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ASPS Supports FDA Panel Recommended Approval of Sculptra;

 New Injectable Will Help HIV Positive Patients

(press release from ASPS)

ARLINGTON HEIGHTS, Ill., March 26 -- The American Society of Plastic Surgeons (ASPS) supports the U.S. Food and Drug Administration (FDA) advisory panel's recommendation yesterday to approve Sculptra, an injectable filler to reconstruct HIV patients suffering from facial lipoatrophy.

Many patients successfully manage HIV for years and feel perfectly healthy; however, the antiretroviral medications they take causes lipoatrophy, a wasting of fat in the face that makes them appear ill.

"The addition of Sculptra to the options we have to restore volume in an HIV patient's face is immeasurable," said Rod Rohrich, MD, ASPS president. "Not only will it allow us to reconstruct the face but also bolster a patient's self-esteem and relieve social anxiety found in many patients concerned about their appearance."

Sculptra is a synthetic polylactic acid that has been marketed under the trade name New-Fill in Europe. It has been used in more than 30 countries throughout the world for the treatment of facial volume imperfections, wrinkles and folds. Possible side effects of Sculptra are redness, bruising, lumping and granulomas.

The ASPS welcomes the introduction of this new filler which adds to the treatments plastic surgeons use to help HIV patients. The society looks forward to additional data and U.S.-based clinical trials of Sculptra especially if the injectable is to be used "off label" for cosmetic use as there may be an increased potential for side-effects in patients with healthy immune systems.

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ASPS is the largest organization of board-certified plastic surgeons in the world and the foremost authority on cosmetic and reconstructive plastic surgery. With nearly 5,000 members, more than any other cosmetic plastic surgery organization, ASPS is the definitive voice of the plastic surgery specialty. Viewed throughout the world as the pinnacle of information for new techniques, advances and plastic surgery trends, the society represents 94 percent of all the board-certified plastic surgeons in the U.S. Ninety-four percent of all ASPS members perform cosmetic plastic surgery and 89 percent of all ASPS members perform reconstructive plastic surgery. ASPS, founded in 1931, represents physicians certified by The American Board of Plastic Surgery or The Royal College of Physicians and Surgeons of Canada.

CONTACT:
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(847) 228-9900
media@plasticsurgery.org

***********

If You Found this Article Helpful You May Enjoy these articles:

FINALLY!! - SCULPTRA FDA APPROVED!!

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