CosmoDerm®/ CosmoPlast®
Collagen Replacement Therapy®


Immediate treatment. Immediate results.
CosmoDerm and CosmoPlast are injected just below the surface of the skin, filling in unwanted lines and wrinkles and adding definition to the lip border. Treatment results are immediate and typically last three to six months, depending on the area being treated. Without ongoing treatments, the collagen is gradually absorbed by the body and your face returns to its original contours.As the only commercially available dermal fillers in the world made from human collagen, CosmoDerm and CosmoPlast offer important advantages.

  • Immediate treatment – no pre-treatment skin test required!
  • Formulated with an anesthetic for comfort.
  • Treatment and recovery usually take less than one hour.
  • Treatment results typically last three to six months.

Your doctor will work with you to develop a treatment program to meet your individual needs. With CosmoDerm and CosmoPlast, you can get started today!

CosmoDerm and CosmoPlast are from Inamed Aesthetics, the only company in the world with more than 20 years of providing safe and effective collagen treatments.

Sometimes, no matter how youthful you feel, your face tells a different story. Sunlight, natural aging and lifestyle factors can diminish the collagen layer that supports the skin. And where collagen diminishes, unwelcome lines and wrinkles may appear.

And here’s the best part. No more skin testing means no more weeks of waiting for the results. Instead, you can smooth away telltale lines and wrinkles or add definition to the lip border with just one quick visit to your physician. And since recovery time is short, you can easily sneak in a treatment during your lunch hour.

COSMODERM / COSMOPLAST COLLAGEN
Replacement Therapy

CosmoDerm and CosmoPlast are dermal fillers approved for the correction of facial wrinkles, acne scars and other soft tissue contour deficiencies, as well as for the restoration of the lip border. The collagen in CosmoDerm/CosmoPlast is purified from human dermal tissue that is grown under controlled conditions. Based on a clinical study conducted by Inamed Aesthetics, a pre treatment skin test is not required. All medical procedures are subject to certain risks. Although treatments with CosmoDerm/CosmoPlast have been found to be a safe, non-surgical option for many skin contour problems, you should be aware of the safety issues and restrictions associated with their use although you should review these points with your physician; we have summarized them as follows:

CosmoDerm/CosmoPlast collagen. Implants must not be used in people with a history of serious allergic (anaphylactic) reaction or a known allergy to lidocaine (a local anesthetic). Though unlikely, it is possible for the needle to be accidentally placed through a blood vessel during injection, which could result in temporary discoloration of the treated area, or in tissue death, leading to a scab and/or scar formation. Injectable collagen, like other substances that are injected, could be accidentally injected into a blood vessel. Although this possibility is remote, it could result in a blockage of the blood flow and loss of circulation in nearby areas. Blood flow blockage resulting in permanent loss of vision in one eye has been reported once since bovine product introduction in 1981. Local necrosis (tissue damage) is a rare event which has been observed following bovine collagen implantation. Most necroses reported through post-marketing surveillance of bovine dermal collagen have occurred after injection into the glabellar region of the face (between the eyebrows)

Some physicians have reported the occurrence of connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus, polymyositis (PM), and dermatomyositis (DM) after bovine collagen injections in people with no previous history of these disorders. Conflicted studies have been published in scientific journals regarding the association between PM/DM and injectable bovine collagen. A connection between bovine collagen injections and the onset of PM/DM. or the other connective tissue diseases listed has not been established. The frequency and degree of such reactions after human collagen injections have not been determined.

An increased frequency of the potential to develop an allergic response to various collagens has been found in people with systemic connective tissue diseases, such as rheumatoid arthritis, juvenile rheumatoid arthritis, and progressive systemic sclerosis (scleroderma). A person with any one of these diseases may thus have an increased risk of experiencing an allergic response to the collagen injection. Additionally, one might notice that the effect of the collagen treatment might not last as long. The frequency and severity of such reactions with human collagen injections has not been determined.

Based on experience with bovine collagen implants, use of CosmoDerm 1 should be limited to 30 mL over a 1-year period. Use of CosmoDerm 2 should be limited to 15 ml over a 1-year period. Likewise, the use Of CosmoPlast should also be limited to 30 mL over a 1-year period. The combination of CosmoDerm 1 and CosmoDerm 2, or of CosmoDerm in conjunction with CosmoPlast should be limited to 30 mL over a 1-year period. Safety of injecting greater amounts on an annual basis has not been established.

The safety of CosmoDerm/CosmoPlast use in people with a known allergy to bovine collagen has not been studied. Injectable collagen should be used with caution in people who have asthma, hay fever, eczema, or haw a history of multiple allergies. People with these conditions may have a greater potential for exhibiting an allergic reaction. As with all procedures involving an injection, CosmoDerm/CosmoPlast collagen implantation carries a risk of infection. Also, previous facial herpes simplex at the site of injection may recur if aggravated by the injection. Active inflammatory skin conditions (e.g. cysts, pimples, rashes, or hives), or in areas where infection is present, require that treatment is postponed until the condition is under control. The safety of treatment during pregnancy or in infants and children has not been studied. CosmoDerm/CosmoPlast should be used with caution. If you are taking medication that affects your immune system or you are using substances that reduce blood clotting, such as aspirin or ibuprofen, you may, as with any injection, experience increased bruising or bleeding at injection sites. The safety and effectiveness of CosmoDerm/CosmoPlast implantation for use in lip augmentation has not been established.

There have been infrequent reports of the injected collagen being visible in the skin, as a small raised or white area at the treatment site. This may persist for a few weeks to several months. Also, some areas (e.g. compressed scars) may resist precise place­ment of the material, which can result in a slight elevation beside the defect. Temporary puffiness around the treatment site should be expected, especially with CosmoDerm implant. You may also notice temporary blushing, slight bruising, and tenderness around the site with the use of either CosmoDerm or CosmoPlast. This should resolve in a few days. Any redness and/or visible swatting that persists for more than a few days should be brought to the attention of your physician.

In a study to evaluate any potential allergic responses to CosmoDerm/CosmoPlast, 428 patients were injected in the forearm with CosmoDerm 1 and under supervision for 2 months. Reported adverse events with less 2 occurrences are as follows: Cold symptoms (4.1%); Flu-like symptoms (2.0%); Urinary tract infections (1.0%). Each of the following was reported 0.7% of the time: bronchitis. strep throat, sinus infection; acid dyspepsia or reflux, back ache, pain/spasm, ear infection, fevers, high blood pressure, insomnia, and sore throat were each reported 0.5% of the time. One subject reported redness and pain one week after the first injection. This was confirmed by the investigator as redness, tenderness, firmness and swelling at the injection site. These symptoms spontaneously resolved after 10 days without treatment or further sequelae. Further testing suggested that these symptoms were not an allergic response to the implant.

Touch-up injections are usually needed to maintain optimal correction. Because both CosmoDerm/CosmoPlast collagen are similar to other components of your skin, they will be altered by the same ongoing mechanical forces such as smiling or other muscle activity and biochemical processes (e.g. aging and active acne) that caused the original skin depressions. Based on clinical experience with bovine collagen, it has been reported that the body may deposit its own collagen at the site of collagen implantation. You should also note that lumpiness and other unsatisfactory results have been reported with bovine collagen.

Advancements in COLLAGEN REPLACEMENT THERAPY®
Over the last 20 years in the U.S., millions of procedures have been performed using Collagen Replacement Therapy® to smooth facial lines and wrinkles.

Collagen, the most abundant natural protein found in the body, provides structural support to your skin and helps keep it looking smooth and supple. However, with time, sunlight and other factors, the collagen in your skin diminishes, your skin loses structure, and unwelcome lines and wrinkles appear.

Now, through advancements in skin science, you can get the proven benefits of Collagen Replacement Therapy, plus more. As the first FDA-approved injectable wrinkle correction treatment to not require a pre-treatment skin test, CosmoDerm® and CosmoPlast® were the first to allow you to receive treatment immediately. Made from natural human collagen, CosmoDerm and CosmoPlast replenish your skin’s lost collagen, restoring skin structure, and provide immediate results with no down time. CosmoDerm and Zyderm® are the only dermal fillers approved by the FDA to treat fine lines like crow’s feet, while CosmoPlast is used to treat deeper wrinkles and to define the lip border. CosmoDerm and CosmoPlast are part of the INAMED family of collagen products, the only available dermal fillers have been formulated with an anesthetic for your comfort.

CosmoDerm® and CosmoPlast® are injected just below the surface of the skin, filling unwanted lines and wrinkles and adding definition to the lip border. Treatment usually takes about 30 minutes – and with no down time, you get immediate, natural looking results that last up to six months.

The first FDA-approved dermal fillers to not require a pre-treatment skin test, CosmoDerm and CosmoPlast replenish your skin’s lost collagen, restoring skin structure.

CosmoDerm®
Human-Based Collagen Explained

COSMODERM and COSMOPLAST<br />
COLLAGEN REPLACEMENT THERAPY

Introduction
What is Collagen?
What are these products?
Where do these products come from and how are they made?
What is the difference between this and other Collagen products on the market?
Can anyone be treated with COSMODERM or COSMOPLAST COLLAGEN implants?
What must my physician consider when using these products?
What else must my physician consider when using these products?
When should I notify my physician?
Are there any special instructions for me to follow after the treatment?
How do COSMODERM and COSMOPLAST COLLAGEN work?
How does COSMODERM COLLAGEN differ from COSMOPLAST COLLAGEN?
Which skin depressions cannot be helped by either material?
How do COLLAGEN creams differ from injectable COLLAGEN?
What is involved in injectable COLLAGEN treatment?
Do the injections hurt?
How will my skin look and feel immediately after treatment?
Does the correction last forever?
How often will I need a “Touch-Up” injection?
Without touch-up injections, how will my skin look?
What other treatments are available to me?

Introduction
Before you begin your collagen treatments, please review this important information.

The way your skin looks is directly related to the way your skin is supported. Collagen is actually part of the natural support structure of your skin. Wrinkles form when this natural collagen layer thins during the course of aging. Other factors that weaken the collagen fibers include exposure to the environment, disease, injury, heredity and lifestyle.

CosmoDerm and CosmoPlast, made of highly purified human-based collagen, can be injected into your skin to fill certain lines and deep facial wrinkles. Based on the results of a clinical study conducted by INAMED Corporation, a pre-treatment skin test, to determine if you might have an allergic response, is not required.

CosmoDerm and CosmoPlast collagen implants are injected into the collagen layer just below the surface of the skin, and are used to fill in unwanted lines and wrinkles and restore the border of the lip. Treatment results are immediate and may last anywhere from three to six months, depending on the area being treated and the amount of collagen used to achieve optimal correction. Without ongoing treatments, the injected collagen is gradually absorbed by the body and your face returns to its original appearance of the skin surface.

Your physician will work with you to develop a treatment program to meet your individual needs.

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 grow. Collagen provides the structure, texture, and shape to your skin.

What are these products?
CosmoDerm and CosmoPlast are INAMED Aesthetics’ new human collagen dermal fillers. They are treatments for smoothing wrinkles, filling furrows (deep wrinkles) and restoring the border of the lip.

CosmoDerm and CosmoPlast are the first FDA-approved dermal fillers that do not require a pre-treatment skin test prior to treatment, making them the first same-day, single-visit dermal fillers commercially available in the United States.

Where do these products come from and how are they made?
The process begins with human dermal fibroblasts, which are the cells in the lower layer of the skin (dermis) that make collagen. The cells are grown in a controlled laboratory environment, so that they behave as if they were in the human body. As the cells grow, they produce natural collagen. When the growth process is complete, the natural collagen is separated from the tissue and purified for injection.

The cell line and growth conditions used to make CosmoDerm and CosmoPlast are the same as those used for over 10 years in the manufacturing of another FDA approved device for burn and skin wound treatment. Recently, scientists developed the ability to isolate the human collagen from these laboratory-grown skin cells, which has permitted the preparation of these highly purified human collagen products.

What is the difference between this and other Collagen products on the market?
Current dermal collagen therapies require a pre-treatment skin test followed by a 28-day waiting period to determine if you will experience an allergic response to treatment. Based on the results of a clinical study conducted by INAMED Corporation, CosmoDerm and CosmoPlast do not require a pre-treatment skin test. Consequently, your physician can offer you the convenience of immediate Collagen Replacement Therapy® without the need for a pre-treatment skin test.

If these products originate from Human Tissue, are they safe?
Yes. The dermal fibroblasts are tested for a variety of potentially harmful substances according to current FDA guidelines. As the tissue is grown, it is tested extensively to ensure quality and safety. Finally, as the collagen is separated from the tissue, it is subjected to additional steps to remove any potential or harmful viruses. The end result of this very careful testing is a safe product free from detectable viruses or potentially harmful substances. In addition to this extensive testing, it is important to recognize that CosmoDerm and CosmoPlast are derived from the same cell source that physicians have been using for years in the treatment of burns and other skin wounds.

Can anyone be treated with COSMODERM or COSMOPLAST COLLAGEN implants?
No. Your physician will ask about your medical history to determine if you are an appropriate candidate for collagen treatment.

CosmoDerm and CosmoPlast collagen implants must not be used in people with a:

  • History of serious allergic (anaphylactic) reactions.
  • Known allergy to lidocaine (a local anesthetic).


What must my physician consider when using these products?
Though unlikely, it is possible for the needle to be accidentally placed through a blood vessel during injection, which could result in temporary change in color of the treated area, or in tissue death leading to a scab and/or scar formation. Injectable collagen, like other substance that are injected (particularly local anesthetics and steroids injected into the head or neck area), could be accidentally injected into a blood vessel. Although this possibility is remote, it could result in a blockage of the blood flow and loss of circulation in nearby areas. As is possible with other dermal fillers, the risk of blood flow blockage exists with human collagen implants.

Local necrosis (tissue damage) is a rare event, which has been observed following bovine (cow) collagen implantation. Most necroses reported through post-marketing surveillance of bovine dermal collagen have occurred after injection into the glabellar region of the face (between the eyebrows).

Some physicians have reported the occurrence of connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus, polymyositis (PM), and dermatomyositis (DM) after bovine collagen injections in people with no previous history of these disorders. Conflicting studies have been published in scientific or medical journals regarding the association between PM/DM and injectable bovine collagen. A connection between bovine collagen injections and the onset of PM/DM or the other connective tissue diseases listed has not been established. The frequency and degree of such reactions after human collagen injections have not been determined.

An increased frequency of the potential to develop an allergic response to various collagens has been found in people with systemic connective tissue diseases, such as rheumatoid arthritis, juvenile rheumatoid arthritis, and progressive systemic sclerosis (scleroderma). A person with any one of these diseases may thus have an increased risk of experiencing an allergic response to the collagen treatment might not last as long. The frequency and degree of such reactions with human collagen injections have not been determined.

What else must my Physician consider when using these products?
Based on experience with bovine collagen implants, the use of CosmoDerm and CosmoPlast collagen implants should be limited to the following amounts over a 1-year period:

  • CosmoDerm 1 should be limited to 30 mL
  • CosmoDerm 2 should be limited to 15 mL
  • CosmoPlast should be limited to 30 mL

The combination of CosmoDerm 1 and CosmoDerm 2, or of CosmoDerm in conjunction with CosmoPlast collagen implant should be limited to 30 mL over a one-year period. The safety of injecting greater amounts on an annual basis has not been established.

Injectable collagen should be used with caution in people who have asthma, hay fever, eczema, or have a history of multiple allergies. People with these conditions may have a greater potential for exhibiting an allergic reaction.

As with all procedures that involve an injection through the skin, CosmoDerm and CosmoPlast collagen implantation carries a risk of infection. Also, previous facial herpes simplex at the site of injection may recur if aggravated by the injection.

CosmoDerm and CosmoPlast collagen implants should not be used in specific areas where inflammation is present (e.g., skin eruptions such as cysts, pimples, rashes, or hives), or in areas where infection is present, until the skin condition is under control.

CosmoDerm and CosmoPlast collagen implants should be used with caution if you are taking medication that affects your immune system.

If you are using substances that reduce blood clotting, such as aspirin or ibuprofen, you may, as with any injection, experience increased bruising or bleeding at injection sites.

The safety of COSMODERM and COSMOPLAST in the following situations has not been studied and require consideration prior to treatment:

  • People with a known allergy to bovine collagen.
  • People during pregnancy or in infants and children.
  • Safety and effectiveness for use in lip augmentation.


When should I notify my physician?
Any redness and/or visible swelling that persists for more that a few days may indicate a reaction to the material. Be sure to report this or any other questionable symptoms to your physician.

Are there any special instructions for me to follow after the treatment?
Your physician will review with you what to expect following treatment with CosmoDerm and CosmoPlast collagen. In the first 24 hours you should avoid:

  • Strenuous exercise
  • Extensive sun or heat exposure
  • Alcoholic beverages

Exposure to any of the above may cause temporary redness, swelling, and/or itching at injection sites. Make-up may be applied a few hours post-treatment if no complications are present (e.g. open wounds, bleeding, and infection).

How do COSMODERM and COSMOPLAST COLLAGEN work?
Both CosmoDerm and CosmoPlast collagen implants enhance the network of collagen fibers already present within the skin. When a physician injects small amounts of collagen directly into areas where collagen has weakened, depressions in the skin can be raised to the level of the surrounding skin. Thus, lines and scars can be reduced.

How does COSMODERM COLLAGEN differ from COSMOPLAST COLLAGEN?
CosmoDerm collagen was designed especially for people with fine wrinkles or scars that are not very deep. 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 scars.

CosmoPlast collagen was designed to treat depressions requiring a stronger treatment material. It is used for more pronounced wrinkles and scars (such as deeper scars, lines, and furrows) and for areas upon which more stress is exerted (such as the corners of the mouth).

CosmoDerm and CosmoPlast collagen implants may be used alone or in conjunction with one another.

Your physician will discuss with you the potential benefits of each and suggest an appropriate course of treatment.

Which skin depressions cannot be helped by either material?
Depressions with sharp edges and narrow “ice pick” acne scars do not usually respond to these treatments.

How do COLLAGEN creams differ from injectable COLLAGEN?
Creams and moisturizers work only on the skin’s surface as a temporary cap to help retain water. CosmoDerm and CosmoPlast collagen implants, however, are medical products that are injected below the skin’s surface where wrinkles begin and where collagen replacement can help.

What is involved in injectable COLLAGEN treatment?
There are three steps: a consultation, the treatment series, and periodic touch-ups.

Do the injections hurt?
You may find that the injections are somewhat uncomfortable. Both CosmoDerm and CosmoPlast collagen implants contain a small amount of lidocaine that helps numb the area temporarily, and most people report that the injections are relatively painless.

How will my skin look and feel immediately after treatment?
Most people feel comfortable in resuming their normal activities following treatment. Temporary puffiness of the treated areas, however, should be expected, especially with CosmoDerm collagen implant.

With both CosmoDerm and CosmoPlast collagen implants, you may also notice temporary blushing, slight bruising, and tenderness around the treatment sites. Like the puffiness, these are normal occurrences and all should clear up within a few days. Although the injected collagen material is generally not visible in the surrounding skin, some people have reported that they were initially able to feel the outline of the injected collagen. As the new collagen is included as part of your own skin, the treatment site takes on the natural look of healthy skin.

Does the correction last forever?
No. Touch-up injections are usually needed to maintain optimal correction. Because both CosmoDerm and CosmoPlast collagen implants are similar to other parts of your skin, they may be altered by smiling, other muscle activity, and biochemical processes (such as aging and active acne) that caused the original skin depressions (such as wrinkles and scars).

Based on clinical experience with bovine collagen, it has been reported that the body may deposit its own collagen at the site of collagen implantation. You should also note that  lumpiness and other unsatisfactory results have been reported with bovine collagen and may also occur with human collagen.

How often will I need a “Touch-Up” injection?
Most people who choose to receive touch-ups for lines or deep wrinkles choose to do so within 3 to 12 months of the original treatment series. For scars, and perhaps those depressions treated with CosmoPlast collagen, the time between touch-ups may be longer. Keep in mind that the amount of collagen used during follow-up treatments will be less than that used in the initial treatment.

Without touch-up injections, how will my skin look?
Correction may reduce gradually until your skin looks like it did before treatment.

Touch-up injections will help you maintain your correction and can provide a long-term solution to problems associated with the surface of your skin.

What other treatments are available to me?
Other treatments for dermal soft tissue augmentation include bovine-based collagen and hyaluronic acid-based dermal fillers. Aside from these treatments, additional options for the correction of fine lines and wrinkles do exist and may be discussed with your physician.

 

 

BEFORE & AFTER PHOTOS

COSMODERM and COSMOPLAST<br />
COLLAGEN REPLACEMENT THERAPY before and after photos
COSMODERM and COSMOPLAST<br />
COLLAGEN photos

Advanced Dermatology P.C. and The Center for Laser and Cosmetic Surgery would like to thank CosmoDerm® and CosmoPlast® for the above supplied web content & photographs.

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