Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction.

BACKGROUND: Tapencarium (RZL-012) (5-(3.6-dibromo-9H-carbazol-9-yl)-N, N, N-trimethylpentan-1-aminium chloride) is a novel injectable synthetic molecule with cytolytic properties, capable of reducing subcutaneous fat volume. OBJECTIVES: The goal of this 3-armed, randomized, double-blind, placebo-controlled phase 2b study was to determine the safety and efficacy of low- and high-dose RZL-012 vs placebo on submental fat (SMF) reduction. METHODS: Patients (n = 151, age 18-65 years) with excess SMF received a single treatment session of RZL-012 or placebo in the submental area, after which they were monitored for 84 days. SMF was assessed at baseline and after dosing with newly developed scales, namely the Clinician Chin Assessment Tool (C-CAT) and Subject Chin Assessment Tool (S-CAT). SMF was also assessed by magnetic resonance imaging (MRI) at screening and on Day 84 after treatment. RESULTS: The proportion of patients who had a 1-grade or 2-grade improvement in C-CAT and/or S-CAT on Day 84 vs baseline was significantly higher in the high-dose RZL-012 group vs the placebo group (P < .002). The relative percentage reduction in MRI-measured SMF volume (Day 84 vs screening) was significantly greater in the high-dose RZL-012 group vs the low-dose RZL-012 or the placebo group (P < .0001). Local injection site reactions were the most common adverse events (AEs). CONCLUSIONS: A single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, patients, and MRI. From a safety perspective, there were no serious AEs and no clinically significant changes in vital signs or laboratory tests over the course of the study.

Battlefield acupuncture: Opening the door for acupuncture in Department of Defense/Veteran's Administration health care.

Battlefield acupuncture is a unique auricular acupuncture procedure which is being used in a number of military medical facilities throughout the Department of Defense (DoD). It has been used with anecdotal published positive impact with warriors experiencing polytrauma, post-traumatic stress disorder, and traumatic brain injury. It has also been effectively used to treat warriors with muscle and back pain from carrying heavy combat equipment in austere environments. This article highlights the history within the DoD related to the need for nonpharmacologic/opioid pain management across the continuum of care from combat situations, during evacuation, and throughout recovery and rehabilitation. The article describes the history of auricular acupuncture and details implementation procedures. Training is necessary and partially funded through DoD and Veteran's Administration (VA) internal Joint Incentive Funds grants between the DoD and the VA for multidisciplinary teams as part of a larger initiative related to the recommendations from the DoD Army Surgeon General's Pain Management Task Force. Finally, Uniformed Services University of the Health Sciences School of Medicine and Graduate School of Nursing faculty members present how this interdisciplinary training is currently being integrated into both schools for physicians and advanced practice nurses at the Uniformed Services University of the Health Sciences. Current and future research challenges and progress related to the use of acupuncture are also presented.

Microscopy analysis of breast implant rupture caused by surgical instrument damage.

BACKGROUND: The mechanism of breast implant rupture has continued to be an important topic throughout the plastic surgery community and regulatory agencies, such as the US Food and Drug Administration. Retrieved ruptured implants returned to Allergan (Santa Barbara, CA; formerly Inamed Corporation) for analysis exhibit various modes of failure, which can include a small pinhole (approximately 1 to 2 mm in size) in the shell, a ruptured shell, or a severely fragmented shell. OBJECTIVE: The failure mechanisms and associated morphologic features for the modes of implant failure can be quite different. The objective of this study is to analyze and describe the rupture characteristics of silicone gel-filled implants that failed because of surgical instrument damage. METHODS: There are several types of diagnostic techniques available to analyze ruptured implants. Visual inspection, physical examination, and photographic analysis provided an overall description of the implant shape and gross features of the shell failure region. These techniques allowed categorization and documentation of the mode of failure and were quite useful as a supplemental tool in the diagnosis of implant failure mechanisms. Microscopy techniques provided details of the ruptured shell region and could be used to determine the cause of breast implant failure. This study involved the use of optical microscopy and scanning electron microscopy in the analysis of ruptured breast implants. RESULTS: Details of the geometry of ruptured shell regions are described. Illustrations are also presented in which 35-mm photography is used to assist in substantiating the cause of failure. Many of the ruptured regions exhibit striations across the thickness of the shell. Micrographs are presented that clearly show that the striations are due to lines in the cutting surface of the surgical instrument that were formed during the manufacturing process. CONCLUSIONS: This article demonstrates that, with the proper background and experience in analyzing ruptured breast implant shells, the features at the failure site can be correctly interpreted and the corresponding failure mechanisms can be diagnosed. Breast implants are subject to surgical instrument damage during implantation, and this damage can develop into a shell rupture, with the failure mode identifiable via microscopy analysis.