Artefill is a dermal filler manufactured by Suneva Medical and it's used for correction of wrinkles such as the naso-labial folds. In an upcoming article in Dermatalogic Surgery, the Journal of the American Society of Dermatologic Surgery (ASDS), Suneva Medical is releasing interim results of an ongoing 5 year study of safety and patient satisfaction with Artefill. The study highlights the safety profile (adverse events, granuloma incidence) and level of patient satisfaction with Artefill at 18 months into the 5 year period of the study.
The study is being conducted at 23 centers around the US and involves 1008 patients who were interested in using fillers to treat their nasolabial folds and had had no recent history of fillers in that area. Patients had an initial injection with Artefill, and up to two more after 30 and 60 days, until full correction was achieved. Patients reported potential adverse events and satisfaction via questionnaire at 6, 12, 18, 24, 36, 48 and 60 months post treatment. The results show that the safety of Artefill is comparable to that of other fillers. 6% of patients experienced adverse events and the majority were minor and none were unanticipated. No serious adverse events were reported, and only one granuloma, which resolved completely with medical treatment. Around 80% of patients were either satisfied or very satisfied throughout the follow up period.
Dr. Steven Cohen, Clinical Professor, University of California, San Diego, CA and co-author said, "Our findings further substantiate the safety of this PMMA microsphere dermal filler and we hope will alleviate some of the misperceptions in the market about its long-term safety profile."
Dr. Cohen, along with Dr. John Joseph, Assistant Clinical Professor, UCLA presented these findings at two recent meetings, the American Society of Aesthetic Plastic Surgery's (ASAPS) Aesthetic Meeting 2010 in Washington, D.C. and the American Academy of Facial Plastic & Reconstructive Surgery's (AAFPRS) International Symposium in Hollywood, FL,
Dr. Joseph added, "Patient satisfaction is critical to our success as surgeons. Our patients have been extremely pleased with the long-term benefits of Artefill and the interim trial results further support this, showing consistent and lasting high patient satisfaction ratings with the product."