Health and Beauty

A smaller nose. Bigger breasts. Slimmer thighs. Plumper lips. Less hair on the body. More hair on the head. Whether we're looking to tighten our tummies or lighten our laugh lines, America's fascination with youth and beauty has long fueled the development of medical products for cosmetic purposes.

The ongoing fight to delay or reverse the aging process has dermatologists and cosmetic plastic surgeons responding with products like Restylane (hyaluronic acid), one of a handful of soft tissue fillers recently approved by the FDA to treat facial wrinkles. Restylane is an injectable gel that acts as a filler to remove the wrinkle, producing instantaneous results. Such products are not as invasive as facelifts, eyelid surgery, and other reconstructive procedures. And they are more effective and last longer than creams, lotions and other topical products, whether over-the-counter or prescription. In addition, the fact that the treatments result in little or no downtime makes them more attractive to those seeking a quick fix. Without making a single incision, Health Experts can erase wrinkles, acne scars and sun damage in a matter of minutes.

"This is a huge industry," says Jonathan K. Wilkin, M.D., a medical officer in the FDA's Division of Dermatologic and Dental Drug Products. "The way people try to move the clock back is through the skin." Basically, he says, through various products and procedures, "they are addressing the effects of gravity on the skin over time."

Aging Skin 101

An increased understanding of the structure and function of the skin is helping to drive the development of products that reduce the visible signs of facial aging, according to the American Academy of Dermatology (AAD).

With aging, all skin cells begin to produce excess amounts of free radicals--unstable oxygen molecules that, under ideal circumstances, are removed by naturally occurring antioxidants within the skin's cells. In aging skin cells, antioxidants are in short supply. The free radicals generated are left unchecked and cause damage to cell membranes, proteins, and DNA. These free radicals eventually break down a protein substance in connective tissue (collagen) and release chemicals that cause inflammation in the skin. It is a combination of these cellular and molecular events that leads to skin aging and the formation of wrinkles, the AAD says.

As we get older, two components of our skin--collagen and elastin--degenerate, setting the stage for the appearance of wrinkles, creases, folds, and furrows. The breakdown of these components, accelerated by sun exposure and gravity, results in the sagging skin of old age.

Considerable research has been done to understand the aging process, and studies now show that products containing bioactive ingredients (those that interact with living tissues or systems) can benefit sun-damaged, discolored, and aging skin, giving consumers new choices for restoring their overall appearance. But why is the FDA reviewing products that simply make people look and feel good when typically the agency evaluates disease-fighting treatments?

"If something that is being implanted into the body could have health consequences, we're concerned about it," says Stephen P. Rhodes, M.S., chief of the FDA's Plastic and Reconstructive Surgery Devices Branch. "Wrinkle fillers affect the structure of the face and could have such health consequences."

Facing Facts

Under the Federal Food, Drug and Cosmetic Act, the FDA legally defines products by their intended uses. Drugs are defined as products intended for treating or preventing disease and affecting the structure or any function of the body. A medical device is a product that also is intended to affect the structure or function of the body, but which does not achieve its primary intended purposes through the chemical action of a drug--nor is it dependent on being metabolized.

The hyaluronic acid in Restylane, although biosynthetically produced (formed of chemical compounds by the enzyme action of living organisms), is almost identical to that in all living organisms. Hyaluronic acid is a structural component of skin that creates volume and shape. Concentrations of hyaluronic acid throughout the body decline with age, causing undesirable changes in the skin. Restylane binds to water and provides volume to easily fill in larger folds of skin left by tissue loss around the mouth and cheeks. "This makes it a structural action," says Rhodes, "much like a chin implant."

In contrast, cosmetics are defined as substances that cleanse, beautify, promote attractiveness, or alter the appearance, without affecting the body's structure or function. This definition includes skin-care products such as creams, lotions, powders and sprays; perfume; lipstick; fingernail polish; and more.

Different laws and regulations apply to each type of product. Some products must comply with the requirements for both cosmetics and drugs. This happens when a product has two intended uses, such as an antidandruff shampoo. A shampoo is a cosmetic because it is intended to clean hair. An antidandruff shampoo is a cosmetic and a drug because it is intended to treat dandruff (which affects the follicles where the hair is formed) and clean hair.

Buyer Beware

Anti-aging products that promise to diminish wrinkles and fine lines are found on many store shelves. However, dermatologists recommend that people consider only those procedures and products that have proven, over time, to be most effective at reversing the aging process. Most Health Experts agree that the leading product to prevent premature wrinkles and sun damage is sunscreen. A broad-spectrum sunscreen that protects the skin from both UVA and UVB rays, with a sun protection factor (SPF) of 15 or higher, can prevent the skin from looking older than it is.

According to the American Society for Aesthetic Plastic Surgery (ASAPS), it's important to realize that although certain products and procedures are effective, they are also limited by the skin's normal aging process. A product that has been deemed effective for erasing wrinkles doesn't necessarily erase wrinkles--there are lots of variables that determine its effectiveness.

For example, the active ingredient in a drug must be delivered to the skin at a therapeutic concentration and remain in the skin long enough to have an effect. Also, because the composition of a man's body differs from a woman's, products or procedures can have different effects. The facial area in men contains hair, for example, and their skin is thicker. This means the blood supply is greater--and so is the risk of bleeding--but it also could mean better healing.

And cosmetic procedures come with risks. If a procedure is performed poorly, the physical and emotional scars could be carried for life. Ask questions, read lables and understand the risks and side effects that may be involved.

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