Poly-L-lactic acid (PLLA) is a biodegradable material that has been used medically for years in many forms such as absorbable sutures, plates and screws. PLLA, under the name New Fill, has been on the market in Europe since 1999 as an injectable volumizer for improvement of facial loss in HIV patients. In the United States, PLLA gained FDA approval for treatment of HIV related facial lipoatrophy in 2004. Though initially approved for use in HIV patients with facial fat loss, PLLA treatment has been also used on an off label basis for cosmetic patients. Fat loss or redistribution is the primary reason for thinning of the face in people as they get older. In July 2009, PLLA treatment was approved by the FDA cosmetically for nasolabial folds. The cosmetic PLLA product is now marketed and available to the public.
Mechanism of Action
PLLA consists of microspheres of a synthetic polymer. The microspheres are less than one micron in diameter and create a reaction that leads to growth of collagen. Studies have shown that after injection into the soft tissue, the microspheres degrade over time into carbon dioxide and water while causing stimulation of type I collagen growth. Imaging studies have shown a threefold increase in skin thickness sustained at 96 weeks. At 9 months PLLA completely disappears and is replaced by collagen. The effects of PLLA treatment have been documented in the Vega, Westminster, Blue Pacific and Apex trials to have lasting results over 24 months. More recent studies have shown the increase in skin thickness to last up to 40 months.
Thank you to Dr. Chris Thiagarajah, our guest blogger today, for sharing his insights and knowledge with us.