Richard A. Baxter

Safety and Tolerability of High-Intensity Focused Ultrasonography for Noninvasive Body Sculpting: 24-Week Data From a Randomized, Sham-Controlled Study

BACKGROUND High-intensity focused ultrasonography (HIFU) is a nonsurgical, noninvasive method for body sculpting in nonobese patients. The technique ablates subcutaneous adipose tissue by causing molecular vibrations that increase tissue temperature and induce rapid cell necrosis. OBJECTIVES The authors evaluate the long-term safety of a HIFU device for sculpting the abdomen and flanks. METHODS Adults with subcutaneous abdominal fat ≥2.5 cm in thickness who met screening criteria were randomized to receive HIFU treatment of the anterior abdomen and flanks at 1 of 3 energy levels (3 passes per patient): 47 J/cm(2) (141 J/cm(2) total), 59 J/cm(2) (177 J/cm(2) total), or 0 J/cm(2) (no energy applied; sham control). Safety was assessed for 24 weeks and included laboratory testing, physical examinations, and documentation of adverse events. RESULTS Adverse events (AE) included mild to moderate discomfort, ecchymosis, and edema, all of which were transient. There were no reports of scarring or burns and no clinically meaningful changes in lipid panel findings, inflammatory markers, or renal or hepatic function. Physical examination results were unremarkable. CONCLUSIONS This HIFU device exhibited an AE profile similar to that of sham treatment. There were no significant changes from baseline in laboratory values, including lipid levels.

Does Implant Insertion with a Funnel Decrease Capsular Contracture? A Preliminary Report

BACKGROUND Capsular contracture remains a common and dreaded complication of breast augmentation. The etiology of capsular contracture is believed to be multi-factorial, and its causes may include biofilm formation due to implant/pocket contamination with skin flora. It has been shown that insertion funnel use reduces skin contact and potential contamination by 27-fold in a cadaver model. After incorporating the funnel into our surgical protocols, we anecdotally believed we were experiencing fewer capsular contractures in our augmentation practices. OBJECTIVES The purpose of this study was to test the hypothesis that capsular contracture related reoperation rates decreased after insertion funnel adoption using data from multiple practices. METHODS At seven participating centers, we retrospectively reviewed the surgical records from March 2006 to December 2012 for female patients who had undergone primary breast augmentation with silicone gel implants. Group 1 consisted of consecutive augmentations done without the insertion funnel, and Group 2 consisted of consecutive augmentations done with the insertion funnel. The primary outcome variable was development of grade III or IV capsular contracture that led to reoperation within 12 months. RESULTS A total of 1177 breast augmentations met inclusion criteria for Group 1 and 1620 breast augmentations for Group 2. The rate of reoperation due to capsular contracture was higher without use of the insertion funnel (1.49%), compared to Group 2 with funnel use (0.68%), a 54% reduction (P = 0.004). CONCLUSIONS The insertion funnel group experienced a statistically significant reduction in the incidence of reoperations performed due to capsular contracture within 12 months of primary breast augmentation.

Serum lipid changes following large-volume suction lipectomy.

Improved techniques have enabled surgeons to perform large-volume liposuction more safely; however, the physiologic consequences of this procedure are not well documented. The possible effects of large-volume liposuction on serum lipids are not well established. This study was done to determine what changes, if any, occurred in serum lipid profiles in 10 consecutive large-volume (1860 to 4744 ml) liposuction cases. In 9 of 10 cases a decrease in the fasting serum cholesterol level was found at 2 months follow-up, averaging 9.5% (p<0.02). No consistent changes occurred in high-density lipoprotein/low-density lipoprotein ratios or triglycerides. This study confirms that fat reduction by liposuction affects fasting serum cholesterol levels.

Indications and practical applications for high-profile saline breast implants.

BACKGROUND High-profile round saline breast implants that permit a better match of implant diameter to the base diameter of the breast are now available. OBJECTIVE The advantages and disadvantages of high-profile breast implants are defined from the point of view of the authors initial experience. METHODS The maximal optimal breast implant was determined on the basis of preoperative measurements, with emphasis on breast base diameter. Patients selected implant size using trial implants in a bra of the desired cup size. The implant profile with the best match to breast base diameter at the selected size range was used. RESULTS Sixty-seven patients, of a total of 164 patients who received saline breast implants during a 14-month period, received high-profile breast implants. CONCLUSIONS High-profile saline implants provide a useful option for the patient who desires an implant size that exceeds the natural breast base diameter in standard profiles. Rippling may be diminished in these cases. A more conical shape may be achieved in cases of periareolar mastopexy with augmentation. Disadvantages of the high-profile design include less mobility of the implant and a less obtuse transition from the chest to the upper breast compared with results achieved with standard round implants.

The Use of Poly-4-Hydroxybutyrate (P4HB) Scaffold in the Ptotic Breast: A Multicenter Clinical Study

Background Mastopexy and reduction mammaplasty are often limited by the patients poor native soft tissue quality, resulting in ptosis recurrence and loss of rejuvenated surgical results. Surgical scaffolds and acellular dermal matrices are used in these procedures to provide physical and mechanical stabilization of weakened or compromised tissue. GalaFLEX scaffold, made from poly-4-hydroxybutyrate (P4HB), is a next-generation product for soft tissue reinforcement that resorbs gradually while aiding tissue regeneration to achieve excellent outcomes. Objectives To assess the clinical performance of GalaFLEX scaffold in soft tissue reinforcement during elective mastopexy and reduction mammaplasty. Methods This multicenter, single-arm, observational study assessed product performance and outcomes of GalaFLEX scaffold when used in breast surgery. Outcomes included ptosis correction and maintenance, associated adverse events, patient and surgeon satisfaction, and mammographic and ultrasound imaging evaluation. Results At 6 centers in the US, 62 of 69 enrolled patients were treated. Of this population, 89.7% had successful ptosis correction and maintenance at 1 year, with high patient and surgeon satisfaction for breast shape, droop/sag of the breast, and maintenance of results at 1 year. There were 5 adverse events deemed related to the device (8.0%), including nerve pain, breast swelling, ptosis, and 2 instances of asymmetry. Conclusions GalaFLEX scaffold safely and successfully supports and elevates breast tissue in mastopexy and reduction mammaplasty, with maintained support at 1 year. Surgeon and patient satisfaction were high. No mammogram or ultrasound interference was detected. Level of Evidence 4