People seek treatments to soften smile lines and crow's feet, fill lips, cheeks and hands, and improve the appearance of facial lines and volume loss caused by age or certain medical conditions. Injecting dermal fillers into the face and hands can achieve these goals, but it is important to understand the risks associated with this procedure. Dermal fillers are gel-like substances that are injected under the skin. They are designed to create a softer or fuller appearance, or both.
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. The FDA regulates dermal fillers as medical devices, and advises people 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 may not be suitable for people with certain conditions, such as bleeding disorders or some allergies.
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. 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.
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.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.
