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What Are the Risks?
by Alexandra Greeley

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."

Article Source:  The full article originally appeared in the May-June 2000 FDA Consumer and contains revisions made in August 2000.

About the Author:
Alexandra Greeley is a writer in Reston, Va.


 

 



 


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