ArteFill
Encyclopedia
Artefill is a non-resorbable injectable
dermal
filler for the correction of wrinkles and lines on the face. Artefill is approved by the U.S. Food and Drug Administration (FDA) for correctıng smile lines (nasolabial folds) but it is widely used "off label" by physicıans
to fill lines and wrinkles all over the face. It is a formulation of medical grade polymethylmethacrylate (PMMA) microspheres and bovine collagen
along with lidocaine and buffers. The PMMA microspheres in Artefill are not absorbed by the body and therefore provide permanent support for wrinkle correction.
, 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.
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, and the data have been published [Dermatol Surg 2007;33:S222–S230].
, etc. PMMA microspheres have been used for cosmetic soft tissue augmentation outside of the USA in an estimated 200,000 procedures over the past 10 years. The PMMA technology has undergone many years of product development—first in Europe and then in the United States. Artecoll, an earlier product using this PMMA technology, was manufactured and sold in Europe and Canada.
The following changes were made to further enhance the product for introduction into the USA as Artefill: 1) manufacturing the PMMA at a facility owned by a USA based company (Suneva Medical, Inc.) and inspected by the FDA, 2) refinement of the PMMA microspheres and manufacturing process, with tightening of the specifications for the PMMA, and 3) manufacturing the bovine collagen at an approved, dedicated, USDA inspected facility in the United States. The FDA then approved Artefill for marketing in the United States in October 2006.
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 supportive foundation for long-lasting wrinkle correction. Artefill is injected 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.
Dr. Arnold Klein
has been a vocal critic of ArteFill.
Klein 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."
Injection (medicine)
An injection is an infusion method of putting fluid into the body, usually with a hollow needle and a syringe which is pierced through the skin to a sufficient depth for the material to be forced into the body...
dermal
Dermis
The dermis is a layer of skin between the epidermis and subcutaneous tissues, and is composed of two layers, the papillary and reticular dermis...
filler for the correction of wrinkles and lines on the face. Artefill is approved by the U.S. Food and Drug Administration (FDA) for correctıng smile lines (nasolabial folds) but it is widely used "off label" by physicıans
Physician
A physician is a health care provider who practices the profession of medicine, which is concerned with promoting, maintaining or restoring human health through the study, diagnosis, and treatment of disease, injury and other physical and mental impairments...
to fill lines and wrinkles all over the face. It is a formulation of medical grade polymethylmethacrylate (PMMA) microspheres and bovine collagen
Collagen
Collagen is a group of naturally occurring proteins found in animals, especially in the flesh and connective tissues of mammals. It is the main component of connective tissue, and is the most abundant protein in mammals, making up about 25% to 35% of the whole-body protein content...
along with lidocaine and buffers. The PMMA microspheres in Artefill are not absorbed by the body and therefore provide permanent support for wrinkle correction.
FDA testing
Artefill was approved by the FDA in October 2006 based on data from a 12-month controlledScientific control
Scientific control allows for comparisons of concepts. It is a part of the scientific method. Scientific control is often used in discussion of natural experiments. For instance, during drug testing, scientists will try to control two groups to keep them as identical and normal as possible, then...
, randomized, double-blind
Double-blind
A blind or blinded experiment is a scientific experiment where some of the people involved are prevented from knowing certain information that might lead to conscious or subconscious bias on their part, invalidating the results....
, 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
Collagen
Collagen is a group of naturally occurring proteins found in animals, especially in the flesh and connective tissues of mammals. It is the main component of connective tissue, and is the most abundant protein in mammals, making up about 25% to 35% of the whole-body protein content...
dermal fillers Zyderm and Zyplast. A total of 251 subjects were enrolled and had either Artefill or the collagen
Collagen
Collagen is a group of naturally occurring proteins found in animals, especially in the flesh and connective tissues of mammals. It is the main component of connective tissue, and is the most abundant protein in mammals, making up about 25% to 35% of the whole-body protein content...
control
Scientific control
Scientific control allows for comparisons of concepts. It is a part of the scientific method. Scientific control is often used in discussion of natural experiments. For instance, during drug testing, scientists will try to control two groups to keep them as identical and normal as possible, then...
injected to treat their facial wrinkles.
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
Collagen
Collagen is a group of naturally occurring proteins found in animals, especially in the flesh and connective tissues of mammals. It is the main component of connective tissue, and is the most abundant protein in mammals, making up about 25% to 35% of the whole-body protein content...
control
Scientific control
Scientific control allows for comparisons of concepts. It is a part of the scientific method. Scientific control is often used in discussion of natural experiments. For instance, during drug testing, scientists will try to control two groups to keep them as identical and normal as possible, then...
, 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
Baseline (medicine)
A baseline in medicine is information found at the beginning of a study or other initial known value which is used for comparison with later data. The concept of a baseline is essential to the daily practice of medicine in order to establish a relative rather than absolute meaning to data...
and 6 months. The dermal filler products used as controls
Scientific control
Scientific control allows for comparisons of concepts. It is a part of the scientific method. Scientific control is often used in discussion of natural experiments. For instance, during drug testing, scientists will try to control two groups to keep them as identical and normal as possible, then...
had lost efficacy
Efficacy
Efficacy is the capacity to produce an effect. It has different specific meanings in different fields. In medicine, it is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances.- Healthcare :...
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
Baseline (medicine)
A baseline in medicine is information found at the beginning of a study or other initial known value which is used for comparison with later data. The concept of a baseline is essential to the daily practice of medicine in order to establish a relative rather than absolute meaning to data...
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, and the data have been published [Dermatol Surg 2007;33:S222–S230].
History
Medical grade PMMA has been used for decades (50+ years) in a variety of medical applications including intraocular lenses to treat cataracts, artificial jointsJoint replacement
Replacement arthroplasty [from Greek arthron, joint, limb, articulate, + -plassein, to form, mould, forge, feign, make an image of], or joint replacement surgery, is a procedure of orthopedic surgery in which the arthritic or dysfunctional joint surface is replaced with an orthopaedic prosthesis...
, etc. PMMA microspheres have been used for cosmetic soft tissue augmentation outside of the USA in an estimated 200,000 procedures over the past 10 years. The PMMA technology has undergone many years of product development—first in Europe and then in the United States. Artecoll, an earlier product using this PMMA technology, was manufactured and sold in Europe and Canada.
The following changes were made to further enhance the product for introduction into the USA as Artefill: 1) manufacturing the PMMA at a facility owned by a USA based company (Suneva Medical, Inc.) and inspected by the FDA, 2) refinement of the PMMA microspheres and manufacturing process, with tightening of the specifications for the PMMA, and 3) manufacturing the bovine collagen at an approved, dedicated, USDA inspected facility in the United States. The FDA then approved Artefill for marketing in the United States in October 2006.
Current usage
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 supportive foundation for long-lasting wrinkle correction. Artefill is injected underneath the wrinkle, just above the skin’s fat layer. The treatment itself is similar to that of temporary dermal fillers like Radiesse, Restylane
Restylane
Restylane is the trade name for a range of injectable fillers with a specific formulation of non-animal sourced hyaluronic acid . Restylane was the first stabilized hyaluronic acid filler on the market and reportedly has been used in over 11 million treatments worldwide .In the United States,...
or Juvéderm
Juvéderm
Juvéderm , one of the newest of the so-called “injectable fillers,” is used by cosmetic, dermatological and plastic surgeons to soften deep folds and reduce wrinkles in the faces of patients. The substance is largely hyaluronic acid, a substance normally found in the skin, muscles, and tendons of...
. 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.Dr. Arnold Klein
Arnold Klein
Arnold William "Arnie" Klein is an American dermatologist and Professor of Medicine/Dermatology at the David Geffen School of Medicine at UCLA in Los Angeles, California.-Background and Education:...
has been a vocal critic of ArteFill.
Klein 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."