Cosmetic Acupuncture

"Based on the information currently available, [the agency] considers risks associated with the devices to include, 'infection, nerve and blood vessel damage, disease transmission between users, scar formation, hyper-pigmentation, skin inflammation, allergic reactions and skin irritation... This draft guidance provides recommendations to manufacturers to consider prior to submitting any microneedling products for FDA review." So, what does this all mean? Following the draft guidance, the FDA will begin reviewing comments received in response to the draft guidance and says, "once we finalize reviewing the comments, we will issue our final guidance." Bottom line: Stay tuned. For now, if you have an at-home dermaroller, check its labeling. If the device claims the following, according to the FDA, it's considered a medical tool: "Treat scars, treat wrinkles and deep facial lines, treats cellulite and stretch marks, treats acne, dermatoses alopecia, stimulate collagen production or angiogenesis, and promote wound healing." These claims have not been reviewed by the FDA at this time. On the flip side, devices that are not deemed medical tools are those that claim to: "Facilitate exfoliation, improve skin’s appearance, and give skin a smoother look and/or feel, or give skin a luminous look." (For more information on the FDA's involvement in microneedling or to check the status of your at-home device, resources are available here in its draft guidance.) Medical tool or not, if you're still insistent upon at-home use, both doctors offer important advice. Marchbein warns to thoroughly cleanse the skin and ensure the dermaroller is clean, to be very cautious of that are applied directly before or after as they penetrate more deeply and can cause heightened irritation, to not use the device if you have a history of keloid scarring or if there is an active infection such as a cold sore or acne breakout, and to avoid the thin, sensitive skin of the upper and lower eyelids. "Microneedling is nearly painless as a topical anesthetic cream is applied prior to treatment and some swelling and redness are expected for a few days post-procedure." Wexler advises to keep the depth of the needle in at-home treatments under 1 millimeter and to "avoid treatments more than once monthly. Do not apply with firm pressure. Do not provoke more than pinpoint bleeding, and avoid make up for two days and continue sunscreen for several weeks." However, you can also skip the DIY dermarolling sesh for an in-office treatment, which involves "repeatedly puncturing the skin with tiny sterile needles that penetrate to various depths in order to create a controlled skin injury to rejuvenate the skin," says Marchbein. When it's performed in a physician's office, "microneedling is nearly painless as a topical anesthetic cream is applied prior to treatment and some swelling and redness are expected for a few days post-procedure." As the treatment is a mechanical process that does not use heat, it's safe for any skin color also, and Marchbein advises it is often paired with topical treatments which contain growth factors.

For the original version including any supplementary images or video, visit https://www.allure.com/story/fda-at-home-microneedling

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