Injectable Micro-implants
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Permanent injectable fillers such as Artecoll, DermaLive & Silicone are the most commonly used permanent soft tissue augmentation products. Although we do not recommend silicone injections they are used illegally in the United States and legally throughout the world. |
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More suitable and safer products such as DermaLive and Artecoll are used for wrinkles, and deep folds such as the nasolabial area (lines that run from nose to mouth) and the glabellar region (frown lines between the brows. They are also used for augmentation of the lips and for filling out acne scars and other types of tissue deficiencies. They are utilized after a temporary "try on" product has been used and it is determined that the patient does in fact want permanency. In this section, we will discuss the various options in permanent soft tissue augmentation with the use of injectable micro-implants. |
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You may click a product name to skip to its summary or you may scroll down for each product summary.
- Metacril
- Evolution
- Formacryl®
- Argiform®
- Bioformacryl
- DermaLive
- Amazing Gel
- Bioplastique®
- Artecoll®
- Arteplast®
- Silicone Injections
- Profill or Profil
- Aquamid®
Return to the Injectable Fillers Index
1. Metacril (the company) Metacrylathe (the product): (technically: Microscopic metacrylathe beads) Also called "Metacrill" by Brazilian surgeons. This injectable micro-implant is essentially made from PMMA (polymethyl methacrylate)-type beads - discovered in Germany in the early 1900's. It is basically similar to Artecoll™ but manufactured in Brazil. "The injections are made with a 27 gauge needle, in rows like toothpicks or fanning out perpendicular to the wrinkle. The body doesn't process the substance, since the chemical was not found very often in the macrophages. The particle size is 40-80 u, in the body it spreads out below the dermis where fat usually is, and your bodies' tissues, collagen, new blood vessels and cells grow around the particles, so removal later is not a good option."
Allergy Test: unknown
Longevity: Metacrylathe is permanent
Approximate Cost: $400 cc (Brazil)
Available in the United States? Metacrylathe is not approved by the FDA for use in the US and it is thought to never receive approval in the US.
Caution: May cause inflammation and nodules of tissue around the treatment area.
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2. Evolution: (technically: positively charged non-animal substance based on medical suture (stitch) material) The material is said to provide a "long-term filling which is complemented by the charge that attracts negatively charged pro-collagen molecules". Once Evolution is injected, the augmentation may diminish by a third, but is reported to build up again over the next two months. It is said that with the help of the suture the augmentation becomes a "mesh of natural collagen". However, you may and additional session two to three weeks later. The augmentation is supposed to last forever.
Allergy Test: Evolution does not require an allergy test and causes minimal swelling.
Longevity: reportedly permanent
Approximate Cost: £400 per 1ml (cc) syringe
Available in the United States? Evolution is not approved by the FDA for use in the US.
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3. Formacryl®: (technically: injectable Hydrophilic polyacrylamide gel (HPG) with 0.04% residual unpolymerized acrylamide) Also known as "acrylic hydrogel" or "Hydrogel" in Europe. Although Formacryl® is not available in the U.S. Since its unveiling a newer, improved version has been released (Argiform™). This injectable was available in Europe and Russia and showed very promising results as a semi-permanent solution to augmentation. Semi-permanent in a sense that it was permanent, yet reversible. Formacryl® is hydrophilic [: having an attraction to water] polyacrylamide (5%), a synthetic polymer, suspended within apyrogenous water (95%). Unlike all of the other injectables, this one stays soft. After it is injected and after the water is absorbed by the body, the HPG remains pliable and plump like your own tissue, not hard like collagen or firm like Artecoll or any of the others. The hydrophilic polyacrylamide retains fluid - so your own fluids keep it plump.
The company (Bioform of Russia) claims, "The very special, cutting-edge production technique – an exclusive patented process, employed for this product – guarantees (unlike numerous other similar products) the absence of the toxic monomer that usually characterizes these polymers – and which is responsible for all the well known devastating secondary effects." They also claim, "...Analyses demonstrate that Formacryl® is: non toxic, non-sensitizing, non-mutagenic, biocompatible, permanent, removable, and physically and chemically stable." Their claim of the product being absolutely radio transparent is a wonderful extra benefit. Also, the particle size is just large enough that it will not migrate or worse, be absorbed by a cell, thereby possibly killing it. Nor is it able to be absorbed and stored within the lymph nodes. Although the residual acrylamide (0.04%) is quite capable of being absorbed by your lymph nodes, is a mutagen and is a neurotoxin.
Allergy Test: Not necessary
Longevity: reportedly permanent yet reversible through aspiration.
Approximate Cost: Unknown
Available in the United States: No, Formacryl is not approved by the FDA for use in the US. but similar products are used all over Europe and in Russia.
Website: http://www.bioform.ru
Caution: Please read more on the negative effects of unpolymerized acrylamide monomer.
The company sent information to us regarding bacterial infection problems with Formacryl so they produced an second generation, improved product called Argiform (below). Argiform is antibacterial and has a lower percentage of unpolymerized acrylamide remaining. It was reported that the amount of unpolymerized acrylamide in the product is "insignificant" and that many of our drinking water supplies in the U.S. as well as agricultural products contain far more. However, we further researched the effects of acrylamide in our drinking water reserves and found that according to the United States EPA (Environmental Protection Agency) there is currently no acceptable means in detecting acrylamide in drinking water.
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4. Argiform®: (technically: injectable ANTI-BACTERIAL Hydrophilic polyacrylamide gel with 0.03% residual unpolymerized acrylamide) ANTI-BACTERIAL Hydrophilic polyacrylamide gel with 0.03% residual unpolymerized acrylamide) The new & improved version has less residual unpolymerized acrylamide than the first generation Formacryl and is anti-bacterial as well. Brought to you by the makers of Formacryl (Bioform, of Russia). Obviously someone considered the residual acrylamide a threat enough to make a formulation with less of a percentage of the residual unpolymerized acrylamide. Bioform advised us that the Formacryl had a higher inflammation problem due to bacterial infections 3-5 years post-injection. This version is entirely better and since the introduction of Formacryl many copy-cat products came out in several other countries. The antibacterial properties are silver ions which repel bacteria. Bioform has since patented the new process and will be offering their innovative product to the world.
Allergy Test: Not necessary
Longevity: reportedly permanent until removed via aspiration
Approximate Cost: Unknown
Available in the United States: no
Website: http://www.bioform.ru
Caution: Please read more on the negative effects of unpolymerized acrylamide monomer. However recent lab reports have shown negligible inflammation or negative reactions.
Contact info: Krasnobogatyrskay street, 42/1103 Moscow, Russia tel./fax: +7 (095) 161-0524, 161-0537 e-mail: info@bioform.ru
Website: http://www.bioform.ru
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5. Bioformacryl: (technically: injectable Hydrophilic polyacrylamide gel with 0.04% residual unpolymerized acrylamide) Same thing as Formacryl in chemical structure but was modeled after Bioform had sent samples and presentations of their product to the Italian company, Progen. Interfal (Ukraine) came first but was very early in production and had a 25% complication rate.
Allergy Test: Not necessary
Longevity: Unknown
Approximate Cost: Unknown
Available in the United States: no
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6. DermaLive: (technically: injectable acrylic hydrogel implant suspended in hyaluronic acid) This French injectable implant is used for dermal and sub-dermal injections. It is made of "acrylic hydrogel" (reportedly: hydrophilic polyacrylamide particles in a hyaluronic acid carrier). This is comparable to creating microspheres of the same material intra-ocular lenses are made of, and mixing it with Restylane and injecting it into your deepest folds. DermaLive is not intended to replace collagen as a treatment for fine lines. It works best in the nasolabial folds for deeper wrinkles as well as lip augmentation although it is not approved for use in the U.S.
Allergy Test: n/a (although rare, some hardening from inflammation or infections can occur)
Longevity: "DermaLive has been used in France for more than three years with the effects still visible." Reportedly permanent - however removal is difficult.
Approximate Cost: Treatment varies from $500 - $1,000 per session.
Available in the United States? no
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7. Amazing Gel: (technically: injectable Hydrophilic polyacrylamide gel with unknown % residual unpolymerized acrylamide) This product is the same as Formacryl, BioFormacryl, Argiform, DermaLive and yes, even the Interfal Gel, are all basically the same thing.
Allergy Test: Not necessary
Longevity: Unknown
Approximate Cost: Unknown
Available in the United States: no
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8. Bioplastique®: (technically: copolymer formed by polydimethylsiloxane/ methylpolysiloxane vulcanized, texturized, fully polymerized, suspended in polyvinylpyrrolidone) Which is a polymer micro-implant 100 and 600 micrometer in size. Bioplastique® is a biphasic (meaning having two phases) copolymer (a product consisting of two substances that combine to make a larger molecule) This copolymer consists of a solid, permanent phase/substance and a carrier gel phase/substance which is absorbed and excreted by the body. Very small, texturized particles of a biocompatible inert polymer, were fabricated and mixed with a hydro-gel solution. The hydro-gel has the consistency similar to honey with exceptional lubricating characteristics. The polymer is freely transported through tissue fluids and excreted, with no changes, by the kidneys. This hydro-gel has been used as a carrier fluid for a variety of medications that have been absorbed and excreted without incident.
Many of us were quite concerned with migration of micro-implants such as Bioplastique®. Here is an explanation to help you understand what size a substance must be in order to not migrate. Most Free Silicone particles, although not proven to cause harm and disorders within the body, are small enough to migrate freely within cell walls and infra-structures. Bioplastique®, however, can not. In order for a substance to remain stationary and be encapsulated by our body's own collagen, its size must be large enough not to be absorbed by the body's cells and vessels and must not be small enough for ease of transportation to the body's lymph nodes. This could prove dangerous as small enough particles could cause cell die off. Bioplastique® particles are both large enough and textured permitting ease of collagen encapsulation (in under 4 weeks).
From Emedicine:
"Bioplastique (Uroplasty BV, Netherlands) is a biphasic material. It consists of solid silicone particles (ranging in size from 100-400 mm) suspended in a polyvinylpyrrolidone (CHNO) carrier.
Once injected, the material elicits a low-grade inflammatory reaction. The carrier is removed by the body and excreted by the kidneys. Collagen encapsulates and localizes the silicone, and animal studies have shown no evidence of foreign body migration. Deposition of collagen progresses, replacing the organic component of the material in a ratio slightly higher than 1:1. Therefore, overcorrection is not advised.
Case series have reported no major complications with Bioplastique other than overcorrection. Subcutaneous placement is recommended to avoid palpable nodularity. Bioplastique is not yet approved by the FDA." (Emedicine.com - Soft Tissue Implants)
This material is not approved for tissue augmentation and is still experimental in areas other than the tissue surrounding urethra walls. This is because it is normally utilized in urinary incontinence. However it has been successfully used in dermis augmentation as well as secondary rhinoplasty applications. It takes up to a week for the hydro-gel to be absorbed and excreted thereafter and is still moldable during that period. Bioplastique® is not "soft" and it is not rock hard, but more like cartilage once encapsulated by your body's own collagen. It is reversible although not easily. The particles must be removed with a micro needle, as in micro-liposuction. It is possible that the area to be corrected (or augmented) may lose it indigenous tissue as well when suctioned out, resulting in an even smaller lip or deeper pitted section of dermis.
Allergy test: Advisable
Longevity: Permanent, yet reportedly reversible but difficult.
Approximate Cost: Unknown
Available in the United States: Bioplastique is not approved by the FDA for use in the US. but is being tested for urinary incontinence outside of the US. It is listed in this section for reference if you come across it.
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9. Artecoll™: (technically: Microscopic homogenous polymethylmethacrylate beads in 3.5% collagen suspension, mixed with 0.3% Lidocaine) This injectable micro-implant is considered to be a Class III device requiring FDA clearance by Pre-Market Approval (PMA) means. In accordance with the Investigational Device Exemption (IDE) regulations it must gain clinical data that proves safe and reliable for approval. It is actually made from PMMA poly (methylmethacrylate) - discovered in Germany in the early 1900's. PMMA in conjunction with medical implantation usage dates back to 1936. Common usage for PMMA include bone cement (like Palacos), dentures, artificial eye lenses, pacemaker covers (like Lucite, Palavit™ and other brands), Plexiglas® and hard contact lenses. Antibiotic-impregnated PMMA ( referred to as "AIPMMA") has been used in the human body since the mid to late 1970's.
The PMMA is formulated into microspheres (extremely small round bits, 32-40 microns in diameter - 4 to 5x the size of a red blood cell) and blended with 0.3% Lidocaine for comfort and collagen (3.5%) as well. The first use for tissue augmentation was in 1989 and it is reported that in the last 10 years, more than 100,000 men and women have been successfully treated with Artecoll™.
It is injected deep within your skin (the Dermal level) through a tunneling technique with a hypodermic needle. They basically inject the needle and push the plunger to deposit the Artecoll™ at the same time pulling the needle out. So, a little cylindrical deposit of Artecoll™ is left in place of the injection tunnel. There are only a few individuals (0.1%) that may have a reaction to Artecoll™. Artecoll™, reportedly, is an inert substance and reported as well-tolerated by the body. Of course the Collagen within the Artecoll™ mixture degrades within 2 to 5 months and the microspheres are are encapsulated (surrounded) by your body's own collagen in about 2 to 4 months. Thus networking added tissue augmentation without migration of the microspheres.
Other augmentation usages:
- Fills folds and wrinkles of the face
- Corrects irregularities of the nose
- Fills in acne pocks and scars
- Can be used for inverted nipple augmentation or to create a permanently erect nipple (although that sounds fishy to me, especially for a woman who will choose to breastfeed later on)
- Injected to augment minor indentations from tissue lost due to trauma or birth defect
- Cosmetic enhancement of the cheeks and chin
Allergy test: Required, due to the collagen carrier
Longevity: permanent
Approximate Cost: $400.-$900 per cc. The cost for Artecoll™ in Alberta, Canada $800.00cdn per syringe
Website: http://www.artecoll-usa.com/
Available in the United States? It is expected to have FDA approval between the last quarter of 2002 and the first quarter of 2003.
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10. Arteplast: (technically: microspheres of polymethylmethacrylate (PMMA) suspended bovine collagen) This injectable was™ introduced to Europe in 1991 and consists of the same material as Artecoll™, Plexiglas™, hard contact lenses, etc. The difference between Arteplast and Artecoll™ is the carrier and the microsphere size. You see the Arteplast is 20-42 microns and the Artecoll™ is 32-40 microns. The smaller size had proved unacceptable due to the possibility of phagocytosis [: the engulfing and usu. the destruction of particulate matter by phagocytes (or : a cell (as a white blood cell) that engulfs and consumes foreign material (as microorganisms) and debris)] After the bovine collagen was absorbed and excreted by the body, the body's collagen surrounded the implant and created augmentation.
Allergy test: Required.
Longevity: permanent
Approximate Cost: unknown, discontinued
*Note: This product was discontinued due to inflammation and granulomas.
Available in the United States: no, see above
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11. Injectable Silicone Oil: (technically: medical grade polysiloxane or polydimethylsiloxane) Although the FDA gave silicone breast implant shells a clean bill of health regarding whether or not it can cause future problems like diseases and disorders; liquid silicone injections were NOT FDA approved for cosmetic applications. In fact, they are illegal (except for clinicals with SilSkin) in the US. Plus, past experiences (and present ones) with injectable silicone report being very unpredictable and having quite a few allergic responses, statistically.
(courtesy: FDA website):
Liquid Silicone Injections
- Has liquid silicone been approved by FDA for injection?
No. FDA has not approved the marketing of liquid silicone for injection for any cosmetic purpose, including the treatment of facial defects or wrinkles, or enlarging the breasts. The adverse effects of liquid silicone injections have included movement of the silicone to other parts of the body, inflammation and discoloration of surrounding tissues, and the formation of granulomas (nodules of granulated, inflamed tissue). - Can FDA prohibit doctors from promoting the injection of liquid silicone, since its marketing has not been approved?
Yes. FDA prohibits manufacturers or doctors from marketing or promoting unapproved products such as liquid silicone. This means that a doctor cannot legally advertise or sell this material. FDA and Collagen and Liquid Silicone Injections
From Emedicine:
"Silicone injection into facial tissues was popularized in the 1960s and 1970s with the introduction of medical grade silicone (MDX 4-4011) by Dow Corning. Microdroplets of silicone are dispersed within the dermal tissues. Fibrosis around these droplets localizes the material, and it is seemingly well tolerated in small amounts in the face. Silicone oil has many advocates among those who used it prior to Food and Drug Administration (FDA) withdrawal of approval. However, silicone, although chemically well tolerated, becomes encapsulated as a foreign body by a chronic inflammatory reaction. Giant cells surround the material and cannot process any ingested material, establishing a low-grade inflammatory nidus. Fibrous tissue surrounds and encapsulates the silicone; this capsule is avascular and is a potential site of infection. A number of late infections, granulomas, and palpable masses have been reported following silicone use." Emedicine.com - Soft Tissue Implants
Update! 12/15/00: There is a loophole making it "legal" for any physician to administer liquid injectable silicone (LIS) to his patient regardless if the FDA deems it safe or not for such uses. It seems that according to a 1997 amendment to the Federal Food, Drug & Cosmetic Act 6 states:
"Nothing in (FD&C Act) shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship."
This means that since liquid injectable silicone (LIS), such as Adatosil, is a legally marketed medical device - not a drug, as it once was considered - it can be given to you, legally. This is why you may notice some websites advertising the use of LIS as a wrinkle filler.
I wrote to the FDA on 12/27/00 and inquired about the status and I hope to hear from them regarding this subject. Since it is the US government and it is the holiday season, I don't expect to receive word for awhile.
Update! 01/09/01: I received a response by US postal mail from Carol J. Shirk, a Consumer Safety Officer in the General Surgery Devices Branch, Division of Enforcement 1 - Office of Compliance for the Center for Devices and Radiological Health (whew!). Shirk advised that the ophthalmic liquid silicone is approved by the FDA for Ophthalmic use only and that they are currently investigating the off-label use for wrinkles by plastic surgeons. She further advised that the use other than for ophthalmic reasons is prohibited at this time.
Update! 04/09/02: I spoke with Diane Richard, vice president for the company which manufactures SilSkin today. Mrs. Richard advised that although a silicone product, SilSkin is " different" than Adatosil or Dow-Corning silicone and that trials are beginning for their product for cosmetic applications. Only time will tell if there will be problems associated with this new product as in the past with other silicone products. If anyone has personal experience or knowledge of this product, please contact me.
Allergy Test: there is no test, problems have taken as long as 3 to 5 years to develop in past silicone products.
Longevity: forever - and difficult, if not impossible, to remove
Approximate Cost: anywhere from $75. - $1,200.US per treatment
Dangers: Injections of Silicone have proven to cause Granulomas, Macrophages, migration, traces found in other organs and lymph nodes, fibrosis, and more in many cases.
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12. Profill or Profil: (technically: suspended microscopic polyethylene beads)
poly*eth*yl*ene (noun)
First appeared circa 1862
: a polymer of ethylene; especially : any of various partially crystalline lightweight thermoplastics that are resistant to chemicals and moisture, have good insulating properties, and are used esp. in packaging and insulation
Also considered an injectable micro-implant. Similar to Artecoll™ although the beads are made from polyethylene and not poly(methyl methacrylate). This injectable is suspended in saline or combined with collagen as a carrier. It is not available in the states and only offered in parts of Europe.
Allergy test: unknown
Longevity: reportedly permanent
Approximate Cost: unknown
Available in the United States: no
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13. Aquamid®: (technically: injectable Hydrophilic polyacrylamide gel (HPG) with unknown residual unpolymerized acrylamide) This product is the same as Formacryl, BioFormacryl, DermaLive , etc. This injectable is available in Europe. It is semi-permanent in a sense that it was permanent, yet reversible and has only slight resorption.
Allergy test: unknown
Longevity: reportedly permanent
Approximate Cost: unknown
Available in the United States: no
References:
APHA Standard Methods, 19th ed., p. 4-118, method 4500-Si D (1995).
ASTM D 859-94, Silica in Water.
EPA Methods for Chemical Analysis of Water and Wastes, method 370.1 (1983).