National report — As the number of nontraditional medical spas grows, so do reports of complications associated with them, sources tell Cosmetic Surgery Times. "These spas are popping up all over the place," says Anita Mandal, M.D., a board-certified facial plastic surgeon based in Palm Beach Gardens, Fla., who has worked with two local medical spas.
"People are getting into it for the money, and usually they're either physicians who have no background in plastic surgery or dermatology, or nonmedical people who view the business as an investment," Dr. Mandal says. To maximize profits, such entrepreneurs often rely on inadequately supervised physician assistants (PAs), registered nurses (RNs) and nurse practitioners (NPs), she adds.
Min-Wei Christine Lee, M.D., M.P.H., a dermatologic surgeon and director of The East Bay Laser & Skin Care Center, Inc., Walnut Creek, Calif., is a member of the American Society for Dermatologic Surgery (ASDS) task force investigating the nonphysician practice of medicine. She contends that nonphysician, nonmedical-licensed ownership of medical facilities violates California's corporate practice of medicine law, while state medical boards, nursing boards and the Food and Drug Administration (FDA) have failed to exercise their authority in such cases.
Doing it right Dr. Lee says one company that plays by the rules is Thermage®. "As part of the FDA requirement for a Class II medical device, ThermaCool™ is sold by or on the order of a physician," says Stephen J. Fanning, chief executive officer of Thermage® Inc. "In addition," he says, "Thermage® requires a medical director to be on site where Thermage® procedures will be performed," and the company's certification process and commitment to long-term customer relationships contribute to Thermage's® strong safety profile. Nevertheless, Dr. Lee says, "Many doctors and nurses are very naïve" when faced with entrepreneurs' pitches to basically rent their licenses. Such propositions are too tempting for many primary care doctors, internists, emergency medicine doctors and residents — and sometimes dermatologists and plastic surgeons — seeking extra cash, she says. Doing it wrong In this climate, Dr. Mandal says the following problems commonly occur:
"Many of these people lack the proper experience or training to appreciate the finesses of injecting Botox (botulinum toxin type A, Allergan) and Restylane (hyaluronic acid, QMed), or dealing with problems when they occur," Dr. Mandal says. It's not that employees of nontraditional medical spas don't know what they're doing, says Michael H. Gold, M.D., medical director at Gold Skin Care Center, Advanced Aesthetics Medi Spa, The Laser and Rejuvenation Center and the Tennessee Clinical Research Center, and clinical assistant professor, division of dermatology, Vanderbilt University School of Medicine and School of Nursing, Nashville. Most patients treated at nontraditional spas do very well, he says. "The problem is that when there's an adverse event, these people don't know how to take care of it," he says. Policing the practice To combat such problems, Dr. Lee says, "The ASDS has taken the stance that if doctors are going to delegate cosmetic procedures, they must properly supervise them. The ASDS believes that proper supervision means a doctor is on-site and overseeing the treatments." However, she points out that ASDS guidelines aren't laws. Accordingly, she says that for the past eight or nine years, "It's getting worse. More and more people are breaking the law." Along with maintaining an active physician presence at every spa, Dr. Mandal recommends that physicians see patients at initial consultations and whenever patients present with complex problems. Likewise, she says one should train PAs and NPs to better recognize abnormalities that are beyond their expertise. The boom in nontraditional medical spas is "not going away," Dr. Gold says. Such spas probably are accounting for more adverse events seen in dermatologists' and plastic surgeons' offices, he adds. However, Dr. Gold says, "The counterargument which dermatologists and plastic surgeons must ask is, how many times do we see adverse events in our clinics?" He says no one has ever studied conclusively whether traditional or nontraditional medical spas create more adverse events. Nip growing problem in the bud According to a recent review of 123 complications resulting from laser treatment by nonphysicians, 78 percent occurred in nontraditional facilities such as freestanding medical spas and shopping-mall laser centers (Narurkar VA. Paper presented at: Annual Meeting of the American Society for Laser Medicine and Surgery (ASLMS); April 5-9, 2006; Boston). Nationally, "There's no real data as to the incidence" of complications generated by nontraditional spas because such data is virtually impossible to get, says Roy G. Geronemus, M.D., director of the Laser & Skin Surgery Center of New York, clinical professor of dermatology at New York University Medical Center and immediate past president of the ASLMS. He adds that although he believes incidence figures had been rising gradually, they've skyrocketed 50 percent to 100 percent in the last six months. To stem the tide, he says the ASDS has been diligently lobbying state regulators to limit the practice of medicine to physicians or those under their direct supervision. Despite ASDS public relations efforts, he adds, "The public is generally unaware of the risks, and of the need to see a trained physician for these procedures." Going forward, Dr. Geronemus says that the more problems related to nontraditional medical spas that surface, "The more likely we are to see regulation." If doctors don't make medical spa treatments safer for the consumer, Dr. Lee says, "We run the risk of making it difficult for every doctor to operate lasers." Dr. Mandal adds, "We, as plastic surgeons and cosmetic dermatologists, have an obligation to contact our medical boards and legislatures to make sure that medical treatments are being performed in law-abiding facilities." Disclosure: Dr. Gold serves on the board of the Medical Spa Society and was medical director of Vanishing Point, a franchised chain of laser hair removal salons in business from 1999 until 2000.
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