DermaPen Recall – Consumer Safety Notice
In April of 2015, Dermapen, LLC was ordered by the FDA to immediately cease the sales and marketing of the Dermapen products in the United States, including the commercial distribution of the device. This means that skin care practitioners should no longer be using the Dermapen and offering it to clients. The FDA issued the discontinuation of the Dermapen as an action to address a problem with the device that violates FDA law. Because the Dermapen is intended to achieve its clinical effect through the creation of “many small puncture wounds in the skin;” the FDA determined that the safe ranges of needle lengths, penetration depths, and speeds of the device are unknown. The FDA’s primary safety concern was the potential for the needles to damage blood vessels and nerves that could be a risk to health. In addition, prior to the recall there were also backflow concerns regarding the Dermapen machine, which could have serious health safety issues.
After the recall, Dermapen, LLC no longer services products or processes returned products in exchange for new products. The FDA has determined that the servicing of any Dermapen product to be impermissible, because the servicing of the device would only perpetuate its continued use. This means that any practitioner using the device cannot guarantee its safety since there is not a way to address mechanical issues or defects in the equipment that could potentially cause permanent damage to the nerves and skin.
Additionally, the FDA stated that Dermapen, LLC was falsely marketing several of their products as “cosmeceuticals.” The Federal Food, Drug, and Cosmetic Act does not recognize any such category as “cosmeceuticals.” A product can be a drug, a cosmetic, or a combination of both, but the term “cosmeceutical” has no meaning under the law.
At this time, no practitioners or physicians should be using Dermapen and offering to clients or patients.
If you are seeking a safe and natural alternative to Dermapen then Rejuvpen is the best option for you. Rejuvapen Micro-Needling™ is a 100% natural treatment. It is a form of fractional collagen induction that repairs from the inside out. Your skin will be firmer and regain its elasticity, so fine lines and wrinkles become visibly reduced, pores are smaller, and you look younger. This treatment uses the body’s natural healing process to promote smoother skin and reduce the appearance of scars and wrinkles. We offer Rejuvapen treatments at Fabulously Flawless. Our clients have seen amazing results. Contact us to schedule your Rejuvpen appointment.
