Injectable soft tissue fillers are used in
patients who have loss of volume related to general aging, sun damage,
facial wasting conditions such as Romberg's Disease and HIV, and for
cosmetic augmentation of contours that are undesirably small and flat
such as the cheeks and lips. Most fillers are place in the second
layer of the skin called the Dermis, where they can be incorporated
with one's own collagen, and others are placed in the third layer
of skin called the
Subcutaneous tissue when bumpiness and hardness is of concern, and
where bulk contour filling is desirable. The current agents are grouped
according composition. |
Natural Biological Fillers |
- Fat grafts.
The new science of Structural fat Grafting of small parcels through
multiple injections of fat harvested with little trauma and cleaned
of blood and oils has contributed to better survival of the fat.
About 60% of the fat is absorbed at 4-6 months. Costs range from
$750 to $4,500 for the face. Low incidence of infection and lumps.
Avoid lower lids and crowsfeet.
- Fascia
grafts soft tissue coverage.
May
resorb. Used in the nose as coverage of thinned areas. No allergy.
Rare infection and thickening. One's own tissue and not rejected.
- Dermal fat grafts.
The dermis and fat of skin used for bulk. Requires donor scar
for harvest and may be bulky. If placed carefully and fixed with
internal sutures, it may serve as nice contouring agent and remain
long term.
|
Processed Biological Fillers. (Biodegradable) |
- Collagen (Bovine)
Cattle Protein, is the gold standard. Should be injected superficially
as the lighter Zyderm II and deeper as the more enduring Zyplast,
for lips, smile and frown lines. Takes about 20-60 minutes.
Fees are $300 to $4000. May last 3- 6 months done this way with
both agents in one session. Some patients indicate it lasts only
1- 3 months if for example small amounts of Zyderm II are used
alone, and by chance if Zyderm I ( the skin test collagen and
the weakest of the three strengths) is used without combining
it with the stronger formd). Skin testing required ( Zyderm I).
2-4% allergic reaction rate. Always absorbed 100% over time. Bumps
can occur if injected too superficially and near the lids. Should
not be injected deep into lips and facial fat. Can cause lumps
around crowsfeet especially if Zyplast is used in larger doses.
Cost about $300 / cc of syringe stock. Can use up to 6 cc around
the mouth and lips in some cases. FDA Approval for small areas
not lip substance injection for considerable bulk; late breakthrough
allergic reactions reported.
- Restoplast
(same as Zyderm)
Available only in Europe Lasts 3-6 months.
- Fibrel (Human Plasma Collagen)
Derived from blood taken from the patient and processed to form
injectable collagen. Lasts 2-4 months. Costs $300 to $5000 for
major bulk injections. No allergies. No skin testing required.
US YES.
- Plasma
Gel ( Human Plasma Collagen Mixed with Vitamin C)
Derived from blood taken from the patient, and processed and mixed
with a Vitamin C preparation. Lasts 2-4 months. 7-10% is said
to be permanent. Costs $250-$500 for limited areas. No allergies.
No skin testing required. US YES.
- Dermalogen
Human modified collagen matrix in phospate buffer at a neutral
pH. No allergic reactions nor skin testing. Usuually 2-3 injections
over a 3 months period. Does last longer than collagen and Fibril
3 - 6 months. $400 and up per injection. US YES.
- Dermicol
(collagen from unknown source)
Colbar R&D Europe. Lasts 4-6 months.
- Isolagen
A biopsy of your own tissue is processed by the company and expanded
to increase the volumeof injectable material. Eight weeks after
the processing it is ready to inject. You then have several injections
scheduled. Does resorb moderately. Expensive. US YES.
- Fascian
Cadaver human tissue in particulate form. High absorption rate.
Larger volumes like 3cc increments can be used deep in dermis
as compared with collagen, but lasts about the same as for collagen.
No allergy testing. Fees are $300 per syringe. Usually two are
used for the lips. US YES.
- Cymetra (Alloderm in Particle Form)
Human particulate cadaver tissue processed to last longer than
collagen. Injectable form of the sheets of tissue in Alloderm.
No allergies and must be supplemented. More expensive than alloderm,
and fascian $500-$1000 per syringe. US YES.
- Alloderm
(Life Cell Corporation Palo Alto, CA)
Cadaver fascia that comes in sheets for soft tissue coverage and
fill. Absorbs in lips and face at one year. May be stiff and bulky
in lips. May last 1-3 years. Costs $1200 to $2500 for both lips.
US YES.
|
| Synthetic
Non Biological Fillers ( Non Biodegradable) |
| Silicone and Teflon |
- Silicone Gel or Oil (MDX 4-4011) (Silikon 1000)
Microdroplets are injected with medical grade material. Highly
regulated. Only off-label use by selected few centers. Serious
complications over time with larger volumes, including lumps,
infection, extrusion, and thickening of the skin and underlying
tissues. Costs vary. Difficult to correct lumps except by direct
excision which leavings scarring.
- Teflon Paste
Glycerin plus polytetraflouroethylene. Severe chronic infections
have occurred. It must be removed in several months. May transport
to liver.
- Bioplastique
Initially encouraging in the early 1990s, a suspension of polymerized
silicone particles ( 70u-140u), purported not to migrate around,
dispersed in polyvinylpolypyrrolidone. Withdrawn from US markets
due to chronic inflammation and rejection problems. Still available
elsewhere. Surgical removal necessary leaving scars. Used in urethra
for urinary incontinence. Feels the consistency of cartilage where
injected.
|
|
Microspheres of Polymethylmethacrylate (20u-40u, 40u-60u)
Discovered in Germany pre-1936
- Artecoll (32u-40u)
Gelatin suspension of collagen or hyaluronate mixed with the above
and with a local anesthetic 0.3% lidocaine. Gaining popularity
worldwide. Selected centers in US. May receive FDA approval for
on label use in 2003. 1% allergy and reactivity rate leaving bumps
and redness. Stays firm! Used for 10 years with over 100,000 injections
experience. Is steep learning curve
to inject as small cylindrical parcels in deep dermis. The collagen
component resorbs in 3 months and mixes with your own collagen.
Liability already shown in US for its use. Requires an allergy
test due to the protein. Use in the nose for irregularities, acne
scars, and all folds and wrinkles of the face. Controlled absorption
may last one year. Costs $600- $4000. Potential
toxicity at more than 7 cc per year.
- Metrex
Canada. Initial results not encouraging.
- Metacril makers of Metacylathe (40u-80u)
Similar to Artecoll distributed in Brazil. Discovered in Germany.
Polymethylmethacrylate micro beads. Spreads out below dermis in
fat. Is permanent and hard to remove if nodules form Cost $400
per injection site. Allergy testing not known. Will not ever be
approved in US.
- Arteplast (20u-42u)
Microspheres of polymethylmethacrylate suspended in bovine (cattle)
collagen like plexiglass and is the same material as Artecoll.
Particles felt to be too small compared with Artecoll and thus
use discontinued and withdrawn.
|
|
Polyethylene Micro Beads
- Profill or Profil
Suspended polyethylene ( same as components in Porex who makes
Medpor facial integrating implants) suspended in saline combined
with collagen as a carrier. Reported as permanent. Allergy testing
? Really similar to Artecoll.beads but is polyethylene though.
|
|
Gortex ( Expanded Polytetraflouroethylene)
Strands or strings for the lips and folds $1200 to $2000 per lip.
- Softform Implant
Hollow tubes like cocktail straw size implanted into nasolabial
folds and lip margins. Stiff and can coil and kink and extrude.
Particles in the implant are 10u-100u. Severe late and chronic
infection may lead to its removal. May be detected in the liver.
|
PTFE (ADVANTA)
Vascular graft material like Gortex permanent and removable |
|
Synthetic Biocompatible Biodegradable Polymer ( Aliphatic Polyesters)
- Polylactic Acid (New Fill) or PLA
Safety by toxicology studies. Usually 4-5 sessions and repeat
at one year. Selected Centers in the US. Costs $800- $6500.
- Evolution
Differing views on what this really is
positively charged non-animal substance from a medical suture
model. Attracts negatively charged pro-collagen particles. Injected
volume decreases by 30 % and then thickens forming a mesh with
collagen. No allergy test required and causes little swelling.
$300 per syringe.
- Restylane ( Q Med Labs in Sweden)
Synthetic hyaluronic acid (used in knee joints to cushion for
arthritis) A natural occurring substance in all living organisms.
May integrate with bodies own hyaluronic acid. May last longer
than collagen. Last 3-4 months in lips and 4-6 months in nasolabial
folds. No skin testing required. Costs $300- $600 for limited
areas. US Clinical Trials.
- Perlane ( Q Med Labs in Sweden)
Thicker version of Restylane for deeper folds and grooves near
the mouth. Said to last 3-9 months. Costs not known. A few centers
using in US in clinical trials.
- Macrolane. (Q Med Labs in Sweden)
Even thicker than Perlane and longer to absorb. May last up to
2 years. Being studied for Breast Augmentation as well. No skin
testing but some are considering skin testing since it has such
a lengthy resorption time. Costs not known. Only used in Sweden.
- Rofilan Hylan Gel
Hyaluronic acid mixed with acid agent to stabilize it. Larger
particle size than hyaluronic gels of other topical fillers and
suppose to last longer. Similar longevity as collagen and other
hyaluronic acid fillers. No allergy testing. Cost $250 - $300.
Not available in US.
- Hylaform
Similar to restylane but made from rooster combs which have hylaluronic
acid No Allergy Testing but rare allergic reactions. Lasts 3-
12 months, usually the former. US Clinical Trials.
- Juv'ederm (L.E.A. Derm)
Hyaluronic Acid No allergy test. Lasts 3-6 months two forms for
fine lines and bulk filling. Paris Not in US.
- MacDermol
(France mainly) No skin test known. Clear gel like restylane.
- AcHyal (Europe, UK )
Non animal based hyaluronic acid. Lasts 3-9 months.
|
| Synthetic
Non Biological Polymers |
|
Polyacrylamide Gels
- Aquamid
2.5% polyacrylamide gel in 97.5% water. No microparticles. Very
elastic and no firmness. Purported to be longlasting. 243 cases
in Europe in 2001 without serious side effects. Very expensive
in the $900-$5000 range.
- Bio-Alcamid
- Formacryl
Injectable polyacrylamide gel with 0.4% unpolymerized polyacrylamide.
Termed an acrylic hydrogel suspended in 95% water. When water
is absorbed stays plump like own tissue and does not harden. It
retains fluid to create its plumpness. No allergy test. May be
removed by aspirating out and said to be permanent. Late bacterial
infection reported at 3-5 years and more inflammatory. Our EPA
regulates acrylamide in drinking water and raises concerns. The
levels in this preparation are very small. Not in US.
- Argiform
Europe and Russia production. Same as formacryl. Is antibacterial
in this new form. The company Bioform in Russia says safer since
presence of silver ions in preparation which repel bacteria. Permanent
but can be removed by needle aspiration.
- Bioformacryl
Same as formacryl. Italian produced. Late problems like Formacryl.
- Dermalive
Acrylic hydrogel implant suspended in hyaluronic acid. Hardening
and infection can occur. Removal difficult. Not designed for superficial
lines in lips. Best for deep nasolabial folds.
- DermaDeep
Like Dermalive for even deep layers including below the dermis.
- Amazing Gel
Injectable hydrophilic polyacrylamide gel with unknown % of residual
unpolymerized acrylamide. No skin testing is necessary. Same as
Formacryl and clones.
- Evolution
Polyvinyl spheres in polyacrylamide gel Decreases then builds
with time ? Permanent no allergy testing and minimal swelling.
Not in US.
- Outline
Hydrophilic polyacrylamide hydrogel. No allergy test and minimal
swelling Similar to Evolution ? Permanent ? Touchups
|
| LIP
EXTERNAL PUMP DEVICES |
Luscious Lips
29.95 can leave minor bruising Does work Repeat sessions necessary
and may be uncomfortable. |
IGIA Lip Enhancer
Same as above 8.95 to 11.95 cost. Use daily can augment effects of
fat injection by personal experience in our practice. |