Injectable Micro-implants

These injectables are made from a variety of materials, ranging from polymethylmethacrylate (PMMA), the material that hard contact lenses and Plexi-Glas products are made of, to hydrophilic polyacrylamide gel, which is regularly used for hydro-seeding and other agricultural applications, protein separation and time-release drugs, to silicone. I have also included oils and other injectable augmentation products which are considered permanent to semi-permanent.

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 and simple cosmetic enhancement. Many are not yet available in the United States, at least not with FDA approval.

Although considered permanent, some of the products are also considered reversible. Cost (usually quoted as “per cc”, “per syringe”, or “per treatment”) and the need for an allergy test prior to use vary from product to product.

The American Society for Aesthetic Plastic Surgery keeps track of what injectables and dermal fillers have been approved by the Food and Drug Administreation (FDA) at glossary_of_injectables_and_dermal_fillers_terms

Amazingel: Also known as Amazing Gel, or Amazingel Single Injection Wrinkle Remover, this product has been commercially available since 1998 and is a medical grade, highly absorbent polyacrylamide gel, meaning that it absorbs water and grows many times larger than its original size. It is unknown if this product has antibacterial properties to decrease the chances of bacterial infections. Polyacrylamide implants are susceptible to bacterial infections several months to even years after injection, as is any implanted foreign object. I have come into contact with several patients who have had infections which occurred several months post-injection.

Amazingel also 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, though, is the polyacrylamide gel. It is also reported to contain a pain-reliever so it is essentially pain-free after the first few initial injections. It is reportedly permanent. It is not approved in the U.S. but is available throughout Asia, and has been brought into the U.S. via Mexico and through direct shipment.

Aquamid: Manufactured by Danish pharmaceutical company, this product is made of hydrophilic polyacrylamide, which can 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 years. It has also been used in cosmetic applications for over a decade. The results are permanent, yet reportedly reversible with dilution and aspiration. Not officially available in the U.S., but some physicians have brought it into the states and are offering it to their patients. Aquamid is available throughout Europe, Australia, Asia, Canada and Mexico. It has CE Marking but no FDA approval.

Argiform: Also known as Argyform. Manufactured in Russia, this product is the second generation polyacrylamide gel comprised of 95% polyacrylamide and 5% water. It uses a silver ion process to help repel bacteria. Permanent, yet reportedly can be removed via aspiration or puncture and manual pressure. Not FDA-approved.

Artecoll: Also Artefill and Artecol. The chemical basis of this product, PMMA, was discovered by a German chemist named German chemist O. Rohm in 1902. Today, common usage for PMMA include bone cement, dentures, artificial eye lenses, pacemaker covers, 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.Its first use for tissue augmentation was in 1989.

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. You may have heard the rumors of Artecoll "rubberizing" at 3 to 5 years post injection. I'd like to state that the product does not actually change chemical structure and "rubberize" or become firm because the product is solid and was such at injection, only suspended in a carrier. 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 degrading the scar tissue. Lumps are possible and have happened in people that I know. An allergy test is required. Results are permanent; however some collagen formation will degrade from the natural effects of aging. Artecoll is not FDA-approved in the U.S., but it does have CE Marking.

Bio-Alcamid or BioAlcamid: An injectable hydrophilic polyalkylamide gel. Reportedly permanent, yet reversible. Not available in the U.S., 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. It has CE Marking but not FDA approval.

Bioplastique: An injectable implant comprised of solid silicone microspheres suspended in a polynivylpyrrolidone vector. Bioplastique is a biphasic, meaning having two phase. 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 is a carrier gel phase/substance which is absorbed and later excreted by the body.

Migration of micro-implants is a concern. In order for a substance to remain stationary and be encapsulated by our body's own collagen, it must be large enough in size not to be absorbed by the body's cells and vessels or transported to the lymph nodes. This could prove dangerous as small enough particles could cause cell die off. Bioplastique's particle makeup reportedly was both large enough and textured to permit ease of collagen encapsulation in under 4 weeks, contributing to the manufacturer's claims of the product's inability to migrate or be carried by the lymph to the lymph nodes.

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, or scraped out. It is possible that the area to be corrected (or augmented) may lose its indigenous tissue when the Bioplastique is suctioned out, resulting in an even smaller lip or deeper pitted section of dermis.

It is not approved by the FDA for use in the U.S., but is used as a contouring injectable. It has CE Marking.

Biopolimero: Also known as silicone oil, Biopolimero comes in in 350, 1000 and 5000 centistokes. The higher the number, the more viscous the oil. This product is permanent and difficult to remove.

It is available in the U.S., usually in towns along the Mexican border, where it is found in abundance, and throughout South America. I absolutely cannot recommend it. People occasionally write to ask me if I have heard of it because someone in San Diego or Florida offers it and it is "cheaper than Restylane and permanent." They usually want to know if it is safe. I advise against it and never hear from them again.

DermaDeep: This French injectable implant is manufactured by Derma Tech and reportedly distributed in over 40 countries. Its sister product, DermaLive (see below), is intended for the upper to mid layers of the skin (dermal). 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. Neither has FDA approval, but DermaDeep has CE Marking.

Dermagen: A mineral-based dermal filler comprised of silica and oxygen. Not FDA-approved.

DermaLive: Hyaluronic acid-based dermal filler with added acrylic hydrogel (a non-resorbable component). Not approved by FDA.

Evolution: This product is comprised of positively charged, porous, polyvinyl microspheres suspended in a polyacrylamide gel. The microspheres are manufactured of the same suture material already used very successfully in microsurgery. Evolution can be injected into the mid-dermis, deep dermis and just below the dermis with reportedly no ill effects. Results reportedly last 2 to 3 years or more. Not available in the U.S., but can be found in Australia, U.K., Africa, throughout Europe and Asia. Evolution has CE Marking.

Kopolymer 4E: Kopolymer 4E is often used to treat lipodystrophy (facial wasting) or for facial contouring and volume restoration. Its results are reportedly semi-permanent, with suggestions of yearly touch-ups. Not available in the U.S., but it can be found in border cities such as San Diego and many areas in Florida.

Metacrill: Comprised of polymethylethacrylate (PMMA) microspheres suspended in a clear carrier made from carboxymethylcellulose. Granulomas are possible. The results are permanent. Not available in the U.S., but found in border cities such as San Diego and many areas in Florida.

Outline: Similar to Evolution, this product comes in 3 sizes: Outline Original (for mid to deep injections), Outline Fine (for shallow injections such as crow's feet) and Outline Ultra (for your deepest folds and lip augmentation). Reportedly lasts 2 to 3 years or more

CE Marking, but no FDA approval. Found in Australia, UK, Africa, throughout Europe and Asia.

Profill or Profil: Containing polyoxyethylene, polyoxypropylene, mineral salts, amino acids and vitamins, this liquid turns to gel on implantation. Correction reportedly lasts 6 to 9 months. Non-FDA approved. Oftentranslucent gelthis translucent gel also

Radiesse (Radiance FN, Radiance): Approved by the FDA, Radiesse is the brand name for an injectable calcium hydroxylapatite-based dermal filler. In general, calcium hydroxylapatite has been safely 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. The calcium hydroxylapatite microspheres are suspended in a polysaccharide carrier which holds the them 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. Some surgeons have speculated longevity at 2 to 5 years. 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. You can read my journal and see my Radiesse before-and-after photos here. I do not recommend this product in the lips.

Silicone Injections (silicone oil): Technically purified medical grade polydimethylsiloxane oil, it is often referred to as liquid injectable silicone (LIS). Silicone, in general, has met much controversy over the last few decades, oftentimes for good reason but sometimes 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 often it is found in many products we use on a daily basis. I will cover the intended uses of silicone oil, as well as its off-label uses.

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 and Cosmetic Act 9, which does not “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 a physician can legally use any FDA approved drug or device as he or she sees fit, if he or she believes it can effectively treat or cure your complaint.

Both Silikon 1000 and Adato Sil-ol 5000 (Adatosil) are FDA-approved for injection into the vitreous cavity of the eye to treat retinal detachment and/or hemorrhage. It is intended to be aspirated at a later date, once the eye has healed, and not kept inside the body indefinitely. Both are also used to treat detachments due to Acquired Immune Deficiency Syndrome (AIDS) -related CMV retinitis, and other viral infections.

SilSkin, a purified silicone oil used for facial augmentation, has not been approved by the FDA for any medical use.

The 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).

The injection of silicone oil, and many other injectable tissue augmentation fillers, triggers a foreign body response, a low grade inflammation that causes the body to respond by trying to either break it down or engulf the product and move it to other organs for excretion, or essentially wall it off from the body. Silicone oil cannot be broken down by the body, so the lower molecular silicones are either engulfed or moved and the higher viscosities remain behind and are encapsulated. 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 occurs 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 silicone injections depend on your body's reaction to create augmentation, or in plain English, bigger lips. Augmentation isn't due to the product itself, so large amounts of silicone oil should not be injected for volume augmentation. The amount of collagen formed is dependent upon your own body's sensitivity to the silicone and the purity of the product. Impure oils will cause too much irritation and may cause serious complications.

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? [If they say “yes”, it's misleading because it is approved for last ditch efforts to stop bleeding in retinal detachments and ocular hemorrhaging. Ask, "For cosmetic use?", and if they say “yes”, then let them know you know they are lying and walk out the door. You don't want a liar working on you. 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, 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, but is a cheaper alternative that many illegal injectors use on their clients. Another product to be aware of is Silicex, which is also not intended for injection into the body.

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

  6. Does migration 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 anesthesia (field block, dental block), local anesthesia only?

  10. What can I expect during the procedure?

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

  12. How much do you charge per cc/ml? This is important. Also, if you are charged per treatment, how much per treatment? Make sure you are not going over the amount that is recommended as safe.

  13. How much can be injected in one area without disrupting vascularity, causing migration and other problems? It is reported no more than .5 to .7 cc/ml per treatment for a set of lips should be injected, but I have seen that figure as low as .2 cc/ml per lip.

  14. How many cc/ml do you inject per treatment?

  15. What if I need only .5 cc/ml at one point, am I charged for the whole cc?

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

  17. Will you be crossing the midline? Crossing the lower midline can cause an unnatural look in a lot of people, but this depends on what you personally find attractive.

  18. What can I expect post-treatment?

  19. What post-treatment instructions must I follow?

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

  21. Do you recommend taping?

  22. Do you recommend flossing the midline of the lower lip each night to create a "pillow". This technique involves placing a piece of floss between your bottom front teeth, pulling it slightly taught over the midline of your lower lip and taping to your chin. This causes a very slight indentation to form in the middle of the lower lip that many refer to as a pillow.

  23. How long must I wait between treatments? Three months is usually best, 4 even better. You must wait until your collagen has stopped forming to truly know your needs after each treatment. Going too fast can result in overfilled lips and “lip greed”. This occurs when you become accustomed to the swelling and when it subsides the result is a little smaller than it was at the initial treatment (although it will grow, or “fluff). Take before-and-after photos to judge your overall facial balance before demanding more. You do not want to end up with “fish lips”.

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

  25. If no treatments are offered at your practice, who can help me if I need my lips reduced or the silicone removed?

Where NOT to Get Silicone Injections

Liquid silicone can be found in the U.S. on the black market, as well as in salons and from traveling injectors using non-medical and medical grades intended for lubrication of surgical instruments. Medical grade does not mean intended for injection into humans. I implore you not to 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 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. Always be sure what you are getting, and do not take their word for it. Insist on seeing the packaging and the updraw. It is best to ask about this in advance so you do not waste your time if the person shows up with pre-filled syringes of questionable product.

If you still want to get silicone injections, please research your physician extensively and follow up on his or her credentials. View 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.

Allergy/Inflammation Test: There is no test to determine if you are a good candidate for silicone injection. 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.

The effects of silicone injections are permanent and difficult to remove. Risks include granulomas, migration, traces found in other organs and lymph nodes, excessive collagen formation, necrosis (tissue death) and silicone embolism.