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WAIKOLOA, Hawaii — Interim results of the largest- and longest-ever U.S. safety study of a soft-tissue filler paint a reassuring portrait of Artefill, the polymethylmethacrylate-based permanent filler.
At 18 months of follow-up in the 5-year study, there has been just one biopsy-confirmed granuloma and no infections in 991 patients who underwent bilateral treatment with a mean 1.25-cc volume of Artefill injected per nasolabial fold, Dr. Christopher Zachary reported at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.
"I think the 18-month results are significant for the fact that there have been so few complications. This is a product which people are extremely skeptical of, but I think it's time for aesthetic physicians around the world to look at this product based on its merits, based on the evidence, not based on the fear we all have that a permanent filler is inherently bad. From my point of view this is a great product. If you are prepared to have something that will last at least 5 years, then Artefill is something to consider," he said in an interview.
Experience has shown that this filler is very easy to use, he added. It is placed deep to fill areas where bone has recessed in patients with substantial volume loss.
"The problem with aging is not simply that the skin is getting old, it's that the underlying structures - be they bone or muscle - are receding. What we're trying to do with this filler is reconstitute the form upon which the skin sits," explained Dr. Zachary, professor and chair of the department of dermatology at the University of California, Irvine.
All of the adverse events documented thus far in the long-term safety study have occurred at rates similar to or lower than those recorded in the pivotal trial of Artefill and described in the current product labeling, he said.
The most frequent adverse event - lumpiness at the area of injection more than 1 month after treatment - has occurred in 1.8% of participants in the 5-year safety study, compared with 4.6% of those in the pivotal trial.
The one inflammatory granuloma that occurred responded completely to a single intralesional injection of triamcinolone and 5-fluorouracil coupled with a course of oral antibiotics, Dr. Zachary noted.
At 18 months, 88% of subjects reported being very satisfied or satisfied with their results, suggesting a lasting correction, he said.
Dr. Zachary serves on the advisory board for and holds shares of stock in Suneva Medical Inc., which markets Artefill. SDEF and this news organization are owned by Elsevier.
WAIKOLOA, Hawaii — Interim results of the largest- and longest-ever U.S. safety study of a soft-tissue filler paint a reassuring portrait of Artefill, the polymethylmethacrylate-based permanent filler.
At 18 months of follow-up in the 5-year study, there has been just one biopsy-confirmed granuloma and no infections in 991 patients who underwent bilateral treatment with a mean 1.25-cc volume of Artefill injected per nasolabial fold, Dr. Christopher Zachary reported at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.
"I think the 18-month results are significant for the fact that there have been so few complications. This is a product which people are extremely skeptical of, but I think it's time for aesthetic physicians around the world to look at this product based on its merits, based on the evidence, not based on the fear we all have that a permanent filler is inherently bad. From my point of view this is a great product. If you are prepared to have something that will last at least 5 years, then Artefill is something to consider," he said in an interview.
Experience has shown that this filler is very easy to use, he added. It is placed deep to fill areas where bone has recessed in patients with substantial volume loss.
"The problem with aging is not simply that the skin is getting old, it's that the underlying structures - be they bone or muscle - are receding. What we're trying to do with this filler is reconstitute the form upon which the skin sits," explained Dr. Zachary, professor and chair of the department of dermatology at the University of California, Irvine.
All of the adverse events documented thus far in the long-term safety study have occurred at rates similar to or lower than those recorded in the pivotal trial of Artefill and described in the current product labeling, he said.
The most frequent adverse event - lumpiness at the area of injection more than 1 month after treatment - has occurred in 1.8% of participants in the 5-year safety study, compared with 4.6% of those in the pivotal trial.
The one inflammatory granuloma that occurred responded completely to a single intralesional injection of triamcinolone and 5-fluorouracil coupled with a course of oral antibiotics, Dr. Zachary noted.
At 18 months, 88% of subjects reported being very satisfied or satisfied with their results, suggesting a lasting correction, he said.
Dr. Zachary serves on the advisory board for and holds shares of stock in Suneva Medical Inc., which markets Artefill. SDEF and this news organization are owned by Elsevier.
WAIKOLOA, Hawaii — Interim results of the largest- and longest-ever U.S. safety study of a soft-tissue filler paint a reassuring portrait of Artefill, the polymethylmethacrylate-based permanent filler.
At 18 months of follow-up in the 5-year study, there has been just one biopsy-confirmed granuloma and no infections in 991 patients who underwent bilateral treatment with a mean 1.25-cc volume of Artefill injected per nasolabial fold, Dr. Christopher Zachary reported at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.
"I think the 18-month results are significant for the fact that there have been so few complications. This is a product which people are extremely skeptical of, but I think it's time for aesthetic physicians around the world to look at this product based on its merits, based on the evidence, not based on the fear we all have that a permanent filler is inherently bad. From my point of view this is a great product. If you are prepared to have something that will last at least 5 years, then Artefill is something to consider," he said in an interview.
Experience has shown that this filler is very easy to use, he added. It is placed deep to fill areas where bone has recessed in patients with substantial volume loss.
"The problem with aging is not simply that the skin is getting old, it's that the underlying structures - be they bone or muscle - are receding. What we're trying to do with this filler is reconstitute the form upon which the skin sits," explained Dr. Zachary, professor and chair of the department of dermatology at the University of California, Irvine.
All of the adverse events documented thus far in the long-term safety study have occurred at rates similar to or lower than those recorded in the pivotal trial of Artefill and described in the current product labeling, he said.
The most frequent adverse event - lumpiness at the area of injection more than 1 month after treatment - has occurred in 1.8% of participants in the 5-year safety study, compared with 4.6% of those in the pivotal trial.
The one inflammatory granuloma that occurred responded completely to a single intralesional injection of triamcinolone and 5-fluorouracil coupled with a course of oral antibiotics, Dr. Zachary noted.
At 18 months, 88% of subjects reported being very satisfied or satisfied with their results, suggesting a lasting correction, he said.
Dr. Zachary serves on the advisory board for and holds shares of stock in Suneva Medical Inc., which markets Artefill. SDEF and this news organization are owned by Elsevier.