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New Device Approval

CosmoDerm™ 1 Human-Based Collagen, CosmoDerm™ 2 Human-Based Collagen and CosmoPlast™ Human-Based Collagen - P800022/S050

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: CosmoDerm™ 1 Human-Based Collagen, CosmoDerm™ 2 Human-Based Collagen CosmoPlast™ Human-Based Collagen
Manufacturer: INAMED Corporation
Address: 5540 Ekwill Street, Santa Barbara, CA 93111 USA
Approval Date: March 11, 2003
Approval Letter: http://www.fda.gov/cdrh/pdf3/p800022s050a.pdf

What is it? CosmoDerm and CosmoPlast Human-Based Collagen implants are sterile injectable liquids made of highly purified human collagen, a natural protein that supports the skin. They’re injected into the skin to correct soft tissue defects such as wrinkles and acne scars. These products also contain lidocaine, which numbs the skin at the site of injection.
CosmoDerm is used for minor skin defects. CosmoPlast is used for more serious defects.

When is it used? To correct soft tissue contour defects, such as wrinkles and acne scars.

What will it accomplish? Previous studies with injections of collagen derived from cows showed that collagen injections can fill soft tissue contour defects. Clinical studies of injections with human collagen showed that the frequency of adverse immune responses (rejection by the body) with the use of CosmoDerm™ 1 Human-Based Collagen is less than 1.3%. Because of the low percent of adverse responses, each of these two products may be injected without a skin test prior to treatment.

When should it not be used?

• In patients with severe or multiple allergies that have led to anaphylactic shock, an acute reaction that requires immediate emergency medical assistance.
• In patients with known allergy to lidocaine.
• In patients with an inflamed or infected skin condition.
• For increasing breast size.
• For implanting into bone, tendon, ligament, or muscle.

Additional information:

• Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf3/p800022s050.html

Other:

• Two methods to remove scars that have been used in the past:
  • http://www.nlm.nih.gov/medlineplus/ency/article/002987.htm
  • http://www.nlm.nih.gov/medlineplus/ency/article/000873.htm

Updated 5/12/2003

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