panelarrow

Acupuncture Gran Alacant

Alicante Acupuncture Treatment

Real-world Cosmetic Acupuncture Alicante Systems Under Scrutiny

Cosmetic Acupuncture

Shari Marchbein , a dermatologist and clinical assistant professor of dermatology at New York University School of Medicine, echoes a similar sentiment. While she recognizes that at-home dermarollers might be less expensive and more convenient, "their safety and efficacy are something that requires further scrutiny." In regard to their efficacy, she explains that with at-home devices, the needles range in lengths of .2 millimeters to 1 millimeter, which leads them to create more superficial wounds than those that would occur from an in-office professional treatment. "If an inappropriate technique is used, or if the needles are not sharp enough, there is a risk of causing superficial tears to the skin." "As such, at-home treatments would not have any significant impact on conditions, such as acne scars and wrinkles, but may produce a superficial exfoliation and brightening/rejuvenation of the skin and can be done two to three times per week," says Marchbein. "Additionally, if an inappropriate technique is used, or if the needles are not sharp enough, there is a risk of causing superficial tears to the skin." To prevent such risks, the FDA released a draft guidance in September, which states some microneedling tools are considered "medical devices," and thus might be subject to the agency's regulations and processes in the future. "We issued this draft guidance in fulfillment of our public health mission," a representative from the FDA tells Allure. "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 This draft guidance provides recommendations to manufacturers to consider prior to submitting any microneedling products for FDA review."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 Following the draft guidance, the FDA will begin reviewing comments received in response to the draft guidance and says, "once we finalize reviewing the comments, we will issue our final guidance."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.

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