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      Keller Funnel Efficacy in “No Touch” Breast Augmentation and Reconstruction: A Systematic Review

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          Background:

          Breast augmentation is one of the most common aesthetic surgical procedures. Tissue expansion followed by permanent implants is the most frequent postmastectomy breast reconstruction method. Implant contamination remains a critical problem with these procedures‚ resulting in acute infection as well as capsular contracture. To reduce the risk of implant contamination, the “no-touch technique” utilizing the Keller funnel has been adopted by many surgeons. This systematic review aims to investigate the advantages of the Keller funnel method for breast augmentation–reconstruction.

          Methods:

          A systematic review of PubMed, Embase, the Cochrane database, and Google Scholar was performed between 2005 and 2021. All clinical-based, retrospective and prospective studies utilizing the Keller funnel method for breast implant insertion were selected.

          Results:

          Six studies were identified for evaluation: five were retrospective cohorts and one was a prospective trial. No randomized controlled trials were found. Outcomes reported included lower rates of capsular contracture (RR, 0.42; P = 0.0006; 95% CI, 0.25–0.69), shorter incision lengths (35.5 ± 2.1 mm), less insertion time (mean = 6 seconds), and decreased complications, and one paper reported ultimately greater patient satisfaction with outcomes (BREAST-Q Score: 92%).

          Conclusions:

          This review suggests that the Keller funnel is a useful method for no-touch breast augmentation and reconstruction surgery. The Keller funnel reduces subsequent capsular contracture rate, surgical time, and incision length and allows for easier insertion. However, our findings support recommendation of a prospective randomized controlled clinical trial with larger population size and follow-up intervals.

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          Most cited references67

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          The PRISMA 2020 statement: an updated guideline for reporting systematic reviews

          The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.
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            Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q.

            Measuring patient-reported outcomes has become increasingly important in cosmetic and reconstructive breast surgery. The objective of this study was to develop a new patient-reported outcome measure to assess the unique outcomes of breast surgery patients. Patient interviews, focus groups, expert panels, and a literature review were used to develop a conceptual framework and a list of questionnaire items. Three procedure-specific questionnaires (augmentation, reduction, and reconstruction) were developed and cognitive debriefing interviews used to pilot each questionnaire. Revised questionnaires were field tested with 1950 women at five centers in the United States and Canada (response rate, 72 percent); 491 patients also completed a test-retest questionnaire. Rasch measurement methods were used to construct scales, and traditional psychometric analyses, following currently recommended procedures and criteria, were performed to allow for comparison with existing measures. The conceptual framework included six domains: satisfaction with breasts, overall outcome, and process of care, and psychosocial, physical, and sexual well-being. Independent scales were constructed for these domains. This new patient-reported outcome measure "system" (the BREAST-Q) contains three modules (augmentation, reconstruction, and reduction), each with a preoperative and postoperative version. Each scale fulfilled Rasch and traditional psychometric criteria (including person separation index 0.76 to 0.95; Cronbach's alpha 0.81 to 0.96; and test-retest reproducibility 0.73 to 0.96). The BREAST-Q can be used to study the impact and effectiveness of breast surgery from the patient's perspective. By quantifying satisfaction and important aspects of health-related quality of life, the BREAST-Q has the potential to support advocacy, quality metrics, and an evidence-based approach to surgical practice.
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              Natrelle Round Silicone Breast Implants: Core Study Results at 10 Years

              Background: Allergan’s Natrelle round silicone-filled breast implants were approved by the U.S. Food and Drug Administration in 2006 based on interim results from the Core Study; final 10-year study results are now available. Methods: Seven hundred fifteen subjects were implanted with smooth and Biocell textured Natrelle round silicone implants and attended clinic visits at 0 to 4 weeks, 6 months, 1 year, and annually through 10 years. Approximately one-third of subjects underwent magnetic resonance imaging at years 1, 3, 5, 7, and 9 to assess rupture. Results: Complication rates showed modest increases over the previously published 6-year rates. The Kaplan-Meier capsular contracture rate was 18.9 percent for augmentation, 28.7 percent for revision-augmentation, and 24.6 percent for reconstruction. Among augmentation subjects, capsular contracture was significantly lower (p = 0.023) for submuscular (15.7 percent) versus subglandular (26.3 percent) placement. The overall rupture rate in the magnetic resonance imaging cohort was 13.0 percent for subjects and 7.7 percent for implants. By the end of the study, 81.8 percent of augmentation subjects still had an original implant in place. Using a five-point scale, 94.2 percent of augmentation, 83.8 percent of revision-augmentation, and 90.7 percent of reconstruction subjects reported being satisfied or definitely satisfied with their implants. Significant improvement over baseline was also seen in overall breast satisfaction and satisfaction with breast size, shape, feel, and how well they matched. Conclusion: The 10-year data from the Natrelle Core Study, which can guide surgeons and patients in decision-making, demonstrate safety and high levels of patient satisfaction. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.
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                Author and article information

                Journal
                Plast Reconstr Surg Glob Open
                Plast Reconstr Surg Glob Open
                GOX
                Plastic and Reconstructive Surgery Global Open
                Lippincott Williams & Wilkins (Hagerstown, MD )
                2169-7574
                23 November 2022
                November 2022
                : 10
                : 11
                : e4676
                Affiliations
                From the [* ]Institute for Reconstructive Surgery, Houston Methodist Hospital, Houston, Tex.
                []Department of Plastic and Reconstructive Surgery, Dicle University Hospital, Diyarbakir, Turkey
                []Division of Plastic Surgery, Department of Surgery, University of California, San Diego, San Diego, Calif.
                [§ ]Department of Plastic Surgery, Royal Free Hospital; and Division of Surgery and Interventional Science, University College London, London, United Kingdom.
                Author notes
                Chris M. Reid, MD, Division of Plastic Surgery, UC San Diego Health, 200 West Arbor Drive MC 8890, San Diego, CA 92103, E-mail: chreid@ 123456ucsd.edu
                Article
                00060
                10.1097/GOX.0000000000004676
                9699649
                36448016
                fe2eef7b-eb45-4aff-b721-c4be336eb438
                Copyright © 2022 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The American Society of Plastic Surgeons.

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

                History
                : 23 May 2022
                : 29 September 2022
                Categories
                Breast
                Original Article
                Custom metadata
                TRUE
                UNITED STATES

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