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Artecoll, Under FDA Review, Offers Some Pluses


 

NEWPORT BEACH, CALIF. — For any dermatologist who wonders whether patients will clamor for the permanent injectable Artecoll when and if it clinches approval from the Food and Drug Administration, David Ellis, M.D., has this answer: yes and no.

At a meeting sponsored by the Foundation for Facial Plastic Surgery, Dr. Ellis predicted a continuing need for a broad array of products to meet patient demand. However, he said that Artecoll may expand the patient population to include those who are squeamish about temporary fillers and want something permanent.

"There is no question that the technology [for permanent filling] is now available, and that it is safer and more effective" than ever before, said Dr. Ellis, professor of otolaryngology and facial and plastic surgery at the University of Toronto.

He has been using Artecoll for about 3 years in women and men in his practice in Canada who don't want to undergo surgery for a facelift but who don't like the idea of periodic injections.

His experience with the injectable has been very favorable, consistent with reports on its use in Europe over the past decade, he said, adding that he has no financial interest in the product. However, Artecoll isn't likely to dampen enthusiasm for existing methods, he predicted at the meeting, which was also sponsored by Medical Education Resources.

Because of heightened consumer awareness, many patients know the options before they ever come in for a consultation, and they often have strong opinions.

"It is very important to match the product with the desires" of the patient, Dr. Ellis stressed.

"I still have one patient who likes collagen, and so I get it for her," he said. It isn't that she is unaware of the benefits of Artecoll; she just prefers collagen.

Artecoll is made up of polymethylmethacrylate microspheres, which are suspended in collagen. The beads, which are a microimplant, spur collagen production to fill in lines over a 2- to 3-month period, Dr. Ellis explained.

Though this technique provides long-term augmentation, it does have its drawbacks. "Even people happy with the correction will feel the implant," according to Dr. Ellis. In clinical practice, Artecoll works best in grooves and creases, and the lip can be a "problem area," he said. In addition, Consumer Reports took a look at cosmetic fillers this past fall and noted that there had been preliminary reports of infection with Artecoll, with resulting red lines.

"These lines are removed through an incision that can scar," Consumer Reports magazine stated.

Dr. Ellis said he has had almost uniformly good results, with implant longevity that matched his use of the product, beginning in 2000.

However, he noted that Artecoll, which is likely to be marketed in the United States as Artefill, will be slightly different if and when it makes its American debut. Because of concerns on the part of the U.S. government and American public over the potential for bovine spongiform encephalitis (BSE), Artefill would be derived from a pristine herd of cattle reared separately in the western United States and subjected to frequent and intensive testing for BSE.

Dr. Ellis also speculated during his presentation that Artecoll users may prefer Dermalive, a permanent filler that may eventually receive federal approval for use in the United States.

Dermalive is made of flexible particles of acrylic hydrogel and hyaluronic acid, and it is not derived from animals. "So, there is no skin test," he noted.

Dr. Ellis has been using Dermalive for at least 1 year, with equally good results. "I find that I get more even flow and avoid lumpiness."

A "few patients will get a lot of swelling and redness," when Dermalive is administered as a permanent filler, so it has some disadvantages, too, he added.

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