Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel.

BACKGROUND: In March 2012, the United States Food and Drug Administration approved Sientra's application for premarket approval of its portfolio of round and shaped silicone gel breast implants based on data from the largest silicone gel breast implant study to date. This article presents the results of Sientra's Core Study at the conclusion of 10 years. METHODS: The Sientra Core Study was a 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's breast implants in augmentation and reconstruction. A total of 1,788 patients (3,506 implants) were enrolled, including 1,116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction. RESULTS: Across all cohorts, the rate of rupture by patient was 8.6%, the rate of Baker grade III/IV capsular contracture was 13.5%, and the rate of reoperation was 31.5%. The rate of capsular contracture was statistically significantly lower for textured devices [9.0%; 95% confidence interval (CI), 7.0-11.5%] compared with smooth devices (17.5%; 95% CI, 14.9-20.4%). There were no cases of breast implant-associated anaplastic large cell lymphoma. Primary reasons for reoperations included capsular contracture (18.8%), and style/size change (19.3%), with over 50% of the reoperations due to cosmetic reasons. CONCLUSION: The 10-year results of Sientra's Core Study support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped breast implants.

Cryolipolysis for Nonsurgical Reduction of Fat in the Lateral Chest Wall Post-Mastectomy.

BACKGROUND: Many patients that have undergone mastectomy surgery are left with residual lateral fat under the arm. While the fat may be associated with pain and cause undesirable bulges in clothing and skin irritation, most post-mastectomy patients are not interested in additional surgery. OBJECTIVES: Cryolipolysis is a nonsurgical procedure for fat reduction. The procedure is typically performed for aesthetic improvement in the abdomen, thighs, and flanks, but cryolipolysis was explored in this study for reconstructive purposes. Efficacy was evaluated for nonsurgical reduction of lateral chest wall thickness post-mastectomy. METHODS: A contoured cup vacuum applicator was used to treat 31 post-mastectomy patients under the arms. All subjects had undergone mastectomy but had never received cryolipolysis or any surgical procedures to reduce lateral chest wall fat. Treatments were evaluated by independent photo review and patient surveys. RESULTS: Three blinded, independent physicians correctly identified 84% of the baseline photographs, demonstrating treatment efficacy. The surveys also found that 87% of subjects reported that cryolipolysis met their expectations; 84% noticed reduction in undesirable tissue; 85% reported better bra fit; and 74% noted that clothing fit more comfortably. Patient questionnaires reveal quality of life improvements post-treatment. While 61% of subjects reported pain in the lateral wall prior to the study, when queried post-treatment, only 13% reported pain; the remaining 87% reported no lateral wall pain. CONCLUSIONS: Results from this study indicate that cryolipolysis nonsurgically reduces unwanted fat and may reduce discomfort from residual lateral chest wall fat in post-mastectomy patients.

Risk factor analysis for capsular contracture: a 5-year Sientra study analysis using round, smooth, and textured implants for breast augmentation.

BACKGROUND: Although there are a few broadly agreed on contributory factors, the multifaceted causes of capsular contracture have remained unresolved for decades. This study investigates a variety of potential risk factors that contribute to capsular contracture in primary augmentation patients. METHODS: The data used for this analysis include 5109 implants in 2560 primary augmentation patients implanted by 34 surgeons based on 5-year results from Sientra's clinical study. Patients were evaluated at annual visits where the capsular contracture Baker grade was recorded. Potential risk factors, including patient attributes, implant attributes, surgery characteristics, pocket irrigation, and postsurgery characteristics, were analyzed using frequency and multivariate models. RESULTS: A total of 265 capsular contracture events in 179 patients were reported through 5 years. The overall Kaplan-Meier rate for capsular contracture was 7.6 percent by device. The unadjusted analysis showed increased odds of capsular contracture in smooth devices, periareolar incision, subglandular placement, antibiotic and steroid pocket irrigation, recommended massage, and surgical bra (p<0.05 for all). Results from the multivariate analysis, adjusting for all variables in the model, found six factors to be independently associated with capsular contracture (i.e., implant placement, implant surface, incision site, hematoma or seroma development, device size, and surgical bra; p<0.05 for all). CONCLUSION: This analysis has provided evidence that submuscular placement and textured implants, in addition to other factors, are significant in reducing the incidence of capsular contracture.

Cell wall integrity controls root elongation via a general 1-aminocyclopropane-1-carboxylic acid-dependent, ethylene-independent pathway.

Cell expansion in plants requires cell wall biosynthesis and rearrangement. During periods of rapid elongation, such as during the growth of etiolated hypocotyls and primary root tips, cells respond dramatically to perturbation of either of these processes. There is growing evidence that this response is initiated by a cell wall integrity-sensing mechanism and dedicated signaling pathway rather than being an inevitable consequence of lost structural integrity. However, the existence of such a pathway in root tissue and its function in a broader developmental context have remained largely unknown. Here, we show that various types of cell wall stress rapidly reduce primary root elongation in Arabidopsis (Arabidopsis thaliana). This response depended on the biosynthesis of 1-aminocyclopropane-1-carboxylic acid (ACC). In agreement with the established ethylene signaling pathway in roots, auxin signaling and superoxide production are required downstream of ACC to reduce elongation. However, this cell wall stress response unexpectedly does not depend on the perception of ethylene. We show that the short-term effect of ACC on roots is partially independent of its conversion to ethylene or ethylene signaling and that this ACC-dependent pathway is also responsible for the rapid reduction of root elongation in response to pathogen-associated molecular patterns. This acute response to internal and external stress thus represents a novel, noncanonical signaling function of ACC.

Consistency between self-report and clinician-administered versions of the Yale-Brown Obsessive-Compulsive Scale.

BACKGROUND: Preliminary efforts to demonstrate the utility of a self-rated version of the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) have been promising; however, earlier reports are based on small clinical samples. The objective of the present study was to evaluate the level of agreement between the clinician-administered Y-BOCS and a self-report version. METHODS: Participants included 86 individuals with a principal diagnosis of obsessive-compulsive disorder (OCD). All participants were given the self-report version of the Y-BOCS to complete offsite and instructed to return it at a second assessment session (within a 2-week time frame), at which time a trained and experienced clinician administered the Y-BOCS interview. RESULTS: The two versions were moderately correlated with the highest correlation observed for the Compulsions subscale. Comparison of scores for individual items revealed several inconsistencies between the two measures: level of agreement was low for resistance items, and the interview version generated higher compulsion severity ratings. CONCLUSIONS: The study provided moderate support for the convergence of the self-report and clinician-administered version of the Y-BOCS, however, important difference were detected between the two assessment methods.