Dermal & Soft Tissue Filler: Poly-L-lactic-acid (Sculptra / NewFill)

Generic name: injectable poly-L-lactic-acid

Brand(s): Sculptra / NewFill

Maker / Website: Sculptra / New-Fill (www.sculptra.com) is produced by Sanofi-Aventis (www.sanofi-aventis.com). In the US, distributed by Dermik (www.dermik.com)

Cost: about $300 - $500 per cc; the cost per cc usually drops as the treatment volume increases

Allergy test required: No

Durability: up to 2 years

Function / Purpose:
Cosmetic augmentation and reconstruction of the face, including treatment of facial lines and folds (e.g. nasolabial folds), replacement of facial volume lost due to age, lipoatrophy and so forth.

Summary:
Poly-L-lactic-acid (Sculptra / New-Fill) is a synthetic filler used mainly to fill out facial contours and to correct defects such as wrinkles, folds and furrows. Since it is composed of nontoxic monomer (lactic acid) naturally occurring in the body, it is highly biocompatible, nontoxic and does not require an allergy test. It is slowly biodegradable but the effects may last as long as two years - much longer than for many other biodegradable fillers, such as collagen or hyaluronic acid.

Details:
Poly-L-lactic-acid (Sculptra / New-Fill) is a synthetic polymer but it is comprised of nontoxic natural monomers (lactic-acid). When it breaks down into monomers inside the tissue, no toxicity should result because lactic acid is a chemcial found naturally in the body. Furthermore, poly-L-lactic-acid degrades more slowly than more common biodegradable fillers, such as collagen or hyaluronic acid. The average durability of Sculptra / New-Fill is 2 years, as opposed to 3-6 month for collagen. Sculptra / New-Fill is generally well tolerated and requires no allergy test. Notably, poly-L-lactic-acid has been used in medical application since 1980s (as a material in dissolvalbe sutures, for example). The most common side effects include tenderness, redness, bruising, or swelling upon injection. These side effects are usually temporary, and if present tend to decrease over the next 3 to 15 days. Other side effects may include small bumps under the skin in the treated area which may appear over time. These bumps are not always visible, and often are only detected by pressing on the skin.

As opposed to many other fillers, the full effect of poly-L-lactic-acid develops only 6-8 week after the injection. The reason is that poly-L-lactic-acid works not so much by mechanically filling space, but by inducing the synthesis and deposition of the body's own collagen, which takes weeks to occur. While some collagen deposition is seen around any foreign material, poly-L-lactic-acid seems particularly effective in that regard. Also, the particle size of in Sculptra (50 microns on average) is optimized to produce maximum collagen deposition. Notably, after all poly-L-lactic-acid has degraded, much of the deposited collagen remains, which partly explains the durability of the results. Of course, the deposited collagen is slowly degraded in the same way as any other collagen in the skin, so the results will dissipate eventually.

FDA has approved Sculptra for correcting lipoatrophy in AIDS/HIV patients, but the actual cosmetic use has been much broader. In Europe, poly-L-lactic-acid is approved for correcting volume / fat loss due to various causes and, again, the actual use has been rather broad.