CosmoDermTM & CosmoPlastTM - Safety Information

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 have 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 skin 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. 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 and effectiveness of CosmoDerm/CosmoPlast implantation for use in lip augmentation has not been established.

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