Approved by the Food and Drug Administration in 2004, Sculptra dermal filler has been used in Europe since 1999, and is also known as New-Fill, or New Filla. It is manufactured by Sanofi-Aventis, and is approved to treat deep folds and wrinkles between the nose and mouth, or nasolabial creases.
Sculptra is also used for facial lipoatrophy, or loss of facial fat, in patients with HIV/AIDs. The synthetic compound in Sculptra has been used for decades in resorbable stitches used after surgery, and is biocompatible, and biodegradable.
How It Works
The key compound in Sculptra is poly-L-lactic acid (PLLA) hydrogel, which belongs to the aliphatic polyesters, and lactic acid synthesized from corn. These microparticles are scientifically combined with carboxymethylcellulose (cellulose polymer), and non-pyrogenic (non-heat generating) mannitol (sugar alcohol) to make a freeze-dried, crystallized substance which is mixed with sterile water before injection. It is a denser dermal filler, which is injected deeply into the dermal layer of skin.
The microscopic crystals in Sculptra, cause a mild inflammatory reaction under the skin, triggering the formation of new collagen. Fibroblast cells which produce collagen, are recruited by the white blood cells surrounding the Sculptra injection, to begin new collagen production. Results from injections are not immediate, but gradual, and natural, however, some improvement in facial structure may be seen within the first few weeks. Sculptra is the first facial injectable, with results that have the capability of lasting up to 2 years. An average of 3 treatments are given over a three month period.
Sculptra Procedure: Treat, Wait, Assess, Re-Treat
Sanofi-Aventis, the manufacturers of Sculptra, offers an extensive program for training board-certified dermatologists and facial plastic surgeons in Sculptra injections. Injections are made only in the deep dermal area, using a tunneling effect. It is not recommended for use with areas of thinner skin, and therefore, does not work well on areas around the eyes or lips. If too much Sculptra is administered at once, the risk of nodule formation is increased. It is wise to do research to locate a doctor who has been sufficiently trained in dosage amounts and technique, to insure patient safety, and to provide optimal results.
The patient first must discuss medical history, and expectations with the doctor. Injections should not be administered if the patient is using blood-thinning or anti-inflammatory medication. Other restrictions are if you have: a depleted immune system, skin infections, open sores, severe allergic reactions, allergic reactions to lidocaine. It has not been determined whether injections affect patients who are pregnant or breast-feeding. There is no pre-test for allergies required when using Sculptra.
The injection sites will be marked, the area will be cleansed and lidocaine may be injected as a local anesthetic before injecting Sculptra. The crystallized form of injection will be diluted with sterile water, and injected into the deep dermal area in strategic, grid form, making the injections blend and less noticeable. It is placed evenly under the skin, and massaged to distribute. On average, 3 injection sessions over a few months are necessary. Areas of injection other than nasolabial folds and creases have not been evaluated for safety and effectiveness, but are sometimes off-label uses.
Sculptra Side Effects
As with any injection, there is risk of infection to the site. Some common side effects may occur, which usually resolve shortly after injections. Side effects experienced may be:
- Tenderness of injection site
- Small bumps or nodules under the skin
How Sculptra Differs From Other Dermal Fillers
Sculptra is injected evenly, using a tunneling effect under, not into the skin, as opposed to “spot” injections. It is a synthetic, crystallized material, which does not contain human or animal products. There are no immediate results, but the results can last up to 2 years, and the change is gradual, and more natural-looking.
Other dermal filler injection sites are not to be touched following treatment, and massaging the injected area is encouraged with Sculptra, to prevent bumps and nodules. Cost of Sculptra can only be estimated after consulting with a doctor, but can range from $400 to $1200 per vial, depending on the area of treatment and number of injections required.
Sculptra seems to be a long-lasting dermal filler, which works very well on nasolabial folds and creases. Most patients who received injections for “laugh lines” in this area, were pleased with the results. Those patients who received injections around their eyes and lips, were not as happy with the outcome. Many had excessive swelling, bruising, and nodule formation, when injections were made to areas other than the nasolabial region. Of major importance, is finding a qualified doctor who is trained in Sculptra injections, discussing areas of treatment, and reviewing what results can realistically be expected. Read more reviews here.