FDA-Approved PMMA Filler Gives Cheeks a Lift

BOSTON – The only polymethylmethacrylate dermal filler approved by the Food and Drug Administration may be a safe and effective option for malar augmentation in patients seeking to reverse age-related volume loss to the outer upper cheek region, according to interim results from a multicenter study.

The synthetic, nonresorbable agent, Artefill, produced significant improvements in malar volume in 24 patients enrolled in a 5-year prospective study and received high patient satisfaction and physician-assessed aesthetic improvement scores at 6 and 12 months, reported Dr. Daniel C. Mills of the plastic surgery department at Loma Linda (Calif.) University at the annual meeting of the American Society for Aesthetic Plastic Surgery. "And so far, with 1.5 years of follow-up under our belt, there have been no safety issues."

To assess the safety and efficacy of the polymethylmethacrylate (PMMA)/bovine collagen filler as a malar implant, Dr. Mills and his colleagues from multiple sites across the country enrolled 24 patients seeking malar augmentation into the open-label investigation.

"Each patient received up to three injections supraperiosteally: a first injection of no more than 6 cc, followed by one or two touch-ups after a month until full correction was achieved, with no patient getting more than 8 cc of the filler," he said. "The mean total volume injected was 5.5 cc." The reason for the serial injections, he noted, was because "this is close to a permanent filler, so we start low to make sure we have the right amount, then go back and add more if necessary."

The study outcomes include baseline and post-treatment assessments (weeks 8, 26, 52, 104, and 260) of malar volume on a 5-point scale: investigator and patient global aesthetic improvement, safety data, patient satisfaction, and patient likelihood to recommend the procedure.

Of the 24 patients in the study, all but one reported being satisfied with the procedure at 8 weeks and 1 year post-injection, "and all of my patients said they had more volume fill as time went by," said Dr. Mills. "It’s worth noting that the [global aesthetic improvement] scores of the one patient who was not satisfied with the outcome did improve."

Overall, malar volume improved significantly. "We saw the lipoatrophy go up one grade across the board, and the physician-assessed aesthetic score improved 96%," Dr. Mills reported. Of the 23 patients who reported being satisfied with the outcome, "the satisfaction rating was uniformly very high and all of them said they would recommend the procedure to other patients."

To date, with close to 1.5 half years of follow-up data, no device-related adverse events or serious adverse events have been reported, said Dr. Mills. He stressed, however, that the agent being investigated is "totally different" than the black market PMMA that is available in other parts of the world.

"The compounded PMMA being used in some countries, such as Brazil and Venezuela, has caused a wide range of complications and resulted in a lot of bad press," he said. "The FDA-approved product that we’re investigating is ultrapure and very uniform."

Artefill was approved by the FDA in 2006 for the treatment of nasolabial folds around the mouth, and is the only FDA-approved filler with a documented durability over a 5-year period, said Dr. Mills.

The product is composed of PMMA microspheres and a water-based carrier gel containing bovine collagen, buffered isotonic water, lidocaine, phosphate buffer, and sodium chloride.

Unlike most of the soft-tissue dermal fillers on the market, the PMMA-based implant provides a permanent support structure for wrinkle correction. "As the bovine collagen degrades over the course of a few weeks postinjection, the PMMA is encapsulated by the patient’s own collagen to stabilize the implant, resulting in continued [aesthetic] improvement over time," he said.

The study was sponsored by Suneva Medical. Dr. Mills disclosed a financial relationship with Allergan.

BOSTON – The only polymethylmethacrylate dermal filler approved by the Food and Drug Administration may be a safe and effective option for malar augmentation in patients seeking to reverse age-related volume loss to the outer upper cheek region, according to interim results from a multicenter study.

The synthetic, nonresorbable agent, Artefill, produced significant improvements in malar volume in 24 patients enrolled in a 5-year prospective study and received high patient satisfaction and physician-assessed aesthetic improvement scores at 6 and 12 months, reported Dr. Daniel C. Mills of the plastic surgery department at Loma Linda (Calif.) University at the annual meeting of the American Society for Aesthetic Plastic Surgery. "And so far, with 1.5 years of follow-up under our belt, there have been no safety issues."

To assess the safety and efficacy of the polymethylmethacrylate (PMMA)/bovine collagen filler as a malar implant, Dr. Mills and his colleagues from multiple sites across the country enrolled 24 patients seeking malar augmentation into the open-label investigation.

"Each patient received up to three injections supraperiosteally: a first injection of no more than 6 cc, followed by one or two touch-ups after a month until full correction was achieved, with no patient getting more than 8 cc of the filler," he said. "The mean total volume injected was 5.5 cc." The reason for the serial injections, he noted, was because "this is close to a permanent filler, so we start low to make sure we have the right amount, then go back and add more if necessary."

The study outcomes include baseline and post-treatment assessments (weeks 8, 26, 52, 104, and 260) of malar volume on a 5-point scale: investigator and patient global aesthetic improvement, safety data, patient satisfaction, and patient likelihood to recommend the procedure.

Of the 24 patients in the study, all but one reported being satisfied with the procedure at 8 weeks and 1 year post-injection, "and all of my patients said they had more volume fill as time went by," said Dr. Mills. "It’s worth noting that the [global aesthetic improvement] scores of the one patient who was not satisfied with the outcome did improve."

Overall, malar volume improved significantly. "We saw the lipoatrophy go up one grade across the board, and the physician-assessed aesthetic score improved 96%," Dr. Mills reported. Of the 23 patients who reported being satisfied with the outcome, "the satisfaction rating was uniformly very high and all of them said they would recommend the procedure to other patients."

To date, with close to 1.5 half years of follow-up data, no device-related adverse events or serious adverse events have been reported, said Dr. Mills. He stressed, however, that the agent being investigated is "totally different" than the black market PMMA that is available in other parts of the world.

"The compounded PMMA being used in some countries, such as Brazil and Venezuela, has caused a wide range of complications and resulted in a lot of bad press," he said. "The FDA-approved product that we’re investigating is ultrapure and very uniform."

Artefill was approved by the FDA in 2006 for the treatment of nasolabial folds around the mouth, and is the only FDA-approved filler with a documented durability over a 5-year period, said Dr. Mills.

The product is composed of PMMA microspheres and a water-based carrier gel containing bovine collagen, buffered isotonic water, lidocaine, phosphate buffer, and sodium chloride.

Unlike most of the soft-tissue dermal fillers on the market, the PMMA-based implant provides a permanent support structure for wrinkle correction. "As the bovine collagen degrades over the course of a few weeks postinjection, the PMMA is encapsulated by the patient’s own collagen to stabilize the implant, resulting in continued [aesthetic] improvement over time," he said.

The study was sponsored by Suneva Medical. Dr. Mills disclosed a financial relationship with Allergan.

BOSTON – The only polymethylmethacrylate dermal filler approved by the Food and Drug Administration may be a safe and effective option for malar augmentation in patients seeking to reverse age-related volume loss to the outer upper cheek region, according to interim results from a multicenter study.

The synthetic, nonresorbable agent, Artefill, produced significant improvements in malar volume in 24 patients enrolled in a 5-year prospective study and received high patient satisfaction and physician-assessed aesthetic improvement scores at 6 and 12 months, reported Dr. Daniel C. Mills of the plastic surgery department at Loma Linda (Calif.) University at the annual meeting of the American Society for Aesthetic Plastic Surgery. "And so far, with 1.5 years of follow-up under our belt, there have been no safety issues."

To assess the safety and efficacy of the polymethylmethacrylate (PMMA)/bovine collagen filler as a malar implant, Dr. Mills and his colleagues from multiple sites across the country enrolled 24 patients seeking malar augmentation into the open-label investigation.

"Each patient received up to three injections supraperiosteally: a first injection of no more than 6 cc, followed by one or two touch-ups after a month until full correction was achieved, with no patient getting more than 8 cc of the filler," he said. "The mean total volume injected was 5.5 cc." The reason for the serial injections, he noted, was because "this is close to a permanent filler, so we start low to make sure we have the right amount, then go back and add more if necessary."

The study outcomes include baseline and post-treatment assessments (weeks 8, 26, 52, 104, and 260) of malar volume on a 5-point scale: investigator and patient global aesthetic improvement, safety data, patient satisfaction, and patient likelihood to recommend the procedure.

Of the 24 patients in the study, all but one reported being satisfied with the procedure at 8 weeks and 1 year post-injection, "and all of my patients said they had more volume fill as time went by," said Dr. Mills. "It’s worth noting that the [global aesthetic improvement] scores of the one patient who was not satisfied with the outcome did improve."

Overall, malar volume improved significantly. "We saw the lipoatrophy go up one grade across the board, and the physician-assessed aesthetic score improved 96%," Dr. Mills reported. Of the 23 patients who reported being satisfied with the outcome, "the satisfaction rating was uniformly very high and all of them said they would recommend the procedure to other patients."

To date, with close to 1.5 half years of follow-up data, no device-related adverse events or serious adverse events have been reported, said Dr. Mills. He stressed, however, that the agent being investigated is "totally different" than the black market PMMA that is available in other parts of the world.

"The compounded PMMA being used in some countries, such as Brazil and Venezuela, has caused a wide range of complications and resulted in a lot of bad press," he said. "The FDA-approved product that we’re investigating is ultrapure and very uniform."

Artefill was approved by the FDA in 2006 for the treatment of nasolabial folds around the mouth, and is the only FDA-approved filler with a documented durability over a 5-year period, said Dr. Mills.

The product is composed of PMMA microspheres and a water-based carrier gel containing bovine collagen, buffered isotonic water, lidocaine, phosphate buffer, and sodium chloride.

Unlike most of the soft-tissue dermal fillers on the market, the PMMA-based implant provides a permanent support structure for wrinkle correction. "As the bovine collagen degrades over the course of a few weeks postinjection, the PMMA is encapsulated by the patient’s own collagen to stabilize the implant, resulting in continued [aesthetic] improvement over time," he said.

The study was sponsored by Suneva Medical. Dr. Mills disclosed a financial relationship with Allergan.