Non FDA-approved Fillers Making Headlines

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New FDA-approved Filler

The new filler that recently received FDA approval for soft-tissue augmentation of wrinkles, folds and lips is:Human-based collagen

Two products containing human-based collagen received FDA approval in March 2003 for the correction of facial wrinkles, acne scars, restoration of the lip border and other soft-tissue contour deficiencies. FDA approval is considered a milestone for patients because unlike bovine collagen, allergy testing is not required, and this makes same-day treatment possible. Side effects are usually limited to temporary redness and swelling around the injection site.

Human-based collagen does, however, resemble bovine collagen in some ways. Results are seen almost immediately and last about three to 12 months. Multiple treatments may be needed to achieve the desired effects.

Several new products, which have not received FDA approval, are undergoing (or have recently completed) clinical trials in the United States. A few of the soft tissue fillers making headlines are:

· Hyaluronic acid gel

· Silicone

· Calcium hydroxyapatite (CaHA)

· Collagen mixed with microscopic plastic spheres

· Collagen harvesting

Hyaluronic acid gel is receiving a lot of attention these days. In gel form, hyaluronic acid, a naturally occurring component of skin, binds to water and provides volume that easily fills wrinkles caused by tissue loss, making it suitable for filling larger folds of skin around the mouth and cheeks. Results from a clinical trial indicate that hyaluronic acid gel can be used to treat nasolabial folds (lines that develop between the edge of the nose and corners of the mouth) and that it works better, lasts longer and requires less filler than collagen.

Many dermatologists believe that once FDA-approved, hyaluronic acid gel can be used to effectively treat acne scars, enhance lips, fill in hollow areas of the face and improve a receding chin.

Injectable silicone is also in the news again. Until banned by the FDA in 1992, silicone was used in the United States for many years to successfully treat wrinkles and acne scars as well as enhance lips, cheekbones and the chin. However, problems emerged when medical-grade silicone was diluted with foreign substances, such as mineral oil and when it was injected in large volumes.

What makes silicone unique is that the results are permanent. Studies are showing that once the desired results are achieved, there is no need for future treatments unless it becomes necessary as the patient ages or disease processes continue.

Side effects may include delayed reactions that induce redness and disfiguring lumpiness as well as the body’s rejection of the silicone, which causes the tiny beads to push out through the skin’s surface. However, side effects are rare when a dermatologic surgeon skilled in the microdroplet technique, a process in which tiny amounts are injected at four to eight-week intervals until the desired effect is achieved, uses this method with a purified silicone product.

Calcium hydroxyapatite (CaHA) is a natural component of bone and teeth that has been used for years to build up jaws, chins and other bony areas. Today, a product containing microspheres of CaHA is being considered for adding lift and volume to the face. When injected into soft tissue, the substance stays soft and pliable, and studies suggest that the results may last as long as two to five years. CaHA appears difficult to remove and may produce lumpiness of unknown duration.

Another injectable soft tissue filler receiving much attention is one being considered as a permanent filler for facial wrinkles and acne scars. Containing 75 percent bovine collagen and 25 percent microscopic plastic spheres, the results are immediate and reportedly permanent since the human body does not absorb the spheres. The plastic spheres act to stimulate the body’s production of collagen, which then forms around the spheres. Side effects may include the formation of lumps after injection, allergic reaction and the spheres moving to another part of the body.

The harvesting of one’s own collagen-producing cells (fibroblasts) holds promise for filling fine facial lines, enhancing lips and correcting scars. Results reportedly last a bit longer than bovine collagen, and side effects are minimal. However, the procedure is time-consuming. First, your dermatologist must remove a small amount of skin tissue and close the area with adhesive or sutures. Your removed tissue is shipped to a company that cultures the fibroblasts using its patented process. In six weeks, the harvested cells are delivered to your dermatologist’s office, and you must return for skin testing because the substance in which the cells are grown can cause an allergic reaction. If you do not show an allergic reaction within two weeks, treatment can begin.