FDA - Cosmetic Laser Surgery - A High-Tech Weapon in the Fight against Aging Skin

by Alexandra Greeley.


Normally this is not a good thing where humans are concerned. In science fiction films the characters vaporized by a laser simply disappear. Patients opting for cosmetic laser surgery, however, suffer a less severe fate: Only their wrinkles and other skin imperfections disappear.

In recent years, lasers have shed their science fictional image to become a surgeon's and dermatologist's most promising weapon in the fight against aging skin. According to the American Academy of Cosmetic Surgery in Chicago, nearly 170,000 Americans, men and women, underwent laser resurfacing of the face in 1998, up from 138,891 in 1996--a 64 percent increase. That's nearly twice the number of the more traditional surgical facelifts performed in the same year.

Laser resurfacing is a very controlled burning procedure during which a laser vaporizes superficial layers of facial skin, removing not only wrinkles and lines caused by sun damage and facial expressions, but also acne scars, some folds and creases around the nose and mouth, and even precancerous and benign superficial growths. In a sense, the laser procedure creates a fresh surface over which new skin can grow.

While the Food and Drug Administration does not regulate how surgeons carry out these procedures, it is responsible for clearing lasers for marketing for the uses requested by the device's manufacturer.

Lasers in Cosmetic Surgery

Since their 1958 discovery, lasers have become a powerful industrial tool, but their applications in medicine have been truly revolutionary. One reason, says Richard Felten, a senior reviewer in FDA's Center for Devices and Radiological Health, is that lasers used as surgical tools can cut through tissue without causing excessive bleeding. In fact, lasers actually can coagulate tissue to stop bleeding. "That's something a knife can't do," Felten says. Also, for many internal procedures, surgeons can get the laser's energy to reach areas within the body more easily than with a scalpel. And finally, the wavelengths of the laser light itself lets surgeons use the device selectively on very specific types of tissues, such as port wine stains or hair follicles, without affecting nearby tissue. (See "Other Laser Treatments")

But using lasers for facial skin resurfacing was discovered almost by accident, Felten says. In the course of treating acne scars with a laser, surgeons noticed that after resurfacing the skin around the scar to make the scar less visible, small adjacent wrinkles were greatly diminished.

"Resurfacing is very appealing to people," says Stephen W. Perkins, M.D., president of the American Academy of Facial Plastic and Reconstructive Surgery and of the Meridian Plastic Surgery Center of Indianapolis, Ind., "because it is a way of refreshing the skin's surface and getting a new layer of non-sun damaged and more youthful skin."

Collagen is a key fibrous protein in the skin's connective tissue, and it helps give the skin its texture. Natural aging and such factors as sun damage and smoking help break down the collagen layer so that the skin's once smooth surface develops wrinkles. New, more youthful collagen actually forms after laser treatment, says A. Jay Burns, M.D., partner in the Dallas Plastic Surgery Institute and assistant professor of plastic surgery at the University of Texas Southwestern Medical School.

Laser resurfacing can often make patients look 10 to 20 years younger, and the results can last for eight to 10 years, says Tina Alster, M.D., director of the Washington Institute of Dermatologic Laser Surgery in the nation's capital. But she warns that after surgery, patients must avoid sunbathing and destroying their skin again. Patients can have a repeat treatment after one year, but usually the first procedure is so successful a follow-up is not needed.
Lasers cannot rejuvenate skin on other parts of the body nor can laser treatment lift or remove sagging jowls or smooth out "crepey" or sagging neck skin. These conditions only respond to traditional cut-and-stitch surgical methods.

Is Resurfacing for You?

Not everyone makes an ideal candidate for laser resurfacing, Perkins explains. "Certain people with very sensitive skin cannot tolerate the medications and lubricants used on the skin during healing." Perkins also feels that the darker-skinned ethnic groups are not candidates because the laser treatment alters the color of skin too dramatically and unpredictably. Alster, on the other hand, believes that in the hands of a very experienced surgeon, people with darker skin tones, although not ideal candidates, can benefit from surgery.

Alster warns that anyone not mentally prepared for resurfacing or who expects instant results is not a good candidate. "This is not easy in-easy out surgery," she says. "Potential patients have to realize that there will be bruising and swelling and they will be holed up in the house for seven to 10 days," she says. "They will have a crusty, oozy, bruised, scabbed, raw-appearing face." Further, they should not expect unflawed skin. "I can't deliver that," she says. "I am not able to give unlined, unscarred skin." Patients, however, can expect a 50 percent or greater improvement.

They must also plan on at least 10 days of healing before applying any makeup. For satisfactory healing, that means following rigorous after-care treatment, including proper skin cleansing, the application of a skin lubricant, and the frequent changing of dressings.

What Are the Risks?

As with any medical procedure, patients may experience certain complications--most temporary--including a prolonged redness of skin, tenderness, easy flushing, and some pigmentary changes, like hyperpigmentation, when the skin appears darker than normal, says Rox Anderson, M.D., director of the Laser Center at Massachusetts General Hospital in Boston.
Other risks are more serious, and possibly permanent, including hypopigmentation, or lightening of the skin. "Somewhere between one to two years after treatment it becomes clear that there is a permanent lightening of the skin color where the resurfacing was done," he says.

And scarring may occur in about 2 percent of the cases, he adds, from poor postoperative care, during which time an infection may develop. Or a surgeon may go too deep during the procedure, creating an injury the skin cannot repair, says Alster.

Consider the case of Anne Jones (not her real name) in semi-rural Mississippi, a stay-at-home mom and a doctor's wife. Wanting to remove some mild acne scars, she went to a well-respected local plastic surgeon, but after a five-month recovery period, Jones realized that something had gone very wrong. "He had just burned my face," she says. It was red, with scar tissue all over, she adds.

Eventually, Jones went for help to an ophthalmologist who had extensive laser knowledge--many ophthalmologists use lasers for corrective eye surgery. He took one look at her and exclaimed, "Oh, I am so sorry this has happened to you." He told her that the surgeon had been too aggressive and had not used the right settings, so that her skin had retained too much heat and had been severely burned.

Because both qualified and unqualified practitioners are flooding the cosmetic laser surgery field, consumers may face some real hazards. "All of a sudden, there's widespread use of lasers by unqualified people," says Perkins, who notes that some laser manufacturers are so eager to sell their products that they stage one- or two-day meetings, or courses, for training. That means that even dentists, obstetricians, gynecologists, and family doctors are now offering laser surgery, says Alster.

"The person planning to do laser surgery must understand the basic physics of how laser energy is absorbed by tissue and how tissue responds," warns FDA's Felten. "Then that person should go where the surgery is performed and watch a skilled surgeon use the equipment." Besides that, says Anderson, the best people to work with lasers on skin conditions are the professionals who best understand skin and surgery of the skin: dermatologists and plastic surgeons.

"Sometimes people may choose the wrong laser, or a surgeon may believe more is better, which can lead to significant burning," says Alster. And some operators don't know they must keep wiping off the partially desiccated skin or that they must keep moving the hand holding the laser instrument during the procedure.

To date, no national policy exists for credentialing those planning to practice laser surgery. Felten says FDA is responsible for granting individual manufacturers permission to market their lasers for the specific indications requested. FDA also often recommends training needed to operate the lasers.

But credentialing is a state function, since states are responsible for the licensing of doctors and nurses, and standards for laser training vary from state to state.
That's bad news for patients like Jones. Two years after her procedure, she has spent nearly $70,000 for both the initial surgery and subsequent consultations and corrective surgeries to remove the scarring. She says she has partially reclaimed her life. But she bitterly regrets undergoing the initial surgery. "I will never look right," says Jones. "I would never do this again."
Finding the Best Surgeon

Selecting a laser surgeon is just like picking a qualified doctor for any medical treatment. "Consumers ask more questions of auto mechanics," says Alster. "This is surgery and with it comes inherent risks and complications. While it is perceived as easy, it is not. When you are talking about skin, it is harder to treat than eyes."

The Internet is a good place to start the search. Consumers can find thousands of Websites, including those for specialists, laser and plastic surgery societies, and information pages. But consumers should be wary of assuming the accuracy of any information taken off the Internet because the unscrupulous can put up their own Web pages just as easily as can the qualified.
Alster suggests interviewing several doctors and evaluating their answers and their credentials. After all, she adds, it's the doctor's skill that counts--the laser is just the doctor's tool.

The next step is crucial: asking the right questions. Alster advises asking where the doctor has trained and if he or she owns or rents the equipment--those who own have likely made a commitment to training and to laser surgery. Ask to see before and after pictures of the doctor's cases, and find out how many different types of lasers the doctor owns and how often each piece of equipment is used. "There is not one laser that does everything," she says, cautioning patients to select a surgeon whose practice offers more than one laser system. "One needs to use [the right] laser for the right lesion. So the person examining you must make the correct diagnosis," she says. Alster herself has at least 10 different lasers in her office.

Of course, the final decision may be difficult, since no doctor can guarantee perfection or complete safety, but well-informed patients with reasonable expectations may be one step closer to younger, fresher-looking skin.

Alexandra Greeley is a writer in Reston, Va.