![]() When FDA approves a new dermal filler or an approved dermal filler for a new indication for use, a Summary of Safety and Effectiveness Data is published, which contains information about the non-clinical and clinical data the FDA reviewed and determined to support a reasonable assurance of safety and effectiveness. ![]() The FDA has NOT approved liquid silicone or silicone gel for injection to fill wrinkles or augment tissues anywhere in the body. A list of approved products and indications for use in the U.S. As such, the safety and effectiveness of these products cannot be assured. The FDA is warning health care providers and patients not to use any Juvederm Ultra 2, 3 or 4, because these products are not approved for use in the U.S. Juvederm is a prescription device that should only be injected and sold by or on the prescription of a licensed health care provider. The FDA is aware that unapproved versions of Juvederm, such as Juvederm Ultra 2, 3, and 4 have been sold and distributed in the U.S., including by online retailers. Collagen is a type of protein that is a major part of skin and other tissues in the body. ![]() When used as a soft tissue filler, PMMA beads are suspended in a gel-like solution that contains cow (bovine) collagen and injected into the face. PMMA beads are tiny, round, smooth particles that are not absorbed by the body. This material is used in other medical devices, such as bone cement and intraocular lenses.
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