ArteFill is a material to be avoided
Please read the multiple other commentaries about AretFill. It is a permanent tissue filler made essentially of microscopic cement beads. The attraction of it is the permanent nature of the treatment - and the problem is exactly the same. Any irregularities or lack of happiness with the result are difficult or impossible to correct. There can be long-term infection problems that don't appear for year after the treatment.
Finally, as we age, a permanent filler can rise up like an island in the ocean. Please stick with the growing group of temporary fillers which will resolve if there are any problems and whose use can be modified as your needs change over the years.
This is a
good question. Artefill, which is now
called Bellafill, is essentially a permanent filler. In a syringe of Artefill of Bellafill, 85% is
bovine collagen and 13% is PMMA or small plastic beads that act as a bio
stimulant. Each bead is about 40 microns
or approximately the size of a cell.
This means that there are millions of these beads in the two little
drops that make up that 13% of a syringe of Bellafill.
Bellafill or Artefill is injected, the collagen gets absorbed. This is standard for all injected collagen
and it takes about 3 to 6 months for that to happen. During this time the PMMA bead act to make
you form your own collagen which is not absorbed. Thus Bellafill or Artefill becomes a long
term r permanent filler which is really your own tissue. A great solution for a filler.
fillers there are potential risks but the 5 year FDA studies show fewer adverse
events than many other fillers.
Artefill is a tiny microsphere wrapped in bovine (cow) collagen. As the bovine collagen goes away, our body produces collagen to then wrap around the microspheres. Very effective if used in the correct location and injected properly. Not reversible, so injection technique is paramount.
ArteFill is an FDA approved non-absorbable injectable filler.
ArteFill, manufactured by Suneva Medical, Inc, is an FDA approved non-absorbable injectable filler used to add volume in areas of the face such as nasolabial folds.
It is a combination of bovine collagen (from cowhide), and polymethylmethacrylate (PMMA) microspheres. The microspheres are non-absorbable. As the body is metabolizing the bovine collagen, it is making new native collagen around the PMMA microspheres. In this way the new collagen produced in response to the PMMA replace the bovine collagen. It has been shown in long term clinical studies that the appearance of nasolabial folds actually improves over a period of time.
If you are interested in injectable fillers, I recommend trying one of the absorbable injectables prior to ArteFill. This will give you an opportunity to see if you like the look prior to having a non-absorbable product injected.
In addition, since some individuals are allergic to bovine collagen, you must get a skin test prior to an ArteFill injection.
Artefill is currently the only FDA appproved non-resorbable filler
Artefill is a filler that has been FDA approved for use in the nasolabial folds and has some components which are permanent. It is a third generation filler, earlier versions were called Artecoll. It consists of collagen and microscopic non-resorbable beads.
Artefill is a good option for someone interested in very long term results. Because of it's permanent nature, it should be used by a very experienced practitioner and it is also a good idea to try shorter term fillers with the same practitioner first.
Because of the collagen component, patients must have a skin test to ensure no allergies to the collagen. Patients should also be prepared to have 2-3 treatments as about half of the volume injected with be resorted and half will be permanent.
For more information about Artefill in our practice, click the link below.
New Artefill safety study
We recently announced interim results from a long-term safety and patient satisfaction study on Artefill, the first and only FDA-approved microsphere-enhanced dermal filler for the correction of smile lines. Our initial analysis is very encouraging as it further validates Artefill’s strong safety profile and high level of patient satisfaction for long-term wrinkle correction.
A granuloma incidence rate of less than 0.1% is also indicative of this and suggests Artefill is as safe as other dermal fillers, such as Juvederm and Restylane.
FOR IMMEDIATE RELEASE
Suneva Medical Announces Positive Interim Data from Five-Year Safety and Patient Satisfaction Study on Artefill®
Study Suggests Artefill Is As Safe as Other Dermal Fillers for Nasolabial Fold Correction
Data Presented at Maui Derm 2010 Meeting
MAUI, HAWAII -- January 25, 2010 – Suneva Medical, a privately-held aesthetic medical device company, today announced 18-month interim results from its prospective, open-label, five-year safety and patient satisfaction study on Artefill for nasolabial fold (NLF) correction. The study assessed adverse events with Artefill starting at 6-months post treatment. Initial results show the incidence of adverse events with Artefill compare favorably to the current label, and that the majority of patients (88%) reported a high satisfaction rating. Upon completion, this will be the largest and longest duration prospective U.S. clinical study of any dermal filler.
The data is being presented by study investigator W. Philip Werschler, M.D., FAAD, FAACS, Assistant Clinical Professor in Medicine/Dermatology at University of Washington, at the Advances in Cosmetic and Medical Dermatology’s “Maui Derm 2010” Meeting taking place in Maui, Hawaii January 23-27th.
Dr. Werschler commented, “Our initial analysis is very encouraging as it further validates Artefill’s strong safety profile and high level of patient satisfaction for long-term wrinkle correction. A granuloma incidence rate of less than 0.1% is also indicative of this and suggests Artefill is as safe as other dermal fillers, such as Juvederm and Restylane.”
The 23-center, prospective, open-label study consists of 1,008 patients who had no recent history of nasolabial fold correction. Patients received an initial treatment with Artefill, and up to two touch-ups after 30 and 60 days, until full correction was achieved. Potential adverse events and satisfaction data are reported by all patients at 2, 6, 12, 18, 24, 36, 48 and 60 months to assess the presence of or absence of adverse events, patient satisfaction, and any changes in health. Potential subject-reported AEs were followed up by phone (non-device related) and/or office visit and possible granulomas were analyzed by biopsy. All study patients will complete a final in-office visit at 60-months.
Niv Caviar, President and Chief Executive Officer of Suneva Medical commented, “These results are consistent with what we observed during the pivotal trial and further validate Artefill’s role as a long-lasting filler in the aesthetic market. We look forward to reporting additional interim results later this year as more patients reach the two-year point.”
Artefill is the first and only FDA-approved microsphere-enhanced collagen filler for the correction of nasolabial folds, better known as smile lines. Since Artefill was approved in 2006, over 20,000 patients have been treated successfully with very high satisfaction rates. For more information visit www.artefill.com <http://www.artefill.com> .
About Suneva Medical
Suneva Medical, Inc. is a medical technology company focused on developing, manufacturing and commercializing novel, differentiated aesthetic products for the dermatology, plastic and cosmetic surgery markets. The Company’s lead product is Artefill®, the first and only microsphere-enhanced collagen filler for the correction of nasolabial folds, or smile lines. For more information visit www.sunevamedical.com
The company who makes it is bankrupt.
Artefill is a permanent filler made up of collagen and plexi-glass beads. In the right location such as the nasolabial area or in scars, it did very good but is no longer available due to the chapter 7 bankrupcy of the company who made it.
Dr. David Hansen