These injectables are made from a variety of materials, ranging from polymethylmethacrylate (PMMA) which is what hard contact lenses and Plexi-Glas are made from, to hydrophilic polyacrylamide gel which is regularly used for hydro-seeding and other agricultural applications, protein separation and time released drugs.  The race for a safe, yet permanent, solution is on.  Most of these substances are designed to be encapsulated by your body's own collagen and remain as a permanent to semi permanent solution for tissue deficiencies simple cosmetic enhancement.  Although many of these may seem like a dream come true, many are not yet available in the United States.  Well, at least legitimately.

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.

   


Return to the Injectable Fillers Index
  


Amazingel (aka Amazing Gel): (technically: injectable hydrophilic polyacrylamide gel with unknown % residual unpolymerized acrylamide monomer, reportedly under 10 ppm) Manufactured by FuHua high Molecular Matter Company, Ltd. and commercially available since 1998, this product is a medical grade, hydrophilic polyacrylamide gel.  It is unknown if this product has antibacterial properties to decrease the chances of bacterial infections.  It is said that this product contains both BFGF and EGF.  BFGF is an acronym for basic fibroblast growth factor, and EGF stands for epidermal growth factor.  The ingredients stimulate elastin production, plus the polyacrylamide gel holds 300 to 400 times its weight in water.  The main augmentation feature of the gel is the polyacrylamide gel.

"On Dec.28,2000, Amazingel got registered in China State Drug Administration. It was also listed in the Sparkle Program of the Ministry of Science and Technology of China." -- credit: V & J Tech Co., Ltd. Company Profile

Allergy Test: n/a
Longevity: permanent
Approximate Cost: Unknown
Caution: The injection site should be kept free of cosmetics, oils, water, soaps, etc. for a full 24 hours.  Failure to do so can result in complications such as infection.  Do not touch the treatment area and if you must clean the area, it should be done with a sterile gauze pad and rubbing alcohol.  Do not apply any cosmetic creams or moisturizers.  Your doctor may have you apply a triple antibiotic ointment with a sterile cotton swab for each injection site.
Available in the United States: It is not approved but is available in the US, France, Germany, Japan, Mexico, Asia, etc. 
CE Marking: unknown
Interesting Factoid: Jocelyn Wildenstein brought this filler back from overseas and had her physician inject it in her lips.
Contact Info: Futian Dist. Shenzhen, China, Shenzhen, China,
Guangdong  (China) 518000; Phone: 86-755-8329 3900; Fax: 86-755-8329 0581
More Information: http://www.fuhua-aesthetic.com/doce/amazingel.htm 

back to top
  


Aquamid:  (technically: injectable hydrophilic polyacrylamide gel (HPG, or PAAG) with 5 ppm residual unpolymerized acrylamide monomer) Manufactured by Danish pharmaceuitcal company, Ferrosan A/S, and distributed by Contura, this product is made of 2.5% hydrophilic polyacrylamide and 97.5% water.  Polyacrylamide can hold between 300 and 400 times its weight in water and has been used in medical applications, drug delivery, intraocular lenses, water purification and agriculture for many, many years.  It has been used in cosmetic applications for over a decade. The results are immediate and should not be under or over corrected.  Aspiration is possible.  

As far as I know, this product does not contain any antibacterial elements to decrease the chances of bacterial infection.   Polyacrylamide implants are susceptible to bacterial infections several months to years after injection.  I have come into contact with several patients who have had infections which occurred several months post-injection.
Allergy test: n/a 
Longevity: permanent, yet reportedly reversible with dilution and aspiration.
Approximate Cost: unknown
Caution: The injection site should be kept free of cosmetics, oils, water, soaps, etc. for a full 24 hours.  Failure to do so can result in complications such as infection.  Do not touch the treatment area and if you must clean the area, it should be done with a sterile gauze pad and rubbing alcohol.  Do not apply any cosmetic creams or moisturizers.  Your doctor may have you apply a triple antibiotic ointment with a sterile cotton swab for each injection site.  
*Special Considerations:  Aquamid should not be injected over other products.  Also, if you have gotten a temporary injectable, you must wait until it has fully dissipated before receiving Aquamid.
Available in the United States: No, okay well not officially, but some physicians have brought it into the states or bought it from those who have and are offering it to their patients. This injectable is available throughout Europe, particularly in Germany, and also in Australia, Asia, Canada, Mexico, and more.
CE Marking: Yes, CE 0543 - March 2001
Websites: http://www.aquamid.info/  
Clinical Studies in PDF: http://www.aquamid.info/CSAquamid.pdf 

back to top
  


Argiform (aka Argyform): (technically: injectable hydrophilic polyacrylamide gel with 0.03% residual unpolymerized acrylamide monomer) Manufactured by Bioform in Russia, this product is the second generation polyacrylamide gel comprised of 95% polyacrylamide and 5% water, it is also manufactured using a silver ion process to help repel bacteria.  

"1.Lips.
Enhancement of lips and correction of a contour of red line. Gel enter through a needle 25 G х 5/8 (0,50х
16 mm) into red edge of lip, or into the nearest sites of a skin. A needle carry out immediately under a skin and parallel to it for all length then start to squeeze out gel gradually deducing a needle and filling gel in the formed wounded channel. Amount of entered gel defines individually, depending on tasks. The number of punctures of tissues can be various. In one two minutes after introduction of gel clasp a lip big and index fingers and will carry out uniform smoothing a lip, trying to receive a smooth relief. If gel enter only in external or only in the central departments of lips in this case mass these sites. Places of puncture needles are very small and going out gel does not occur, however in the beginning nevertheless it is better to compress lips in a place of puncture to move tissues of the wounded channel. It is not necessary to enter more than 1,0 ml of gel into each lip at once. Muscles of lips (circular) it is intimate join with red line and at increase of volume of gel they will squeeze out it during mechanical movements along tissues and in due course surpluses of gel can appear as condensation under a mucous membrane, and also along muscular bunches of lifters and come downers of lips. A recommended doze of introduction for the first reception of 0,5 ml in each lip. During 2-4 weeks on occasion it is possible to see some reduction of volume of tissue - the patient beforehand should be warned about a probable additional injection." -- credit: Technique Recommendations Argiform, Bioform, Ru

Allergy Test: n/a
Longevity: Permanent, yet can be removed via aspiration or puncture and manual pressure. 
Approximate Cost: Unknown

Caution:
The injection site should be kept free of cosmetics, oils, water, soaps, etc. for a full 24 hours.  Failure to do so can result in complications such as infection.  Do not touch the treatment area and if you must clean the area, it should be done with a sterile gauze pad and rubbing alcohol.  Do not apply any cosmetic creams or moisturizers.  Your doctor may have you apply a triple antibiotic ointment with a sterile cotton swab for each injection site.  
*Special Considerations:  Argiform should not be injected over other products, especially those which are hydrophobic.  Also, if you have gotten a temporary injectable, you should wait until it has fully dissipated before receiving Argiform.

Available in the United States: No, not yet -- but I am hopeful.  If the feedback is good, I think this may be the injectable product I will choose.
CE Marking: unknown
Website: http://www.bioform.ru 
Contact info: Krasnobogatyrskay street, 42/1103
Moscow, Russia
tel./fax: +7 (095) 161-0524, 161-0537
e-mail: info@bioform.ru
Clinical Studies in Zip file, with photos: http://www.bioform.ru/ar/ar-en/clinical.zip 
Toxicology Report in Zip file: http://www.bioform.ru/ar/ar-en/toxicology-16.zip 

back to top
  


Artecoll (aka Artefill;  Artecol):  (technically: polymethylmethacrylate microspheres suspended in 3.5% denatured bovine collagen, mixed with 0.3% Lidocaine) Manufactured by Artes Medical, PMMA was discovered by a German chemist named German chemist O. Rohm in 1902.  PMMA in conjunction with medical implantation usage dates back to as early as 1936.  Today, 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. 

Gottfried Lemperle, of Artes Medical, first developed the idea of implanting microspheres of PMMA for sofy tissue augmentation.  The PMMA in Artecoll is formulated into microspheres (extremely small round balls, 32 to 40µm - 4 to 5x the size of a red blood cell).  The denatured bovine collagen is used as a vector and of course the Lidocaine is appreciated to relive the pain during injection.  Artecoll also contains a phosphate buffer, sodium chloride (saline), and distilled water.  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.

Artecoll is injected deep within your skin (the dermal level), through a tunneling technique with a hypodermic needle.  They basically inject the needle, push the plunger to deposit the Artecoll and at the same time pull the needle out.  This way, a little cylindrical deposit of Artecoll is left in place of the injection tunnel.  There are only a few individuals (reportedly 0.1%) that may have a reaction to Artecoll.  PMMA is an inert substance and reported as well-tolerated by the body.  Of course, the bovine collagen within the Artecoll mixture resorbs within 2 to 3 months and the microspheres are then encapsulated by your body's own collagen within 2 to 4 months.  Thus, networking added tissue augmentation without migration of the microspheres.

You may have heard the rumors of Artecoll "rubberizing" at 3 to 5 years post injection.  I'd like to correct that the product does not actually change chemical structure and "rubberize" or become firm because in all actuality the product is solid. Amazingly, in my experience these comments came from people who had absolutely NO experience with the product.  However,  these reports may have stemmed from excess collagen formation (scar tissue) which would result in a firm or "rubber-like" feel of the lips if implantation is not performed correctly, or over-correction is administered, or if an inflammatory response is experienced.  Tissue can continue to form and become tightly interwoven, resulting in firm lips.  Injections of Kenalog, a corticosteroid, can assist in breaking up the scar tissue.  Lumps are possible and have happened in people that I know.  Like I said, Kenalog injections can usually remedy this.

Allergy test: Required, due to the collagen carrier
Longevity: permanent
Cost: Lips started from $400 per .5 cc (Mexico), prices are approximate as I am seeing upwards of $400.-$1,500 per .5 cc in the US
Available in the United States? Artecoll was recently recommended by 4 out of 5 panel members for FDA approval.
CE Marking: Yes
Website: http://www.artesmedical.com 
Contact Info: Artes Medical, Corp., 4660 La Jolla Village Drive, Suite 825 San Diego, CA. 92122
Preclinical Review in PDF: http://www.fda.gov/ohrms/dockets/ac/03/briefing/3934b1_02_precl-fda.pdf

back to top


Arteplast: (technically: microspheres of polymethylmethacrylate (PMMA) suspended bovine collagen) This injectable was comprised of the same material as Artecoll, PMMA, however the size of the microspheres was smaller, the surfaces were irregular.  Also, the collagen was reported to be less pure and the microspheres had residual monomer.  The PMMA microspheres in Arteplast were 20-40µm, compared to Artecoll, which is 30 to 40µm.  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)] Granulomas formed and problems persisted.  Arteplast was then removed from the market and replaced by Artecoll.
Allergy test: required, due to the bovine collagen carrier 
Longevity: permanent
Cost: n/a - discontinued
*Note: This product was discontinued due to persistent inflammation and granulomas. 
Available in the United States: No

back to top


Bio-Alcamid or BioAlcamid: (technically: injectable hydrophilic polyakylimide gel)  The company, Progen (now Polymekon, Italy) did at one point distribute a Russian-made (Bioform) product named, Formacryl.  However, Progen/Polymekon, either formulated a similar product made of polyacrylamide (note the difference of the main ingredient in other gels which use polyacrylamide) in 2000 or reportedly renamed the Formacryl product and sold it under the name BioFormacryl.  The BioFormacryl website did at one point redirect to Polymekon's website.  The domain was dropped from Polymekon's possession.  I have watched the claims evolve from 95% polyacrylamide (note compound) and then to 96-97% polyakylimide.  The website did, at one point, quote verbatim Formacryl/Argiform's "First Water Endoprothesis" and additional descriptions originally created by Bioform of Russia.  

Regardless, Polymekon's current website has a discrepancy regarding Bio-Alcamid's ratio of polyakylimide to water.  In the first paragraph of the FAQ section, the company states the product is comprised of 96% water, and 4% polyakylimide in the first paragraph and then a 97% to 3% ratio on the same page, in the seventh paragraph.  Polymekon does claim that Bio-Alcamid is removable through aspiration or puncture and manual pressure. 
Allergy test: n/a 
Longevity: permanent, yet reversible. 
Approximate Cost: unknown
Available in the United States: No ,but some patients have gotten it from their surgeons who have brought it into the country or bought it from those who have.  It is available in Mexico, and found in border cities.
CE Marking: Reportedly, yes.
Website:
http://www.bioalcamid.com/ 

back to top


Bioformacryl: (technically: injectable hydrophilic polyacrylamide gel with 0.04% residual unpolymerized acrylamide monomer).  This was the product I was referring to above.  A company named Progen (now Polymekon, Italy) did at one point distribute a Russian-made (Bioform) product named, Formacryl.  However, Progen/Polymekon, either formulated a similar product made of polyacrylamide (note the difference of the main ingredient in other gels which use polyacrylamide) in 2000 or reportedly renamed the Formacryl product and sold it under the name BioFormacryl.  The website, bioformacryl.com did, at one point, quote verbatim Formacryl/Argiform's "First Water Endoprothesis" and additional descriptions originally created by Bioform of Russia.
Allergy Test: n/a
Longevity: permanent
Cost: unknown
Available in the United States: No, and it has since disappeared from the market.
Website: The now defunct website, bioformacryl.com had at one point redirected to Polymekon's website.  The domain was dropped from Polymekon's possession and is up for sale.

back to top


Bioplastique: (technically: solid, vulcanized methylpolysiloxane microspheres, suspended in polyvinylpyrrolidone) Bioplastique is an injectable implant comprised of solid silicone microspheres (100 to 400, and even 600 µm) suspended in a polynivylpyrrolidone vector. Bioplastique is a biphasic (meaning having two phases) The copolymer (a product consisting of two substances that combine to make a larger molecule) consists of a solid, permanent phase/substance (the solid silicone microsphere) and the second, a carrier gel phase/substance which is absorbed and later excreted by the body.  Very small, texturized particles of the solid silicone were mixed with the hydro-gel solution.  The hydro-gel has the consistency similar to honey with exceptional lubricating characteristics.  The copolymer is transported through tissue with injection and the hydrogel is 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 so we began researching the possibilities.  In order for a substance to remain stationary and be encapsulated by our body's own collagen, and 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's particle makeup reportedly were both large enough and textured permitting ease of collagen encapsulation (in under 4 weeks) which contributed to their claims of the inability to migrate or be carried by the lymph to the lymph nodes.  

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)

Interestingly enough, a study on April of 2000 found problems of migration in a 10 month old girl:

"A 10–month–old girl was found to have a firm, enlarged pelvic lymph node during an extravesical ureteric reimplantation, 2 months after injection with 0.7 mL of BioplastiqueTM for the endoscopic treatment of bilateral grade III reflux. The lymph node was excised and a biopsy of the silicone implant taken at the ureteric orifice. Histopathological examination showed numerous refractile foreign bodies surrounded by giant cells in both the excised lymph node and the implant (Fig. 1). Each sample was examined by scanning electron microseopy (SEM) and X–ray dispersion analyses (Philips XL30 Field Emission Gun SEM fitted with an integrated EDAX DX4i Energy Dispersive X–ray Analyser). Images of the tissue were recorded using both secondary electron and back–scattered electron detectors (Fig. 2a,b). Silicone was detected in both the biopsy and the lymph node. Several of these particles measured 5–15 µm, but particles of up to 100 µm were found in the lymph node" --credit: BJU International (April 2000), 85.4; Migration of particulate silicone after ureteric injection with silicone

"Comment: Bioplastique (silicone) is reported to have a particle size of 100–400 µm and thus is expected to have a lower risk of particle migration than have other injectable biomaterials [1,2]. This case not only identified migration of silicone to a lymph node but also shows that a significant proportion of the silicone particles were of < 50 µm, suggesting that Bioplastique has no advantage over PTFE. Silicone has previously been found to migrate after injection of large volumes of its particulate form [3] but not from small volumes, as injected in the present patient. It is also known that migration occurs from solid plastic implants, haemodialysis tubing and during infusion–pump assisted intravenous fluid administration [4]. The exact mechanism by which plastic particles migrate within the body has not been explored so far, but embolization may be one possibility; phagocytosis by macrophages may also have a role and this seems to be the most likely way for particles to migrate into the regional lymph node. Whether the particles entrapped in the macrophages may subsequently be caused beyond the lymph node, and whether this may have clinical consequences in the long term, is uncertain." --credit: BJU International (April 2000), 85.4; Migration of particulate silicone after ureteric injection with silicone

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.

More Information: Dr. Roger Kessels wrote us and advised: "Bioplastique should not be used in lip augmentation or wrinkles [by US surgeons] until it is approved by the US [FDA].  Bioplastique has CE Mark and is used throughout the world, except the US, to augment soft tissues and to treat contour defects.  Bioplastique is mainly used to correct chins, noses and to augment the cheekbone area"  Dr. Roger Kessels.

  • Bioplastique as a complement in conventional plastic surgery - Aesthetic Plast Surg 1998 Nov-Dec;22(6):444-50

  • Bioplastique at 6 years: clinical outcome studies - Plast Reconstr Surg 1997 Nov;100(6):1570-4

  • Chin augmentation using minimally invasive technique and bioplastique - Plast Reconstr Surg 1995 May;95(6):985-92

However, use in the US is well documented not only in chin augmentation and secondary rhinoplasty, but lip augmentation as well.  Bioplastique is also used regularly in lip augmentation in Australia.

Allergy test: n/a although advisable if you have polymer allergies, and for general caution.
Longevity: Permanent, removable by excision.
Approximate Cost: unknown
CE Marking: Yes
Available in the United States: Bioplastique is not approved by the FDA for use but it is used as a contouring injectable regardless. It is used in Australia for lip augmentation and has been used in the US for lip augmentation, as well.  Photos are viewable in the above PDF file.

back to top


Biopolimero: (technically: purified, medical grade polydimethylsiloxane oil)  Also known as silicone oil, Biopolimero comes in in 350, 1000 and 5000 centistokes.  The higher the number, the more viscous the oil.  
Allergy/Inflammation Test: There is no test one can take to determine if you are a good candidate.  Either you will have problems or you will not.  There is no definitive evidence regarding silicone allergy, per se.  However, if you find that you have an allergy towards polymers, you may want to consider something else.  There are persons who simply cannot tolerate foreign bodies of any kind.
Longevity: Permanent, and difficult to remove. 
Cost: $350. to $500. per treatment
Caution: Granulomas, migration, traces found in other organs and lymph nodes, excessive collagen formation, necrosis, silicone embolism.
Available in the United States? 
Yes, usually near border towns - this product is found in abundance in Mexico.

back to top


Biopolymere: (technically: unknown, possibly polydimethylsiloxane) I have very little information on this product.  I believe it is made by Biocell Ultravital.  I have seen claims that Biocell's headquarters are located in Lucerne, Switzerland and also has research Institutes in Paris, Germany and Holland.  They make anti-aging injectable products and reportedly, a product called Biopolymere.  At first I thought it was the same as Biopolimero, however I think Biopolymere is just a generic term for a biopolymer silicone, or silicone containing compound.  Regardless, I think I would be very wary of it until you can find out definitive information which can be verified that it is a product made for injection into the human body. As I said, the informationon this product is unclear.  If anyone has any information, please let me know.
Allergy Test: unknown
Longevity: unknown
Cost: unknown
Available in the United States? unknown

back to top


DermaDeep: (technically: injectable mixture of 40% hydroxyethylmethacrylate (HEMA), ethylmethacrylate (EMA) suspended in 60% hyaluronic acid) This French injectable implant is manufactured by Dermatech and distributed in reportedly over 40 countries.  The syringe is pre-filled and each 1.2 cc of product containing 200 mg of acrylic hydrogel (hydroxyethylmethacrylate (HEMA), ethylmethacrylate (EMA)) particles measuring 45 to 65µm (averaging 55µm) in diameter, 14.4 mg of hyaluronic acid, in enough phosphate buffer (pH 7.2) sufficient for 1cc.  This product is intended for use in the dermal and sub-dermal layers.  

It's sister product, DermaLive (see below) is intended for mid to deep layers of the skin (dermal and subdermal applications).  DermaDeep is intended for the deepest layers of the skin and tissue deficiencies or for tissue contouring.  Both are not suitable for superficial wrinkles, but both are fine for lip augmentation.
Allergy Test: n/a
Longevity: unknown; I haven't found an actual approximation but have read "almost permanent", and "several years"
Cost: Treatment varies from $500 - $1,000 per session.
CE Marking: Yes
*Special Considerations:  DermaDeep should not be injected over other products.  Also, if you have gotten a temporary injectable, you must wait until it has fully dissipated before receiving DermaDeep.
Contraindications:
"There is a known incompatibility between hyaluronic acid and the quaternary ammonium compounds such as benzalkonium chloride. It is therefore appropriate never the place DERMADEEP in contact with such products, or with medico-surgical equipment that has been treated with this type of product." --credit: http://thaiaccommodation.com
Caution: The injection site should be kept free of cosmetics, oils, etc. for a full 12 hours.  Failure to do so can result in complications such as infection and local inflammation.  Do not touch the treatment area and if you must clean the area, it should be done with a sterile gauze pad and rubbing alcohol.  Do not apply any cosmetic creams or moisturizers.  Your doctor may have you apply a triple antibiotic ointment with a sterile cotton swab for each injection site.   Do keep your treatment area out of direct sunlight or artificial UV light for at least a week.
Available in the United States?
No, but some surgeons have brought it into the country.
Website: http://www.dermadeep.com 

back to top


Dermagen: (reportedly: "polymeric compound of natural silica and oxygen")  Dermagen may be a fancy description for a substance very similar to silicone.   Although the candy-coated description would make someone want to go out and get it right away.  According to Dr. Carlos Soria's website...

    "Not a synthetic, Dermagen is polymeric (long-chain) compound of natural silica and oxygen. During manufacture, the silica is melted at 2,000 degrees temperature, stripped of free radicals, and then purified and sterilized. An all natural mineral solution, which never hardens, moves, or disappears, as does collagen. Perfect for permanent lip, chin and cheek augmentation, smile and frown lines, skeletal hands, etc." 

Silicones are synthetic polymers and are made by combining oxygen and silicon and in high temperatures and pressures can produce polydimethylsiloxane (PDMS). The fluids are made from linear chains of PDMS whereas the gels are lightly crosslinked to give it a thicker cohesiveness.  PDMS is what is found in silicone-filled breast implants and the highly-crosslinked version of silicone is what the breast implant shells are made from.

If anyone has any information on who manufactures this and what it truly consists of, please let me know.
Allergy Test: unknown, but I would suggest it having spoken to the amount of patients I have who have gotten this injected and experienced inflammation.
Longevity: permanent
Cost:  $400. a cc in Mexico 
Available in the United States? Yes unfortunately, along the border towns - especially in San Diego.  It is not approved here, however, and I doubt it ever will be.
Update! I was told that this IS essentially, silicone by several physicians, both American and Mexican. I was also told that the offering physician has many litigations against him and will not personally offer anyone information on the chemical make up of Dermagen.  No other person that I have heard of offers Dermagen but this one physician.  
Update! 10/19/01: A friend of mine, who shall remain nameless, had Dermagen injected into her hands by this particular surgeon and with the product in question.  She has had nothing but trouble and is getting a biopsy very soon. This physician told her that it was not silicone and recommended that she get an X-ray to prove it.  She did so and saw nothing although got a second opinion by an American surgeon who said small amounts of silicone surrounded by fibrous tissue may not show up on the X-ray so the biopsy was ordered.  I am waiting word and will update this section as soon as I find out.
Update: 02/12/02: The biopsy at John Hopkins showed it appeared to be silicone.  She is having it excised.  I have asked several doctors in Mexico and they advised they have treated several patients who have gotten this product injected.
Update! 05/12/02: Yet another girl on our boards has had problems with Dermagen.  She had it put in her nasolabials and it is inflamed and nodulistic.  She just wants it OUT and warns against anyone getting this filler.
Update! 11/22/02:  The emails from patients with problems after having Dermagen injected are increasing.  Although I am not an expert, it is obvious to me that this product is less than ideal or possibly unsafe.  I cannot recommend it whatsoever.  

back to top


DermaLive: (technically: injectable mixture of 40% hydroxyethylmethacrylate (HEMA), ethylmethacrylate (EMA) suspended in 60% hyaluronic acid) This French injectable implant is manufactured by Dermatech and distributed in reportedly over 40 countries.  The syringe is pre-filled and each 1.2 cc of product containing 200 mg of acrylic hydrogel (hydroxyethylmethacrylate (HEMA), ethylmethacrylate (EMA)) particles measuring 45 to 65µm (averaging 55µm) in diameter, 14.4 mg of hyaluronic acid, in enough phosphate buffer (pH 7.2) sufficient for 1cc.  This product is intended for use in the dermal and sub-dermal layers.  

It's sister product, DermaLive (see below) is intended for mid to deep layers of the skin (dermal and subdermal applications).  DermaDeep is intended for the deepest layers of the skin and tissue deficiencies or for tissue contouring.  Both are not suitable for superficial wrinkles, but both are fine for lip augmentation.
Allergy Test: n/a
Longevity: unknown; I haven't found an actual approximation but have read "almost permanent", and "several years"
Cost: Treatment varies from $500 - $1,000 per session.
CE Marking:
Yes
*Special Considerations:  DermaDeep should not be injected over other products.  Also, if you have gotten a temporary injectable, you must wait until it has fully dissipated before receiving DermaDeep.
Contraindications:
"There is a known incompatibility between hyaluronic acid and the quaternary ammonium compounds such as benzalkonium chloride. It is therefore appropriate never the place DERMADEEP in contact with such products, or with medico-surgical equipment that has been treated with this type of product." http://thaiaccommodation.com
Caution: The injection site should be kept free of cosmetics, oils, etc. for a full 12 hours.  Failure to do so can result in complications such as infection and local inflammation.  Do not touch the treatment area and if you must clean the area, it should be done with a sterile gauze pad and rubbing alcohol.  Do not apply any cosmetic creams or moisturizers.  Your doctor may have you apply a triple antibiotic ointment with a sterile cotton swab for each injection site.   Do keep your treatment area out of direct sunlight or artificial UV light for at least a week.
Available in the United States?
No, but some surgeons have brought it into the country.
Website: http://www.dermalive.com 

back to top


Evolution: (technically: positively charged polyvinyl microspheres suspended in hydrophilic polyacrylamide gel with unknown % residual unpolymerized acrylamide monomer, pH 7.4) Manufactured by ProCytech (France), this product is comprised of positively charged, porous, polyvinyl microspheres 40µm in diameter, suspended in a polyacrylamide gel.  The polyvinyl microspheres are manufactured of the same suture material already used very successfully in microsurgery.  The positive charge attracts  a negatively-charged glucosaminoglycan (GAG), called hyaluronic acid, which is naturally found in our skin.  You may be familiar with hyaluronic acid because of the new temporary injectable fillers such as Perlane and Restylane.  The positive charge also attracts other glucosaminoglycans (GAGs) which are responsible for forming collagen.  These two are very important in the process and significantly helps with the integration of your own collagen and the resulting plumpness of your skin.  Evolution can be injected into the mid-dermis, deep dermis and just below the dermis with no ill effects.  
Allergy Test: n/a
Longevity: Reportedly 2 to 3 years or more
Cost:  Ł400 per 1cc syringe
CE Marking: Yes
Available in the United States? No, unfortunately -- but can be found in Australia, UK, Africa, throughout Europe and Asia
Website: http://www.evolution-outline.com/ 

back to top


Formacryl: (technically: hydrophilic polyacrylamide gel with unknown % residual unpolymerized acrylamide monomer) Formacryl is no longer on the market as its replacement, Argiform, is an improved version.  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 was comprised of 5% polyacrylamide, a synthetic polymer, suspended within 95% apyrogenous water.  Unlike all of the other injectable microsphere suspensions or bovine collagen, this one stays soft.  After it is injected gel remains pliable and plump like your own tissue, not hard like collagen or firm like Artecoll because of the hydrophilic nature of the implant itself because your own fluids keep it plump.

Bioform did at one point supply a company named Progen (now Polymekon) with Formacryl to hopefully distribute the product.  Progen later renamed the product and sold it under the name, "Bioformacryl."   

Bioform later ceased making Formacryl due to the bacterial infections which surfaced even years post-injection.  They discovered that polyacrylamide gels could harbor bacteria, which created inflammatory and infectious responses.  Bioform improved the product with the addition of a silver ion process which hindered the accumulation of bacteria in the gel, and called it Argiform.
Allergy Test: n/a
Longevity: reportedly permanent yet reversible through aspiration or puncture and manual pressure. 
Cost: unknown
Available in the United States:  No longer available and was never available in the US
Website: http://www.bioform.ru 

back to top
   


Kopolymer 4E: (technically: polioxyethlene fatty acid and elastin copolymer gel) Developed by the Dermabiol Institute of Kuhra Vital GmbH, Lucerne, Switzerland, Kopolymer 4E comes in 5 ml (cc) vials and is comprised of a copolymer based on a fatty acid of polioxyethylene-4.  Kopolymer 4E also contains elastin. Kopolymer 4E is often used for lipodystrophy, facial contouring and volume restoration.
Allergy Test: n/a

Longevity: Reportedly permanent
Cost: unknown
Available in the United States? No, but it found in border cities such as San Diego and many areas in Florida.

back to top


Metacrill: (technically: polymethylethacrylate mirospheres suspended in carboxygluconatehydrolactic of magnesium)  This product is comprised of polymethylethacrylate (PMMA) microspheres, 20 to 80µm in diameter, suspended in a clear carrier made from carboxygluconatehydrolactic of magnesium.  The product comes in 10 and 20 cc (ml) vials and is used for all a variety of cosmetic and reconstructive applications.  

 A patient I know from Brazil writes:

"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 - Personally, I think a little more research into the liver and kidneys would be called for, and I doubt the FDA will ever approve this treatment in the US.  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.  Dr. Serra said he had no patients out of several hundred who had required removing the substance.  Side effects (basically none) other than swelling can be treated with ice and corticosteroids in extreme cases.  I asked also about heavy frown lines between my eyes, and Serra said he recommended BOTOX for that, since he had seen some cases of atrophy (resulting in sagging or general paralysis) with Metacrill between the eyes...

...as for procedure details, he first applies EMLA cream and  tapes your face to hold the cream on (occlusion), and waited on 4 other patients as I waited for the EMLA to become effective... 

...The shots have a pain killer mixed in, but it is still uncomfortable, and I almost fainted (for real). There was a lot of blood from one side of my face, and unfortunately, seeing that, having taken a Tylenol 3 for back pain, and being nervous and overheated made my blood pressure drop. The right side of my face reacted badly with swelling immediately, whether it was the chemicals or hitting a blood vessel, or psychosomatic.  He had to stop for a few minutes while I recovered, then he did the other side of my face and went back to finish up the first side.  His English is excellent, so this is a big plus for tourists.  After spending the weekend in bed with ice and pain killers, I am feeling better today.  The swelling is down, and I get the feeling that it is going to be a very successful improvement for me, especially after the touch up in a month. "

Follow Up (3/23/01): "I had my second round of facial injections today, which went much better, I didn't faint this time, but he did hit a vein again.  The chemical, a Metacrill-like substance - it turns out it doesn't have a name yet... BV- something.  Its the same chemical as Metacrill, I believe, but the agent it is mixed with is hydro-cellulose, which is non-reactive in the body, so it has no chance of allergic response and less swelling than Metacrill.  The doctor (Mario Soares Serra) uses it in a 30% solution for the first treatment, and then a 20% solution on the second treatment.  I think it did cause some small granulomas in my face, but they can't be felt or seen, only if I squeeze my fingers on the inside and outside of my cheek, then I can feel a few bumps or tubular ridges where the injections were.  The dr. said these are actually needed to support the sagging of the tissue, and that they get softer, but I'm not sure I buy that explanation, its more like that is the chemical proving that it is permanent.  Your own collagen surrounds the plastic molecules and I'm sure that if the treatments were given too much, too quickly, the body would produce some scar tissue.  Anyway, I hope there will be no need for more treatments."

Allergy Test: n/a
Longevity: permanent
Cost: $500 - $1000 per cc  ($300. cost)
Available in the United States? No, but it found in border cities such as San Diego and man areas in Florida.
Caution: Granulomas are possible.

back to top


Metrex: (technically: acrylate and methacrylate spheres suspended in a liquid that turns into a gel when warmed ) Developed by the Dermabiol Institute of Kuhra Vital GmbH, Lucerne, Switzerland, this product is comprised of 20% microspheres made of acrylate and methacrylate, 45% coplymer 4-G, 15% polyethylenglycol, 10% ascorbic acid, 5% cryptoxantine, and 5% unknown stabilizer.  Metrex comes in pre-filled 1.5 ml syringes or 5 ml (cc) vials.  What is really interesting about this implant is that when it is cold, it is in a liquid state -- when it reaches body temperature it becomes more viscous and turns into a malleable gel.  It actually must be cooled from 35.6°F to 42.8°F before injection to liquefy it.
Allergy Test: unknown
Longevity: permanent
Available in the United States: No

back to top


Outline: (technically: positively charged hydrophilic polyacrylamide gel with unknown % residual unpolymerized acrylamide monomer, pH 7.4) Manufactured by ProCytech (France), this product is similar to Evolution but is comprised only of positively charged hydrophilic polyacrylamide gel.  The positive charge attracts a negatively-charged glucosaminoglycan (GAG), called hyaluronic acid, which is naturally found in our skin.  You may be familiar with hyaluronic acid because of the new temporary injectable fillers such as Perlane and Restylane.  The positive charge also attracts other glucosaminoglycans (GAGs) which are responsible for forming collagen.  This is very important in the process and significantly helps with the integration of your own collagen and the resulting plumpness of your skin.  Outline can be injected into the mid-dermis, deep dermis and just below the dermis with no ill effects.  
Allergy Test: n/a
Longevity: Reportedly 2 to 3 years or more
Cost:  Ł400 per 1cc syringe

CE Marking: Yes
Available in the United States? No, unfortunately -- but can be found in Australia, UK, Africa, throughout Europe and Asia
Website: http://www.evolution-outline.com/ 

back to top


Profill or Profil: (technically: suspended microscopic polyethylene beads) I have found very little information about this product, if anyone has any information, please let me know.  Profill is made from polyethylene [: 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].  This injectable is suspended in either a polysaccharide or combined with collagen as a carrier.  
Allergy test: unknown, I assume yes if the vector is bovine collagen
Longevity: reportedly permanent
Cost: unknown
Available in the United States: No.

back to top


Procell: (technically:  a synthetic polymer containing mostly Elastine, Hyaluronic Acid, and Metacrylate Fibers). Developed by the Swiss Kuhra Vital Division of the Dermabiol Institute, this product is comprised of 20% elastine, 20% hyaluronic acid, 20% methacrylate fibers, 10% Nucleic Desoxiribe Acid,  10% Polyoxiethylene, 10% unknown emulsifier, 5% Amino Acid isocoproical and 5% 3-Methyl Pentaenoical.  Procell comes in 1.5 ml (cc) syringes.  This product is designed to stimulate your own cellular growth.
Allergy Test: n/a
Longevity: Approximately 2 years
Cost: $500. per 1.5cc
Available in the United States:  

back to top


Radiance: (technically: calcium hydroxylapatite, (CaHA) microspheres suspended in an aqueous, polysaccharide gel)   Radiance is not FDA approved as of yet for cosmetic applications, but is approved for Radiographic Tissue Marking. Radiance is manufactured by Bioform of Franksville, Wisconsin (not to be confused with BioForm of Russia) from microspheres of (75 to 125 microns) synthetic calcium hydroxylapatite, which is very similar to the HA found in our teeth and bones.  In general, calcium hydroxylapatite has safely been used in the body for many applications including dental applications where bone build-up is needed for reconstruction and also in block form for cosmetic applications such as cheek, jaw, cranial and chin implants.  Calcium hydroxylapatite creates a lattice where the surrounding cells can be incorporated from ossification in bony areas to a stable scaffold in which soft tissue can grow.  Radiance comes in pre-filled 1cc syringes.

With Radiance, the calcium hydroxylapatite microspheres are suspended in a polysaccharide carrier which holds the microspheres in place until it is resorbed and the collagenation takes place.  When injected in soft tissue, away from bone, fibroblasts work by building reportedly a non-scar tissue collagen type, thus creating volume in the treatment area.  
Allergy test: n/a 
Longevity: Although no one can say for sure, some surgeons have speculated longevity being at least 2 to 5 years -- some report over 6 years and counting in non-cosmetic applications of Coaptite in Europe.  
Removal: This type of product is not easily removed.  However, excessive collagen production can be dealt with using injections of a corticosteroid like Kenalog.
Caution: Please seek out an experienced injector and be sure that the product is Radiance or Radiance FN, and not Coaptite or even "homemade" hydroxylapatite powder mixed with a saline or other carrier.
Approximate Cost: $600. to $1,600. per cc - although I have been told it costs the surgeon approximately $600. a cc.
Available in the United States: Yes, however it is in the investigational stages for cosmetic use.  Radiance is FDA approved for Radiographic Tissue Marking.  Several of our board members have Radiance in their lips and can discuss their experiences with you on our message board.
Website: www.bioforminc.com 

back to top


Radiance FN: (technically: calcium hydroxylapatite, (CaHA) microspheres suspended in an aqueous, polysaccharide gel)   Radiance FN is not FDA approved as of yet for cosmetic applications, but is approved for Radiographic Tissue Marking and Vocal Fold Insufficiency. Radiance FN is manufactured by Bioform of Franksville, Wisconsin (not to be confused with BioForm of Russia) from microspheres of calcium hydroxylapatite (25 to 45 microns), synthetic calcium hydroxylapatite, which is very similar to the HA found in our teeth and bones.   In general, calcium hydroxylapatite has safely been used in the body for many applications including dental applications where bone build-up is needed for reconstruction and also in block form for cosmetic applications such as cheek, jaw, cranial and chin implants.  Calcium hydroxylapatite creates a lattice where the surrounding cells can be incorporated from ossification in bony areas to a stable scaffold in which soft tissue can grow.  Radiance FN's HA microspheres are smaller and intended to be used in applications needing a smaller needle.  Radiance FN comes in pre-filled 1cc syringes.

With Radiance FN, the calcium hydroxylapatite microspheres are suspended in a polysaccharide carrier which holds the microspheres in place until it is resorbed and the collagenation takes place.  When injected in soft tissue, away from bone, fibroblasts work by building reportedly a non-scar tissue collagen type, thus creating volume in the treatment area.  
Allergy test: n/a 
Longevity: Although no one can say for sure, some surgeons have speculated longevity being at least 2 to 5 years -- some report over 6 years and counting in non-cosmetic applications of Coaptite in Europe.  
Removal: This type of product is not easily removed.  However, excessive collagen production can be dealt with using injections of a corticosteroid like Kenalog.
Caution: Please seek out an experienced injector and be sure that the product is Radiance or Radiance FN, and not Coaptite or even "homemade" hydroxylapatite powder mixed with a saline or other carrier.
Approximate Cost: $600. to $1,600. per cc - although I have been told it costs the surgeon approximately $600. a cc.
Available in the United States: Yes, however it is in the investigational stages for cosmetic use.  Radiance FN is FDA approved for the treatment of Vocal Fold Insufficiency and Radiographic Tissue Marking.  Several of our board members have Radiance (not FN) in their lips and can discuss their experiences with you on our message board.
Website: www.bioforminc.com 

back to top


Rhegecoll: (technically: methacrylate and copolymer 4-G suspended primarily in bovine collagen ) Developed by the Swiss Kuhra Vital Division of the Dermabiol Institute, Rhegecoll is comprised of 40% bovine collagen, 15% A.D.N./DNA (?), 15% copolymer 4-G, 10% methacrylate, 10% unknown emulsifier, 5% embryoblasts, 5% unknown stabilzer.  This product comes in 1.5 ml (cc) syringes
Allergy Test:  Kuhra Vital advises that no allergy pre-test is necessary but with 40% bovine collagen, I'd recommend one anyway.
Longevity: Reportedly 2 years minimum
Cost: $500. per 1.5 cc
Available in the United States:  

back to top


Silicone Injections (Silicone Oil): (technically: purified, medical grade polydimethylsiloxane oil) Often referred to as Liquid Injectable Silicone  or simply, LIS.  Silicone, in general, has met much controversy over the last few decades.  Some issues, with good reasons and others due to junk science.  I could write pages upon pages about the issues which have revolved around the use of all forms of silicones and more pages still on how much it is found and used in many products we use on a daily basis.  But since this isn't about the controversy of the compound itself, I won't.  If you are interested just type in silicone in Google and thousands websites will be returned.  Just be sure what you read is backed by real science.  I will, however, cover the intended uses of silicone oil and the off-label uses, as well.  I will cover the glory and cover the not so bright and shiny side of liquid silicone injections.

Firstly, injections of silicone oil are not approved for cosmetic use in the United States, no matter what anyone tells you.  The off-label use of an approved medical device is, however, allowed because of the Federal Food, Drug & Cosmetic Act 9, which states:

CHAPTER IX - MISCELLANEOUS
SEC. 906 PRACTICE OF MEDICINE. --

Nothing in this 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 section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.

This means a physician can legally use any FDA approved drug or device, as he sees fit, if he believes it can effectively treat or cure your complaint.  Both Silikon 1000 and Adato Sil-ol 5000 (originally approved under the name "Adatomed Silicone Oil 0P5000") -- also called simply Adatosil -- are approved, but for injection into the vitreous cavity of the eye in the event of retinal detachment and/or hemorrhage.  It is intended to help save a person's eyesight.  And it is also intended to be aspirated at a later date and not kept inside the body indefinitely.

Re: Adatosil 5000: "AdatoSil 5000™ was approved by FDA through the Premarket Approval process (PMA) on November 4, 1994, pursuant to section 5 15(d)( 1)(B) (ii) of the Act. It is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitroretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, giant tears, and following perforating injuries. AdatoSil 5000™ is also indicated for primary use in detachments due to Acquired Immune Deficiency Syndrome (AIDS) -related CMV retinitis, and other viral infections." --credit: Larry D. Spears Acting Director, Office of Compliance Center for Devices and Radiological Health (FDA)

Re: SILIKON 1000: "This device is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, giant tears, and following perforating in injuries. SILIKON 1000 is also indicated for primary use in detachments due to Acquired Immune Deficiency Syndrome (AIDS) related CMV retinitis and other viral infections affecting the retina." --credit: PMA Final Decisions Rendered for September 1997

Re: SILISKIN: "SilSkin is a purified 1000cs silicone oil manufactured by RJ Development [a subsidiary of Richard-James, Inc.] and currently under investigation for facial soft tissue augmentation. At present, SilSkin is an investigational device limited by Federal law to investigational use." --credit: http://richard-james.com/page0005.htm 

"Liquid Silicone Injections

  1. 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).

  2. 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." --credit: http://www.fda.gov 

"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." --credit: Emedicine.com - Soft Tissue Implants

The Method of Augmentation By Silicone Oil Injections
The injection of silicone oil, and many injectable tissue augmentation fillers, triggers a foreign body response by the accumulation of phagocytes, macrophages, lymphocytes, etc.  This low grade inflammation causes your body to respond by trying to either break it down, by engulfing the product and by moving it to other organs for excretion.  Silicone oil cannot be broken down by the body so the lower molecular silicones are either engulfed and moved and the higher viscosities remain behind when they are encapsulated.  The macrophage accumulation triggers fibroblasts to begin encapsulating the silicone oil, to wall it off from the rest of the body.  Imagine the silicone as a grain of sand, and your body as the oyster.  The body forms collagen layers around the silicone and eventually augmentation is gained in the form of fibrous tissue.  If the body cannot find relief after encapsulating the silicone, it will continue to form more and more collagen around the product, eventually causing a firm nodule.  The good thing about encapsulation is that it can help keep the majority of the liquid silicone where it was injected and hinder its migration into the surrounding tissues.

So remember, the augmentation isn't due to the product itself, large amounts of silicone oil should not be injected for volume augmentation.  It is the body's inflammatory response which triggers the formation of collagen that is the method of augmentation.  The amount of collagen formed is dependent upon your own body's sensitivity to the silicone, and the purity of the product.

Questions To Ask Your Physician When Getting Silicone Injections: (Printer-friendly Version)

  1. What is your medical training and title?  Are you an M.D., a D.O. an R.N. or a P.A.? (Independently verify their credentials, if necessary)

  2. Is silicone oil approved?  [see what they say, if they say 'yes' it's misleading because it is approved for last ditch efforts to stop bleeding in retinal detachments and ocular hemorrhaging.  If they say yes, ask, "For cosmetic use?" and if they say yes, then let them know you know they are lying and walk out the door.  If they say no, I usually say nothing.]

  3. How long have you been injecting silicone? 

  4. What type/brand of silicone have you worked with in the past and what do you prefer and use now? (Remember which products are approved for injection into the human body.  Also if they simply say Silicone 1000, do ask who manufactures it.  Silicone 1000 only explains that it is a 1000 centistoke silicone oil.  Even if they say it is medical grade, there are medical grades which are not intended for injection into the body and are intended to lubricate cutting surfaces.  One such oil is Dow-Corning 360 Medical Fluid. This oil is NOT intended for injection into the body.)

  5. Have any of your patients had problems with granulomas, severe inflammation or migration? 

  6. Does migration this occur over time? 

  7. What's the longest you have been in contact with one of your patients post-treatment? 

  8. Can I get silicone safely injected over other products and vice versa? 

  9. What do you use for pain relief?  EMLA, Regional, Local?

  10. What can I expect during the procedure?

  11. How many cc do you think I will need for my particular desires? 

  12. Hoe many cc do you inject per treatment?

  13. How much do you charge per cc?  

  14. What if I need only 1/2 cc at one point am I charged for the whole cc? 

  15. How much can be injected in one area without disrupting vascularity and causing problems?

  16. Do you use a tunneling technique in the vermilion border; do you use a microdroplet or other technique? 

  17. What can I expect post-treatment?

  18. What post-treatment instructions must I follow?

  19. Do you recommend massage or does this increase the risk of migration?

  20. How long must I wait between treatments? 

  21. If I have trouble, what treatment options do you offer (Kenalog, excision, etc)  

  22. If no treatments are offered at your practice, who can help me if I need it removed?

Where NOT to Get Silicone Injections
Liquid silicone can also be found in the US on the black market, as well as salons using non-medical and medical grades intended for lubrication of surgical instruments.  Medical grade does not equal intended use for human injection.  I simply implore that you do not go to any of these places to get silicone injections for any reason.  There is no quality control, sterility is questionable and if the person is operating outside of a medical office -- there is a reason.  Please do not choose to get silicone injections from an unlicensed person, in a hotel, in a salon, at someone's own home, or at your own home.

If you still want to get silicone injections, please research your physician extensively and follow up on his or her credentials, please view updated photos (dated if possible) of the physician's past patients.  Also ask what type of silicone they are using and ask to see the vial.  The most commonly used products are Silikon 1000 or Adatosil 5000.  Dow-Corning does NOT make a silicone oil intended for injection into the human body, no matter what they say.  

Allergy/Inflammation Test: There is no test one can take to determine if you are a good candidate.  Either you will have problems or you will not.  There is no definitive evidence regarding silicone allergy, per se.  However, if you find that you have an allergy towards polymers, you may want to consider something else.  There are persons who simply cannot tolerate foreign bodies of any kind.
Longevity: Permanent, and difficult to remove. 
Cost: $350. to $1,500. per treatment
Caution: Granulomas, migration, traces found in other organs and lymph nodes, excessive collagen formation, necrosis, silicone embolism.
Available in the United States?  Yes, 
Silikon 1000, Adatosil 5000 are approved by the FDA, however not for cosmetic applications.   SilSkin has been granted pre-market approval to conduct clinical trials only.  Other forms of silicone are found and offered in the US, from imported "medical grade" oils to those which are not intended for human injection.
Websites of Interest:

Approved Silicone Oils

Silicone Not Intended For Injection

Silicone Removal Information:

Contact & Website Information:

Alcon Laboratories, Inc. (Silikon)
6201 South Freeway
Fort Worth, TX 76134
Tel: 817-551-8430
http://www.alconlabs.com 
Bausch & Lomb (Adato Sil-ol)
1 Bausch and Lomb Pl
Rochester, NY
Tel:  585-338-6000
http://www.bausch.com
Richard-James (SilSkin)
Centennial Park
2 Centennial Drive
Peabody, MA 01960
Tel: 978.532.0666
http://www.richard-james.com

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.
Update! 03/25/03: I met with Diane Richard at the American Academy of Dermatology Meeting in San Francisco (Mar. 21-25, 2003) and viewed some before and after photos and was given some clinical data of their progress so far.  I would still like to speak to any patients who are participating in the clinicals
.

back to top


Silicex: (technically: silicone compound emulsion) Manufactured by Rhodia SIlicones, this product's full name is Silicex Antifoam 140.  Silicex is NOT intended for injection into the body.  Product information is below:

"Silicex Antifoam 140: Excellent general purpose foam control agent particularly suited to cementing & gas scrubbing.

  • Chemical name: Silicone compound
  • Market segment: Cementing Fluids, Drilling Fluids, Stimulation Fluids, Production Fluids
  • End use :Water based fluids, Water based fracturing fluids
  • Functions :Foam control agent

  • Available in :Europe / Middle East / Africa, North America" 

NON-IONIC AQUEOUS EMULSION OF DIMETHYLPOLYSILOXANE
Description
: Silicex antifoam 140 is a non-ionic aqueous emulsion containing dimethylpolysiloxane, and is highly effective for prevention, control and elimination of foam in aqueous media. Active ingredient concentration is 30%, offering the advantage of very quick action and lengthy duration of the defoaming effect.

STANDARD APPLICATIONS
Silicex antifoam 140 is particularly suitable for use in industrial processes requiring the elimination or control of foam within a wide range of pH, such as :

  • Extraction, distillilation and dehydration processes

  • Surfactant preparations

  • Manufacture of soaps and detergents"

--credit: Rhodia - Home, Personal Care & Industrial Ingredients Product sheet

It is described by the company as a milky white emulsion liquid with a slight odor and no suspended particulate matter Do not get this injected into your body.  You may have heard the bad press of Silicex injections for wrinkles and lip augmentation.  It is not intended for human or animal injection under any circumstances.
Allergy Test:  n/a
Longevity: n/a
Cost: n/a
Available in the United States:  Yes
Website: http://www.rhodia-hpcii.com 

back to top

              

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).
Email Interview with Gottfried Lemperle, of Artes Medical - San Diego
Dewan, P.A., Hoebeke, P., E. hall, H., Chow, C.W., Edwards, G.A. & Terlet, J. Migration of particulate silicone after ureteric injection with silicone.  BJU International 2000 85 (4), 557-7

  

 


Return to the Injectable Fillers Index

home | facial procedures | body procedures | surgeon info | consultation info | surgery preparation
photo gallery | FAQ | message boards | chat | just for fun | enhancement news | miscellaneous | links

Are you lost? View Site Index

 

Yes They're Fake! Cosmetic Plastic Surgery & Beauty Network
Copyright © 1999-200
6 Enhancement Media, All rights reserved.
Please read Usage Agreement 
This page was last updated: 04/07/2006