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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. 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. |
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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to the Injectable Fillers Index
AlloDerm:
(technically: Acellular human
cadaveric dermis) Go into the doc's office saying that one! AlloDerm
is made by LifeCell Corporation in Palo Alto, California. It is basically
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 until all that is remaining 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
the Gore-Tex 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. So, if you
don't mind having cadaver skin inside your lips maybe this will work for you.
I have been told that augmentation can last up to 2 years, maybe a little over
one year, depending upon your body. However, patients have reported
augmentation after 5 years.
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.
 Patient Journal: If you would
like to read a personal story and view photos of a patient with AlloDerm in the
upper lip visit "My
AlloDerm Lip".
Allergy Test: n/a
Cost: Approximately $1,000. - $2,200. per lip (averaging $1,200.)
Longevity: reported to last 12 - 24 months on average (possibly
indefinitely) Depends upon the individual as well.
Website: http://www.lifecell.com/healthcare/products/alloderm/whatitis.cfm
How AlloDerm Is Processed (with diagrams): http://www.lifecell.com/healthcare/products/alloderm/patented.cfm
How AlloDerm Works (with diagrams): http://www.lifecell.com/healthcare/products/alloderm/howitworks.cfm
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Apligraf:
(technically: bi-layered skin substitute) Although I am usually against any
profiting by donated tissues, Apligraft is cultured using keratinocytes and
fibroblasts derived from neonatal foreskins which are specifically obtained for
commercial use. The donor's parents reportedly have signed consent forms
and know that their infant's keratinocytes and fibroblasts will extracted from
their circumcised foreskin. Apligraf is approved for treatment of venous
ulcers and diabetic foot ulcers. Apligraf is supplied as a circular disk
approximately 75mm in diameter by 0.75mm thick and is rarely used for cosmetic
lip augmentation.
Allergy Test: unknown
Contraindications: This product should not be used in patients
susceptible to adverse reactions associated with bovine collagen.
Cost: unknown
Longevity: unknown
Website: http://www.organogenesis.com/
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CosmoDerm
1: (technically:
human collagen dermal filler) CosmoDerm 1 Human-Based Collagen is manufactured
from human tissue which has been grown in a controlled laboratory environment.
Device Description:
"CosmoDerm and CosmoPlast Human-Based Collagen implants are sterile
devices composed of highly purified human-based collagen that is dispersed in
phosphate-buffered physiological saline containing 0.3% lidocaine. CosmoDerm
Human-Based Collagen implants are available in two forms: CosmoDerm™ 1
Human-Based Collagen and CosmoDerm™ 2 Human-Based Collagen. CosmoDerm™ 2
Human-Based Collagen implant contains almost twice the collagen concentration
of CosmoDerm™ 1 Human-Based Collagen. CosmoPlast™ Human-Based Collagen is
a sterile device composed of highly purified human-based collagen that is
crosslinked with glutaraldehyde, and dispersed in phosphate-buffered
physiological saline containing 0.3% lidocaine.
CosmoDerm and CosmoPlast Human-Based
Collagen implants contain collagen purified from human fibroblast cell culture.
The cell line used for collagen production is qualified by extensive testing for
viruses, retroviruses, cell morphology, karyology, isoenzymes, and
tumorigenicity. Prior to release each lot of human collagen is tested for
protein concentration, purity, pH, lidocaine content, residue on ignition,
differential scanning calorimetry, extrusion, appearance, sterility and
pyrogenicity. CosmoDerm and CosmoPlast Human-Based Collagen implants are sterile
and supplied in individual treatment syringes packed with sterile needles, ready
for use. CosmoDerm and CosmoPlast Human-Based Collagen implants are single use
devices." --credit: Summary of Safety and Effectiveness Data http://www.fda.gov/cdrh/pdf/P800022S050b.pdf
From FDA New Device Approval
Notification: "CosmoDerm and CosmoPlast Human-Based Collagen implants
are sterile injectable liquids made of highly purified human collagen, a natural
protein that supports the skin. They’re injected into the skin to correct soft
tissue defects such as wrinkles and acne scars. These products also contain
lidocaine, which numbs the skin at the site of injection. CosmoDerm is
used for minor skin defects. CosmoPlast is used for more serious defects."
--credit: http://www.fda.gov/cdrh/mda/docs/p800022s050.html
Allergy Test:
Not necessary due to the low incidence of sensitivity. The frequency of
adverse immune responses were determined to be at 1.3%
Longevity: 3 to 6 months
Contraindications: "CosmoDerm
and CosmoPlast Human-Based Collagens must not be used in patients with severe
allergies manifested by a history of anaphylaxis. CosmoDerm and CosmoPlast
Human-Based Collagens contain lidocaine and must not be used in patients with
known lidocaine hypersensitivity. CosmoDerm and CosmoPlast Human-Based
Collagens are contraindicated for use in breast augmentation, and for
implantation into bone, tendon, ligament, or muscle." --credit: Summary of
Safety and Effectiveness Data http://www.fda.gov/cdrh/pdf/P800022S050b.pdf
Cost: unknown
Available in the United States? Yes. CosmoDerm 1 Human-Based
Collagen is approved for injection into the papillary dermis for soft
tissue contour irregularities such as wrinkles and acne scarring.
Website: www.Inamed.com
FDA's PMA Approval (PDF): http://www.fda.gov/cdrh/pdf/P800022S050a.pdf
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Cosmoderm
2: (technically: human
collagen dermal filler) CosmoDerm 2 Human-Based Collagen is manufactured
from human tissue which has been grown in a controlled laboratory environment.
Device Description:
"CosmoDerm and CosmoPlast Human-Based Collagen implants are sterile
devices composed of highly purified human-based collagen that is dispersed in
phosphate-buffered physiological saline containing 0.3% lidocaine. CosmoDerm
Human-Based Collagen implants are available in two forms: CosmoDerm™ 1
Human-Based Collagen and CosmoDerm™ 2 Human-Based Collagen. CosmoDerm™ 2
Human-Based Collagen implant contains almost twice the collagen concentration
of CosmoDerm™ 1 Human-Based Collagen. CosmoPlast™ Human-Based Collagen is
a sterile device composed of highly purified human-based collagen that is
crosslinked with glutaraldehyde, and dispersed in phosphate-buffered
physiological saline containing 0.3% lidocaine.
CosmoDerm and CosmoPlast Human-Based
Collagen implants contain collagen purified from human fibroblast cell culture.
The cell line used for collagen production is qualified by extensive testing for
viruses, retroviruses, cell morphology, karyology, isoenzymes, and
tumorigenicity. Prior to release each lot of human collagen is tested for
protein concentration, purity, pH, lidocaine content, residue on ignition,
differential scanning calorimetry, extrusion, appearance, sterility and
pyrogenicity. CosmoDerm and CosmoPlast Human-Based Collagen implants are sterile
and supplied in individual treatment syringes packed with sterile needles, ready
for use. CosmoDerm and CosmoPlast Human-Based Collagen implants are single use
devices." --credit: Summary of Safety and Effectiveness Data http://www.fda.gov/cdrh/pdf/P800022S050b.pdf
From FDA New Device Approval
Notification: "CosmoDerm and CosmoPlast Human-Based Collagen implants
are sterile injectable liquids made of highly purified human collagen, a natural
protein that supports the skin. They’re injected into the skin to correct soft
tissue defects such as wrinkles and acne scars. These products also contain
lidocaine, which numbs the skin at the site of injection. CosmoDerm is
used for minor skin defects. CosmoPlast is used for more serious defects."
--credit: http://www.fda.gov/cdrh/mda/docs/p800022s050.html
Allergy Test:
Not necessary due to the low incidence of sensitivity. The frequency of
adverse immune responses were determined to be at 1.3%
Longevity: 3 to 6 months
Contraindications: "CosmoDerm
and CosmoPlast Human-Based Collagens must not be used in patients with severe
allergies manifested by a history of anaphylaxis. CosmoDerm and CosmoPlast
Human-Based Collagens contain lidocaine and must not be used in patients with
known lidocaine hypersensitivity. CosmoDerm and CosmoPlast Human-Based
Collagens are contraindicated for use in breast augmentation, and for
implantation into bone, tendon, ligament, or muscle." --credit: Summary of
Safety and Effectiveness Data http://www.fda.gov/cdrh/pdf/P800022S050b.pdf
Cost: unknown
Available in the United States? Yes. CosmoDerm 2 Human-Based
Collagen is approved for injection into the deep dermis for soft tissue
contour irregularities such as wrinkles and acne scarring.
Website: www.Inamed.com
FDA's PMA Approval (PDF): http://www.fda.gov/cdrh/pdf/P800022S050a.pdf
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CosmoPlast:
(technically: crosslinked
human collagen dermal filler) CosmoPlast is manufactured from human tissue which
has been grown in a controlled laboratory environment. Due to its
crosslinked natural, CosmoPlast is reserved for deeper lines, but can be used
off-label for the lips.
Device Description:
"CosmoDerm and CosmoPlast Human-Based Collagen implants are sterile
devices composed of highly purified human-based collagen that is dispersed in
phosphate-buffered physiological saline containing 0.3% lidocaine. CosmoDerm
Human-Based Collagen implants are available in two forms: CosmoDerm™ 1
Human-Based Collagen and CosmoDerm™ 2 Human-Based Collagen. CosmoDerm™ 2
Human-Based Collagen implant contains almost twice the collagen concentration
of CosmoDerm™ 1 Human-Based Collagen. CosmoPlast™ Human-Based Collagen is
a sterile device composed of highly purified human-based collagen that is
crosslinked with glutaraldehyde, and dispersed in phosphate-buffered
physiological saline containing 0.3% lidocaine.
CosmoDerm and CosmoPlast Human-Based
Collagen implants contain collagen purified from human fibroblast cell culture.
The cell line used for collagen production is qualified by extensive testing for
viruses, retroviruses, cell morphology, karyology, isoenzymes, and
tumorigenicity. Prior to release each lot of human collagen is tested for
protein concentration, purity, pH, lidocaine content, residue on ignition,
differential scanning calorimetry, extrusion, appearance, sterility and
pyrogenicity. CosmoDerm and CosmoPlast Human-Based Collagen implants are sterile
and supplied in individual treatment syringes packed with sterile needles, ready
for use. CosmoDerm and CosmoPlast Human-Based Collagen implants are single use
devices." --credit: Summary of Safety and Effectiveness Data http://www.fda.gov/cdrh/pdf/P800022S050b.pdf
From FDA New Device Approval
Notification: "CosmoDerm and CosmoPlast Human-Based Collagen implants
are sterile injectable liquids made of highly purified human collagen, a natural
protein that supports the skin. They’re injected into the skin to correct soft
tissue defects such as wrinkles and acne scars. These products also contain
lidocaine, which numbs the skin at the site of injection. CosmoDerm is
used for minor skin defects. CosmoPlast is used for more serious defects."
--credit: http://www.fda.gov/cdrh/mda/docs/p800022s050.html
Allergy Test:
Not necessary due to the low incidence of sensitivity. The frequency of
adverse immune responses were determined to be at 1.3%
Longevity: 3 to 6 months
Contraindications: "CosmoDerm
and CosmoPlast Human-Based Collagens must not be used in patients with severe
allergies manifested by a history of anaphylaxis. CosmoDerm and CosmoPlast
Human-Based Collagens contain lidocaine and must not be used in patients with
known lidocaine hypersensitivity. CosmoDerm and CosmoPlast Human-Based
Collagens are contraindicated for use in breast augmentation, and for
implantation into bone, tendon, ligament, or muscle." --credit: Summary of
Safety and Effectiveness Data http://www.fda.gov/cdrh/pdf/P800022S050b.pdf
Cost: unknown
Available in the United States? Yes. CosmoDerm 1 Human-Based
Collagen is approved for injection into the papillary dermis for soft
tissue contour irregularities such as wrinkles and acne scarring.
Website: www.Inamed.com
FDA's PMA Approval (PDF): http://www.fda.gov/cdrh/pdf/P800022S050a.pdf
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CYMETRA
or Micronized AlloDerm: (technically:
micronized acellular human cadaveric dermis) made by LifeCell Corporation
in Palo Alto, California. This is a particulated form of LifeCell's first
creation, AlloDerm. Before injection, your
surgeon will rehydrate the product with Lidocaine, and may add saline and
epinephrine. The Lidocaine is, of course, for comfort to the patient
during injection. Cymetra has a shelf life of 2 years adding to the ease
of storage, making it less expensive for you, the patient. The product is
presented in 330 mg dry particulate in a 5cc syringe. The product must be
reconstituted before
use; 330 mg is enough for 1cc (ml) of rehydrated, injectable Cymetra.
"The collagens and elastin in
Cymetra provide structure for cell repopulation, and most importantly,
preserved proteoglycans and proteins direct the patient's own cells to
initiate revascularization and cell repopulation, integrating into the
patient's own tissue. Because it is human tissue, Cymetra is metabolically
compatible with patient's body, it will not elicit an inflammatory response
nor graft rejection." --credit: http://www.lifecell.com/healthcare/products/cymetra/howitworks.cfm
Multiple visits are usually
necessary to sufficiently stimulate fibroblast activity and adequate soft tissue
augmentation.
Allergy Test: n/a
Contraindications: "Use of Cymetra
in patients exhibiting autoimmune connective tissue disease is not recommended.
Cymetra is contraindicated in infected or nonvascular surgical sites, unless
specifically prescribed by their physician. Allograft tissue used to produce
Cymetra is supplied in an antibiotic-supplemented medium. Therefore, Cymetra may
contain trace amounts of the supplemented antibiotics. The specific antibiotics
are listed on the packaging label. Cymetra should not be used in patients
sensitized to those specific antibiotics. Patients should avoid nonsteroidal
anti-inflammatory drugs, including aspirin, for the two weeks preceding
treatment with Cymetra. Ancillary agents that may cause inflammation at the
treatment site should be avoided. Cymetra should not be used in periocular line
correction or glabellar contouring." --credit: http://www.lifecell.com/healthcare/dfus/cymetra.cfm
Longevity: 3 - 9 months, also great when used in secondary rhinoplasty
applications
Cost: Pretty expensive; $600-$900 (per 1.0 cc) Approximately $1,500 for
2.0 cc Twice the price of collagen and seems to last the same time as such.
Available in the United States? Yes
Website: http://www.lifecell.com/healthcare/products/cymetra/
and http://www.lifecell.com
Preparation Instructions (PDF): http://www.lifecell.com/healthcare/dfus/cymetra_dfu.pdf
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Dermalogen
Human Tissue Matrix: (technically:
pooled human cadaveric collagen) Previously
manufactured by Collagenesis (Beverly, Massachusetts) this product
was very similar to Cymetra. However, I believe this company has gone
out of business. Collagenesis filed Chapter 11 in the U.S. Bankruptcy
Court in Boston (#19656).
Dermalogen had been used
extensively in soft tissue augmentation and repair before disappearing form
the market. It seemed to last longer than
the bovine collagen in almost all patients I have spoken to in the past.
Plus no reactions from those who are allergic to the bovine collagen.
Dermalogen was formed from a process which cleanses donor collagen derived
from cadaver tissue. Initially, you got about 3 injections every two
weeks, so there is a gradual build up period. It had been known to
last in patients for up to 9 months, but normally lasts 3 - 6 months.
Dermalogen contained fibrels and proteoglycans to stimulate your own
collagen production and vascularization. Dermalogen did not contain
any form of anesthetic. Most patients preferred either local or
regional injections of anesthetic beforehand.
Allergy Test: n/a
Longevity: varies; anywhere from 3-6 months (possibly 9 months)
Cost: Approximately $400. per cc
Available in the United States? Dermalogen is no longer manufactured
as far as I know. Unless of course it was bought out by another
company.
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Dermaplant
Allograft Surgical Implant: (technically:
Acellular human cadaveric dermis) Previously manufactured by
Collagenesis (Beverly, Massachusetts) this product was very similar
to AlloDerm. However, I believe this company has gone out of business.
Collagenesis filed Chapter 11 in the U.S. Bankruptcy Court in Boston
(#19656). Dermaplant had been used extensively in soft tissue
augmentation and repair before disappearing form the market.
Allergy Test: n/a
Longevity: unknown
Cost: unknown
Available in the United States? Dermaplant is no longer manufactured
as far as I know. Unless of course it was bought out by another
company.
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Fascian:
(technically: injectable
irradiated human cadaveric preserved particulate fascia lata) made by Fascia
Biosystems in Beverly Hills This product was introduced in April of 1999.
Fascia is comprised of the lateral (outside) sheets of Fascia from
cadaveric thighs. 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. Fascia
is a firm, yet spongy, natural human tissue that can be used for soft tissue
augmentation, acne scarring and other scars.
Fascian comes in
dry, particulated form and is pre-packaged in measured syringes. Fascian
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. Fascian reportedly
takes the many months body for the to break it down.
However, everyone I
have ever spoken to about it in my own personal experience (including surgeons)
said that it lasted about as long as collagen, was lumpy, was difficult to
inject and even had a lot of swelling and discomfort after. Also that the
injector had to be very skilled to give the treatment, plus the syringes clogged
up making it even more difficult to inject. Fascia grafts themselves seem
to be fine from your own body like the temporal fascia. The particulated
nature of Fascian may be it's very downfall. When something is already
broken down smaller, the body will find it easier to break it down faster.
Allergy test: n/a
Longevity: Fascia Biosystems reports 6 to 8 months, but our independent
patients and surgeons reported 3 to 6 months at most.
Cost: Fascian at cost is $125. per syringe if you buy 1-9 syringes
and $115. per syringe if you buy 10 or more syringes. However, patients
are usually charged between $300. and $500. per treatment.
Available in the United States: Yes
Website: www.fascian.com
Update! 02/24/01:
This was sent to us from an ex-employee "...he [Dr. Burres] chose to go
with a generic syringe that is hard to hold during injection. Also, and
very important, Fascian is NOT from fascia lata, but from the gastrocnemius [:
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 clumpier and more likely to clog the needle during injection.
If there were clinicals [: trials]
to prove efficacy (Dr. Burres doesn't want to spend the money) gastrocnemius
could possibly prove to be less successful as a filler material."
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Surgisis
Soft Tissue
Graft:
(technically: porcine (pig) acellular collagen matrix) Manufactured
by Cook Biotech, Inc. (SIS Technology), Surgisis is tissue derived from the
submucosa of pigs. It is used similarly to AlloDerm, but a lot cheaper
considering the source. The product resembles a mesh and actually lasts
considerably longer than AlloDerm. Your body seeds the graft with
fibroblasts and it becomes your own. The product is presented
freeze-dried, in sealed packages.
Allergy test: n/a
Longevity: Reportedly several years to possibly permanent.
Cost: unknown
Available in the United States: Yes
Caution: If you are allergic to anything porcine (pig) derives, please
let your surgeon know.
Website: http://www.cooksis.com
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Surgisis
ES Soft Tissue Graft:
(technically: porcine (pig) acellular collagen matrix)
Manufactured by Cook Biotech, Inc. (SIS Technology), Surgisis is tissue derived
from the submucosa of pigs. It is the same as Surgisis but it has enhanced
strength due to twice the thickness. The product resembles a a thicker
mesh. Your body seeds the graft with fibroblasts and it becomes your own.
The product is presented freeze-dried, in sealed packages.
Allergy test: n/a
Longevity: Reportedly several years to possibly permanent.
Cost: unknown
Available in the United States: Yes
Caution: If you are allergic to anything porcine (pig) derives, please
let your surgeon know.
Website: http://www.cooksis.com
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