CosmoDermTM & CosmoPlastTM - Safety Information

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 Allergan 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) reactions 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 postmarketing surveillance of bovine dermal collagen have occurred after injection into the glabellar region of the face (between the eyebrows).

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