of Barbering and Cosmetology, at the recent American Med Spa Association Medical Spa Boot Camp in San Jose, CA. “They also can’t use any metal needles, period…[California] estheticians are prohibited from using metal needles, as well as anything that might be used in a manner that is disapproved by the FDA.” Underwood also touched on the issue of needle depth, adding, “[California] doesn’t define depth. We do say [estheticians] can’t go below the epidermis.”
The California and Illinois boards are influential regulatory agencies, so it stands to reason that this is the direction the industry will likely be forced to head. Because of this, it is probably a good idea for medical spa professionals to begin treating microneedling as strictly medical in order to limit their exposure to regulatory penalties. If you have previously employed estheticians to perform the procedures, this could harm your bottom line. However, conforming to this standard now will acclimate your employees to this new reality and shield your business from future legal issues.