||A major contributor to this article appears to have a close connection with its subject. (December 2014)|
Artefill is an injectable, non-absorbable wrinkle filler for the correction of nasolabial folds (smile lines). Artefill became the first and only permanent dermal filler approved by the U.S. Food and Drug Administration (FDA) in October 2006. Artefill contains injectable polymethylmethacrylate (PMMA) microspheres, collagen, and lidocaine, and is a third-generation filler succeeding Arteplast and Artecoll, which haven been marketed outside the U.S. since 1994 and used in over one million patients. Artefill meets strictest FDA GMP-manufacturing requirements, specifically related to the quality and narrow size distribution of the PMMA microspheres (40 microns) and the bovine collagen carrier (virally and genetically closed herd). The PMMA microspheres in Artefill (20% by volume) are not absorbed by the body and therefore provide a permanent scaffold for autologous collagen encapsulation with the patient's own fibro-vascular soft tissue (80% by volume). Newly formed soft tissue around each individual microsphere ensures a soft and natural augmentation result and the permanent nature of the PMMA microspheres explains the unmatched wrinkle correction with Artefill in regards to long-term duration.
Artefill was approved by the FDA in October 2006 based on data from a 12-month controlled, randomized, double-blind, clinical trial conducted at medical centers throughout the U.S.A. The study compared outcomes for patients treated with Artefill with those of patients treated with the bovine collagen dermal fillers Zyderm and Zyplast. A total of 251 subjects were enrolled and had either Artefill or the collagen control injected to treat their facial wrinkles. The inventors of the injectable PMMA technology Prof. Dr. Gottfried Lemperle and Stefan Lemperle, MD, PhD created the 'Lemperle Assessment Scale' (LAS), which created a new FDA standard for the measurement of wrinkle correction efficacy.
When evaluated 6 months after injection, which was the primary evaluation period, the wrinkle correction persisted in patients treated with Artefill compared to the wrinkle correction in the patients treated with the collagen control, who returned to their pre-treatment status. The Artefill patients were also evaluated one year after treatment, and demonstrated continued safety and wrinkle correction as compared to baseline and 6 months. The dermal filler products used as controls had lost efficacy by 6 months. A follow-up study of Artefill treated patients from this pivotal trial who were evaluated after a 5-year period has recently been completed. Wrinkle ratings for these patients at five years were compared to baseline and six months after treatment. The results showed continued and improved wrinkle correction at five years and demonstrated a similar safety profile to the pivotal trial.
Artefill's injectable PMMA microsphere technology was invented in the mid 1980s by German Plastic Surgeon Prof. Dr. med. Gottfried Lemperle and his son Dr. med. Martin Lemperle and first patented in Europe in 1989. Prof. Lemperle's technology has been used extensively for aesthetic soft tissue augmentation outside of the USA since 1994 and has since undergone 20-years of continued product development—first in Europe and then in the United States. After the U.S. patent was issued, Prof. Lemperle's second son Stefan Lemperle,MD,PhD,MBA formed Artes Medical Inc. in San Diego, CA in 1999 to bring their technology to the U.S. In order to secure FDA approval, Artes Medical had to conduct a controlled FDA clinical trial and meet stringent FDA quality requirements, including good manufacturing practices (GMP). This seven-year effort led to the creation of third-generation Artefill, which received FDA approval in October 2006, becoming America's first and only permanent injectable wrinkle filler. Artecoll, an earlier-generation product using a similar PMMA technology, has been manufactured and sold world-wide outside of the U.S. since 1994 and has been used in over one million patients. After Artes Medical's NASDAQ IPO in December 2006, the company's technology and 35,000 sq. ft. GMP manufacturing facility were acquired by Suneva Medical in 2009. Suneva markets Artefill in the U.S., Canada, Singapore and South Korea. In December 2014, Suneva announced that it changed the product name from Artefill to Bellafill.
Artefill is an FDA-approved non-resorbable wrinkle filler used by dermatologists and plastic surgeons for the correction of smile lines known as nasolabial folds. Artefill is only sold to physicians who have undergone product training. Artefill is different from temporary dermal fillers which are eventually absorbed by the body and require repeat injections. The PMMA microspheres in Artefill are not absorbed by the body. These microspheres provide a permanent support matrix for long-lasting wrinkle correction due to collagen encapsulation with the patient's own tissue. Artefill is injected into the deep dermal layer underneath the wrinkle, just above the skin’s fat layer. The treatment itself is similar to that of temporary dermal fillers like Radiesse, Restylane or Juvéderm. It involves injections with a fine needle over a few minutes. Patients resume normal activities immediately and most patients require 1 or 2 treatments, depending on the depth of their wrinkles and folds.
Potential risks and side effects
The most common adverse events associated with Artefill treatment are similar to those observed with other dermal fillers, and include mild swelling and reddening at the treatment site. These side effects usually resolve within 24 hours. Occasionally, there is mild bruising that typically disappears in 3 to 7 days. Less common side effects include rash and itching, persistent swelling or redness, and increased sensitivity at injection sites. A skin test is required before initial treatment to make sure the patient is not sensitive to bovine collagen. For further product safety and efficacy information please see the Instructions For Use.
Klein, who was hired as a wrinkle filler consultant in 2006 by the maker of Botox and temporary wrinkle filler Juvederm, Allergan Corporation, says that the product has a risk of long-term effects such as lumps because of its longer duration, and in a letter to the FDA delivered in July 2007, he and co-signing physicians said ArteFill "may pose immediate, debilitating and disfiguring health risks."
- http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm077416.htm. Missing or empty
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