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COLLAGEN INJECTION FAQ
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Q - Do Collagen Injections Work for Making Plumper and Fuller Lips - A - Yes
Q - Is the treatment safe? A - Yes, but there are numerous potential side
effects.
Q - Is the treatment expensive? A - Collagen Injections are not cheap. Each
treatment generally costs between $200 and $400 and collagen lip injections must be
repeated every month or every several months to maintain the effect.
Q - Are there natural ways to achieve plumpler lips without collagen inject surgery?
A -Yes
Complete Lafemme Lip Maximizing Formula, Body Innoventions Lip Explosion and Sovage
Transdermal Lip Plumper are also established and research proven natural methods of
achieving plumper lips and fuller looking lips without side effects and expense of
surgical collagen injections.
COLLAGEN INJECTIONS FACT SHEET:
The following information has been prepared by the Food and Drug Administration and
other sources to answer questions about the regulatory status and the possible risks of a
special cosmetic procedure called collagen injection. FDA has approved collagen injections
for some purposes; it has not approved liquid silicone injections for any purposes.
What is injectable collagen?
Injectable collagen is a liquid made from the connective tissue of cows or pigs that is
injected into and under the skin for cosmetic purposes. Two trade names for the type
derived from cows are Zyderm and Zyplast, both manufactured by the Collagen Corporation.
Another product, manufactured from pig collagen by Mentor Corporation, is known as Fibrel.
What Is Collagen?
Collagen is actually part of the natural support structure of your skin. Wrinkles form
when its natural collagen thins. This loss is mostly a factor of aging, but sun exposure,
pollution, health, heredity, and lifestyle also play a role. Collagen replacement therapy
(Using Zyderm and Zyplast collagen implants) replenishes the skin's collagen layer,
smoothing lines and wrinkles, and adding definition to lip borders from the inside out,
with immediate results. Collagen has been FDA approved and used successfully on millions
of patients for over 15 years!
What are the FDA-approved uses for injectable collagen?
Injectable collagen has been approved by FDA for filling in "contour
deformities" in the skin such as acne scars and wrinkles. It is not approved for
"augmentation"œthat is, for enlarging otherwise normal facial features. It
is also not approved for injection directly into the pigmented area of the lips (but it
can be used to correct wrinkles on the skin bordering the lips).
How long do the effects of treatment last?
To maintain the effect, collagen injections are usually repeated periodically.
The time between treatments varies depending on the patient and the part of the face being
treated. Generally, the effects of treatment last from a few months to about a
year-and-a-half. In some cases, the effects are shorter-lasting, especially in the lip
area where the effects seldom last more than a month or two.
What are the risks of collagen treatments?
About 3 percent of the population is allergic to collagen, and these people
should not receive the treatments. (This includes individuals who have had allergic
reactions to other collagen-containing products, such as surgical sutures and sponges.)
Collagen injections should also not be given to people with severe allergies to numerous
other substances.
People may be allergic to collagen and not know it. For this reason, all patients
considering collagen injections must first be tested for collagen allergy. To do this, the
doctor injects a small amount of collagen in the forearm and watches for a reaction for
four weeks before beginning any treatment. Even the allergy test is not perfectœa
small percentage of patients who do not react to the test have developed allergies during
the course of treatment.
Collagen allergies can take the form of rash, hives, joint and muscle pain, headache, and,
in a few cases, severe reactions that include shock and difficulty breathing. Other
adverse effects that have occurred after collagen injections, and which appear to have
been related to the injections, include infections, abscesses, open sores, lumps, peeling
of the skin, scarring, recurrence of herpes simplex, and partial blindness.
Patients with certain connective tissue diseases may have an increased risk of severe
allergic reactions to collagen injections. These connective tissue diseases include, but
are not limited to, rheumatoid arthritis, scleroderma, and juvenile rheumatoid arthritis.
They also include polymyositis and dermatomyositis ("PM/DM"), which are chronic,
progressive, sometimes fatal inflammatory disorders. Thus, collagen injections should be
used with caution in people who have had these diseases. Some experts recommend that
people who have had these diseases should either not be given collagen injections at all
or should be given multiple skin tests before treatment.
Some physicians have reported that patients developed PM/DM and other connective tissue
diseases after receiving collagen injections even though they never had these diseases
before. FDA is investigating whether there is a cause-and-effect relationship between
having collagen treatments and later developing PM/DM or similar diseases.
Because collagen stays in the body and continues to be absorbed, the possible effects of
collagen injections before or during pregnancy are unknown.
Should doctors administering collagen injections provide patient with information on
possible side effects of this product?
Yes. The manufacturers provide doctors with a patient brochure that explains the possible
risks of collagen injections and identifies patients who should not receive this
treatment. The package insert that doctors receive says that patients should be given a
copy of this brochure before the initial allergy test for collagen is performed.
If a person is considering collagen injections, what should he or she discuss with the
doctor?
In addition to reading the brochure carefully, patients should discuss with doctors the
advantages and disadvantages of collagen injections, including how often treatments need
to be repeated to maintain the effect. Patients should ask about the potential risks and
tell the doctor about any history of allergies or connective tissue diseases such as
rheumatoid arthritis or scleroderma.
Liquid Silicone Injections
Has liquid silicone been approved by FDA for injection?
No. 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).
Can FDA prohibit doctors from promoting the injection of liquid silicone, since its
marketing has not been approved?
Yes. FDA prohibits manufacturers or doctors from marketing or promoting unapproved
products such as liquid silicone. This means that a doctor cannot legally advertise or
sell this material.
Collagen Injection Side Effects
Collagen injections, although not considered surgical procedures, carry some of the same
risks as cosmetic surgery. Risks include:
A reaction to the anesthesia - liquid collagen injections contain a local anesthetic
(lidocaine).
Allergic reaction - collagen injections are derived from bovine collagen, so anyone who is
allergic to bovine products should not receive this treatment. Other side effects
may include:
Redness
Swelling or bruising
Itching
Abscesses
Open sores
Peeling
Scarring
Lumpiness
Collagen Injection Costs:
Costs vary widely by area and type of injection but generally average around $250
per treatment
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