May 2004
Dear Paula,
Perhaps you can provide me with some information on a new product being used and advertised by a physician in Tampa, Florida, to fill wrinkles and plump lips. The product is named "Radiance," and is "a creamy synthetic, biocompatible form of calcium hydroxyapatite, a material found naturally in everyone's body, a safe injectable gel that plumps lips and fills in wrinkles." The claim is that it's FDA-approved for use in all parts of the human body. Moreover, Radiance also boasts one-to-one correction, no allergic/sensitivity problems, and it requires no pre-testing, minimal downtime, and lasts at least 3 to 5 years (10 to 20 times longer than collagen). It costs $1,500 for one treatment, which they claim is enough to do lips and nasolabial folds.

What do you think? Have you heard anything about this? I always read your column, and appreciate your up-front, matter-of-fact candor. I really hate paying over-inflated prices for hyped-up products.

Jan, via email

Dear Jan,
In the world of injectable dermal fillers, there is a grab bag of substances that are all touted as being "the best" for filling in facial lines. Despite the claims and boasts you will inevitably hear or read about, "the best" is merely a relative term, and most often the claims are not based on comparative studies or independent research. Which product is considered "best" or "preferred" is often determined by whatever the newest procedure happens to be, what is receiving attention in fashion magazines, what ads are currently running, or, more often than not, what method your doctor happens to personally like best. What's disconcerting about it is that most of these substances are so new that they have no long-term safety data of any kind.

Though it may sound "best" when a particular injectable dermal filler is a natural material, it doesn't necessarily make it better for skin or indicate how long results will last. There is no added benefit to a substance just because it is found naturally in the body. As you will see from the list below, there are lots of natural dermal fillers, even those harvested from your own body, that are not automatically the preferred option. In the formidable list of injectable dermal fillers, each one has its own pros and cons.

Alloderm (approved by the FDA for cosmetic corrective use) is processed human tissue prepared from cadaver skin in such a way that it retains its underlying structure. Duration is about one to two years. It is considered stable and easy to use (Source: www.emedicine.com, www.emedicine.com/ent/topic43.htm).

Amazing Gel, also called Formacryl, ioFormacryl, Argiform, and DermaLive (not approved by the FDA for cosmetic corrective use), is a polyacrylmaide gel and is considered to be one of the most long-lasting and potentially permanent fillers available, with low risk of complications, though it requires skill to administer it properly (Source: Aesthetic Plastic Surgery, July-August 2001, pages 249-255).

Artecoll (approval by the FDA for cosmetic corrective use is pending) is polymethyl methacrylate (PMMA) mixed with collagen. It is believed to be permanent. Because of its potential permanence, injecting Artecoll requires greater skill. Risks include lumping of the product after injection; inflamed, hardened, grain-sized tissue at the injection site; and migration of the material (Sources: American Society of Plastic Surgeons, www.plasticsurgery.org; American Journal of Dermatopathology, June 2001, pages 197-202; and Aesthetic Plastic Surgery, September-October 1998, pages 356-365).

Autologen (does not require FDA approval) is collagen produced from the patient's own skin. It can last from nine months to one year (Source: Clinical Plastic Surgery, October 2000, pages 507-513).

Autologous Fat (does not require FDA approval) is produced from the patient's own fat. No allergy testing is required. Harvesting the fat is an involved process. There is no consensus on longevity, but, depending on the source, the claim is anywhere from weeks to years (Sources: www.emedicine.com and www.emedicine.com/derm/topic515.htm).

Bioplastique (not approved by the FDA for cosmetic corrective use) is particles of silicone suspended in a liquid gel. It is considered to be safe, with minor risk of migration. It may be permanent, but there are no long-term studies as of yet (Source: www.facialplasticsurgery.net/injectable_fillers_micro_implants.htm#).

CosmoDerm or CosmoPlast (recently approved by the FDA for cosmetic corrective use) is human-derived collagen and is considered to be safer than bovine-derived collagen. CosmoDerm is for minor skin defects; CosmoPlast is for more serious defects. Overcorrection is needed to achieve ideal results.

Cymetra (approved by the FDA for cosmetic corrective use) is a micronized version of Alloderm (see above). Cymetra is not recommended for use between the eyes or around the eye area.

Dermal Grafting (does not require FDA approval) is tissue harvested from a patient and reinjected as a filler. It usually results in a scar at the graft site (where the tissue was removed).

Fascian (does not require FDA approval) is a type of collagen derived from cadavers. Fascian is firm, yet pliable. Duration is about six months to one year, the same as for other collagen-type injections.

Gore-Tex, also called SoftForm and UltraSoft (approved by the FDA for cosmetic corrective use), is a nonabsorbable, synthetic material used for soft tissue augmentation and considered to be permanent. If not injected correctly, the injected material can be felt under the skin (Source: Dermatologic Surgery, October 2002, pages 901-908).

Hylaform (not approved by the FDA for cosmetic corrective use) is hyaluronic acid, a substance found in human skin, although this version is derived from rooster combs. It is considered to be somewhat longer-lasting than collagen and supposedly has less risk of clumping or allergic reaction (Sources: www.emedicine.com/derm/topic515.htm; and Journal of the American Academy of Dermatology, December 2001, pages 930-933).

Radiance (approved by the FDA for certain bone-related surgeries, but not for cosmetic corrective use) is a form of calcium hydroxyapatite. Calcium hydroxyapatite is bone cement and has been used for years to repair many types of skeletal defects. It has been shown to have stable results, ease of use, and excellent adaptability; however, there is minimal research concerning its success for wrinkles (Source: British Journal of Plastic Surgery, January 2000, pages 24-29).

Restylane and Perlane (not approved by the FDA for cosmetic corrective use) are similar to Hylaform in that they are forms of hyaluronic acid. Restylane is derived from bacteria. Perlane is meant for deeper wrinkles. Overcorrection is generally not needed with these substances as it is for collagen or fat injections. Restylane and Perlane can last from six months to one year. (Sources: Journal of the European Academy of Dermatology and Venereology, November 1999, pages 183-192; Journal of the American Academy of Dermatology, December 2001, pages 930-933; and www.emedicine.com/derm/topic515.htm).

Silikon 1000 (approved by the FDA for certain eye-related injections, but not for cosmetic corrective use) is injectable silicone oil used off-label as a permanent dermal filler. The two greatest risks are that the silicone will migrate to areas where you don't want it, and that it will form hard granules under the skin (Source: Dermatological Surgery, March 2003, pages 211-214).

Zyderm I, Zyderm II, and Zyplast (approved by the FDA for cosmetic corrective use) are different combinations of cow-derived collagen. These materials are absorbable and, therefore, overcorrection is necessary to maintain results. Duration is limited, ranging from six to nine months. Allergy testing is mandatory because about 5% of patients may experience hypersensitivity to injectable bovine (cow) collagen (Sources: www.emedicine.com; and www.emedicine.com/derm/topic515.htm).

After all is said and done, the major issue for fillers is one of longevity (Radiance just doesn't have enough of a track record to have any agreed-upon expectations), followed by ease of use, and—ultimately—the skill of the doctor. Regardless of the material, there is a learning curve to injection techniques as well as understanding how the varying substances affect skin. That means you need to find a doctor who has been injecting dermal fillers for some time, and who has loads of experience.