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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?
Additional information:
Other:
Updated 5/12/2003
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