The latest on microneedling
Thank you for writing. You’re helping others because I’d like to make the point that it’s important NOT to do microneedling or lasers to reduce scarring… until you have good control of the acne for at least 3-6 months. These procedures may temporarily aggravate acne that isn’t under good control. Especially if it’s inflammatory acne.
Here is some of the latest FDA information and it’s ruling on microneedling. I really agree with these and they are from 2018.
- Microneedling is now covered under the Code of Federal Regulations (CFR). 21 CFR 878.4430
- There is now a legally binding definition of of this procedure. “A device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.” This is NOT include transdermal injection, for example Botox/Dysport.
- This now includes any dermaroller, microneedling pen, or single needle used for any purpose. For example wrinkles, collagen induction or acne.
What this means for you, if you are currently a provider of these services:
- Imported dermarollers or pens are now illegal, unless FDA approved.
- Facilities inspections and website searches will occur.
- Penalties or sanctions may be issues by the FDA.
What this means for you, if you currently receive or are a consumer of these services and will help prevent:
- Adverse tissue reactions caused by all sort of things, for example, faulty sterilization or manufacture by the company making it.
- Cross contamination by chemicals in manufacturing
- Electric shocks or interference with other medical devices (like pacemakers).
- Damage to underlying tissue including nerves, blood vessels, and pigment.
Bottom Line: These devices can cause harm and the regulations will help prevent complications above that have already been reported.