After reading the information on your website I am confused. There are several distributors of dermaroller type devices in the USA but only two official distributors for the original Dermaroller. Yours comes from Germany and the others either from England, China or Korea or perhaps are manufactured elsewhere.

To a consumer the other dermaroller type devices appear to be the same. After looking at the other respective websites they make what would be considered legitimate claims about their products. You say their quality and standards and claims are false.

The Dermaroller had to be registered in the USA with the FDA etc. in order to qualify as medical devices. Don’t the other dermaroller type devices in the USA have to also register with the FDA and subject to their oversight just as yours is? How does this occur and why hasn’t the FDA taken action? What set of facts am I missing?

I am concerned about my health and safety. Can you please clarify these issues for the consumer.

Sincerely,
Tony

Dear Tony,

Let me try to clarify your confusion, and also note that this is not an official legal advice.
If someone, a company or a person, has a protected name it is called Trademark®. Once your Trademark or Trade name is registered and approved this is indicated with an affix ™ or ® at the end of the Trademark and is the intellectual property of the registrant. Therefore no third party may use this term on his brand. If a third party uses the Trademark without permission this is an infringement and a criminal act and subject to legal claims. http://www.uspto.gov/web/offices/tac/tmlaw2.pdf
So don’t get confused and simply follow our distributor list then you’ll be always on the right track and you are sure to buy the ORIGINAL that follows the “rules” set in force by the law.

Any person or enterprise that registers a Medical Device (MD) with the FDA in the US or with so called Notified Bodies in Europe MUST fulfil certain requirements BEFORE the registration. If a registrant does not apply with theses rules, regulations, directives and laws the MD is considered as an adulteration, and the registrant must face all consequences. These regulations can be found:
For the US: http://google2.fda.gov/search?q=Part+820&x=0&y=0&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*

For Europe:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:HTML

As these governmental bodies are flooded with registrations it is virtually impossible for them to check if each applicant has fulfilled all his obligations. Therefore it is unlikely that such a huge body like the FDA acts on his own. It is the applicant’s duty to comply with the rules! If not he must face the consequences and possible punishment by impinging against the respective laws.
To make it easier to understand, here is a simple example: You are obliged by law to carry all your identification papers with you when driving a car, such as ID-card, car registration, insurance, etc. If a police officer catches you – more or less accidentally – without the papers, that clearly prove that you are entitled to drive this car, you have to face the consequences and pay a fine – as a minimum. The same will happen to manufacturers of medical devices that are not in accordance with the regulations.

It is a sad affair that many infringers try to get around the law and deliberately hazard the health consequences of their customers. Unfortunately the Internet is a huge platform where these people can hide – but only for a short while. In the end they must face the consequences. We have filed complaints to the FDA but it takes some time until they act. If you and many others feel fooled by these trademark pirates and Medical device adulterators, please write your own complaint http://www.fda.gov we are sure the FDA takes it serious.

Best regards
Your Dermaroller Team

Thank you for your inquiry. What puzzles me a bit is your term: kellosis. I never heard it and you possible used the wrong term, because in case the scar would be a KELOID, things would be totally different. But they way you describe it, it seems to be a normal little scar.
I do not see any reason why not to treat a kid, a human, like we are, only smaller.
Do NOT treat your kid yourself. Please contact a dermatologist and we shall send him the device plus an instruction. It is very easy to use. First a topical numbing cream has to be applied, that needs about 30 minutes to become effective. The treatment will take about 1 minute. In return I would like to have a close up photo of the scar before and one 6 weeks after the treatment.

Best regards
Horst Liebl

Thank you for addressing these problems and your confusion to us. I am happy to answer your questions in detail.

Home Care Dermaroller and Beauty Mouse, both have 0.2 mm long needles. Both instruments are made for transdermal enhancement of active substances.
In order to get your skin used to micro-needling, start SLOW, only once or twice a week. Especially the skin of the thighs can have an initial histaminic reaction when the Beauty Mouse is used vigorously. The needles alone will stimulate your epidermis, good peptides can support this action. As we are talking about STIMULATION, it should not be overdone. Unfortunately many people believe, the more, the better. Stay with our advice, 2 or maximum 3 times a week and you’ll see positive results after about 4 weeks. Naturally you can use your products daily (of course with less penetration). A home care roller is sufficient for about 100 applications.
Copiers only copy! But in the end they simply do not know what they are talking about. They simply cannot know why we have chosen this roller diameter and not another one, why this needle separation angle, what kind of steel, end so on. If a copier would have at least some ethics and intelligence, he would not copy, he would invent something better.
Can you imagine how much it costs to build a manufacturing site for medical devices according to European law and to obtain a CE mark? How much one has to invest to be under constant government observation for quality insurance? Far over 200.000 Euro. A copier has to invest nothing. They buy simple steel pins from the needle industry and fool people pretending they have quality. Have you ever seen any scientific evidence from them? All they do is to steel our intellectual property!
What is a peel? You are reducing the thickness of your epidermis by acids and you are facing risks of skin damage if the peel is not done properly. As all scales, especially these of your stratum corneum, are subject to aging, due to a increased renewal cycle of your keratinocytes, they lose their transparency and the skin looks not as fresh as you wanted it to be (when you were in your Twenties). Acid removes these aged scales in several layers and your skin looks fresher – more transparent. On the long run the Dermaroller has a much better effect. It takes off the uppermost scales mechanically and by stimulating the renewal cycle of your epidermal cells, scales maintain their initial transparency – it is a simple as that. (Please refer to: http://www.dermaroller.de/us/epidermis-thickness/epidermis-thickness.html ).
As a manufacturer of medical devices we have to stick to the law (European Directive MDD 93/42 EEU) and classify our products. Only an initial gamma sterilisation can rest assure that a product is sterile! Once it is used, dispose it! Needling devices that penetrate the dermis are invasive instruments. If the plastic parts could stand the heat of an autoclave, the Dermaroller could be re-sterilised, BUT with the advert effect, that the needle tips become blunt – immediately! Ask your husband or friend to shave with a sterilised blade. I am sure he will ask for a divorce the same day.
Human dermis has an average thickness of 1.5 mm and new collagen forms only in the upper corium, about 0.5 mm below the epidermis. So why in this world to use 2.5 mm or even longer needles only to puncture the muscles underneath the skin? – it simply makes no sense. I only can assume all copiers must be men (mostly from Asia where all copies come from), and most of their funny thinking is: the longer, the better! But sensible needling has nothing to do with oversized needles, it is a matter of intelligence, and I am afraid, this is only given to a few in this world – at least in respect of microneedling.
Your last point: Home treatment with 2.5 mm long needles. If you like pain – do it! If you think, you are your own physician – do it! If you want to damage your skin and risk possible infections and permanent disfigurement – do it! If you are intelligent – go to a physician that is familiar with the real Collagen-Induction-Therapy (CIT).

Thank you for your attention and best regards
Horst Liebl

Thank you forwarding this interesting issue on SINGLE USE.

Aside from the Home Care Dermaroller with needle length of only 0.15 mm, ALL medical Dermaroller models such as MF8, CIT and MS4 (needle length ranging from 0.5 to 1.5 mm) for scar treatment, skin rejuvenation etc. are SINGLE USE, DISPOSABLE, gamma sterilized medical devices class IIa, according to European directive 93/42 EEU.

The reasons for this classification is easy to understand:
• Needles longer than 0.2 mm penetrate into the dermis, and such a penetration is called invasive.
• Any instrument, even an injection needle that penetrates the skin, MUST be sterile.
• For economic reasons we manufacture the Dermaroller from plastic parts with incorporated steel needles. All parts are glued by a medical approved bonding. (We also could make the Dermaroller from metal, but this would result in an extreme high price).
• Before delivery the Dermaroller is sealed in a bag, packed in a carton and gamma sterilized, the best and most efficient way of sterilization. (For environmental and health reasons ethylene oxide gas sterilization is widely banned in Europe).
• Due to its structure the Dermaroller CANNOT be re-sterilized in an autoclave, may it be steam or hot air.

Even though we would use plastic parts (poly amid, etc.) that can stand heat above 200° C, the heat will always affect the needles, because any metal, also stainless steel, changes its molecular structure when exposed to temperatures above 100°C. The needle tip is the most difficult part to tool. And the extreme thin tip is the first part that will change its structure when exposed to high temperatures. In simple words: it will get blunt. You may not see it with the bare eye, but you definitely will feel it. Blunt or badly tooled needles (like these of all copies) result in high penetration forces, and these high penetration forces result in skin damage.
Make your own experiment with almost no cost: Put a new razor blade into an autoclave. You can bet it will never shave a hair again!

We cannot force a physician NOT to re-use a Dermaroller for a second or third treatment – hopefully on the same patient. Some of them store and soak the needling device in disinfectants or simple alcohol. This is NO safe end efficient method for sterilization! It only disinfects the device! And here we face another problem: Most of these disinfectants will, or at least, can affect the needles bonding and damage the instrument.

A physician bears responsibility for what he/she is doing, and I am sure most of them will follow the rules set out by the manufacturer. Why to take a risk where is not necessity?

And another good and most important reason NOT to re-use a medical Dermaroller that was used on scars or acne scars. The fibrotic scar tissue can be so hard that the fine needle tips are subject to extreme wear. The following treatments with this used instrument will result is poor results, high penetration forces and pain. Why should anyone take such a risk? And why to accept poorer results with a used instrument?

A price for a treatment may differ from country to country and it depends where you live. But keep in mind: in general only 2 to 4 treatments are required to fight even the worst acne scars and have them improved by at least 70 to 80% permanently (provided the procedure is done the right way and new instruments are used). Usually physicians sell a “treatment” and that includes the device, and here I mean a NEW one.

We know that the Dermaroller is a perfect instrument for an effective treatment, and that is the reason why it was copied to often. But always keep one important point in mind: Copiers never invest in science, they only copy (devices and pictures) but do not understand the philosophy behind an instrument. They use cheap materials for a quick Dollar, and the customer is the cheatee.

Of course a copier will always recommend the reuse of his falsification many times. And why? Their needles are of such a poor quality that it does not matter if they are used once or if they are re-sterilized. Dull is dull and will stay dull.

Best regards
Horst Liebl

Congratulations on the new website and this wonderful blog. It is very informative and a great help to patients like me who have been struggling for years because of acne scars.
I have been a follower of your old website, carefully reading about articles on this procedure dermarolling.
This is a relatively new procedure in the Philippines and I am quite happy to know that many clinics are now offering it. I am fully aware (thru information from the old website) that your medical rollers are for one patient and SINGLE use only. However, my dermatologist insisted that it can be used up to six times (She is using the MF8, 1.5mm). Is is me, or is my understanding of english is poor, as label of the container says that it is a SINGLE USE, DISPOSABLE INSTRUMENT. Please shed us light on this issue.

Janice

It was never reported to us that the Home Care Dermaroller with its short needles of less than 0.2 mm would cause an ongoing inflammation when properly used on healthy skin. However as it applies with all new applicators, some people tent to overdo things. We feel that two (2) Dermaroller sessions per week are sufficient. Even without any additional skin care the fine needle stimulate the epidermis for a faster renewal that usually results in an increase of epidermal thickness (see our website). The outermost skin layer, the stratum corneum, closes so fast after pricking that it is more than unlikely that the skin gets inflamed or this layer is destroyed. Just keep in mind that shaving the skin, like many men do daily, takes parts of the stratum corneum away. This can be easily tested: Apply an After-Shave-Lotion immediately after shaving. You’ll experience a burning sensation. But if you wait for some 5 to 10 minutes and then apply the alcohol lotion, nothing will happen – the stratum corneum is already completely closed.

What concerns us more is the uncontrolled use of skin care product, mainly those that contain higher doses of Retinol and AHAs (Alpha hydroxy acids). These are ACIDS!!! and may have a certain effect ON the skin. But as a needling device is able to enhance these substances by 200 fold and possible more, these acids can, and most likely will affect the skin negatively with strong skin irritation and long prevailing redness, flaking and possibly ongoing inflammation. Therefore this paragraph must be understood as a strong WARNING! Under all circumstances a dermatologist should be asked for advice before using such products along with the Dermaroller!

Keep your Dermaroller and use it sensibly as you mentioned. But also keep in mind: Nothing lasts forever! Even the best steel is subject to wear and tear – or have you ever met a surgeon that uses his scalpel over and over again? Keep the Dermaroller clean, store it well and see it as used up after one year, based on 2 uses per week. If any copier claims hundreds of treatments with the same device I would considers this as a cheat.

Best wishes
Horst Liebl

I have been using my homecare version of the dermaroller and am very certain that it is helping me get better results from my skincare actives.

However, I recently read an article that made me wonder if the homecare roller could contribute to ongoing inflammation by disturbing the stratum corneum permeability barrier if you use it more frequently than every 2 weeks. And based on the article, it sounds as though long term inflammation could have very negative results on my skin over time.

If you could address this, I would greatly appreciate it since I would like to keep using my roller!

Please email me if you need the pdf with the complete article.

Many thanks,

Bethany

Chronic inflammation is etiology of extrinsic aging
Author: Thornfeldt, Carl R
Source: Journal of Cosmetic Dermatology, Volume 7, Number 1, March 2008 , pp. 78-82(5)

Excerpt:

Any degree of repeated or chronic disruption of the stratum corneum barrier has been documented to activate chronic inflammation. Acute inflammation followed by complete rejuvenation of the stratum corneum permeability barrier does not seem to induce or exacerbate destructive chronic inflammation if more than 2 weeks elapses between treatments.

http://www.ingentaconnect.com/content/bsc/jcd/2008/00000007/00000001/art00015;jsessionid=1as1b46rel71l.alexandra

I feel that your doctor is right not to perform a peeling during the sunny season. Whatever peeling he may use, phenol acid or any other fruit acid in various concentrations, any acid destroys (removes) the epidermis. Peelings fall under the category of ablative procedures such as dermabrasion or ablative laser resurfacing. In the end these procedures have one goal in common: thermal removal of the epidermis. This removal forces the skin to build up a new epidermal layer. Unfortunately these ablative techniques have been associated with prolonged healing times (like all burn wounds), persistent skin redness, scarring, even permanent loss of skin pigmentation. As the protective epidermis is removed, the skin becomes very sensitive to sun damage and the patient is not allowed to expose its skin to sunlight for several weeks and often month. Darker and therefore highly pigmented skin often reacts very negatively to ablative procedures and results quite often in permanent pigment damages. Another and grave disadvantage of these methods is that the (new) skin is thinner, and a second treatment is very unlikely.
This is most likely the reason why your doctor postponed your peeling session.

If I were you I would consider a Collagen Induction Therapy (CIT) with the Dermaroller®. Simply because the advantages are obvious:
A Dermaroller procedure can be perfomed at any time of the year! No social down time – no sun sensitivity – no negative side effects – no pigment problems – and as the Dermaroller needles induce new collagen fibers, your skin becomes thicker. And last but not least, a CIT is inexpensive and worth the money with permanent results. Depending on your skin condition 2 to 3 treatments (CIT) may be required. And if you want to support the physician’s CIT results, use the Home Care Dermaroller after the CIT. Even the very short needles have a positive effect on your epidermis and will thicken it. For more detailed information, please refer to our website http://www.dermaroller.com

Best regards
Michael Tomerius
Vice President Dermaroller Sarl

Thank you for contacting us. I think we can hush your fears. Although this drug is unknown in Europe, after searching the web we could not find any evidence, that Lisinopril has a degrading impact on Collagen type I. As we do not see any correlation between a drug for hypertension, we feel a Collagen Induction Therapy (CIT) can be performed successfully, provided your doctor uses the original Dermaroller®, simply to make sure you can expect the best results.
It is not the needling therapy as such, but in rare cases some people may not tolerate the numbing cream. Also keep in mind, depending on your skin condition, your may need 2 to 3 CIT treatments. They should be separated at least six weeks, as new collagen formation of type III needs time to mature.
Please ask your doctor and good luck.

Regards
Horst Liebl

Thank you addressing this question to our BLOG. Originally Minoxidil was a drug developed to fight high blood pressure. There are rumors and claims that patients used this drug also developed an increase of hair growth (???). Today this drug (Rogaine) is widely used to fight hair loss. Over the years the drug concentration was up-scaled from 1 to 5%. We cannot comment if this drug or others can improve hair growth or reverse hair loss. Personally we believe this rumors became a myth over the years.

We have been asked many times why we do not recommend the use of this drug in combination with the Dermaroller. We have good reasons for our refusal. Let me explain:

Not only would we fool you and million others if we would make such claims. The structure of the human skin prevents that drugs or cosmetics can penetrate the stratum corneum, the uppermost layer of the epidermis. We have absolute prove that not more then 0.01% of a hydrophilic (water and/or alcohol) formulated solution can be absorbed by the skin. The rest evaporates or goes into your pillow – an expensive experience. See: http://www.dermaroller.de/us/science/science.html

Naturally things look different when this blood pressure controlling drug is enhanced into the skin by a needling device. It immediately will enter into your blood stream and things can quickly get out of control and you definitely can get a problem, even a heart failure, especially then when you have a coronary deficiency (what many people do not know). If you enhance such a drug into your skin with the help of an enhancing device, this would be the same if you play with open fire near a leaking gas pipe!

If copiers of the original Dermaroller recommend a needling device in combination with such drugs against hair loss, they definitely lie and encourage you to risk your health.

Therefore our conclusion is clear: DON’T DO IT!!!

We can imagine that this statement doesn’t comfort you. But you definitely can enjoy life with some lost hair – even it is hard to except in the beginning. But the risk to suffer for the rest of your life is not worth it.

Sincerely yours,
The Dermaroller Team