Mark L. Jewell

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

Summary: 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.

Anaplastic large T-cell lymphoma and breast implants: a review of the literature.

Background: Anecdotal reports and one case-control study suggested an association, without evidence of causation, between breast implants and anaplastic lymphoma kinase–negative anaplastic large T-cell lymphoma (ALCL), a rare non-Hodgkins lymphoma. This review summarizes the published evidence, including case reports and epidemiologic studies. Methods: A PubMed search limited to English language articles was conducted using the search terms “breast implant” and “lymphoma,” “primary T-cell breast lymphoma,” or “breast implant and ALCL” to identify all published cases of breast-associated ALCL. Results: A total of 18 publications were retrieved describing 27 cases of ALCL in breast implant recipients. Breast-associated ALCL occurred in women with and without implants. Approximately 78 percent of cases (21 of 27) were CD30+ anaplastic lymphoma kinase–negative, with an indolent clinical course. Both saline- and silicone-filled devices were identified; however, implant style and surface texture were largely unreported. The tumor stage at diagnosis was I in 16 of 27, II or higher in seven of 27, or unreported in four of 27. No prospective epidemiologic study has linked implants and ALCL; however, a single case-control study in Dutch women reported increased odds of association between ALCL and implants, and an estimated frequency of one in 1 million women with and without breast implants. Conclusions: An association, without evidence of causation, was reported between breast implants and ALCL. Further study is required to confirm this association. Breast-associated ALCL occurred rarely in women with and without breast implants and had a primarily indolent clinical course, which may provoke a revision of the World Health Organization nomenclature for lymphoma; however, aggressive clinical behavior was also reported. The cases of ALCL were not confined to a specific type of implant. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, V.

Clinical Application of VASER-assisted Lipoplasty: A Pilot Clinical Study

BACKGROUND Although lipoplasty is the most frequently performed aesthetic surgical procedure, ultrasound-assisted lipoplasty (UAL) has not been widely adopted because of its increased potential for complications, complex and bulky instrumentation, additional cost, and steep learning curve. OBJECTIVE We report on the use of the VASER ultrasound device in lipoplasty procedures and compare the clinical outcomes obtained by means of VASER-assisted lipoplasty with those of other UAL devices. METHODS A superwet technique was used, and the wetting solution was uniformly distributed in the intended treatment area. Skin protection measures included use of specially designed skin ports to protect the incision edges and wet towels adjacent to the port locations. Access incisions were 3 to 4 mm in length. The VASER device was used in VASER (pulsed ultrasound) mode by 2 investigators (P.B.F. and M.L.J.); the continuous ultrasound mode was used by these investigators only if tissue emulsification was not readily achieved by using the VASER mode. A third investigator (E.B.d.S.P.) primarily used the continuous mode. Effective fat fragmentation in either mode was achieved by a maximum of 1 minute of treatment time per 100 mL of infused wetting solution. RESULTS In a series of 77 patients treated by 3 different clinicians, satisfactory results were obtained with no major complications. This contrasts with an incidence of complications of 7.9% (median, 4.9%) for first- and second-generation UAL devices as determined by statistical analysis of the literature. CONCLUSIONS The initial clinical experience with VASER-assisted lipoplasty indicates that it is a safe and efficient technique for body-contouring surgery. (Aesthetic Surg J 2002;22:131-146.).

Managing late periprosthetic fluid collections (seroma) in patients with breast implants: a consensus panel recommendation and review of the literature.

Background: The goal of this consensus is to establish an algorithm for the management of patients who develop a late or delayed periprosthetic fluid collection. A work group of practicing plastic surgeons and device industry physicians met periodically by teleconference and discussed issues pertinent to the diagnosis and management of late periprosthetic fluid collections in patients with breast implants. Based on these meetings, treatment recommendations and a treatment algorithm were prepared in association with an editorial assistant. Method: The work group participants discussed optimal care approaches developed in their private practices and from evidence in the literature. Results: The consensus algorithm and treatment and management recommendations represent the consensus of the group. Conclusions: The group concluded that late periprosthetic fluid collection (arbitrarily defined as occurring ≥1 year after implant) is an infrequently reported occurrence (0.1 percent) after breast implant surgery and that, at a minimum, management should include clinically indicated ultrasound-guided aspiration of fluid, with appropriate cultures and cytologic testing. Further evaluation and additional treatment is recommended for recurrence of periprosthetic fluid collection after aspiration, or clinical suspicion of infection or neoplasia.

A prospective, multi-site investigation of patient satisfaction and psychosocial status following cosmetic surgery

BACKGROUND Although several studies have investigated patient satisfaction and changes in body image following aesthetic plastic surgery, few have investigated more specific dimensions of body image, including dysphoric emotions that occur in specific social situations or body image quality of life. In addition, few studies have investigated changes in body image that may occur in concert with changes in more general areas of psychosocial functioning, such as depressive symptoms and self-esteem. OBJECTIVE This prospective, multi-site study investigated postoperative satisfaction and changes in psychosocial status following cosmetic surgery. METHODS One hundred patients recruited from 8 geographically diverse surgical practices completed psychometric measures of body image, depressive symptoms, and self-esteem prior to surgery. Seventy-two patients completed the 3-month postoperative assessment, 67 completed the 6-month assessment, and 63 completed the 12-month assessment. All statistical tests on changes after surgery were conducted using the sample of 72 patients who completed the 3-month assessment. A Last Observation Carried Forward analysis was used to account for patients who did not complete the subsequent follow-up assessments. In addition, they reported their postoperative satisfaction as well as self-rated attractiveness at the 3 postoperative assessment points. RESULTS Eighty-seven percent of patients reported satisfaction with their postoperative outcomes. Patients also reported significant improvements in their overall appearance, as well as the appearance of the feature altered by surgery, at each of the postoperative assessment points. Patients experienced significant improvements in their overall body image, their degree of dissatisfaction with the feature altered by surgery, and the frequency of negative body image emotions in specific social situations. All of these improvements were maintained 12 months after surgery. CONCLUSIONS These results add to a growing body of literature documenting improvements in body image following cosmetic surgery.

Randomized sham-controlled trial to evaluate the safety and effectiveness of a high-intensity focused ultrasound device for noninvasive body sculpting.

Background: High-intensity focused ultrasound presents a noninvasive approach to body sculpting for nonobese patients. The purpose of this study was to evaluate the safety and effectiveness of a high-intensity focused ultrasound device for sculpting of the abdomen and flanks. Methods: Adults (aged 18 to 65 years) with subcutaneous abdominal fat greater than or equal to 2.5 cm thick who met screening criteria were randomized to receive high-intensity focused ultrasound treatment of the anterior abdomen and flanks at energy levels (a total of three passes each) of 47 J/cm2 (141 J/cm2 total), 59 J/cm2 (177 J/cm2), or 0 J/cm2 (no energy applied, sham control). The primary endpoint was change from baseline waist circumference at the iliac crest level at posttreatment week 12. Subjective aesthetic assessments included the Global Aesthetic Improvement Scale and a patient satisfaction questionnaire. Safety assessments included adverse events, laboratory values, and physical examinations. Results: For the primary endpoint, in the intent-to-treat population, statistical significance versus sham was achieved for the 59-J/cm2 (–2.44; p = 0.01) but not the 47-J/cm2 treatment group (–2.06 cm; p = 0.13). In a per-protocol population, statistical significance versus sham was achieved for both the 59-J/cm2 (–2.52 cm; p = 0.002) and the 47-J/cm2 treatment groups (–2.10 cm; p = 0.04). Investigator subjective measures of global aesthetic improvement and patient satisfaction also favored each active treatment versus sham. Adverse events included mild to moderate discomfort, bruising, and edema. Laboratory values and physical examinations were unremarkable. Conclusions: Treatment with this high-intensity focused ultrasound device reduced waist circumference and was generally well tolerated for noninvasive body sculpting. Reduction in waist circumference was statistically significant with both active treatments (per protocol). CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II. Figure. No caption available.

Noninvasive Body Sculpting Technologies with an Emphasis on High-Intensity Focused Ultrasound

BackgroundBody-sculpting procedures are becoming increasingly popular in the United States. Although surgical lipoplasty remains the most common body sculpting procedure, a demand exists for noninvasive alternatives capable of reducing focal adiposity without the risks of adverse events (AEs) associated with invasive excisional body-sculpting procedures.MethodsThis report describes the mechanism of action, efficacy, safety, and tolerability of cryolipolysis, radiofrequency ablation, low-level external laser therapy, injection lipolysis, low-intensity nonthermal ultrasound, and high-intensity focused ultrasound (HIFU), with an emphasis on thermal HIFU. The articles cited were identified via a PubMed search, with additional article citations identified by manual searching of the reference lists of articles identified through the literature search.ResultsEach of the noninvasive treatments reviewed can be administered on an outpatient basis. These treatments generally have fewer complications than lipoplasty and require little or no anesthesia or analgesia. However, HIFU is the only treatment that can produce significant results in a single treatment, and only radiofrequency, low-level laser therapy, and cryolipolysis have been approved for use in the United States. Early clinical data on HIFU support its efficacy and safety for body sculpting. In contrast, radiofrequency, laser therapy, and injection lipolysis have been associated with significant AEs.ConclusionsThe published literature suggests that noninvasive body-sculpting techniques such as radiofrequency ablation, cryolipolysis, external low-level lasers, laser ablation, nonthermal ultrasound, and HIFU may be appropriate options for nonobese patients requiring modest reduction of adipose tissue.

Evaluation of a Novel High-Intensity Focused Ultrasound Device for Ablating Subcutaneous Adipose Tissue for Noninvasive Body Contouring: Safety Studies in Human Volunteers

BACKGROUND High-intensity focused ultrasound (HIFU) is an energy-based medical technology with many clinical applications. A device under clinical investigation in the United States (LipoSonix; Medicis Technologies Corporation, Bothell, Washington) uses HIFU to reduce localized deposits of abdominal adipose tissue. OBJECTIVES The authors describe the results from their clinical trial investigating the safety of this HIFU device in human patients. METHODS Over the course of three studies evaluating the safety of the HIFU device for ablating human subcutaneous adipose tissue (SAT), 152 healthy patients were treated with total HIFU energy doses of 47 to 331 J/cm(2)), including patients who presented for elective abdominoplasty and underwent treatment to areas identified for subsequent excision. The safety of each treatment regimen was confirmed before the energy levels were raised. Abdominoplasty was performed up to 14 weeks following the HIFU procedure, and a pathologist performed histopathological analyses of excised tissues. Safety evaluations included an assessment of clinical chemistry and hematology profiles, physical examinations, and adverse events. RESULTS Posttreatment ultrasound confirmed that the HIFU effects were limited to targeted SAT layers. Histopathology revealed well-demarcated disruption of adipocytes within the targeted SAT. Phagocytosis of released lipids and cellular debris occurred after 14 to 28 days. Phagocytized lipids underwent normal hepatic metabolism. Healing progressed normally and was 95% complete after eight to 14 weeks. Adverse events consisted primarily of temporary treatment discomfort, edema, erythema, dysesthesia, and ecchymosis. There were no changes in clinical laboratory parameters, and no serious device-related adverse events occurred. Optimal clinical outcomes were achieved with lower energy levels, which provided beneficial effects with the least amount of discomfort. CONCLUSIONS HIFU appears to provide a safe means for removing and remodeling unwanted deposits of abdominal SAT.

Risks and opportunities for plastic surgeons in a widening cosmetic medicine market: Future demand, consumer preferences, and trends in practitioners' services

Background: The American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgery launched a joint Cosmetic Medicine Task Force to address the growing trend of non–plastic surgeons entering the cosmetic medicine field. The task force commissioned two surveys in 2007 to determine consumer attitudes about choosing cosmetic medicine providers and to learn about the cosmetic services that plastic surgeons offer. Methods: The first survey obtained responses from 1015 women who had undergone a cosmetic procedure or were considering having one within 2 years. The second survey obtained responses from 260 members of the two societies. Results: Compared with other practitioners, plastic surgeons enjoy higher rates of satisfaction among their patients who undergo noninvasive procedures. Injectables present a particularly promising market for plastic surgeons. Half of consumers surveyed said they were very concerned about complications associated with injectables, and generally, the higher the perceived risk of the procedure, the higher the likelihood that a patient would choose a plastic surgeon to perform it. In addition, injectables were among the noninvasive treatments most frequently being considered by consumers. However, almost half of consumers said that if they had a positive experience with a non–plastic surgeon core provider for a noninvasive procedure, that physician would likely be their first choice for a surgical procedure. Conclusions: These findings suggest that plastic surgeons, and especially those who are building young practices, must expand their offerings of nonsurgical cosmetic services to remain at the core of the cosmetic medicine field.

SERI surgical scaffold, prospective clinical trial of a silk-derived biological scaffold in two-stage breast reconstruction: 1-year data

Background: SERI Surgical Scaffold is a long-term bioresorbable silk-derived biological scaffold developed to provide soft-tissue support and repair. Methods: SURE-001 (ClinicalTrials.gov identification no. NCT01256502) is a prospective, single-arm study in the United States of patients undergoing two-stage, implant-based breast reconstruction using SERI. Results: A total of 139 patients were enrolled and will be followed for 2 years; in this article, the authors report interim data on 71 patients followed for 1 year. Investigator satisfaction scores (mean ± SD) at 6 and 12 months were 9.2 ± 0.98 and 9.4 ± 0.91, respectively (10 = very satisfied). SERI was rated easy/very easy to use in 98 percent or more of cases across five categories in stage I surgery. Patient satisfaction with the treated breast(s) (mean ± SD) was higher at 6 (4.3 ± 0.87; 5 = very satisfied) and 12 months (4.5 ± 0.82) compared with screening (3.6 ± 1.09; p < 0.0001). Key complication rates (per breast) were tissue necrosis (6.7 percent), seroma (5.7 percent), hematoma (4.8 percent), implant loss (3.8 percent), capsular contracture (1.9 percent), and breast infection (1.0 percent). None were attributed to SERI by the investigators. In 13 patients (14 breasts) who underwent unplanned radiation therapy, one complication was reported. Conclusions: In this interim report, high levels of investigator and patient satisfaction, and ease of use of SERI were reported. Prospectively collected complication rates were similar to those reported in primarily retrospective studies of two-stage, implant-based breast reconstructions using other implantable soft-tissue support materials such as acellular dermal matrices. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.