Injectable Bio-Implants
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Semi-permanent, biological injectable fillers such Cymetra and Fascian offer augmentation options without synthetic products. They can be 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). |
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They are also used for augmentation of the lips and for filling out acne scars and other types of tissue deficiencies. They can be utilized after a temporary "try on" product has been used or used as a first time product for the above indications. In this section, we will discuss the various options in soft tissue augmentation with the use of injectable bio-implants. |
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These implants are usually derived from cadavers at the time of death. Usually their dermis or muscle fascia (the gray/white covering over our muscles) or tissue-derived collagen is harvested and brought to a lab, for sterilization and other tests and processing that allows the allograft (a piece of tissue) to become "generic" . The processing allows our body to accept the allograft as it's own - although absorption can be a problem resulting in decreased augmentation later on. Also there is the possibility of a rejection and infection. These products are meant to act as a scaffold rather than an implant - which allows your own collagenation to anchor itself within the product. Thereby taking its place with possibly permanent augmentation.
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1. CYMETRA™ or Micronized AlloDerm™: (technically: micronized acellular human cadaveric dermis) made by LifeCell Corporation in Palo Alto, California. This is basically a powdered form of LifeCell's first creation, AlloDerm. When a doctor uses this injectable form of AlloDerm for tissue augmentation he need only rehydrate the product with a solution of saline and if desired, Lidocaine for comfort to the patient and inject the desired amounts into the underlying dermis. Micronized AlloDerm has a shelf life of 2 years adding to the ease of storage, making it less expensive for you, the patient.
Allergy Test: As with AlloDerm, an allergy/skin test is unnecessary
Longevity: varied reports of longevity. Usually no longer than 6 months.
Cost: $600-$900 (per 1.0 cc) Approximately $1,500 for 2.0 cc
Available in the United States? Yes.
Special Uses: Cymetra has been successfully used in the tip of the nose to cover visible cartilage grafts.
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2. Fascian™: (technically: injectable irradiated human cadaveric preserved particulate fascia lata) made by Fascia Biosystems in Beverly Hills This product was introduced in April of 99. Fascia is the big white sheets of "wrapping" that covers your muscles and some organs, keeping them compact, yet mobile. Its primary makeup is collagen protein and is very thick and dense. It takes the body many months and in some case, decades to break it down. It is more "cushy" as Fascia is a firmly yet spongy natural human tissue that can be used for soft tissue augmentation, acne scarring and other scar re-collagenation. Anywhere there is tissue loss, practically permanent augmentation can be achieved with fascia. Fascian™ comes in dry form pre-packed in measured syringes that must be re-hydrated with saline or a saline/Lidocaine mixture for comfort. An added bonus is that Fascian™ does not have to be refrigerated. It is stored at room temperature until re-hydration and used.
Allergy test: Not necessary
Longevity: The Fascia Biosystems reports 6 - 8 months, although independent researchers report 3 - 6 mo. at the most.
Approximate Cost: unknown
Available in the United States: yes
Website: http://www.fascian.com
Update: It is reported that Fascian™ is actually made from the gastrocnemius [the fascia from : the largest and most superficial muscle of the calf of the leg that arises by two heads from the condyles of the femur and has its tendon of insertion incorporated as part of the Achilles tendon -- called also gastrocnemius muscle] . This material is reported to be clumpier and more likely to clog the needle during injection.
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3. AlloDerm™: (technically: Acellular human cadaveric dermis) Although this product is not an injectable product - we have including this information because this is the whole version of Cymetra™. AlloDerm is made by LifeCell Corporation in Palo Alto, California. This product is made from donor tissue (cadaver tissue obtained at the time of death). The Tissue Banks surgically remove a thin layer of skin tissue (an allograft) from the 'donor', place into an antibiotic solution and transport it to Lifecell Corp. There, the allograft is 'processed' by removing the epidermis and all of the cells in the dermis which may cause rejection. The resulting AlloDerm graft is the protein framework without any human cells. Reportedly, there is absolutely no way whatsoever to contract any disease or virus from this product. They do extensive testing and bloodwork on the donors and they even remove the donor's DNA. The remaining material is a collagen/protein framework. There are none of the donor's components to cause rejection by a recipient's body and there have been no case reports of anyone contacting any disease, not even AIDS, from an AlloDerm graft. The donor beforehand, had been tested with FDA licensed tests ruling out AIDS, Hepatitis B & C, HIV types 1 & 2 and syphilis. After that it is individually checked under a microscope to insure the safety of a disease free graft. It is used in burn victims, surgeries and periodontal disease. But, this too, gets absorbed eventually. The AlloDerm comes in freeze dried sheets and pieces approximate to the size needed are rehydrated in a sterile solution. After full rehydration the AlloDerm is inserted or "draped" where needed.
Now, unlike synthetic, non-injectable implants which can be removed. AlloDerm, essentially, cannot be. At least it would be a difficult task. Unless it is rejected or there is an infection the tissue attaches to the allograft scaffold. It is softer inside the lips and the tissue basically becomes 'your own'. The whole version seems to last longer than the particulated version, Cymetra™.
Additionally, AlloDerm can be used to augment other areas of the body that have been subjected to tissue loss or deterioration, i.e. "draping" for burn injuries & cancer excisions as well as an implant under the surface of the skin to correct soft tissue defects. When applied as a surface skin, an extremely thin allograft of the patient's own skin is placed on top to provide the amount of tissue needed.
Allergy Test: Not necessary.
Approximate Cost: $1,000. - $2,200. per treatment.
Longevity: reported to last 12 - 24 months - average but has shown to last several years thus far in many patients.
Available in the United States: yes
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4. Dermalogen: (technically: pooled human cadaveric collagen) This product is injectable human collagen. It seems to last longer than the bovine collagen in almost all patients, plus no reactions from those who are allergic to the bovine collagen. The Dermalogen is a formed of cleansed donor collagen derived from cadaver tissue. Initially, you get about 3 injections every two weeks, so there is a gradual build up period. It has been known to last in patients for up to 9 months, but normally lasts 3 - 6 months. Dermalogen does not contain any form of anesthetic, due to this fact many patients say that it reminds them of bee stings. Some physicians offer a 'nerve block' (regional anesthesia).
Allergy Test: Reportedly not necessary.
Longevity: varies; anywhere from 3-6 months (possibly 9 months)
Approximate Cost: $400. per cc
Special Note: May not be available any longer.
Available in the United States: yes