FDA Approval Status for Radiesse

On December 22, 2006, the FDA approval status for Radiesse was released, giving BioForm Medical full approval. The original application for drug approval was filed on Dec. 22, 2005, with amended applications being submitted on May 4, November 9, and December 20, 2006.

What Is Radiesse?

Radiesse is classified as a calcium hydroxylapatite gel implant, available in 1.3cc and 0.3cc dosages. It is a minimally invasive procedure administered by a physician using a syringe to reduce moderate to severe wrinkles in the facial area. The gel acts as a filler which gives the skin a smoother appearance.

Radiesse Potential Side Effects

BioForm Medical states there have been no reports of allergic reaction and the side effects reported are minimal. During clinical trials, the most common side effects reported by patients included redness, swelling, pain, bruising, tenderness and itching.

Benefits of Radiesse

The benefits of the treatment can be noticed instantaneously. Although individual results will vary depending on the patient's particular attributes, age and lifestyle, the treatment was reported to last up to a year or more.

Individuals who are considering using Radiesse for the first time should consult with a health care professional prior to administration. Notify the physician of any medications or health conditions prior to starting treatment.

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