Dermapen Recall

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 resultsContact us to schedule your Rejuvpen appointment.

Permanent Cosmetics Safety Information

BUYER BEWARE – Permanent Cosmetics Safety Information

Permanent Cosmetics Safety Information – Choosing a Professional

As with any important purchase decision in life we all want to make sure that we do our homework first. We want to make sure that the product and service we are buying is the best we can get. The same goes when it comes to Permanent Cosmetics. All reputable Certified Permanent Cosmetic Professionals will not hesitate to answer your questions, show their work, or display their credentials. Here are several tips that will help you make the most informed decision when choosing your Certified Permanent Cosmetic Professional.

 

Is the Business Legitimate?:
Opening and operating any small business requires hard work and commitment. It means the owner has made a significant financial investment for expenses such as rent, utilities, permits, payroll, insurances, and taxes. Some people make money “on the side” by doing Permanent Makeup from home or in a back room of a salon. They charge less because they can afford to—by operating without the same overhead expenses. They ask for cash and do not accept credit cards or personal checks (usually to avoid paying income taxes). If a client has a problem or wants to file a complaint, those “technicians” usually disappear. So it is important to select a Certified Permanent Cosmetic Professional who is law abiding, dedicated to customer service, and committed to being in business long-term. Consider the win-win situation of paying a little more to support a Certified Permanent Cosmetic Professional who owns an established, legitimate business—if it survives and grows, it will still be there in the future when you need another appointment.

 

Inspect the Facility:
Before your procedure is scheduled, visit the business and evaluate its cleanliness and environment. Is it quiet and relaxing, or noisy with loud music, conversation, or the sound of hair dryers? There should be a room used specifically for Permanent Makeup procedures, ask to see it. Is the room separate and sanitary? Can you smell chemicals from hair sprays or acrylic nails contaminating the air? Move on if you’re not allowed to inspect the room. If it’s occupied, schedule a time to see it later. If the location is a doctor’s office, do not assume the tattooist will do good-looking work. Most physicians advertising Permanent Makeup do not perform procedures themselves—they hire a nurse or technician to work for them, or they rent out a room. So you must screen a Permanent Makeup artist working in a doctor’s office as thoroughly as anyone else.

 

How Much Training Does the Artist Have?:
All Permanent Makeup schools are not alike—basic training varies from a DVD course to a few days, several weeks or several months. Tuition ranges from $99 for a DVD to a few hundred dollars to several thousand dollars. Students—and later their clients—get what they pay for. So ask for details about the artist’s training and look at certificates. Guidelines by the AAM and SPCP recommend that a fundamental course of instruction be 100 hours minimum. Ask to see the artist’s basic training certificate to check for hours. Also ask to see certificates for advanced courses and training in Blood-Bourne Pathogen Control that follows CDC-OSHA guidelines.

 

Ask About the Equipment Used:
Do not rely fully on an artist’s reassurance about using sterile needles. Even when single-use sterile needles are used, diseases can be transferred between people through body fluid and air-borne particle contamination of the machine—this is called “cross-contamination.” With most tattoo devices, many steps are needed to clean and disinfect the motor mechanism and hand piece. The parts must be autoclaved to be sterilized or disposed of and replaced completely. If the artist skips a step or performs one incorrect, cross-contamination can occur. And some machines should never be used because they allow cross-contamination even when properly cleaned. The only devices that prevent that from happening are the disposable Nouveau Contour System, I-Star System, or manual hand tools. With other types of equipment, there is no way to guarantee safety unless it has been inspected and approved by the health department.

Ask for References and Referrals:
Any reputable Permanent Makeup artist should willingly provide references of satisfied clients. If he/she cannot or will not provide any, you should go elsewhere. Referrals are also important—ask your friends, family members, or co-workers if they have had Permanent Makeup applied by someone they would recommend. But don’t rely solely on referrals—follow the guidelines on this page to choose the best technician for you.

 

Consider Price LAST:
Even in today’s economy, you should never make a decision about a cosmetic procedure based on price alone. With few laws regulating Permanent Makeup, as a consumer you are at risk. A low price can mean an artist is a beginner and needs experience, or is not busy and needs money, or is cutting corners to save time or supply costs. An experienced and skilled Permanent Makeup artist who practices safely, correctly, and ethically will not have the lowest prices—because she cannot remain in business otherwise. So follow the tips above and ask many questions. Remember “you get what you pay for” and a cheap price can cost you more in the end—ugly makeup, pain, or a disease. Permanent Makeup is an investment in your face and body. It can last a lifetime, so it is worth paying a little more to protect your looks and your health.

 

Above all, protect yourself and your health. Don’t rush into making a quick decision. Remember, you pay for what you get, and you certainly don’t want to be “paying for it later” when you don’t get the results you want or if you have other problems.