Despite many marketing claims, there is no skin care product that can replace volume like injectable filler does, says Nancy Samolitis, MD, an anti-aging expert and board-certified dermatologist specializing in cosmetic and laser dermatology at Facile in West Hollywood. The FDA advises you to work with a licensed healthcare provider who has experience injecting dermal fillers, who knows the fillers, anatomy, handling complications and, most importantly, informs you of the risks and benefits before receiving treatment. Dermal fillers are gel-like substances that are injected under the skin. Dermal fillers are designed to create a softer or fuller appearance, or both.
FDA Regulates Dermal Fillers as Medical Devices. As reported in clinical trials, the effects of most FDA-approved dermal fillers are temporary because they are made of materials that the body eventually breaks down and absorbs. The injection procedure may have to be repeated to maintain the desired effect. There is only one FDA-approved dermal filler that is not absorbed by the body.
It is made with polymethylmethacrylate (PMMA) beads suspended in a solution containing bovine (cow) collagen. PMMA beads are small, round, smooth, plastic. As with any medical procedure, there are risks associated with the use of dermal fillers. Most side effects reported in clinical trials and post-marketing surveillance occur soon after injection and disappear within a few weeks.
In some cases, side effects may appear weeks, months, or years later. People should be tested for allergies before receiving dermal fillers made with certain materials, especially animal-derived materials, such as collagen. Inadvertent Injection into Blood Vessels The most serious risk associated with dermal fillers is accidental injection into a blood vessel. Filling that enters a blood vessel can cause skin necrosis (tissue death), stroke, or blindness.
While the chances of this happening are low, if it occurs, the resulting complications can be serious and can be permanent. Removing Dermal Fillers If you want to have your fillers removed or reduced because of side effects, you may need additional procedures to reduce the filler or surgery to remove it. These procedures carry their own risks. Keep in mind that it may be difficult or impossible to remove some fillers.
The FDA has also approved botulinum toxin products such as Botox, Dysport, Xeomin and Jeuveau to treat facial wrinkles. These products are not dermal fillers. They are injectable medications that work by preventing muscles from contracting, so wrinkles are not seen as much. The safe use of dermal fillers in combination with Botox and other treatments has not been evaluated in clinical studies.
Although botulinum toxin products are derived from the same bacteria that cause botulism, the amounts used for cosmetic purposes are purified and are many orders of magnitude smaller. The FDA has approved these injectable drugs for temporary improvement in the appearance of one or perhaps several types of facial lines, including frown lines, forehead lines, and crow's feet. Side effects reported in clinical trials include facial weakness, drooping of the eyelids and drooping of the eyebrows. Other adverse events included localized pain, swelling, redness and bruising at the injection site.
In rare cases, injections have caused double vision, dry eyes, or difficulty swallowing or breathing. Injection of botulinum toxin products for cosmetic purposes is not recommended for use during pregnancy or breastfeeding. If you have had a problem with a dermal filler or other FDA-regulated product, you can voluntarily report it to MedWatch, the FDA's safety information and adverse event reporting program. Sign up to receive email notifications for updates. If you are not satisfied with the look of the filling, don't panic in most cases, you can have them adjust it. A dermatologist may inject additional filler to maintain balance or may dissolve it completely, depending on the type.
The wonderful thing about hyaluronic acid fillers is that there is an enzyme that can be injected into the area to dissolve the product. Botox injections are given by healthcare providers who specialize in treating any part of the face. Most dermatologists and ophthalmologists offer Botox treatments. One of the advantages of Botox is that the injections are safe and effective for most people without the need for surgery or recovery time. In general, a dermal filling procedure is performed on an outpatient basis. The number of injections you receive and the depth of insertion depend on the type of filling you request.
There is minimal pain involved and you will be able to resume your normal activities right away. You may need to postpone more strenuous activities for a day or two after the procedure. Because many forms of Juvederm contain lidocaine, many patients prefer this skin filler because local anesthesia makes the process more comfortable. Juvederm works great for multiple areas, including the lips and nasolabial areas (those parenthesis marks between the nose and mouth). Juvederm Voluma is the first FDA-approved filling in the U.
S. UU. for volumizing.