![]() 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. Polymethylmethacrylate beads (PMMA microspheres): PMMA is a non-biodegradable, biocompatible, man-made polymer.The effects of PLLA generally become increasingly apparent over time (over a period of several weeks) and its effects may last up to 2 years. PLLA is a long lasting filler material that is given in a series of injections over a period of several months. This material has wide uses in absorbable stitches and bone screws. Poly-L-lactic acid (PLLA): PLLA is a biodegradable, biocompatible man-made polymer.While in the body, calcium hydroxylapatite will be visible in x-rays and may obscure underlying features. The effects of this material last approximately 18 months. For wrinkle filling in the face or for the hand, calcium hydroxylapatite particles are suspended in a gel-like solution and then injected into the wrinkle in the face or under the skin in the back of the hand. Calcium hydroxylapatite: Calcium hydroxylapatite is a type of mineral that is commonly found in human teeth and bones.The effects of this material last approximately 6 – 12 months. In some cases, hyaluronic acid used in dermal fillers is chemically modified (crosslinked) to make it last longer in the body. Sources of hyaluronic acid used in dermal fillers can be from bacteria or rooster combs (avian). It is able to combine with water and swell when in gel form, causing a smoothing/filling effect. Hyaluronic acid: Hyaluronic acid is a type of sugar (polysaccharide) that is present in body tissues, such as in skin and cartilage.The materials used in dermal fillers include: Absorbable (temporary) materials Some dermal fillers also contain lidocaine, which is intended to decrease pain or discomfort related to the injection. The FDA has approved only one product made from a material that remains in the body and is not absorbed. Most dermal fillers have a temporary effect, because they contain materials that are absorbed by the body over time. The FDA's approval is based on the review of data collected from controlled clinical studies that evaluated the safe and effective use of the wrinkle fillers when injected into specified areas of facial tissue and the hands.
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