The formation of permanent hard nodules.Leakage or rupture of the filler material at the injection site or through the skin (which may result from tissue reaction or infection).Migration (movement of filler material from the site of injection).Severe allergic reaction (anaphylactic shock) that requires immediate emergency medical assistance.The following rare risks have also been reported to the FDA: Raised bumps in or under the skin (nodules or granulomas) that may need to be treated with injections, oral antibiotics, or surgically removed.Difficulty in performing activities (only observed when injected into the back of the hand).The risks associated with unapproved uses of dermal fillers, or with the use of unapproved products are not known. The following risks accompany FDA-approved uses of dermal fillers. Patients should be tested for allergies before using fillers made with certain materials, especially animal-derived materials (for example, cow (bovine) or rooster comb). Complications reported include necrosis (death of tissue), vision abnormalities including blindness, and stroke. While the chances of this happening are low, if it does happen, the resulting complications can be serious and may be permanent. The most concerning risk associated with the use of dermal fillers is unintentional injection into a blood vessel, leading to blocked blood vessels and poor blood supply to tissues. In some cases, side effects from a dermal filler injection may appear weeks, months, or years after injection. Swelling and pain after hand treatment may last a month or longer. Most side effects associated with dermal fillers occur shortly after injection and many resolve in a few weeks. It is important to understand their limits and probable risks.Īny dermal filler can cause temporary side effects, permanent side effects, or both. The FDA is aware of serious adverse events with the use of needle-free devices for injection of dermal fillers and has issued a Safety Communication regarding the risk of using needle-free devices for injection of dermal fillers.Īs with any medical procedure, there are risks involved with the use of dermal fillers. The FDA has also not approved any dermal fillers for over-the-counter (OTC) use. ![]() ![]() The safety and effectiveness of needle-free devices for injection of dermal fillers is not known. Needle-free devices are not approved by the FDA for the injection of dermal fillers. Silicone injections can lead to long term pain, infections, and serious injuries, such as scarring and permanent disfigurement, embolism (blockage of a blood vessel), stroke, and death. Injectable silicone is not approved for any aesthetic procedure including facial and body contouring or enhancement. These uses for dermal fillers are not approved by the FDA. Inject the glabella (area between eyebrows), nose, periorbital area (around the eyes), forehead, or neck.Implant into bone, tendon, ligament, or muscle.Increase breast size (breast augmentation).The FDA recommends against using dermal fillers or any injectable filler for body contouring and enhancement to: Correction of contour deficiencies, such as wrinkles and acne scars. ![]()
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