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Medical Devices
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Information for Patients
Before deciding to have injectable wrinkle fillers, you should:
- Be aware that the safety of these products is unknown when used during pregnancy, in breastfeeding females or in patients under 18 years of age.
- Be aware that the safety is unknown when these products are used with Botox or other wrinkle therapies.
- Be aware that the safety is unknown when these products are used repeatedly over a long period of time.
- Be aware that the safety of these products have only been studied when in used in the face.
- Make sure you know the type of product that is being used for you and all its possible side effects.
- When considering these fillers, talk with a doctor who can refer you to a specialist in the fields of dermatology and plastic surgery.
- Select a doctor who is trained to perform the wrinkle filler injection procedure.
- Ask for Patient Labeling for the product that your doctor plans to use; this is available for some injectable wrinkle fillers.
- Have realistic expectations about the benefits you want to achieve; discuss the amount of correction that you expect and the amount of correction that your doctor expects to be able to achieve based on your situation.
- Be aware that insurance does not usually cover elective procedures such as wrinkle correction.
You should NOT use these products if any of the following applies to you:
- You have severe allergies marked by a history of anaphylaxis (acute allergic reaction)
- You are allergic to collagen or eggs
- You are allergic to lidocaine
- Your skin is inflamed or infected
- You are prone to form excessive scarring (keloids) and/or thick scarring (hypertrophic scars)
- You have a bleeding disorder
In addition, if you have an active inflammatory condition, (cysts, pimples, rashes or hives) or infection, wrinkle filler injection should be postponed until this inflammatory condition is controlled.
FDA has approved these products only as injectable wrinkle fillers. They should not be used for:
- Plumping the lips (lip augmentation)
- Increasing breast size (breast augmentation)
- Implanting into bone, tendon, ligament, or muscle
- Implantation into blood vessels, because it may obstruct blood flow
You should also know that FDA has not approved silicone, liquid or gel, for injection to fill tissues.
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