Top 10 Micro-Needling False Claims

Top 10 Micro-Needling False Claims of Micro-Needling Sellers

Dermaroller® originated and developed the skin medical micro-needling or the Collagen Induction Therapy (CIT) concept.  The Home Dermarollers® are also their creation. Companies based in England, Korea, China and Africa have copied Dermaroller's® designs. They have concocted their own versions of the facts and attempt to compare themselves with Dermaroller®. In this discussion we want you to focus on medical micro-needling devices not on the Home Dermarollers®. In other words, the focus is on medical micro-needling devices that have needles that are 0.5 mm or longer.

The difficulty that surfaces is that when it comes to a device that appears to be very simple to imitate, reproduce and manufacture, the public and medical professionals can be easily mislead and deceived. As is common, there is more to the engineering of a device than meets the eye. This has lead to false claims being made by unethical manufacturers and resellers of micro-needling devices. The false claims need to be exposed, debunked and will be addressed. Some of these claims do indeed have to do with public safety issues. Without a doubt, Dermaroller® expects counterclaims to surface on the internet made by other manufacturers and resellers attempting to defend the basis for their false claims. Below are the most common false claims about micro-needling that are propagated by online sellers and companies that try to compete with Dermaroller® medical devices:

Claim 1: Micro-Needling devices are re-useable

FALSE. If you believe the claim made by micro-needling companies and online resellers, then the answer would be yes. The claim could possibly be true if the devices were entirely made of metal. However, that is not the case. All medical micro-needling devices have a plastic roller into which metal micro-needles are embedded and then glued or fused into the roller. They are designed to be disposable. After each use, the needles dull and may loosen. The needles CAN’T be re-sharpened after use. Re-using a micro-needling device whose needles have dulled will require more force to penetrate and may tear the skin. This leads to greater pain, tissue damage, potential of infection, and less than optimal results. A surgeon would never reuse a disposable surgical device. By doing so, he invites a poor outcome and potential problems. So, why would you? For more information please click here Can Medical Dermaroller® Devices Be Reused?

Claim 2: Medical Micro-Needling devices can be re-sterilized

The FDA establishes standards and has the public's safety in mind. All medical/surgical devices have to be sterile prior to their use. This same standard applies to all medical/surgical disposable devices. Consider this: if it is important for a device to be sterile prior to a procedure, then it is equally important that it remain sterile if it is to be reused. An apparent double standard, don't you think? We do NOT recommend re-sterilizing a disposable product. Alcohol or similar solutions do NOT sterilize. Autoclaves use heat and will deform the plastic. The roller and the needles are therefore ruined. This increases the risk of infection, injury and pain during a procedure. For your safety, every Medical Dermaroller® device is guaranteed to be gamma sterilized and is designed for single use only. Please refer to Sterilization.

Claim 3: The more needles and the longer the needles the better the results, right? 

This is absolutely false. Consider that your facial skin at its deepest thickness is no more than 1.5 mm. Most other companies are selling rollers with 3 mm needles in length for one good reason. They need to sell longer needles to achieve adequate skin penetration. Therefore, this flaw requires that more force be applied to penetrate the skin increasing pain, trauma to the skin and the risk of injury. Their needles lack in engineering quality and design, and most importantly, sharpness. In contrast, if a Dermaroller® micro-needling device is used, the same results can be obtained with a roller that has 1.5 mm needles or less in length. Dermaroller® micro-needles are designed to be strong, very sharp and yet flexible in order to achieve maximal results.

In order to respond to the claim that more needles are better the "Fakir Effect" will be explained. Many have witnessed or seen pictures of a religious man laying on a bed of nails. This man is called a Fakir. Then, as he lays on the bed of nails either a heavy cement block is placed on his abdomen or someone stands on his belly. Miraculously, no nails penetrate the skin of the holy man. How is this possible? Why don't the needles penetrate and severely injury the man? The answer lies in the number of needles that were imbedded in the bed of nails. The greater the number of nails, the more force is required for the nails to be able to penetrate the skin. With a large number of nails his weight becomes evenly distributed amongst the nails, therefore it becomes difficult for any one nail to penetrate the skin because there is not enough force on any one nail to drive the nail through the skin. However, if the number of nails is significantly reduced, the weight becomes distributed amongst a lesser number of nails. There will be more force or weight on each nail, and they will easily penetrate the skin.

In short, an excessive number of micro-needles in a roller only means that significantly greater force will have to applied onto the roller in order for the micro-needles to begin to penetrate the skin. More needles only serve to make a roller inefficient. The risk of injury increases. Medical Dermaroller® devices have the appropriate number of micro-needles to be effective. This is another good reason for choosing Dermaroller® engineered medical devices.

Claim 4: All micro-needles are the same

Not true. Not all micro-needles are manufactured the same. In addition to the risks associated with weak standard steel or acupuncture needles, these needles also cut and tear holes in the skin. This creates real wounds hindering and altering proper cell and skin regeneration. Dermaroller® micro-needles are the sharpest and contain the best surgical grade needle engineering design in the industry. It contains specific alloys to achieve maximum cell regeneration while creating the smallest skin puncture possible.

Claim 5: Thinner micro-needles are better

In most cases, a thinner needle simply means a weaker needle. They’ll just buckle and bend more easily during a CIT procedure. A thin needle is necessary, but it’s only safe to use when it can sustain and bear a force of at least 2,000 Newtons (1 Newton = 1 kg·m/s²). Very simply, the needles have to be very strong and sharp.

Claim 6: Frequent treatments = better results

Not true. Unlike other unethical vendors, we recommend waiting at least 6-8 weeks between each procedure. Sometimes more time is needed depending on the condition being treated. This basic waiting period allows for the maturation of the repair and regenerative process to complete its cycle.  Repeating the procedure sooner than six to eight weeks in between each procedure provides no additional clinical benefit. It only invites additional risk, trauma and unnecessary costs. This is a circumstance where more is definitely not better.

Claim 7: Companies say they are "FDA Certified" or "FDA Cleared"

Companies based in England, South Africa, Korea and China claim to be certified by using terms such as "FDA Certified" or "FDA Cleared" or "FDA Approved". These companies are making false claims. These are made up certifications. Making any of the claims listed above only serve to alert you that a company is not in compliance with FDA regulations, is falsely advertising and is perhaps fraudulent. The only factual statement that is allowed to be made in the US is that a device is indeed “Registered with the FDA”. All Medical Dermaroller® micro-needling devices are Registered with the FDA as Class I medical devices. Dermaroller® is compliant with federal and state laws and regulations. The manufacturer is also not allowed to claim that it is FDA registered. Some companies also imprint the FDA logo on their labels, websites, containers or packages. The FDA does not permit the use of their logo. Please see link below to verify this information for yourself. 

Ask the manufacturer directly if you are uncertain or have questions about their product. If the manufacturer or distributor is US based, it should be able to answer all of your questions satisfactorily. If not, here are some links that may help you answer your concerns. FDA website link that states no company is allowed to use their logos on any advertisements. 

Claim 8: I can safely do it at home

Yes and we can also give ourselves our own hair cuts. CIT is a relatively "simple" medical procedure. That is true. However, a Dermaroller® medical procedure requires expertise beyond simply rolling the skin. It should be performed by a trained medical professional who will perform a medical assessment prior to a procedure in order to obtain maximal results. The medical professional will apply a topical anesthetic on your skin to numb it. Why? Because the thin and tiny micro-needles, which will vary in length depending on your skin condition, will cause pain. It is rare for anyone to tolerate micro-needles greater than 1 mm without numbing cream. There are those rare few individuals that have an extremely high pain tolerance which can tolerate the medical procedure without any anesthetic. Don't be deceived into believing that you can get the same results as a trained medical professional by doing it yourself as many other companies claim. For your own safety consult a medical professional and you will avoid infections, other potential complications, and most importantly, waste your funds. In the US it is illegal for beauty salons, estheticians and other non-medical personnel to perform medical micro-needling or to use topical anesthetics.

Claim 9: Anyone can do medical micro-needling

Medical micro-needling is considered a medical/surgical procedure in the US. Why? Because according to state laws and regulations performing a procedure with a micro-needling device which contains needles that are 0.5 mm or greater in length is considered a Medical Procedure. Therefore, by law only medical professionals can perform CIT. Medical micro-needling reaches deep into the dermis. It can cause damage when performed incorrectly. This is why CIT or medical micro-needling is considered a medical procedure worldwide. If you were undergoing a surgical procedure, wouldn’t you want to make sure the practitioner knows how to do it correctly? This is why we protect patients by selling Medical Dermarollers® only to medical professionals and by providing Certified Dermaroller® training. See Who Can Perform CIT?

Claim 10: Since others say their devices are FDA registered I am safe

MAYBE. Most micro-needling companies based abroad are getting away with claiming "FDA Approved" to market their rollers as being safe and effective. Most are not following established FDA standards. Each medical device must be in a sealed clearly labeled container. On each container there must be an indication of the method used in sterilizing the product, the date of production and expiration, lot number and the type of device contained therein. Medical micro-needling started in Europe and is relatively new to the United States. The FDA has not yet set specific micro-needling standards to follow. As an ethical company, Dermaroller® doesn't just stop at being registered with the FDA. It is also registered in the European Union and Austraila. It adheres to strict production and safety standards. Patient safety is considered paramount. Click this link to be directed to the FDA website so you can verify if a certain micro-needle device is actually registered with the FDA.

If you have any questions or wish to verify the basis for these claims, please call us during business hours 9AM-5PM PST. 866.326.8412

 

 

 

Testimonials
"I chose Dermaroller ® due to it's impecable reputation and widespread use throughout Europe. I have seen Dermaroller ® time and time again win awards for standard of care. "
Ira Lee NP
Dermaroller Practitioner
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"As a integrative doctor when I saw what the Dermaroller ® was doing with my patient's energy and the increases blood flow to her face I knew that this was an amazing device. The women that I trained on had major acne scars. "
Jorge Moreno DO
Dermaroller Practitioner
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"My client's, co-workers, and myself are amazed and thrilled with my results. "
Maggie Griffith , HairArts Spa
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"I recommend Dermaroller treatments to my friends all the time. "
Tammy H , Medical Dermaroller Patient
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FAQs

"Where do I go to see if a micro-needling company is Registered with the FDA?"
"Am I safe even if a micro-needling company claims that it is FDA registered?"
"Can any one perform medical micro-needling?"
"Can I achieve the same results if I use a micro-needling device at home?"
"There are a lot of companies claiming to be FDA Approved. Is Dermaroller® FDA Approved?"
"If I use my micro-needling device more frequently will I achieve better results?"
"Are thinner needles like acupuncture needles better?"
"Are all micro-needling device needles engineered the same?"
"If a roller has more and longer needles, will I get better results?"
"Can micro-needling devices be cleaned or sterilized for repeated home use?"
"Can a medical micro-needling device be reused?"
"Is the Dermaroller® a CE marked medical device? Are any of the alternative skin needle-rollers CE marked?"
"Why should I use a trained practitioner and an authorized Dermaroller® Clinic?"

Testimonials

I chose Dermaroller ® due to it's impecable reputation and widespread use throughout Europe. I have seen Dermaroller ® time and time again win awards for standard of care.

As a integrative doctor when I saw what the Dermaroller ® was doing with my patient's energy and the increases blood flow to her face I knew that this was an amazing device. The women that I trained on had major acne scars.