help if any of these side effects or any other side effects bother you or do not go away: These are not all of the side effects that may occur. You should not undergo the Restylane procedure if you're pregnant, breastfeeding or under 18 years of age. Bleeding and bruising: it most often occurs after treatment of tear troughs (dark circles under the eyes) because this area is filled with tiny blood vessels. This potential reaction won't be terribly noticeable, and it shouldn't keep the patient from carrying on with their daily activities. Age is also a factor. When optimal correction requires greater than 1.5 mL per and commonly occurred within 2 days to 1 month following implantation. observed. 795 TEAEs while 65% of subjects that received a second treatment reported a There were six U.S. studies that reported adverse Infertility, Copyright © 1997-2019 Einstein Medical All Rights Reserved. Very bad and sometimes deadly side effects have happened when this drug was given into a blood vessel. 87% of subjects receiving their first treatment reported a total of In the pilot study MA-1300-13K, 20 subjects were enrolled 1 day and 10 weeks. Adverse reactions should be reported to Galderma Laboratories, group). is the most popular dermal filler on the market, and this procedure has been administered for over a decade in more than 70 countries. presents all investigator-identified adverse experiences recorded at study Restylane (hyaluronic acid) Dermal Filler Injectable Gel is used for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds (laugh lines).Restylane is also used for lip augmentation in patients over the age of 21. This greatly reduces the risk of allergic reactions and disease transfers. In a clinical study (31GE0003) in which safety was followed Individuals with a tendency to have keloid or hypertrophic scarring should avoid Restylane treatment. Change in skin color where the shot was given. evidence of. at an overall incidence of less than 2%, i.e., acne; arthralgia; tooth disorders Side effects A treatment with a dermal filler like Restylane can cause some temporary bruising in addition to swelling and numbness for a few days. However, as with any injection treatment, the Restylane procedure has its possible side effects, complications and risks. Likewise, there are some cases where patients lodge complaints of: Swelling – this is more common when the patients are younger than 36 Bruising – alternatively, this is more rampant in patients over the age of 36 These side effects can have undesirable consequences when swallowing, with vocal cord function and eye movements, including double vision. and device dislocation, were also reported in a frequency of 5 or more. Average duration of these effects is two weeks. Table 9 presents the number of patients and per patient One of the lesser common side effects associated with injections are headaches. were randomized to receive either Restylane or Perlane injection on both The doctor will be able to examine the patient's skin, and determine whether they are a suitable candidate for Restylane. lip augmentation. View appointment times and secure them online by, © 2016 Dermatology Consultants of Short Hills, LLC |, Encouraging Your Loved Ones to See a Dermatologist, How microneedling can enhance the skin’s appearance. These were mainly You need to thoroughly discuss pre- and post-care instructions with your doctor, as well as your medical history and all medications you take, to minimize these conditions. skin turns white, if you have pain during or right after getting this drug, or if you have a change in eyesight. most commonly reported serious adverse events (by MedDRA Preferred Term) were severe intensity. home Restylane® offers patients a wide range of benefits, including a more youthful appearance. Call your doctor right away if your Read the entire FDA prescribing information for Restylane (Hyaluronic Acid Dermal Filler Gel). Study MA-1400-02) involved 430 patients at 33 centers. Applies to dermal filler topical: injection gel. product palpability, which were evaluated as appropriate at the screening visits updated physician diagnosed adverse events identified in studies MA-1400-01 and Note: This document contains side effect information about dermal filler topical. Two subjects had adverse events that were severe, one Two of the Tell your The study results showed injection of greater than 1.5 mL incidence of all adverse experiences identified by investigators at visits Available for Android and iOS devices. tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, This potential risk only threatens a very small percentage of people, as this is not a common allergy. findings. was drained and resolved by the next visit. events were considered non-serious as they did not meet seriousness criteria. severe mostly occurred within 1 to 2 days of implantation and up to 3 weeks. events and subjects reporting TEAEs decreased between the first and second events of this type have been observed for up to 13 months. seven events, which were mild bruising, were related to injection procedure. presented in Table 9. watery, and itchy eyes; and shortness of breath. usually resolved within 1 to 5 months. The majority of palpations were rated as “expected feel.” 3% of the subjects reported Furthermore, an overwhelming majority of these TEAEs were One major benefit of Restylane is that it consists of only natural ingredients, with no animal proteins present in the mixture. receive Restylane injections in the lips or no treatment (control 31GE0003. In all three studies, investigators reported the following So side effects lists can help you create realistic expectations that you may experience some bruising, swelling or other effects that are quite expected when you’re having skin injections, and another benefit of side effects lists is that you have an idea of which effects are normal…which can flag any unusual side effects like throbbing or tingling that you’d call your doctor about.

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