A longer-lasting injectable filler, Radiesse®, specifically meant for facial enhancement, obtained FDA approval in January after two years of off-line availability. This long-lasting particle-based dermal filler is composed of calcium hydroxyl apatite—used to treat vocal cord disorders, bladder incontinence, in dental reconstruction and to promote bone growth. Best used to fill deeper creases such as the nasolabial folds from the nose to the mouth, or those from the mouth down the chin, Radiesse means patients can put off a facelift for a decade at least, according to Dr. Ben Lee, double-board certified plastic surgeon in Englewood, CO, lasts up to two years.

Injections of Radiesse can be used to augment the cheeks and chin, improve the jowls by taking away depression lines nicknamed “marionette lines.” Cosmetic surgeon Dr. Lee said he noticed dramatic results using Radiesse for the first time. The product works below the skin’s surface, to stimulate the production of collagen and encourage tissue regeneration. It does more than just temporarily fill-in facial lines and wrinkles; it rebuilds the skin’s foundation and delivers immediate, natural-looking results. It also can help add dimension to faces that have lost volume, and results are instant after a single treatment session. And it’s biocompatible, so no allergy testing is required.

Never one to be the first to offer the latest treatments, Dr. Lee explains that surgeons, like the general public, are consumers just like laypeople. “I take every pitch for every new product with a grain of salt,” he adds until seeing for himself that the product meets and exceeds the standards promised by the sales rep.

Made of smooth calcium hydroxylapitite (CaHA) microspheres suspended in a water-based gel carrier, Radiesse is not a good choice to plump the lips or in other areas with frequent movement. As Radiesse is injected, the gel and Radiesse Microspheres form a construction scaffolding of sorts, stimulating new collagen production and encouraging tissue growth in and around the injection area. Over time, the body absorbs the gel carrier while collagen has started to grow and infiltrate the area, replacing the gel with natural tissue. The Radiesse Microspheres continue to provide the support and structure for your body to grow new tissue and collagen until the Microspheres are also safely and naturally absorbed into your body

Manufactured by BioForm Medical, Inc., a privately-held medical aesthetics company, the next-generation cosmetic dermal filler is the first filler containing advanced calcium-based microsphere with a proven 12-month benefit in multiple clinical studies. Because Radiesse is a robust, full-bodied material, it provides physicians a superior level of control, predictability and finesse for facial applications. Because of its composition Radiesse is not a good choice to plump the lips or in other areas with frequent movement. Another reason it can’t be used around the mouth is that it will show through under the skin, Dr. Lee adds.

FDA approval of Radiesse for treatment of facial wrinkles and folds was based on the results of a pivotal clinical trial supporting Radiesse's safety and effectiveness. Clinical studies prove that Radiesse® lasts longer than the former leading filler. In a head-to-head split-face study between Radiesse and Restylane®, Radiesse delivered the longer lasting improvements.

Key findings in clinical trials showed:

• 82 percent of nasolabial folds treated with Radiesse showed improvement after six months. This was significantly higher than the control which showed improvement in only 27 percent of treated folds.
• After six months, the fold treated with Radiesse was more improved in 79 percent of patients compared to the control treated fold. The folds treated with the control rated more improved in only 5 percent of patients.
• The nasolabial folds treated with Radiesse required approximately half as much volume than the folds treated with the control.
• Radiesse is a longer-lasting injectable dermal filler used in many cosmetic, reconstructive and therapeutic applications to augment soft tissue, such as facial wrinkles, folds and contours.

Radiesse is manufactured and distributed by BioForm Medical, Inc., a privately-held medical aesthetics company headquartered in San Mateo, California.