A well recognized component of facial aging is loss of fat volume. This loss results in a sunken, hollow appearance to the face, which may be difficult to describe, but is easy to recognize. The face looses its round contours and sharp demarcations develop between different regions of the face. Volume augmentation is a large component of comprehensive facial rejuvenation.

Facial volume restoration can be achieved in several ways. There are many commercially available injectible fillers to augment the face. Products such as Restylane, Juvederm, Scupltra, and Radiesse are now a part of the popular culture lexicon. Although these fillers are easy to administer, they lack permanency. Fat grafting is a permanent technique for restoration of facial volume, and an attractive alternative to the commercially available facial fillers.

Dr. Khosh performs fat grafting in Manhattan, as an office based procedure. Small amounts of fat is gently harvested from the lower body, prepared carefully, and then meticulously injected into appropriately chosen areas of the face. Fat transfer can be used to enhance the appearance of the cheeks, brow, temple, and the orbital regions. Patients notice not only improved facial contours, but also more vibrant and healthier skin. A secondary benefit that has been postulated to be due to growth factors or stem cells present in the fat graft.

Sculptra is the only FDA approved injectable filler for general facial augmentation and volumization. Sculptra stimulates the body to replace collagen over time, and restores lost volume and helps to fill depressions or hollowness around the face.

Unlike other facial fillers such as Restylane, Juvederm, and Radiesse, the aesthetic results from Sculptra are not immediately evident. It typically takes several weeks to notice the improvement from Sculptra injections. The enhancement is gradual and subtle. It typically requires two sessions of Sculptra injections to achieve the final desired outcome. Sculptra is longer lasting that other facial fillers, and the results usually last up to two years.

We are offering one session of FREE Sculptra injections to a limited number of patients. Interested patients should contact my assistant Betty at 212-262-0056 ext 209 to schedule a treatment.

On July 29th, 2009, the FDA approved Sculptra Aesthetic for the correction of shallow to deep nasolabial fold, contour deficiencies and facial wrinkles. Sculptra is an injectable filler composed of poly-L-lactic acid, which stimulates formation of collagen to thickening of skin and reduction of lines, wrinkles, and contour deficits.

Sculptra is as a series of two to four injections administered at six to eight weeks apart. Clinical studies show the results to last upto two years. Sculptra had been previously approved by the FDA in 2004, for use in HIV patients who had suffered facial fat loss as a side effect of their HIV medication. The manufacturing company, Sanofi-Aventis, gained FDA approval for use in the general population after demonstrating the safety of the product in additional clinical studies.

Sculptra joins other facial fillers such as Collagen (Cosmoderm, Cosmoplast), Hyaluronic Acid (Restylane, Perlane, Juvederm Ultra, Juverderm Ultra Plus), and Calcium Hydroxylapetite (Radiesse) as an FDA approved facial filler. Sculptra should be administered by qualified physicians and has been found to have few side effects such as: localized injection site redness and tenderness. There have been infrequent reports of nodule formation. Amongst the FDA approved facial fillers, Sculptra has the longest duration of action.

There is a plethora of products that are being used as dermal fillers to smooth lines, depressions, and/or wrinkles in the face. In the US, the FDA regulates sale and promotion of these substances. Many available injectable fillers are not sold in the US due to lack of FDA approval. Amongst the FDA approved filler agents, the major indication for use is correction of naso-labial folds. However, physicians are allowed to inject dermal fillers into other parts of the body following a thorough discussion with patients, as an off-label use of the filler. The fillers can be broadly classified to synthetic and natural. The synthetic products tend to last longer, but are considered to be at higher risk for lumping or migration.

It must be kept in mind that since the commonest indication for injectable fillers is cosmetic improvement of lines and wrinkles, as opposed to other medical drugs and devices that are developed to treat or prevent maladies or deformities. The safety profile of filler agents is therefore specially important. A list of most common dermal fillers is provided, with my own thoughts and conclusions reserved for the last paragraph.

Silicone Fluid:Dow Corning introduced medical grade silicone in the 1950’s for soft-tissue augmentation. The FDA banned the use of silicone as a soft-tissue filler in 1967 due adverse reactions. However, silicone continued to be approved by the FDA for use inside the eye, as treatment for treat retinal detachments. The FDA Modernization act of 1997 allows the off-label use of silicone to augment soft tissues. A new micro droplet injection technique has greatly reduced adverse reactions, such as migration and inflammation, seen earlier. Silicone is classified as a permenent filler.

Bovine Collage (Zyderm and Ayplast):Zyderm and Zyplast were introduced in 1981 and 1983 respectively. They are comprised of collagen fibers which have been extracted from the hide of specially designated cows. The clinical effect of bovine collagen lasts from three to four months. Bovine collagen is one of the safest fillers on the market. However, collagen use has waned due to availability of longer lasting alternatives. Collagen injections need to be preceded with a skin test, due to 3% risk of allergic reaction.

Hyaluronic Acid (Restylane, Juvaderm Ultra, Perlane, Juvaderm Ultra Plus):Hyaluronic acid is naturally found in all living beings as a polysacchride (a complex sugar) molecule that binds water in the space in between cells. In humans, the molecules in broken down and replaced within one to two days. The manufacturers have been able to prolong longevity of the hyaluronic fillers, through a process known as cross-linkage. Currently, hyaluronic acids are the standard of injectable dermal fillers. They last between six to nine months, and exhibit very few adverse effects. Hyaluronic acid fillers are the only fillers that can be immediately reversed by injection of an enzyme known as hyaluronidase.

Polylactic Acid Microspheres (New-Fill/Sculptra):Sculptra (formerly New-Fill) is a suspension of microspheres composed of poly-L-lactic acid (same as some absorbable sutures) suspended in methylcellulose. It was introduced in Europe in 1999, and in the US in 2004. The suspension in diluted with sterile water before injection into the face. Typically a series of 2 to 3 injections are necessary to achieve the desired effect. Results last up to two years. In the US, the FDA has approved the use of Sculptra for treatment of HIV related lipodystrophy (loss of facial fat in HIV patients secondary to anti-viral medications). Sculptra is utilized as a facial filler in non-HIV patients, as an off-label indication. There have been reports of palpable nodules with the use of Sculptra, but problems have diminished with newer injection techniques. Sculptra should not be used in the lips.

Calcium-Hydroxylapetite Microspheres (Radiesse):Radiesse is a white, paste-like suspension of calcium hydroxylapetite (the substance present in bone and tooth) which gained FDA approval for injection into the nasolabial folds in 2006. It is commonly used in off-label fashion to augment cheeks and enhance the midface. Radiesse dose NOT form bone when injected into skin. It usually lasts one year in the body. Use of Radiesse in the lips is discourage as it can form a lumps due to action of muscles.

Polyacrylamide Gels (Aquamid and Bio-Alcamid):Polyacrylmides are polymers of a water solulable crystal which is used in soft contact lenses, and Gro-Beast toys. Aquamid is approved in Europe and Bio-Alcamid is approved in Europe, Israel, and Mexico. Polyacrylmides are not approved by the FDA for use in the US. In Russia and China, Polyacrylmide gels have been injected in large quantities for breast, buttock, and calf augmentation, and in facial lipodystrophy. The duration has been variously reported as form one year to twenty years, depending on the injected volume. Its clinical behavior is similar to liquid silicone. There have been a relatively large percentage of complications with this filler. Complications such as migration, granuloma (swelling and nodule formation), and infection.

Polymethylmethacrylate Microspheres (Arteplast/Artecoll/Artefill):Artefill, formerly Artecoll, is a 20% suspension of polymethylmethacrylate microspheres (tiny glass beads) in bovine collagen. The bovine collagen is resorbed by the body after four months, but the polymethylmethacrylate microspheres persist and become encased by fibrous tissue to give a sustained result. Due to presence of bovine collagen, as a carrier for the microspheres, patients need to be pre-tested to ensure absence of allergy to bovine collagen. Artefill gained FDA approval as a dermal filler in October 2006. However, the company stopped production in November 2008, due to disappointing sales results. There had been concerns regarding complications such as granuloma (lump) formation or infection with this “permanent filler”.

Poly-Hydroxymthyl-Methacrylate Particles (Dermalive/DermaDeep):Dermalive is similar in its chemical structure to Artefill. Dermalive is a 40% suspension of resorbable poly-hyroxyethyl-methacrylate fragments mixed in hyaluronic acid. It was introduced in Europe in 1998. It is used only for deep injections, as superficial injections caused a high incidence of granuloma formation. This product is not FDA approved and not sold in the US. Some doctors have brought the product into this country and advertise its use.

Bottom Line: The long list above is still incomplete in regards to all the available options for injectable dermal fillers. Most products gain regulatory approval in Europe, Asia, or Canada before achieving FDA approval. This should give us a level of comfort to know that the FDA sets the bar very high for approving dermal fillers. I recommend that only products with FDA approval be considered for injection, as such products have passed a rigorous regulatory process. Although “permanent fillers” promise a lasting solution to wrinkles, the long term effects are not known for many such products. I, therefore, prefer long lasting but non-permanent fillers with proven track record such as hyaluronic acid products (Restylane, Perlane, Juvederm, or juvederm Ultra Plus) or calcium hyroxylapetite (Radiesse).