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.

This website will not take the place of a consultation with your physician, but it will answer some of the questions often asked about treatment with injectable collagen. It will also help you and your physician decide whether CosmoDerm and CosmoPlast collagen treatments can help to smooth your skin.

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 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 substances 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 injection. Additionally, one might notice that the effect of 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 than a few days may indicate a reaction to the material. Be sure to report this or any other questionable symptoms to your physician.

SHOULD I BE AWARE OF ANY OTHER TYPES OF REACTIONS?

Yes. 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. This may persist from a few weeks to several months. Also, some areas (such as certain types of scars) may resist precise placement of the material, which can result in a slight bump beside the defect.

In a study to evaluate any potential allergic responses to CosmoDerm and CosmoPlast, 428 patients were injected with CosmoDerm 1 into the forearm and followed for 2 months . Listed in Table 1 (in descending order of frequency) are all reported adverse events with two or more occurrences in this study. 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 . Further testing suggested that these symptoms were not an allergic response to the implant.

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?