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Permanent Fillers - Artefill and Silikon 1000

 

Artefill is the only FDA approved permanent filler that is on the market today that is a non-re-absorbable injectable. The FDA approved this filler in November 2006; however Artefill (Artecoll) has been in use since the late 1980’s, longer than most other cosmetic fillers on the market. While some doctor’s praise the product for its long lasting results (which may still be apparent five years after the treatment), others are wary of injections that are just that – permanent.

 

 

 

Artefill is made up of Polymethylmethacrylate (PMMA) microspheres suspended in 3.5% denatured bovine collagen with 0.3% lidocaine. The lidocaine is added to help reduce the discomfort that is associated with this injection. Polymethylmethacrylate (PMMA) is a synthetic polymer that has been used with great success in medical implants, such as bone cement, dentures, and pacemaker covers. In the use of a dermal filler, it is being used under the brand of ArteFill or Artecoll in Europe.

 

 

 

This product was originally produced and distributed by Artes Medical.  Artes Medical filed for bankruptcy protection last year - and now Cowen Heathcare Royalty Partners have bought the assets of Artes out of bankruptcy early this year for an undisclosed price.  Artefill is now being manufactured under a new name - Suneva Medical.

Artefill is the first and only FDA Approved microsphere-enhanced collagen filler indicated for the nasolabial folds. 

The indications of Artefill is for treatment of medium-to-deep wrinkles, folds and furrows, particularly nasolabial folds; acne scars, lip augmentation, etc.  An allergy test is required with this product because of the bovine collagen component of the injection, which can take 4 weeks before an actual injection of the product can be made.

 

 

                                      

                                                 Image courtesy of Artes Medical

 

The portion of the injection that has the bovine collagen - is used primarily to provide a smooth suspension and aid in skin matrix integration. After the injection of Artefill, the bovine collagen degrades and dissipates over a period of few weeks. During this time, the PMMA gets encapsulated in the patient’s own collagen which is the body’s natural response to a foreign material and collagen. Artefill has a very high desirable result with a low risk of filler migration. There have been cases of the injection area becoming hard or bumpy, which in fact might be excessive scar tissue formation. If this does happen, an injection of a steroid may help.

The biggest concern is that the face continues to change with time, but permanent injectables like Artefill remain where they were injected, which may not complement the face’s appearance as it ages. Other problems like lumps (like granulomas) which can occur years after injection of any permanent material, and would require surgical excision. Some of these problems are not correctable. However, recent studies show that patients look better five years after treatment than they did six months afterward.

 

 

 

What it is:  Synthetic Microspheres suspended in a collagen gel

Pros:  Longest lasting results – permanent

         Microspheres are five times smaller than the material in temporary fillers.

Cons:  If you are not happy with the outcome, results last upward of five years

Allergy Testing:  Yes Required

How long it lasts:  Up to five years or more

 

 

                    

                                                         Image courtesy of Artes Medical

                                                              Patient injected in with Artefill

 

 

Some of the advantages of Artefill include the following:

  • Immediate results with no down time

  • A simple in-office procedure

  • Excellent safety profile

  • Results improve over the course of several months

  • Usually requires only 1 or 2 treatments

  • Product stands the test of time – been around since the late 1980’s

  • Permanent filler – lasts up to 5 years or more

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    Some of the disadvantages of Artefill include the following:

  • Allergy testing must be done since there is a component of bovine collagen in the product

  • Lumpiness or granulomas might occur

  • Difficult surgical excision or injection of steroid needed with granulomas

  • Persistent swelling or redness

  • Increased sensitivity to injection site

  • Permanent filler

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    More about Artefill

     

     

                                              

                                                Licensed image for CosmeticSurgeryForums.com

     

    Silikon 1000 has become increasingly more popular over the last few years as patients have longed for permanent results with lip augmentation. Silikon 1000 is a medical grade pure form of silicone which is purified polydimethylsiloxane, which has FDA approval for treatment of retinal detachment of the eye and is made by Alcon Labs (Fort Worth, Texas).

    It currently does not have an approval for cosmetic purposes. However, Silikon 1000 has been used as filler by cosmetic surgeons and dermatologist for over 30 years with good lasting results. Although the FDA has not specifically approved the cosmetic use of the agent, the FDA modernization act of 1997 allows licensed physicians to use these agents “off label” for other purposes; similar to the numerous uses for BOTOX before it was approved for cosmetic procedures.

    A similar product, Silskin by Richard-James, Inc. (Peabody, Mass.), received an Investigational Device Exemption for a clinical trial on facial wrinkles in 2003. Both products are used off-label as permanent facial fillers.

     

                                                        

                                                   Image courtesy of Alcon - Silikon 1000

     

     

    Silikon 1000 is used commonly for soft tissue defects or facial augmentation including lips, lines, cheeks, under the eye area, and for HIV associated facial wasting. This product provides a very natural looking permanent solution for patients today. The composition of Silikon 1000 comes ready for injection as sterile, clear, colorless silicone oil. The formulation is supplied and packaged by Alcon in 8.5mL each. No skin test is required with this filler and there is no downtime.

    Silikon 1000 is best injected with utilizing a “Micro-droplet Technique” and normally the injections are spaced out within six to eight week interval so that the patient’s own collagen will form a capsule around the silicone bead to encapsulate it, by stimulating skin cells (known as fibroblasts) to produce new collagen around each micro-droplet.

    Once a micro-droplet is surrounded, collagen production stops. Through repeated injections over several months the combination of silicone micro-droplets and new collagen gradually fills depressions by building soft-tissue by encouraging the production of new collagen, the skin’s natural structural protein.

     

     

     

    Important facts about Silikon 1000

    Composition of Silikon 1000:  sterile, clear, colorless silicone oil - Made by Alcon Labs

    FDA Approved:  Silikon 1000 is a silicone oil substance that is FDA approved for treatment of detached retinas - it is not approved for cosmetic use.

    Formulations Available:  one formula available supplied in 0.4cc and 0.8cc each

    Longevity of Silikon 1000:  Permanent

    Cost of Silikon 1000 Treatment:  $500 - $1500 per treatment

    Allergy Testing:  Not Required

     

     

     

     

    With the silicone bead becoming encapsulated by the patient’s own collagen, it helps secure the product from not migrating. Micro-droplet technique entails the injection of several small drops of sterile Silikon 1000 into numerous points within a desired site. Once injected, the liquid silicone remains chemically unchanged and is consequently enclosed by the collagen capsule produced by the patient’s own skin.

     

    Micro-droplet technique minimizes the occurrence of overcorrection and migration of the silicone that has frequently been seen with other injection techniques that involves a large volume. The micro-droplet technique of silicone provides a safe, slowly progressive, and very natural appearing result in all areas of potential treatment.

     

     

     

     

    Several treatments might be needed in order to get the desired results, as with less material injected (from .4 to .6 cc) seems to yield fewer complications than larger amounts injected over time. The results are permanent, so it is better to go slow with Silikon 1000 over time with multiple treatments so that the physician can manage the results better. The results are lasting and also instantaneous.

    Silicone is often a less painful treatment than other dermal fillers and patients usually resume their daily activity, without restrictions, immediately. Like other lip enhancement treatments, a topical, local, or a nerve block is offered for comfort and may involve some post-treatment swelling and numbness. These minimal post treatment symptoms subside within an hour.

     

                                       

     

    Progression photos of a patient with Silikon 1000 here

     

     

     

    ADVANTAGES AND DISADVANTAGES OF SILIKON 1000

    • Advantages of Silikon 1000

    There are many advantages of using Silikon 1000. It is manufactured by Alcon and is FDA approved to be a safe and effective for use for retina detachment. Having the filler injected with the micro-droplet technique allows for a gradual natural result and that allows for fewer chances of migration or granulomas.

    The biggest advantage and or disadvantage of this filler is the fact that the result is long term and more than likely permanent, so no need for continued injections on a routine basis with periodic maintenance. The treatment because it is permanent is more economical than the other fillers. There is slight or mild swelling after the injection; however this is mainly caused from the dental block that is given before the injection. The dental block wears off within two hours. Some physicians have stated that there is 25% less swelling with Silikon 1000 versus Restylane.

     

    • Disadvantages of Silikon 1000:

    The disadvantages of Silikon 1000 include abnormal lumps and granulomas might occur. The possibility of migration is with this product, so it is very important to start out very slow and not to have a large amount injected at once.

    Some of the side effects from the Silikon 1000 injections are:

    • idiosyncratic inflammation

    • bleeding from the injection site

    • tenderness

    • swelling

    The biggest disadvantage is that it is permanent, so it is best that you make sure this is what you want. It is recommended that you start with a temporary filler first, especially if you have never gotten any facial or lip injections, so that you can see if this is the look you are going to like. Silikon 1000 is a permanent filler, and there is no going back after it is injected.

    These reactions normally are rare and can be minimized with appropriate substance volume and injection technique.

    If complications should arise, they are managed with a variety of procedures including:

    • Local injections of cortisone

    • Removal of tissue

    • Electrodessication

    • Antibiotics

    • With some patients, time alone can help resolve these problems

     

     

     

    MORE IMPORTANT INFO ABOUT SILIKON 1000

    • It is very important that you go to a board certified physician with expertise in the use of silicone and its potential complications.

    • It is also very important that the silicone product that your physician is using is either Silikon 1000 or Adatosil 5000 - Do not take anything else as a substitute for this product.

    • All injections with Silikon are done in the micro-droplet technique.

     

    Before and After Photos of Silikon 1000

     

     

     

     

     

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