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TOP INJECTABLES | FILLERS
RADIESSE® | RESTYLANE®

FDA approved to smooth and fill-in facial wrinkles and folds.
Benefits, risks, side-effects / after-effects.
How long will the injectable filler be effective?


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Injectable Fillers: FDA Information on Radiesse® & Restylane®

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Injectables fill in moderate to severe facial lines and folds.


All information provided by the Food and Drug Administration of the United States of America / FDA.gov

WARNING!
The following is general information on injectable fillers Radiesse® and Restylane®.
It is not medical advice nor authored by a medical professional.

Marionette lines, also called nasolabialines, run from the corners of your nose to the corners of your mouth.
Obvious nasolabia lines are a common concern for the more mature face.

Radiesse®
Product Name: Radiesse
PMA Applicant: BioForm Medical, Inc.
Address: 4133 Courtney Road, Suite #10 Franksville, Wisconsin 53126
Approval Date: December 22, 2006
Approval Letter: visit FDA and type in "Radiesse"

What is it? Radiesse is an injectable calcium hydroxylapatite implant in the form of a gel.

How does it work? Radiesse works by temporarily adding volume to facial tissue and restoring a smoother appearance to the face.

When is it used? Radiesse is intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. It is injected by a doctor into areas of facial tissue where moderate to severe facial wrinkles and folds occur. The gel temporarily adds volume to the skin and can give the appearance of a smoother surface.

What will it accomplish? Radiesse will help smooth moderate to severe facial wrinkles and folds. The smoothing effect lasts up to six months.

Side effects of Radiesse include:

  • bruising,
  • redness,
  • swelling,
  • pain,
  • tenderness, and
  • itching

When should it not be used? Radiesse should not be used in patients who have:

  • a hypersensitivity to any of the components of the product
  • severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies.

Additional information: The Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050037


Restylane®
Product Name: Restylane®Injectable Gel
Applicant: Medicis Aesthetics Holdings, Inc
Address: 8125 N Hayden Road Scottsdale , AZ 85258
Approval Date: March 25, 2005]


What is it?
Restylane® is a transparent hyaluronic acid gel that is injected into facial tissue to smooth wrinkles and folds, especially around the nose and mouth (nasolabial folds). Hyaluronic acid is a protective, lubricating and binding gel substance that is produced naturally by the body.

How does it work?
Restylane® works by temporarily adding volume to facial tissue and restoring a smoother appearance to the face. The effect lasts for about 6 months.

When is it used?
Restylane® is injected by a doctor into areas of facial tissue where moderate to severe facial wrinkles and folds occur. The gel temporarily adds volume to the skin and can give the appearance of a smoother surface.

What will it accomplish?
Restylane® will help smooth moderate to severe facial wrinkles and folds. In a clinical study most patients needed one injection to achieve optimal wrinkle smoothing; about one-third of patients needed more than one injection to get a satisfactory result. The smoothing effect lasted about six months.

Side effects of Restylanetm include:

  • bruising
  • redness
  • swelling
  • pain
  • tenderness
  • itching

When should Restylane not be used?
Restylane® should not be used in patients who have:

  • severe allergies marked by a history of anaphylaxis ( hypersensitivity to the ingestion or injection of a drug or protein)
  • multiple severe allergies
  • severe allergies to gram-positive bacterial proteins

Restylane should not be used for:

  • breast augmentation
  • implantation into bone tendon, ligament, or muscle, or implantation into blood vessels, because it may obstruct blood flow.

For more information on adverse effects and update news:
visit www.FDA.gov
Put the word "Restylane" into the search box.



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