Robinson D.M.,SkinCare Physicians |
Kaminer M.S.,SkinCare Physicians |
Baumann L.,Baumann Cosmetic and Research Institute |
Burns A.J.,Dallas Plastic Surgery Institute |
And 6 more authors.
Dermatologic Surgery | Year: 2014
BACKGROUND: High-intensity focused ultrasound (HIFU) is a noninvasive alternative to traditional invasive body sculpting procedures. OBJECTIVE: To assess the effectiveness and tolerability of HIFU treatment using high and low fluence settings with 2 treatment techniques, grid repeat (GR) and site repeat (SR). MATERIALS AND METHODS: Two multicenter studies were conducted. Subjects underwent 1 HIFU treatment with 1 of 5 treatment protocols (total fluence, 150-180 J/cm2). Primary end point was change from baseline in waist circumference (CBWC) at 12 weeks. Secondary end points included CBWC at 4 and 8 weeks and investigator- and subject-Assessed clinical improvement. Adverse events were monitored throughout the study. RESULTS: In the intent-to-treat (ITT) population, all subjects had a statistically significant mean circumferential reduction of 22.3 6 2.9 cm (p <.0001) from baseline at 12 weeks, with no significant differences among the 5 treatment groups (ITT: p =.153). Analysis of secondary end points in the ITT population demonstrated a significant circumferential reduction starting as early as 4 weeks in all subjects (21.1 6 1.9 cm, p <.0001). Most subjects in all treatment groups showed improvements at 12 weeks as rated by the investigators and subjects. CONCLUSION: High-intensity focused ultrasound treatment using either a low or high fluence setting in a GR or SR method is effective for circumferential waist reduction, resulting in statistically significant CBWC in all treatment groups. © 2014 by the American Society for Dermatologic Surgery, Inc.
Jewell M.L.,Jewell Plastic Surgery Center |
Jewell M.L.,Oregon Health And Science University |
Jewell M.L.,Savin Center |
Jewell M.L.,Private Practice |
And 3 more authors.
Plastic and Reconstructive Surgery | Year: 2011
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/cm (141 J/cm total), 59 J/cm (177 J/cm), or 0 J/cm (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/cm (-2.44; p = 0.01) but not the 47-J/cm treatment group (-2.06 cm; p = 0.13). In a per-protocol population, statistical significance versus sham was achieved for both the 59-J/cm (-2.52 cm; p = 0.002) and the 47-J/cm 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). © 2011 by the American Society of Plastic Surgeons.
PubMed | Jewell Plastic Surgery Center
Type: Journal Article | Journal: Plastic and reconstructive surgery | Year: 2011
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.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.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.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.Risk, V.