Orange County Register

Photos: Above, patient before (left) and after treatment with Artefill. (Photos courtesy of Dr. Lorrie Klein) Below, Dr. Klein.

FIGHTING FACIAL FOLDS — FOREVER?

A year ago, the plastic-based facial filler Artefill was on its way to extinction.

Its manufacturer, Artes Medical of San Diego, only managed to ward off bankruptcy until December, at which point Artefill was off the market.

Now it’s back, having been acquired by Suneva Medical, a new San Diego-based company that relaunched it in June.  Many — but not all — cosmetic doctors welcome the return of a product that can rejuvenate patients’ smile lines for years without any need for repeat injections.

The downside of Artefill is that, if a doctor makes a mistake while injecting Artefill, it’s hard to correct, and sometimes impossible. Unlike injections of the leading fillers Restylane and Juvederm, made by Irvine-based Allergan, the effects don’t simply fade away as months pass.

“This is not for beginners, either first-time filler patients or first-time injectors,” said Dr. Christopher Zachary, chairman of the UCI Department of Dermatology.

“I totally agree,” said dermatologist Dr. Lorrie Klein of Laguna Niguel during this week’s online “In Your Face CHAT.” “Patients should not only try a temporary filler first to make sure they like the results, but they should also try out the doctor first! Make sure you go to an extremely experienced injector (not just a good surgeon, etc), but that they do lots of fillers, plus have experience with Artefill.”

Such cautions can’t guarantee success, according to dermatologist Dr. Mark G. Rubin of Beverly Hills.

Commenting on Artefill when it was still produced by Artes Medical, he said, “A scary part is that, if you look in the literature, every single injectable material that’s out there has (produced lumps in the skin). There’s nothing you can use that is completely safe. … I view this as a niche product.”

Suneva’s chief executive, Niv Caviar, told Dow Jones that the company plans to market Artefill to people who are tired of getting repeated injections of Juvederm or Restylane.

Zachary is taking part in a five-year study of Artefill that the Food and Drug Administration required. So far, he said, Artefill is proving to be as safe as other fillers.

The FDA did everyone a favor when they insisted that Artes Medical perform a five-year Artefill safety study. Although the high cost of this study broke the bank (the company went bust), it is now resurrected as a much stronger, leaner, more defined operation known as Suneva.

The five-year Artefill safety study (now 18 months out) is demonstrating that this product has a safety profile at least as safe as the shorter-acting fillers, which will be a real boon for this new company.

Artefill has a variety of uses, Klein said. “It is approved for the smile lines (naso-labial folds) but many of us use it for the marionette lines [wrinkles extending downward from the outer corners of the mouth], the ‘lunchtime’ nose job and occasionally other areas such as cheeks and jawlines.”

It’s not suitable for injection between the eyebrows because of the potential for blocking arteries there, she said.

NUTS AND BOLTS OF ARTEFILL

What: microscopic spheres of a plastic, polymethyl methacrylate, suspended in a gel of bovine collagen (pictured in photo taken through microscope)

Treatment cost: $1,000 to $3,000, depending on the doctor, type of treatment, and amount used.

Lasts: 5+ years

Common areas filled with Artefill among Klein’s patients:

• 90% — smile lines
• 50%+ — marionette lines
• 30% — other areas

Artefill patients in 12 months at Klein’s practice: 30 to 50.

Potential problems: injected filler can be seen or felt if the injection is too shallow, or because the skin ages around it; rarely causes small bumps under the skin.

Rating by RealSelf.com readers: 67 percent favorable. By comparison, Juvederm gets a 59 percent rating, while Restylane is at 58 percent.

In the second portion of this post, Klein comments on photos that show the changes that Artefill produced in two of her patients.  Before-and-after photos of other Artefill patients are at the bottom of the page  “Closeup: Artefill patients.”

Also in the second portion of this post is a gently edited transcript of the portion of the Oct. 21 online chat about Artefill.

Related links:

• CEO quits as maker of ArteFill posts $12.3 million loss (May 2008)
• Economy kills 2 anti-aging companies (December 2008)
• Permanent filler ArteFill reaches 7,000-patient mark (April 2008)
• Comparison shopping for facial-fold fighters (October 2007)

Here are two Artefill patients with Klein’s comments about them:

Patient 1 — before treatment.

Patient 1 — after treatment.

Dr. Lorrie Klein: Notice the smile lines (between nose and corners of the mouth). They are not as deep, yet appear natural.
Colin Stewart: What’s the time lapse between the two photos?
Dr. Lorrie Klein: 6 weeks later. The results are immediate but we wanted to wait for the redness and swelling to disappear before taking photos.

Patient 2 — before treatment.

Patient 2 — after treatment.

Dr. Lorrie Klein: You should notice his [changed] smile lines. I also injected his cheeks, so notice how the hollowness is improved.

PARTIAL TRANSCRIPT OF OCT. 21 ONLINE CHAT

Colin Stewart: Now let’s talk about Artefill. It’s a filler that’s injected like more common products such as Restylane and Juvederm, but it’s basically made of tiny plastic spheres (in layman’s language). It’s not absorbed by the body, so its effects last a long time. Are the effects permanent?

Dr. Lorrie Klein: Artefill is approved for one year but the studies (so far) show five-year longevity and safety. Theoretically, it may be permanent but since it ages with you it will need replenishing as your skin ages.

Colin Stewart: Can you explain that further?

Dr. Lorrie Klein: Artefill’s microspheres (what you call “plastic”) stimulate your skin to make its own collagen around them. This natural collagen ages along with the rest of your skin’s collagen. With age, it diminshes.

Colin Stewart: Ah, so the spheres remain in place, but collagen around them gradually goes away?

Dr. Lorrie Klein: Yes.

Colin Stewart: How long has it been around, and how long have you been using it?

Dr. Lorrie Klein: It was approved in 2006 and I have been using it since 2007.

Colin Stewart: How much do Artefill treatments cost?

Dr. Lorrie Klein: Anywhere from $1000 to $3000, depending on how much is used and who you go to.

Reader/Register staffer Cindy McNatt: And it can’t be used between the eyes?

Dr. Lorrie Klein: It is riskier to inject thicker fillers there because of the blood vessels in that area.

Colin Stewart: I realize that I don’t understand the problem with fillers and blood vessels. Does filler block them? Aren’t blood vessels everywhere?

Dr. Lorrie Klein: The potential (but rare) chance of blockage is the problem. If an artery in this area was blocked by a filler, it could cause damage to the overlying skin.

Colin Stewart: Overall, where CAN Artefill be used?

Dr. Lorrie Klein: It is approved for the smile lines (naso-labial folds) but many of us use it for the marionette lines (corners of the mouth), the “lunchtime” nose job and occasionally other areas such as cheeks and jawlines.

Colin Stewart: How many patients have you treated with Artefill over the past 12 months?

Dr. Lorrie Klein: Probably somewhere between 30 and 50.

Colin Stewart: What percentage, roughly, are smile lines, etc.

Dr. Lorrie Klein: 90% have smile lines treated, 50% or more have marionette lines treated and and 30% also have other areas treated.

Colin Stewart: When Dr. Christopher Zachary, chairman of the UCI Department of Dermatology, learned that we were going to discuss Artefill, he sent along his observations about it because he’s involved in a five-year study of its safety. I’d like your comments on some of what he had to say.

ZACHARY: Artefill is a unique niche product that fills the ‘permanent’ space, unlike the temporary fillers such as hyaluronic acids, or the intermediate fillers like Sculptra and Radiesse. But this is not for beginners ….. either first-time filler patients or first-time injectors……

Dr. Lorrie Klein: I totally agree.  I think patients should not only try a temporary filler first to make sure they like the result,  but they should also try out the doctor first! Make sure you go to an extremely experienced injector (not just a good surgeon, etc), but that they do lots of fillers, plus have experience with Artefill.

You also want to make sure you like THEIR technique with a temporary filler before they put in Artefill.

Colin Stewart: As I understand it, if a doctor makes a mistake while injecting Artefill, it’s hard to correct – sometimes impossible. Unlike injections of Restylane or Juvederm, the effects don’t simply fade away as a few months pass.

Dr. Lorrie Klein: You are correct. That’s why it is crucial to carefully choose who you go to for a longer lasting filler. Problems are usually due to technique, not the product.

Colin Stewart: Another comment from Dr. Zachary that I’d like you to respond to …

ZACHARY: The FDA did everyone a favor when they insisted that Artes Medical performed a 5 year Artefill safety study. Although the high cost of this study broke the bank (the company went bust), it is now resurrected as a much stronger, leaner, more defined operation known as Suneva. The 5 year Artefill safety study (now 18 months out) is demonstrating that this product has a safety profile at least as safe as the shorter-acting fillers, which will be a real boon for this new company.

Dr. Lorrie Klein: Yes I agree it is very safe. Suneva is a much stronger company with better management.

Colin Stewart: Final Zachary comment…

ZACHARY: Oddly enough, it is the plastic surgeons who are the major users of this product. They are more accustomed to using permanent fillers than the dermatologists.

Dr. Lorrie Klein: Dermatologists tend to be more conservative and slower to accept a more long lasting product. More and more of us are using Artefill now however as we are the specialty that does the most injections.

Those of us who have cosmetically oriented practices want to offer our patients all the safe choices.

Posts with the “Dermal fillers” tag:

You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.