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Biomedical subjects

Mark L Jewell

Publications and source records attributed to Mark L Jewell.

6 recordsLinked to original sources

Consensus recommendations for soft-tissue augmentation with nonanimal stabilized hyaluronic acid (Restylane).

The American Society for Aesthetic Plastic Surgery recently reported that there were nearly 12 million cosmetic procedures (2.1 million surgical and 9.7 million nonsurgical) performed in the United States in 2004. Almost 900,000 of the nonsurgical procedures were soft-tissue augmentation procedures using hyaluronic acid fillers. Restylane (Medicis Aesthetics, Inc., Scottsdale, Ariz.), nonanimal stabilized hyaluronic acid, was approved for use in the United States in December of 2003. Although the use of all fillers increased from 2003 to 2004, use of hyaluronic acid fillers increased nearly 700 percent. The dramatic increase in all cosmetic procedures reflects the growing trend, especially with increasing job competition, to maintain a youthful lifestyle and appearance. Basic recommendations for aesthetic use of Restylane were established based on short- and long-term efficacy and safety studies (Medicis Aesthetics, package insert). With the widespread and growing use of Restylane, a cross-sectional panel of experts with extensive clinical experience, including cosmetic dermatologists and surgical specialists (cosmetic, plastic, and ocular), convened to develop consensus guidelines for the use of Restylane. This supplement reviews the aesthetic affects of aging on the face, the role of fillers in facial soft-tissue volume replacement, and general principles for the use of Restylane, including patient comfort and assessment techniques. Specific recommendations for Restylane use in each potential target area, including type of anesthesia, injection techniques, volume for injection, use in combination with other procedures, and expected longevity of corrections, are provided. Techniques for optimizing patient outcomes and satisfaction and for minimizing and managing expected problems and potential complications are described.

Cosmetic Techniques↗

Decision and management algorithms to address patient and food and drug administration concerns regarding breast augmentation and implants.

During the U.S. Food and Drug Administration's advisory panel hearings to evaluate the premarket approval for conventional silicone gel implants on October 14 and 15, 2003, panel members and patient advocate representatives focused on four specific areas of concern: reoperation rates in primary breast augmentation; levels, depth, and methods of patient education and informed consent; modes, frequency, and management of silicone gel implant device failures, including management of "silent" ruptures; and methods of monitoring and managing symptoms or symptom complexes that may or may not be associated with connective tissue disease or other undefined symptom complexes. These concerns, with a reported 20 percent reoperation rate for primary augmentation within just 3 years, and a lack of concise, definitive management protocols addressing these areas of concern may have contributed to the Food and Drug Administration's rejection of the premarket approval, despite the panel's recommendation for approval. This article presents decision and management algorithms that have been used successfully for 7 years in a busy breast augmentation practice (Tebbetts and Tebbetts). The algorithms have been further expanded and refined by a group of surgeons with diverse experiences and expertise to address the following clinical situations that coincide with concerns expressed by patients and the Food and Drug Administration: implant size exchange, grade III to IV capsular contracture, infection, stretch deformities (implant bottoming or displacement), silent rupture of gel implants, and undefined symptom complexes (connective tissue disease or other). In one practice (Tebbetts and Tebbetts) that uses the TEPID system (tissue characteristics of the envelope, parenchyma, and implant and the dimensions and fill distribution dynamics of the implant), implant selection is based on quantified patient tissue characteristics, pocket selection is based on quantified soft-tissue coverage, and anatomic saline implants have fill volumes that are designed to minimize shell collapse and fold fatigue; in this practice, the algorithms contributed to a 3 percent overall reoperation rate in 1662 reported cases with up to 7 years of follow-up, compared with a 20 percent reoperation rate at 3 years in the 2003 premarket approval study.

Algorithms↗