NOV-DEC 2016

MedEsthetics—business education for medical practitioners—provides the latest noninvasive cosmetic procedures, treatment trends, product and equipment reviews, legal issues and medical aesthetics industry news.

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4 NOVEMBER/DECEMBER 2016 | Med Esthetics EDITORIAL ADVISORY BOARD Mary Lee Amerian, MD Santa Monica Laser and Skin Care Center, Santa Monica, CA Saul R. Berger, MD Medical Director, The New Age Aesthetic Center, Encino, CA Michael H. Gold, MD Assistant Clinical Professor, Vanderbilt University Medical Center Founder, Gold Skin Care Center, Nashville, TN Bruce Katz, MD Clinical Professor Dermatology, The Mount Sinai School of Medicine Director, Juva Skin & Laser Center, New York Lorrie Klein, MD Assistant Clinical Professor, University of California-Irvine Medical School Founder, OC Dermatology & Euro Day Spa, Laguna Niguel, CA Allan Share President, International Medical Spa Association, Minnetonka, MN David H. McDaniel, MD Laser & Cosmetic Center of Virginia, Virginia Beach, VA Vic Narurkar, MD Associate Clinical Professor of Dermatology, UC Davis Medical School Chief of Dermatology, California Pacifi c Medical Center, San Francisco, CA Ava Shamban, MD Assistant Clinical Professor of Dermatology, UCLA-Geffen School of Medicine; Director, AVA MD, Santa Monica, CA Hema Sundaram, MD Director, Sundaram Dermatology, Cosmetic & Laser Surgery Center, Rockville, MD and Fairfax, VA Wm. Philip Werschler, MD Spokane Dermatology Clinic and Werschler Aesthetics, Spokane, WA ¥ 603.354.3291 In September, the U.S. Food and Drug Administration (FDA) held a hearing on the use of human cells, tissues, and cellular and tissue- based products—collectively categorized as HCT/P—in medicine. At issue are four FDA draft guidance documents currently under consideration that would help defi ne how providers may use HCT/P in clinical practice. These guidelines could dramatically affect aesthetic medicine practitioners, particularly regarding their use of autologous fat transplant and platelet-rich plasma (PRP). Healthcare providers, including representatives of the American Society of Plastic Surgeons (ASPS), attended the hearing to share their views, and a panel at Plastic Surgery The Meeting 2016 in Los Angeles highlighted the concerns voiced by ASPS members. The two key areas of concern include the FDA's narrow defi nition of "manual manipulation" and its desire to restrict the use of HCT/P to "homologous use only," meaning any transplanted tissue or cellular structures must perform the same basic function in the recipient site as in the donor site. The FDA defi nes adipose as exclusively structural; therefore, decellularizing adipose tissue would violate the proposed regulations as it eliminates the fat's structural capacity—a view with which the ASPS disagrees, arguing that adipose is both a structural and a regenerative tissue. In addition, the ASPS is encouraging the FDA to consider the intended use of transplanted material when looking at its manual manipulation guidelines, which—in their current form—would eliminate enzymatic digestion, separation of cell population, exposure to drugs or growth factors, genetic manipulation and cryopreservation of cells and tissue. The ASPS is scheduled to publish its recommendations on the regulation of HCT/P by the end of 2016 in Plastic and Reconstructive Surgery. This is not the fi rst time—and likely not the last—that regulators have struggled to keep pace with current practices in medicine. Alternative therapies, including the use of bioidentical hormones, supplements and vitamin infusions, have placed providers in the crosshairs of not only the FDA, but also state medical boards. Several states have enacted Health Freedom laws to shield practitio- ners offering alternative therapies from regulatory action. But in most states providing—and more importantly, marketing—these treatments can put your practice at risk. On page 14, healthcare attorney Allyson Avila provides guidance on how to offer effective alternative therapies without run- ning afoul of current laws and regulations. One of the key functions of the FDA is to provide a risk-benefi t analysis of new drugs and devices to guide practitioners and patients as they work to determine the best treatments for each particular concern. In skin care, providers must also consider the benefi ts of antiaging topicals, such as reti- noids and skin lightening ingredients, and weigh the risk of further drying aging skin that is already struggling to maintain healthy levels of hydration. On page 24, writer Linda W. Lewis provides an overview of the most effective topical skin hydrators for different skin types and age groups. Fractional laser resurfacing has allowed a wide range of patients to enjoy the benefi ts of ablative laser rejuvenation. But these treatments are not without risk. To learn more about proper patient selection, indications, and pre- and post-ablative laser skin care, turn to "Selective Ablation" on page 40. As aesthetic practitioners continue to innovate with new devices, techniques and a growing body of knowledge on the wide range of services available, it is important to stay informed and employ best practices to ensure that your patients are getting the safest and most effective treatments. We appreciate being part of your educational armamentarium and look forward to sharing the latest treatment and practice management advances with you. Keeping Apace Inga Hansen Executive Editor/Associate Publisher EDITOR'S NOTE

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