7月29日赛诺菲-安万特美国公司（Sanofi-aventis U.S.）当日宣布，该公司填充剂Sculptra Aesthetic已获得美国FDA批准用于健康人注射填充浅至深层鼻唇沟及其他面部皱纹，其主要成分为PLLA聚乳酸，持效时间最长可达2年。

SCULPTRA™ 聚左乳酸(PLLA)，乃是一種注射性的骨膠原促生物質，注射至皮膚深層後，刺激皮膚內細胞增生骨膠原。

新的骨膠原增生期間，會漸漸令面型回復飽滿，改善太陽穴凹陷及面頰萎縮等老化徵狀，令用者持久而自然地發放青春的光采。

特点：Sculptra是FDA批准的第一个能安全、有效地治疗该并发症的突破性药物。

Sculptra Aesthetic则是Sculptra的美容适应症产品，而Sculptra之前已于2006年获FDA批准用于治疗HIV患者的面部脂肪萎缩证。

此次FDA审批是基于一项随机、比较、盲审、平行组、多中心研究（为期25个月），其中涉及233名患者，对照产品是一种已获得FDA批准的人胶原填充剂。

安全性
 
生物相容性 - 能與體內本身組織相容，不會互相排擠。
生物分解性 - 能於體內自然分解，不會長留體內。
主要成份聚左乳酸(PLLA)在醫學界使用超過30年。
產品使用前無需進行敏感測試。

禁忌症：
- 对产品成分过敏
- 有瘢痕形成或增生性疤痕病史
- 注射区有急性皮肤感染或炎症
- 唇红区
- 不建议注射眼周区域

副反应：
- 注射区出血、压痛、疼痛/不适、发红、瘀肿、痕痒等
- 皮下小肿块（当按压注射区域时显见）
- 较大肿块（部分为迟发性，可能伴有炎症或皮肤脱色）
- 研究中出现肿块的几率低，且大部分可自行消退。

Sculptra®...a sculpting agent that restores volume to correct the signs of facial fat loss

Sculptra® is an enduring treatment approved by the FDA for restoration and/or correction of the signs of facial fat loss, or lipoatrophy. When the word lipoatrophy is broken down, "lipo" means "fat," and "atrophy" means "the loss of." Facial lipoatrophy is the loss of fat beneath the skin, which can result in sunken cheeks, indentations, and hollow eyes.
Sculptra® is a safe, synthetic, and biocompatible material that is injected below the surface of the skin in the area of fat loss. It provides a gradual and significant increase in skin thickness, improving the appearance of folds and sunken areas.
Sculptra® has been safely used outside the United States since 1999 in over 150,000 patients under the trade names New-Fill™ and Sculptra®.
What It Does
Sculptra® is an injectable product that restores and corrects the signs of facial fat loss by replacing lost volume. Sculptra® provides an increase in skin thickness, helping to create a more natural facial appearance in those with lipoatrophy.
The following section is designed to help you learn more about Sculptra® and answer any questions that you might have:
What is Sculptra®?
Sculptra® is a synthetic injectable material known as "poly-L-lactic acid." Poly-L-lactic acid is a biocompatible, biodegradable material that has been widely used for many years in dissolvable stitches, soft tissue implants, and other types of implants.
How does Sculptra®work?
Sculptra® is injected below the surface of the skin in the area of fat loss. Sculptra® provides a gradual increase in skin thickness. Visible results appear within the first few treatment sessions.
Sculptra® will not correct the underlying cause of the facial fat loss, but will help improve the appearance by increasing skin thickness in the treated area.
Are skin tests required before treatment with Sculptra®?
No, skin testing is not required prior to use.
Are the results from Sculptra® immediate?
No. After the first treatment, it may appear that Sculptra® worked immediately. Typically, patients will experience some degree of edema associated with the injection procedure, which will give the appearance of a full correction by the end of the injection session (within about 30 minutes). The injection-related edema typically resolves in several hours to a few days, resulting in the "reappearance" of the original contour deficiency. Sculptra® takes time to gradually correct the depression in the skin.
How many treatments are required?
Each patient should be evaluated individually. More than one treatment session may be required (usually at least two sessions). Patients with severe facial fat loss may require 3 or more treatment sessions.
How long do treatment effects last?
Treatment effects will differ for each person. In a clinical study, the treatment results lasted for up to 2 years after the first treatment session, in most patients. Touch-up treatments may be needed to maintain the desired effect.
How quickly can I return to my daily activities?
Most patients feel comfortable going back to their normal activities following treatment.
Will I be able to apply make-up after treatment?

Make-up may be applied a few hours after treatment if no complications are present (for example, open wounds or bleeding).
What are the possible side effects of treatment with Sculptra®?

The most common side effects of Sculptra® include immediate and transient injection-related events such as bleeding from the injection site, discomfort, erythema or inflammation, ecchymosis, and edema.
Click here to review the Sculptra® Patient Guide.