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U.S. Department of Health and Human Services

Medical Devices

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Information for Patients

Before deciding to have injectable wrinkle fillers, it is recommended that:

  • You seek a specialist in the fields of dermatology or plastic surgery.
  • Select a doctor who is trained to perform the wrinkle filler injection procedure. Having wrinkle filler injected should be considered a medical procedure, not a cosmetic treatment.
  • You know the type of product that is being used and all possible side effects.
  • You ask for the patient labeling for the product that your doctor plans to use. Patient labeling should be available for all FDA approved injectable wrinkle fillers.
  • You have realistic expectations about the benefits you want to achieve. Discuss the amount of wrinkle smoothing effect that you expect and the amount of wrinkle smoothing effect that your doctor expects to be able to achieve based on your situation.

Additionally, you should be aware that:

  • FDA approval is based on controlled, clinical study of these products when used in the face.
  • The safe use of these products with Botox or other wrinkle therapies has not been evaluated in a controlled, clinical study.
  • The safe use of these products repeatedly over a long period of time has not been evaluated in a controlled, clinical study.
  • Health insurance does not typically cover elective surgical procedures such as wrinkle correction.
  • The safety of these products is unknown when used during pregnancy, while breast feeding or in patients under 18 years of age.

You should NOT use some of these products if any of the following applies to you:

  • Your skin is inflamed or infected. If you have an active inflammatory condition, (cysts, pimples, rashes, or hives) or infection, wrinkle filler injection should be delayed until this inflammatory condition has been managed.
  • You are prone to excessive scarring (keloids) and/or thick scarring (hypertrophic scars)
  • You have a bleeding disorder
  • You have severe allergies or have a history of anaphylaxis (acute allergic reaction)
  • You are allergic to collagen or eggs (when considering wrinkle fillers that contain collagen or egg derived products)
  • You are allergic to animal products (when considering wrinkle fillers that contain materials from animals)
  • You are allergic to lidocaine (when considering wrinkle fillers that contain lidocaine)
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