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Contents:1. What is collagen?Collagen is a natural protein that provides structural support. It is found throughout the body –in skin, muscle, tendon, and bone. Fibers of collagen are woven together like threads in fabric to form a framework into which new cells can row. In the skin, collagen provides texture, resiliency, and shape. The collagen in human skin is very similar to the collagen found in certain animals. As a result, animal collagen has had many medical applications; for example, animal collagen has been used in sutures for over a century. Heart valves used during surgery are also made of collagen. Injectable Zyderm and Zyplast Collagen Implants are made of collagen from cow skin that has been highly purified. 2. How was injectable collagen developed?In the early 1970’s, a
group of biochemists and physicians at 3. How long has injectable collagen been used?Injectable collagen was
first used to treat patients in 1976. Since
then, over 500,000 people have been treated with either Zyderm or Zyplast
Collagen Implants. The procedure
is administered routinely by over 3,500 physicians nationally, and in more
than 20 other countries. 4. How do Zyderm Collagen and Zyplast Collagen work?Both Zyderm and Zyplast
Collagen Implants lend additional support to the collagen network within the
skin. When a physician injects
small amounts of either material directly into areas where the body’s own
collagen has been weakened, depressions can be raised to the level of the
surrounding skin. Thus, lines
and scars can be minimized, texture is improved, and the skin has a softer
and more even tone. Skin before and after collagen replacement 5. How does Zyderm Collagen differ from Zyplast Collagen?Zyderm Collagen was
formulated especially for people with small or superficial contour problems.
It can be particularly effective in smoothing delicate frown and
smile lines, as well as the fine creases that develop at the corners of the
eyes and above and below the lips. It
can also help correct certain kinds of shallow scars. Zyplast Collagen was
designed to treat depressions requiring a stronger material.
It is used for more pronounced contour problems (such as deeper
scars, lines, and furrows) and for areas upon which more force is being
exerted (such as the corners of the mouth). Zyderm and Zyplast Collagen
Implants may be used alone or in conjunction with one another.
Your physician will determine the potential benefits of each and an
appropriate course of treatment. 6. Which skin depressions cannot be helped by either material?Depressions with sharp
edges and narrow “ice pack” acne scars do not usually respond to these
materials. 7. Should injectable collagen take the place of surgical procedures such as face-lifts and dermabrasion?No.
Injectable collagen treatments are not meant for people who have
excess facial skin or for those who want a major resurfacing of the skin.
However, doctors often use Zyderm or Zyplast Collagen Implants in
conjunction with surgery to fill in depressions not amenable to surgery.
By using injectable collagen following a face-lift or dermabrasion,
surgical results can be enhanced. 8. How do collagen creams differ from injectable collagen?Regardless of the
ingredients, moisturizers work only on the skin’s surface as a temporary
cap to help retain water. Zyderm
and Zyplast Collagen Implants, however, are medical products that are
injected below the skin’s surface where contour problems begin and where
collagen replacement can help. 9. Can anyone be treated with Zyderm Collagen or Zyplast Collagen Implants?No.
Your doctor will inquire about your medical history and administer a
skin test to determine if you are an appropriate candidate for treatment. If
you have a history of allergy to other bovine (cow) collagen products,
severe allergies (indicated by a history of anaphylaxis [shock], or a
history of presence of multiple severe allergies), if you are currently on
cortisteroid or immunosuppressive therapy, e.g. prednisone, or are
undergoing or planning to undergo desensitization injections to meat
products, you cannot receive injectable collagen.
Also, people who are sensitive to lidocaine cannot receive collagen
implants, as a small amount of this anesthetic is contained in Zyderm and
Zyplast Collagen Implants, and in Collagen Test Implant.
Furthermore, people who have had a previous allergic reaction to
either Zyderm or Zyplast Collagen may not be re-treated.
Neither Zyderm nor Zyplast Collagen Implant should be used for breast
augmentation, and neither material should be injected into bone, tendon,
ligament or muscle. If you have a personal
history of autoimmune disease which includes (but is not limited to)
rheumatoid arthritis, psoriatic arthritis, scleroderma (including CREST
syndrome), systemic or discoid lupus erythematosus, or polymyositis, a
dietary allergy to beef, or if you have recently been on cortisteroid or
immunosuppressive therapy, your physician may want to administer additional
skin tests before deciding if you should be treated. If you have any questions
about these medical conditions, be sure to discuss them with your doctor.
You will also be skin tested prior to treatment.
Anyone who exhibits a sensitivity to the material, as demonstrated by
the skin test, cannot proceed with treatment. 10. What is involved in injectable collagen treatment?There are three steps: a
skin test, the treatment series, and periodic touch-ups. 11. How does the skin test work?To determine if you are
eligible for treatment with either Zyderm or Zyplast Collagen Implant, your
doctor will inject a small amount of collagen into your forearm, just below
the skin’s surface. Both you
and your doctor should watch the test site closely for four weeks for any
signs of sensitivity to the material such as redness, swelling, or itching.
Pay special attention to our test site during the first three days
since the majority of the test reactions occur during this period.
At the first sign of any of these problems, contact your doctor. Only about three out of
every 100 tested patients show a sensitivity to the test and cannot be
treated with injectable collagen; 97 percent of all tested patients can be
treated. 12. When does treatment start?Treatment can begin after
the four-week test observation period if you are not sensitive to the skin
test. Treatment involves a
series of office visits –usually two weeks apart.
Most patients see considerable improvement in one to three treatment
sessions depending on the size, shape, and texture of the area undergoing
treatment. 13. Do the injections hurt?You may find that the
injections are somewhat uncomfortable, particularly around the nose or lips.
However, both Zyderm or Zyplast Collagen Implants contain a small
amount of lidocaine that helps numb the area temporarily, and most people
report that the injections are relatively painless. 14. How will my skin look and feel immediately after treatment?Most patients feel
comfortable in resuming their normal activities following treatment.
Temporary puffiness of the treated areas, however, should be
expected, especially with Zyderm Collagen Implant. With both Zyderm and
Zyplast Collagen Implants, you may also notice temporary blushing, slight
bruising, and tenderness around treatment sites.
Like the puffiness, these are normal occurrences and all should
subside within a few days. Although
the material is generally not visibly distinguishable from the surrounding
skin, some patients have reported that they are initially able to feel the
outline of the injected collagen. However, as the new
collagen is incorporated into your own skin, the treatment site takes on the
natural look and feel of healthy skin. Any
redness and/or visible swelling that persists for more than a few days may
indicate a reaction to the material. Be
sure to report this or any other questionable symptoms to your doctor. 15. How common are treatment reactions?With more than 500,000
people treated to date, only a small number of patients (approximately 1-2
percent) have developed an allergic reaction after one or more treatment
injections. These reactions may
consist of prolonged redness, swelling, itching and/or firmness at some or
all injection sites. Most have
lasted between three and four months, but in some cases have exceeded one
year. In less than 1% of tested
patients, formation of a scab and sloughing (shedding) of the tissue at the
treatment site have been noted, which can result in a shallow scar.
On rare occasions, abscess formation ahs occurred at implantation
sites. These reactions develop
weeks to months following injections, and may result in induration and/or
scar formation. Also, in fewer than 5 per
1000 patients, the following have been reported: systemic complaints such as
flu-like symptoms (nausea, fever, dizziness, headache, malaise, joint
aches), rash, blurred vision, tingling, numbness or difficulty in breathing. Of the patients who have
developed an allergic reaction after treatment, one-half had an unreported
or unrecognized response to the reactions could have been prevented.
The remaining one-half of this group developed allergic reactions
despite a response-free skin test. An additional one percent
of individuals experience symptoms similar to those of an allergic reaction
that may, however, occur periodically. Recent
research has shown that some of these patients are allergic to bovine
collagen. If you observe any symptoms
such as redness and/or swelling, please inform your physician.
He or she will determine if you should discontinue treatment; no
further injectable collagen can be administered to anyone who has
experienced an allergic reaction to the material. 16. Are there any other types of reactions I should be aware of?Yes.
There is a possibility that you could experience a reaction related
to t he injection process itself. However, this does not mean it is
necessary to discontinue treatment. For
instance, mild bruising or a slight blush could occur at the injection site.
If you have previously had facial herpes simplex at the site of injection,
there is a chance that the injection process itself could provoke another
herpes simplex eruption. If you
are using aspirin or non-steroidal anti-inflammatory drugs that reduce
coagulation, you may experience increased bruising or bleeding at injection
sites. In addition, any
injection carries a small risk of infection. Some physicians have
reported the occurrence of connective tissue diseases such as rheumatoid
arthritis, systemic lupus erythematosus, polymyositis (PM) and
dermatomyositis (DM) subsequent to collagen injections, in patients with no
previous history of these disorders. Conflicting
studies have been published in scientific journals regarding the association
between PM/DM and injectable collagen. A
causal (cause and effect) relationship between collagen injections and the
onset of PM/DM, or the other connective tissue diseases listed, has not been
established. Also, an increased
incidence of cell-mediated and humoral immunity to various collagens have
been found in systemic connective tissue diseases such as rheumatoid
arthritis, juvenile rheumatoid arthritis, and progressive systemic sclerosis
(scleroderma). Patients with
these diseases may thus have an increased susceptibility to an allergic
response and/or accelerated clearance of their implants when injected with
bovine dermal collagen preparations. If
you have any of these diseases, you should discuss this specifically with
your doctor. It is possible that, during
the process of administering injectable collagen, the needle could be
accidentally placed into or through a blood vessel.
This has been reported to have occurred in less than 1% of patients
treated. However, if it
should happen, it could result in temporary discoloration of the treated
area and/or formation of a scab, and sloughing (shedding) of this tissue at
the treatment site can result in a shallow scar.
Also, as with other substances that are injected (particularly local
anesthetics and steroids injected into the head and neck or the
extremities), there is a remote possibility of accidental injection of the
material into a blood vessel. This
could result in blockage of the blood flow and loss of circulation to nearby
sites, which in one case resulted in permanent loss of vision in one eye. There have been infrequent
reports of the injected collagen being visible in the skin, in the form of a
small raised or white area at the treatment site, which may persist from a
few weeks to several months. Also,
some areas (such as compressed scars) resist precise placement of the
material, resulting in a slight elevation beside the defect. An understanding of the
safety of injectable collagen is based on clinical data from 1978 to the
present. Ongoing research will
continue to provide more information. 17. Does the correction last forever?No. Touch-up injections are
usually needed to maintain maximum correction.
Because both Zyderm and Zyplast Collagen Implants are similar to your
own skin, they will be altered by the same ongoing mechanical forces such as
smiling or other muscle activity and biochemical processes – such as aging
active acne – that caused the original skin depressions.
It has been reported that the body may deposit its own collagen at
the site of collagen implantation. You
should therefore be aware that part or all of the correction may last for 2
years or longer. 18. How often will I need a “touch-up” injection?Most patients who choose to
receive touch-ups for lines or furrows do so within 3 to 12 months of the
original treatment series. For
scars, and perhaps those depressions treated with Zyplast Collagen, the time
between touch-ups may be longer. But
keep in mind that the amount of collagen used to restore full correction
will be considerably less than that used in the initial treatment series. Use of Zyderm I Collagen
Implant in an individual patient should be limited to 30 cc over a one-year
period. Use of Zyderm II
Collagen Implant in an individual patient should be limited to 15 cc over a
one-year period. The combination
of these products or of Zyderm in conjunction with Zyplast in an individual
patient should be limited to 30 cc over a one-year period.
The safety of injecting greater amounts on an annual basis has not
been established. 19. Without touch-ups treatments, how will my skin look?Correction may subside
gradually until skin looks like it did before treatment. Touch-up injections will
help you maintain your correction and can provide a long term solution to
skin contour problems. The the price is based on the quantity of product used, at a charge of $200.00 /0.5 cc. Patch test dose of the
collagen costs
$50.00
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