What Are Artefill Injection Risks?

I heard a doctor on TV say that Artefill was risky, but my friend had it injected and it looks really good. Is Artefill safe? Does anything last as long, like maybe silicone?

Doctor Answers 17

Artifill has inherent disadvantages

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Artifill uses PMMA (plastic) beads, materials which are non-biologic and have no natural defenses against infection. If bacteria form around the beads, the body has no defense against them (i.e. no blood vessels of its own to carry white blood cells or antibiotics) as the bacteria multiply on the foreign object. The body will often try to encapsulate the involved area with scar tissue, calcium deposits and inflammatory tissue as white blood cells degranulate, or discharge their acid sack contents in an attempt to kill the bacteria. This creates an inflammatory lump that is often palpable below the skin surface. Occasionally the lump becomes infected and red. This process can take months to years to occur. The beads and inflammatory reaction can move over time as the dynamic process of the inflammatory response of the body acts on the bead complex.

We have found in our practice the best way to treat the problem is to surgically remove the lumps, usually with small incisions hidden if possible in natural creases or anatomic borders.

Autologous tissue from the patient's own tissues such as LiveFill (fascial fat grafts), all alive when they are placed, are a more permanent, more durable method of augmenting soft tissue in the face. LiveFill grafts have the disadvantage of not being universally available and of being more expensive than injected fillers, and requiring an outpatient surgical procedure to place.

If patients are interested in temporary fillers, current hyaluronic acid (HA) fillers last approximately 6 months (Juvederm, Restylane), and are therefore less durable than Artefill. However HA fillers offer much greater biocompatability, and tend to go away over time. If the results are undesireable, they eventually go away. This is not the case with Artecoll, Artefill or silicone, where bad effects of the injection are often permanent.

There are many patients who have had Artecoll and Artefill injections with no problems and have appreciated the long lasting results. However I have difficulty balancing the risks or a permanent or semipermanent filler with the benefits of longer duration of action. I would agree with the statement that they are risky, for the reasons above.


Beverly Hills Plastic Surgeon
4.9 out of 5 stars 194 reviews

Artefill and mass hysteria? Let's separate the truth from the nonsense.

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First, let me express my skepticism about how many "draining granulomas" my colleagues have seen from ArteFill "8 years after" its injection. Artefill was approved for use in 2006 (THREE years ago). So any patients injected eight years ago would have either 1) not been injected with Artefill, or 2) were from the very early beginning of the experimental study group of patients prior to its approval.

Indeed, granulomas are hard to treat (not impossible). But what is the relative risk? My same colleagues who ply the public with hysterical claims of its risk are the same ones who confidently recommend surgical procedures with much higher rates of complications. The granuloma risk from Artefill is on the order of 1 in 800 patients. The risk of having a bad outcome from rhinoplasty? Perhaps as high as 1 in 10 to 1 in 20 patients.

I like Artefill, I use it (in addition to other fillers), and I've injected family members with it. It needs to be done correctly and for the right indications. But let's put risk into perspective.

All the best,

--DCP

David C. Pearson, MD
Jacksonville Facial Plastic Surgeon

Artefill®'s safety lies in the hands of the injector

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I have been injecting Artefill® for many years now in practically every part of the face and body, including the hands, lower eyelids, acne scars, nose, vermillion border. I have only seen two small granulomas in well over 800 patients which were easily and rapidly treated.

As with all permanent fillers, only small amounts should be injected at a time and in multiple planes. An expert injector of any filler (whether it be temporary such as hyaluronic acid [Restylane®, Juvederm®, Belotero®], Radiesse™ or permanent such as Artefill®, Aquamid™ or fat) should have a light touch and avoid injecting "lakes" of filler which are far more problematic. Since the center of these "lakes" have no blood supply to receive antibiotics or the body's own antibodies, they can become more easily infected. The same holds true with any permanent filler, whether it be Aquamid® or natural fat transfer for that matter.

My patients and I have been extremely satisfied with Artefill®, and have seen less untoward effects than with many of the hyaluronic acid fillers (which produce a swollen, bluish tinge around the eyes on a number of occasions).

Randal Haworth, MD, FACS
Los Angeles Plastic Surgeon
4.6 out of 5 stars 56 reviews

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Artefill, formerly known as Artecoll

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ArteFill is a gel filler consisting of millions of synthetic microspheres (polymethylmethacrylate or PMMA) suspended in purified bovine (cow) collagen. This product sounded like a bad idea to me when it was first introduced. Countless reports of lumps, bumps, and granulomas by patients who have been injected with this product. Over the last few years, this product has become less and less popular and currently, the company is in bankruptcy.

Michael Law, MD
Raleigh-Durham Plastic Surgeon
4.8 out of 5 stars 123 reviews

Artefill can be good - but they are bankrupt

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Artefill is a good product but there are some long term problems such as granulomas which can be very difficult to treat. Of note, the company which makes Artefill filed for Chapter 7 bankruptcy at the end of 2008.

There are other permanent options including silicone, but some fat from the belly or thighs can be used in places that would be otherwise amenable to Artefill or other permanent fillers.

D.J. Verret, MD
Dallas Facial Plastic Surgeon

Artefill Is Cost Effective, Long Lasting, Natural Feeling and Has An Excellent Safety Profile

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Unfortunately most of the answers listed to this question come from physicians who answered more than 5 years ago.  The product has undergone dramatic improvements since that time. The  artefill particle has been improved to markedly reduce any of the previous generation risks.It now has less or equal  risk than many of the other fillers like Sculptra, Juvederm, Radiesse or Restylane.  Facial filler satisfaction ratings with  Artefill show high rates of satisfaction for over  one year. Artefill is a dual action filler that visibly corrects wrinkles but also has microspheres that support the skin.  So many people rent their fillers paying thousands of dollars annually to restart from ground zero each time  with Artefill you own the filler ,it is economically  and aesthetically the best choice in my opinion.

Mark Berkowitz, MD
Sterling Heights Oculoplastic Surgeon
4.8 out of 5 stars 65 reviews

Artefill Risks

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Artefill has the same risks as any other filler. These include bruising, infection and allergic reactions. These risks are very low however and in fact, over the last 6 years that I have been using Artefill I have never seen or heard of these problems. The product can make excessive tissue or scar if you are prone to this type of problem and you should be screened for this prior to your injection. There are some remedies if this happens.

The safety profile of Artefill is exceedingly good with no reports of adverse reactions to the FDA by the makers of the product in the first 5 years of the product's use.

Not only is Artefill safe it also has been shown to have very high patient satisfaction when it is implanted by experienced injectors.

To date, the studies show that Artefill will last at least 5 years.

I hope that helps.

Brian Windle, MD
Kirkland Plastic Surgeon
4.9 out of 5 stars 64 reviews

Artefill safety

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I have been using artefill or artecoll its previous product name for over a decade in Canada.  Its biggest risk is palpable lumps.  These are generally small and often palpable but not visible.  True granulomas are rare and I have never seen one  in the hundreds of cases ive done.  Artefill is most useful for correctiing pitted acne scars where small quantities are injected.  Its other use is in correcting subtle nasal bone asymmetry after rhinoplasty. In my opinion it should not be used in large quantities. It should be injected in sub dermal or deep dermal plain. When used for lip augmentation patients should be advised that they will likely  have palpable textural changes and possible lumps in their lips.

Philip Solomon, MD, FRCS
Toronto Facial Plastic Surgeon
4.4 out of 5 stars 119 reviews

Long term development of granulomas

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I have seen draining granulomas develop in patients 8 years after their ArteFill was injected who had no problems in between. This is very alarming and difficult to treat. Avoid all permament fillers!

Artefill: Fact or Fiction. It is amazing the lack of knowledge that exists out there?

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Good Day.

The goal of any medical, including cosmetic, treatment is to minimize risks and optimize results.

You are prudent to question a treatment that may be permanent so you don't have to deal with a long-term complication.

Myths:

The current manufacturer is going bankrupt. 

Suneva has just reached its 10th anniversary as the sole manufacturer and distributor in the US.

Granulomas (firm areas) are common. The incidence combining the first four FDA Artefill (US name changed to Bellafill in 2015) showed an incidence of granuloma formation of 1.7%. In my clinical experience for five years with nearly 1600 syringe my granuloma incidence is 0%. I took over for another physicians practice and from 2009 to 2013, three granulomas were observed with all three resolved by treatment with serial Kenalog injections by myself. 

Facts:

Bellafill (artefill) is made of 80% bovine (cow) collagen and 20% methylmethaculate microsomes (small bodies) that stimulates human collagen synthesis. About 80% of the volume initially injected is produced by the hosts (you) collagen production. There is only one herd of cows where the collagen is harvesting in the US, which is outside of Philadelphia. The FDA made this request so they could monitor the herd for diseases to prevent them from being transferred through the product.

Bellafill can be injected anywhere on the face, except the bulk of the lip. The clinical outcomes have been documented to be safe with effective volume replacement in the medical literature.

The longest dermal filler study in the world showed that 82% of patients felt they looked the same or better at five years compared to one year post-injection of Bellafill. 

Facial Volume Replacement Options:

Temporary:

1. Hyaluronic acid fillers, such as Restylane an Juvaderm

2. Sculptra or L-Lactic acid to stimulate collagen synthesis. The manufacturer suggests that the volume effect lasts about two years.

Permanent:

1. Facial silastic implants

2. Facial fat transfer with platelet rich plasma and stem cells

3. Bellafill. Injection in the proper anatomical site, injecting amounts that are not excessive, and minimizing side effects by using a microcannula.

I practice in Southern California and Las Vegas, NV. It is against the law to inject Silikon in Nevada. And, there is virtually no other medical severe prohibitions than this in Nevada.

I have treated numerous women who had liquid silicone injected into the lips that produced a chronic inflammatory response (about 4% of patients) and produced enlarging lips, hard lips, and deformity of lip movements. This treatment is to excise all the inflammatory tissue containing the silicone, like cancer surgery. After the surgery heals, then lip augmentation is contemplated and performed, usually with a soft silastic lip implant (Surgisils Permalip). 

In summary, bellafill is a safe and effective long-term if not permanent filler. Bellafill is one of three permanent facial volume replacement option along with silastic implants and fat transfer, each with there advantages and limitations. 

Robert J. Troell, MD, FACS
Las Vegas Facial Plastic Surgeon
4.9 out of 5 stars 23 reviews

These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.